Interpril

Interpril may be available in the countries listed below.

Ingredient matches for Interpril

Lisinopril

Lisinopril is reported as an ingredient of Interpril in the following countries:

• Indonesia

International Drug Name Search

Poly Hist DHC Liquid

Pronunciation: FEN-il-EF-rin/pir-IL-a-meen/dye-HYE-droe-KOE-deen
Generic Name: Phenylephrine/Pyrilamine/Dihydrocodeine
Brand Name: Poly Hist DHC

Poly Hist DHC Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory tract infections, or allergies. It may also be used for other conditions as determined by your doctor.

Poly Hist DHC Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Poly Hist DHC Liquid if:

• you are allergic to any ingredient in Poly Hist DHC Liquid or to codeine


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, narrow-angle glaucoma, known or suspected bowel blockage (paralytic ileus), a stomach ulcer, or you are unable to urinate


• you have very slow or shallow breathing, severe asthma, or you are having an asthma attack


• you take droxidopa, sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Poly Hist DHC Liquid:

Some medical conditions may interact with Poly Hist DHC Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other narcotic pain medicines (eg, morphine)


• if you have a history of adrenal gland problems (eg, Addison disease, an adrenal gland tumor), heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, liver or kidney problems, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, slow or shallow breathing, curvature of the spine (scoliosis), or thyroid problems


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), other lung or breathing problems (eg, chronic bronchitis, emphysema, slow or irregular breathing), chronic cough, or breathing problems when you sleep (eg, sleep apnea), or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, a recent head or brain injury, growths in the brain (eg, tumor, lesions), increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have a history of constipation, stomach or bowel problems (eg, chronic inflammation, ulceration of the bowel, or diarrhea due to antibiotic use); gallbladder problems (eg, gallstones); pancreatitis; a blockage of your stomach, bladder, or bowel; trouble urinating; an enlarged prostate or other prostate problems; or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol or drug abuse, mental or mood problems (eg, depression), suicidal thoughts or behavior, you are in alcohol withdrawal, or if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Poly Hist DHC Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased


• Furazolidone, linezolid, or MAOIs (eg, phenelzine) because severe high blood pressure and fever may occur


• Anticholinergics (eg, scopolamine), barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, HIV protease inhibitors (eg, ritonavir), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Poly Hist DHC Liquid's side effects


• Quinidine or rifamycins (eg, rifampin) because they may decrease Poly Hist DHC Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Poly Hist DHC Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Poly Hist DHC Liquid


• Naltrexone because it may decrease Poly Hist DHC Liquid's effectiveness. Withdrawal symptoms may also occur in patients who are physically dependent on opioids. Do not take naltrexone until you have stopped taking Poly Hist DHC Liquid for 7 to 10 days and you have had a negative naloxone challenge test

This may not be a complete list of all interactions that may occur. Ask your health care provider if Poly Hist DHC Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Poly Hist DHC Liquid:

Use Poly Hist DHC Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Poly Hist DHC Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Poly Hist DHC Liquid with a full glass of water (8 oz/240 mL).


• Drink plenty of water while taking Poly Hist DHC Liquid.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Poly Hist DHC Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Poly Hist DHC Liquid.

Important safety information:

• Poly Hist DHC Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Poly Hist DHC Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Poly Hist DHC Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Poly Hist DHC Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not take diet or appetite control medicines while you take Poly Hist DHC Liquid without checking with your doctor.


• Poly Hist DHC Liquid has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Poly Hist DHC Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.


• Poly Hist DHC Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Poly Hist DHC Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Poly Hist DHC Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Poly Hist DHC Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Poly Hist DHC Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Poly Hist DHC Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, slow or shallow breathing, and trouble urinating.


• Caution is advised when using Poly Hist DHC Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Poly Hist DHC Liquid should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. They may be at greater risk of severe and possibly fatal breathing problems.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Poly Hist DHC Liquid while you are pregnant. Some ingredients of Poly Hist DHC Liquid may be found in breast milk. Do not breast-feed while taking Poly Hist DHC Liquid.

When used for long periods of time or at high doses, Poly Hist DHC Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Poly Hist DHC Liquid stops working well. Do not take more than prescribed.

Some people who use Poly Hist DHC Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Poly Hist DHC Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Poly Hist DHC Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; lightheadedness; loss of appetite; nausea; nervousness or anxiety; sweating; trouble sleeping; upset stomach or mild stomach pain; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); persistent trouble sleeping; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain; slow or shallow breathing; tremor; trouble urinating or inability to urinate; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Poly Hist DHC side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; cold and clammy skin; coma; confusion; hallucinations; limp muscles; seizures; severe dizziness, drowsiness, lightheadedness, or headache; slow or shallow breathing; small pupils; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Poly Hist DHC Liquid:

Store Poly Hist DHC Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Poly Hist DHC Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Poly Hist DHC Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Poly Hist DHC Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Poly Hist DHC Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Poly Hist DHC resources

• Poly Hist DHC Side Effects (in more detail)
• Poly Hist DHC Use in Pregnancy & Breastfeeding
• Poly Hist DHC Drug Interactions
• 0 Reviews · Be the first to review/rate this drug

Reye's Syndrome Medications

There are currently no drugs listed for "Reye's Syndrome".

Definition of Reye's Syndrome: A sudden, sometimes fatal, disease of the brain (encephalopathy) with degeneration of the liver, occurs in children (most cases 4-12 years of age), comes after the chickenpox (varicella) or an influenza-type illness, is also associated with taking medications containing aspirin. The child with reye's syndrome first tends to be unusually quiet, lethargic (stuporous), sleepy, and vomiting. In the second stage, the lethargy deepens, the child is confused, combative and delirious. And things get worse from there with decreasing consciousness, coma, seizures, and eventually death. The prognosis (outlook) depends on early diagnosis and control of the increased intracranial pressure. Reye's syndrome is a good reason to have your child immunised against chickenpox and not give the child aspirin for fever.

Learn more about Reye's Syndrome

Micromedex Care Notes:

• Reye's Syndrome

Medical Encyclopedia:

• Reye syndrome

Drug List:

Gel-Kam Dental Therapy Pak

Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N

What is Gel-Kam Dental Therapy Pak (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

Fluoride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Gel-Kam Dental Therapy Pak (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I discuss with my healthcare provider before using Gel-Kam Dental Therapy Pak (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.

If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.

Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use Gel-Kam Dental Therapy Pak (fluoride topical)?

Use this medication exactly as directed on the label, or as it was prescribed by your dentist or doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.

Swish this medication in your mouth without swallowing. Then spit it out.

Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I avoid while using Gel-Kam Dental Therapy Pak (fluoride topical)?

Do not swallow fluoride topical. Spit it out after use.

Gel-Kam Dental Therapy Pak (fluoride topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of the following side effects:

• 
  

  discolored teeth;

  
  


• 
  

  weakened tooth enamel; or

  
  


• 
  

  any changes in the appearance of your teeth.

  
  

Less serious side effects may include:

• 
  

  stomach upset;

  
  


• 
  

  headache; or

  
  


• 
  

  weakness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gel-Kam Dental Therapy Pak (fluoride topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Gel-Kam Dental Therapy Pak resources

• Gel-Kam Dental Therapy Pak Side Effects (in more detail)
• Gel-Kam Dental Therapy Pak Use in Pregnancy & Breastfeeding
• 0 Reviews for Gel-Kam Therapy Pak - Add your own review/rating

• APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information


• EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer)


• Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer)


• Prevident 5000 Booster Prescribing Information (FDA)


• Prevident 5000 Dry Mouth Prescribing Information (FDA)


• Prevident 5000 Enamel Protect Prescribing Information (FDA)


• Prevident 5000 Sensitive Prescribing Information (FDA)

Compare Gel-Kam Dental Therapy Pak with other medications

• Prevention of Dental Caries

Where can I get more information?

• Your pharmacist can provide more information about fluoride topical.

See also: Gel-Kam Therapy Pak side effects (in more detail)

folic acid Oral, Injection

FOE-lik AS-id

Commonly used brand name(s)

In the U.S.

• FA-8


• Folacin-800


• Nature's Blend Folic Acid


• ViloFane-Dp 7.5

Available Dosage Forms:

• Tablet


• Injectable


• Solution


• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For folic acid

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Folic acid (vitamin B 9) is necessary for strong blood.

Lack of folic acid may lead to anemia (weak blood). Your health care professional may treat this by prescribing folic acid for you.

Some conditions may increase your need for folic acid. These include:

• Alcoholism


• Anemia, hemolytic


• Diarrhea (continuing)


• Fever (prolonged)


• Hemodialysis


• Illness (prolonged)


• Intestinal diseases


• Liver disease


• Stress (continuing)


• Surgical removal of stomach

In addition, infants smaller than normal, breast-fed infants, or those receiving unfortified formulas (such as evaporated milk or goat's milk) may need additional folic acid.

Increased need for folic acid should be determined by your health care professional.

Some studies have found that folic acid taken by women before they become pregnant and during early pregnancy may reduce the chances of certain birth defects (neural tube defects).

Claims that folic acid and other B vitamins are effective for preventing mental problems have not been proven. Many of these treatments involve large and expensive amounts of vitamins.

Injectable folic acid is given by or under the direction of your health care professional. Another form of folic acid is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Folic acid is found in various foods, including vegetables, especially green vegetables; potatoes; cereal and cereal products; fruits; and organ meats (for example, liver or kidney). It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, heat may reduce the amount of folic acid in foods.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of folic acid needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in micrograms (mcg) for folic acid are generally defined as follows:

Persons	U.S. (mcg)	Canada (mcg)
Infants and children Birth to 3 years of age	25–100	50–80
4 to 6 years of age	75–400	90
7 to 10 years of age	100–400	125–180
Adolescent and adult males	150–400	150–220
Adolescent and adult females	150–400	145–190
Pregnant females	400–800	445–475
Breast-feeding females	260–800	245–275

Before Using folic acid

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to folic acid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Phenytoin


• Tea

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Pernicious anemia (a type of blood problem)—Taking folic acid while you have pernicious anemia may cause serious side effects. You should be sure that you do not have pernicious anemia before beginning folic acid supplementation

Proper Use of folic acid

Dosing

The dose of folic acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of folic acid. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    
    
    • Adult and teenage males—150 to 400 micrograms (mcg) per day.
    
    
    • Adult and teenage females—150 to 400 mcg per day.
    
    
    • Pregnant females—400 to 800 mcg per day.
    
    
    • Breast-feeding females—260 to 800 mcg per day.
    
    
    • Children 7 to 10 years of age—100 to 400 mcg per day.
    
    
    • Children 4 to 6 years of age—75 to 400 mcg per day.
    
    
    • Children birth to 3 years of age—25 to 100 mcg per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—150 to 220 mcg per day.
    
    
    • Adult and teenage females—145 to 190 mcg per day.
    
    
    • Pregnant females—445 to 475 mcg per day.
    
    
    • Breast-feeding females—245 to 275 mcg per day.
    
    
    • Children 7 to 10 years of age—125 to 180 mcg per day.
    
    
    • Children 4 to 6 years of age—90 mcg per day.
    
    
    • Children birth to 3 years of age—50 to 80 mcg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

Missed Dose

If you miss a dose of folic acid, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

folic acid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Fever


• general weakness or discomfort


• reddened skin


• shortness of breath


• skin rash or itching


• tightness in chest


• troubled breathing


• wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: folic acid Oral, Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More folic acid Oral, Injection resources

• Folic acid Oral, Injection Side Effects (in more detail)
• Folic acid Oral, Injection Use in Pregnancy & Breastfeeding
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Wellbutrin Tablets

Generic Name: bupropion hydrochloride

Dosage Form: tablet, film coated
WELLBUTRIN®

(bupropion hydrochloride)

Tablets

Warning

Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of WELLBUTRIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. WELLBUTRIN is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Use in Smoking Cessation Treatment: WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL® are not approved for smoking cessation treatment, but bupropion under the name ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.

All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN in the postmarketing experience. When symptoms were reported, most were during treatment with ZYBAN, but some were following discontinuation of treatment with ZYBAN. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of ZYBAN.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. (See WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS: Information for Patients.)

Wellbutrin Tablets Description

WELLBUTRIN (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The empirical formula is C13H18ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:

WELLBUTRIN is supplied for oral administration as 75-mg (yellow-gold) and 100-mg (red) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: 75-mg tablet − D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide; 100-mg tablet − FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Wellbutrin Tablets - Clinical Pharmacology

Pharmacodynamics

The neurochemical mechanism of the antidepressant effect of bupropion is not known. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine, and does not inhibit monoamine oxidase or the re-uptake of serotonin.

Bupropion produces dose-related central nervous system (CNS) stimulant effects in animals, as evidenced by increased locomotor activity, increased rates of responding in various schedule-controlled operant behavior tasks, and, at high doses, induction of mild stereotyped behavior.

Bupropion causes convulsions in rodents and dogs at doses approximately tenfold the dose recommended as the human antidepressant dose.

Pharmacokinetics

Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. In humans, following oral administration of WELLBUTRIN, peak plasma bupropion concentrations are usually achieved within 2 hours, followed by a biphasic decline. The terminal phase has a mean half-life of 14 hours, with a range of 8 to 24 hours. The distribution phase has a mean half-life of 3 to 4 hours. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days. Plasma bupropion concentrations are dose-proportional following single doses of 100 to 250 mg; however, it is not known if the proportionality between dose and plasma level is maintained in chronic use.

Absorption:The absolute bioavailability of WELLBUTRIN in humans has not been determined because an intravenous formulation for human use is not available. However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact.

Distribution: In vitro tests show that bupropion is 84% bound to human plasma protein at concentrations up to 200 mcg/mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion, whereas the extent of protein binding of the threohydrobupropion metabolite is about half that seen with bupropion.

Metabolism: Bupropion is extensively metabolized in humans. Three metabolites have been shown to be active: hydroxybupropion, which is formed via hydroxylation of the tert-butyl group of bupropion, and the amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that cytochrome P450IIB6 (CYP2B6) is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 isoenzymes are not involved in the formation of threohydrobupropion. Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one-half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion. This may be of clinical importance because their plasma concentrations are as high or higher than those of bupropion.

Because bupropion is extensively metabolized, there is the potential for drug-drug interactions, particularly with those agents that are metabolized by or which inhibit/induce the cytochrome P450IIB6 (CYP2B6) isoenzyme, such as ritonavir or efavirenz. In a healthy volunteer study, ritonavir at a dose of 100 mg twice daily reduced the AUC and Cmax of bupropion by 22% and 21%, respectively. The exposure of the hydroxybupropion metabolite was decreased by 23%, the threohydrobupropion decreased by 38%, and the erythrohydrobupropion decreased by 48%.

In a second healthy volunteer study, ritonavir at a dose of 600 mg twice daily decreased the AUC and the Cmax of bupropion by 66% and 62%, respectively. The exposure of the hydroxybupropion metabolite was decreased by 78%, the threohydrobupropion decreased by 50%, and the erythrohydrobupropion decreased by 68%.

In another healthy volunteer study, KALETRA® (lopinavir 400 mg/ritonavir 100 mg twice daily) decreased bupropion AUC and Cmax by 57%. The AUC and Cmax of hydroxybupropion were decreased by 50% and 31%, respectively (see PRECAUTIONS: Drug Interactions).

In a study in healthy volunteers, efavirenz 600 mg once daily for 2 weeks reduced the AUC and Cmax of bupropion by approximately 55% and 34%, respectively. The AUC of hydroxybupropion was unchanged, whereas Cmax of hydroxybupropion was increased by 50%.

Although bupropion is not metabolized by cytochrome P450IID6 (CYP2D6), there is the potential for drug-drug interactions when bupropion is coadministered with drugs metabolized by this isoenzyme (see PRECAUTIONS: Drug Interactions).

Following a single dose in humans, peak plasma concentrations of hydroxybupropion occur approximately 3 hours after administration of WELLBUTRIN. Peak plasma concentrations of hydroxybupropion are approximately 10 times the peak level of the parent drug at steady state. The elimination half-life of hydroxybupropion is approximately 20 (±5) hours and its AUC at steady state is about 17 times that of bupropion. The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of the hydroxybupropion metabolite. However, their elimination half-lives are longer, 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs are 1.5 and 7 times that of bupropion, respectively.

Bupropion and its metabolites exhibit linear kinetics following chronic administration of 300 to 450 mg/day.

Elimination: Following oral administration of 200 mg of 14C-bupropion in humans, 87% and 10% of the radioactive dose were recovered in the urine and feces, respectively. However, the fraction of the oral dose of WELLBUTRIN excreted unchanged was only 0.5%, a finding consistent with the extensive metabolism of bupropion.

Populations Subgroups: Factors or conditions altering metabolic capacity (e.g., liver disease, congestive heart failure [CHF], age, concomitant medications, etc.) or elimination may be expected to influence the degree and extent of accumulation of the active metabolites of bupropion. The elimination of the major metabolites of bupropion may be affected by reduced renal or hepatic function because they are moderately polar compounds and are likely to undergo further metabolism or conjugation in the liver prior to urinary excretion.

Hepatic: The effect of hepatic impairment on the pharmacokinetics of bupropion was characterized in 2 single-dose studies, one in patients with alcoholic liver disease and one in patients with mild-to-severe cirrhosis. The first study showed that the half-life of hydroxybupropion was significantly longer in 8 patients with alcoholic liver disease than in 8 healthy volunteers (32 ± 14 hours versus 21 ± 5 hours, respectively). Although not statistically significant, the AUCs for bupropion and hydroxybupropion were more variable and tended to be greater (by 53% to 57%) in volunteers with alcoholic liver disease. The differences in half-life for bupropion and the other metabolites in the 2 patient groups were minimal.

The second study showed that there were no statistically significant differences in the pharmacokinetics of bupropion and its active metabolites in 9 patients with mild-to-moderate hepatic cirrhosis compared to 8 healthy volunteers. However, more variability was observed in some of the pharmacokinetic parameters for bupropion (AUC, Cmax, and Tmax) and its active metabolites (t½) in patients with mild-to-moderate hepatic cirrhosis. In addition, in patients with severe hepatic cirrhosis, the bupropion Cmax and AUC were substantially increased (mean difference: by approximately 70% and 3-fold, respectively) and more variable when compared to values in healthy volunteers; the mean bupropion half-life was also longer (29 hours in patients with severe hepatic cirrhosis vs. 19 hours in healthy subjects). For the metabolite hydroxybupropion, the mean Cmax was approximately 69% lower. For the combined amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, the mean Cmax was approximately 31% lower. The mean AUC increased by about 1½-fold for hydroxybupropion and about 2½-fold for threo/erythrohydrobupropion. The median Tmax was observed 19 hours later for hydroxybupropion and 31 hours later for threo/erythrohydrobupropion. The mean half-lives for hydroxybupropion and threo/erythrohydrobupropion were increased 5- and 2-fold, respectively, in patients with severe hepatic cirrhosis compared to healthy volunteers (see WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

Renal: There is limited information on the pharmacokinetics of bupropion in patients with renal impairment. An inter-study comparison between normal subjects and patients with end-stage renal failure demonstrated that the parent drug Cmax and AUC values were comparable in the 2 groups, whereas the hydroxybupropion and threohydrobupropion metabolites had a 2.3– and 2.8–fold increase, respectively, in AUC for patients with end-stage renal failure. A second study, comparing normal subjects and patients with moderate-to-severe renal impairment (GFR 30.9 ± 10.8 mL/min) showed that exposure to a single 150-mg dose of sustained-release bupropion was approximately 2-fold higher in patients with impaired renal function while levels of the hydroxybupropion and threo/erythrohydrobupropion (combined) metabolites were similar in the 2 groups. The elimination of bupropion and/or the major metabolites of bupropion may be reduced by impaired renal function (see PRECAUTIONS: Renal Impairment).

During a chronic dosing study in 14 depressed patients with left ventricular dysfunction (history of CHF or an enlarged heart on x-ray), no apparent effect on the pharmacokinetics of bupropion or its metabolites was revealed, compared to healthy volunteers.

Left Ventricular Dysfunction: The effects of age on the pharmacokinetics of bupropion and its metabolites have not been fully characterized, but an exploration of steady-state bupropion concentrations from several depression efficacy studies involving patients dosed in a range of 300 to 750 mg/day, on a 3 times daily schedule, revealed no relationship between age (18 to 83 years) and plasma concentration of bupropion. A single-dose pharmacokinetic study demonstrated that the disposition of bupropion and its metabolites in elderly subjects was similar to that of younger subjects. These data suggest there is no prominent effect of age on bupropion concentration; however, another pharmacokinetic study, single and multiple dose, has suggested that the elderly are at increased risk for accumulation of bupropion and its metabolites (see PRECAUTIONS: Geriatric Use).

Gender:A single-dose study involving 12 healthy male and 12 healthy female volunteers revealed no sex-related differences in the pharmacokinetic parameters of bupropion.

Smokers: The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers. Following oral administration of a single 150-mg dose of bupropion, there were no statistically significant differences in Cmax, half-life, Tmax, AUC or clearance of bupropion or its active metabolites between smokers and nonsmokers.

Indications and Usage for Wellbutrin Tablets

WELLBUTRIN is indicated for the treatment of major depressive disorder. A physician considering WELLBUTRIN for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS).

The efficacy of WELLBUTRIN has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III.

Major Depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

Effectiveness of WELLBUTRIN in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use WELLBUTRIN for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Contraindications

WELLBUTRIN is contraindicated in patients with a seizure disorder.

WELLBUTRIN is contraindicated in patients treated with ZYBAN® (bupropion hydrochloride) Sustained-Release Tablets; WELLBUTRIN SR® (bupropion hydrochloride), the sustained-release formulation; WELLBUTRIN XL® (bupropion hydrochloride), the extended-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent.

WELLBUTRIN is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in such patients treated with WELLBUTRIN.

WELLBUTRIN is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of WELLBUTRIN and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with WELLBUTRIN.

WELLBUTRIN is contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up WELLBUTRIN.

Warnings

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.

Table 1

Age Range	Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated
Increases Compared to Placebo
<18	14 additional cases
18-24	5 additional cases
Decreases Compared to Placebo
25-64	1 fewer case
≥65	6 fewer cases

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for WELLBUTRIN should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment: WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL are not approved for smoking cessation treatment, but bupropion under the name ZYBAN is approved for this use. Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation (see BOXED WARNING, ADVERSE REACTIONS). These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke. When symptoms were reported, most were during bupropion treatment, but some were following discontinuation of bupropion therapy.

These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. All patients being treated with bupropion as part of smoking cessation treatment should be observed for neuropsychiatric symptoms or worsening of pre-existing psychiatric illness.

Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial.

Screening Patients for Bipolar Disorder

 A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that WELLBUTRIN is not approved for use in treating bipolar depression.

Bupropion-Containing Products

Patients should be made aware that WELLBUTRIN contains the same active ingredient found in ZYBAN, used as an aid to smoking cessation treatment, and that WELLBUTRIN should not be used in combination with ZYBAN, or any other medications that contain bupropion, such as WELLBUTRIN SR (bupropion hydrochloride), the sustained-release formulation or WELLBUTRIN XL (bupropion hydrochloride), the extended-release formulation.

Seizures

Bupropion is associated with seizures in approximately 0.4% (4/1,000) of patients treated at doses up to 450 mg/day. This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted. The estimated seizure incidence for WELLBUTRIN increases almost tenfold between 450 and 600 mg/day, which is twice the usually required daily dose (300 mg) and one and one-third the maximum recommended daily dose (450 mg). Given the wide variability among individuals and their capacity to metabolize and eliminate drugs this disproportionate increase in seizure incidence with dose incrementation calls for caution in dosing.

During the initial development, 25 among approximately 2,400 patients treated with WELLBUTRIN experienced seizures. At the time of seizure, 7 patients were receiving daily doses of 450 mg or below for an incidence of 0.33% (3/1,000) within the recommended dose range. Twelve patients experienced seizures at 600 mg/day (2.3% incidence); 6 additional patients had seizures at daily doses between 600 and 900 mg (2.8% incidence).

A separate, prospective study was conducted to determine the incidence of seizure during an 8-week treatment exposure in approximately 3,200 additional patients who received daily doses of up to 450 mg. Patients were permitted to continue treatment beyond 8 weeks if clinically indicated. Eight seizures occurred during the initial 8-week treatment period and 5 seizures were reported in patients continuing treatment beyond 8 weeks, resulting in a total seizure incidence of 0.4%.

The risk of seizure appears to be strongly associated with dose. Sudden and large increments in dose may contribute to increased risk. While many seizures occurred early in the course of treatment, some seizures did occur after several weeks at fixed dose. WELLBUTRIN should be discontinued and not restarted in patients who experience a seizure while on treatment.

The risk of seizure is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with WELLBUTRIN.

• Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.


• Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.


• Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.

 Recommendations for Reducing the Risk of Seizure: Retrospective analysis of clinical experience gained during the development of WELLBUTRIN suggests that the risk of seizure may be minimized if

• the total daily dose of WELLBUTRIN does not exceed 450 mg,


• the daily dose is administered 3 times daily, with each single dose not to exceed 150 mg to avoid high peak concentrations of bupropion and/or its metabolites, and


• the rate of incrementation of dose is very gradual.

WELLBUTRIN should be administered with extreme caution to patients with a history of seizure, cranial trauma, or other predisposition(s) toward seizure, or patients treated with other agents (e.g., antipsychotics, other antidepressants, theophylline, systemic steroids, etc.) that lower seizure threshold.

Hepatic Impairment

WELLBUTRIN should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced dose and/or frequency is required, as peak bupropion, as well as AUC, levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 75 mg once a day in these patients (see CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

Potential for Hepatotoxicity

In rats receiving large doses of bupropion chronically, there was an increase in incidence of hepatic hyperplastic nodules and hepatocellular hypertrophy. In dogs receiving large doses of bupropion chronically, various histologic changes were seen in the liver, and laboratory tests suggesting mild hepatocellular injury were noted.

Precautions

 General: Agitation and Insomnia: A substantial proportion of patients treated with WELLBUTRIN experience some degree of increased restlessness, agitation, anxiety, and insomnia, especially shortly after initiation of treatment. In clinical studies, these symptoms were sometimes of sufficient magnitude to require treatment with sedative/hypnotic drugs. In approximately 2% of patients, symptoms were sufficiently severe to require discontinuation of treatment with WELLBUTRIN.

Psychosis, Confusion, and Other Neuropsychiatric Phenomena: Depressed patients treated with WELLBUTRIN have been reported to show a variety of neuropsychiatric signs and symptoms including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Because of the uncontrolled nature of many studies, it is impossible to provide a precise estimate of the extent of risk imposed by treatment with WELLBUTRIN. In several cases, neuropsychiatric phenomena abated upon dose reduction and/or withdrawal of treatment.

Activation of Psychosis and/or Mania: Antidepressants can precipitate manic episodes in bipolar disorder patients during the depressed phase of their illness and may activate latent psychosis in other susceptible patients. WELLBUTRIN is expected to pose similar risks.

Altered Appetite and Weight: A weight loss of greater than 5 lbs occurred in 28% of patients receiving WELLBUTRIN. This incidence is approximately double that seen in comparable patients treated with tricyclics or placebo. Furthermore, while 35% of patients receiving tricyclic antidepressants gained weight, only 9.4% of patients treated with WELLBUTRIN did. Consequently, if weight loss is a major presenting sign of a patient’s depressive illness, the anorectic and/or weight reducing potential of WELLBUTRIN should be considered.

Allergic Reactions: Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment have been reported in clinical trials with bupropion. In addition, there have been rare spontaneous postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion. A patient should stop taking WELLBUTRIN and consult a doctor if experiencing allergic or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) during treatment.

Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity have been reported in association with bupropion. These symptoms may resemble serum sickness.

Cardiovascular Effects: In clinical practice, hypertension, in some cases severe, requiring acute treatment, has been reported in patients receiving bupropion alone and in combination with nicotine replacement therapy. These events have been observed in both patients with and without evidence of preexisting hypertension.

Data from a comparative study of the sustained-release formulation of bupropion (ZYBAN® Sustained-Release Tablets), nicotine transdermal system (NTS), the combination of sustained-release bupropion plus NTS, and placebo as an aid to smoking cessation suggest a higher incidence of treatment-emergent hypertension in patients treated with the combination of sustained-release bupropion and NTS. In this study, 6.1% of patients treated with the combination of sustained-release bupropion and NTS had treatment-emergent hypertension compared to 2.5%, 1.6%, and 3.1% of patients treated with sustained-release bupropion, NTS, and placebo, respectively. The majority of these patients had evidence of preexisting hypertension. Three patients (1.2%) treated with the combination of ZYBAN and NTS and 1 patient (0.4%) treated with NTS had study medication discontinued due to hypertension compared to none of the patients treated with ZYBAN or placebo. Monitoring of blood pressure is recommended in patients who receive the combination of bupropion and nicotine replacement.

There is no clinical experience establishing the safety of WELLBUTRIN in patients with a recent history of myocardial infarction or unstable heart disease. Therefore, care should be exercised if it is used in these groups. Bupropion was well tolerated in depressed patients who had previously developed orthostatic hypotension while receiving tricyclic antidepressants and was also generally well tolerated in a group of 36 depressed inpatients with stable congestive heart failure (CHF). However, bupropion was associated with a rise in supine blood pressure in the study of patients with CHF, resulting in discontinuation of treatment in 2 patients for exacerbation of baseline hypertension.

Hepatic Impairment: WELLBUTRIN should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients, a reduced dose and frequency is required. WELLBUTRIN should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis.

All patients with hepatic impairment should be closely monitored for possible adverse effects that could indicate high drug and metabolite levels (see CLINICAL PHARMACOLOGY, WARNINGS, and DOSAGE AND ADMINISTRATION).

Renal Impairment: There is limited information on the pharmacokinetics of bupropion in patients with renal impairment. An inter-study comparison between normal subjects and patients with end-stage renal failure demonstrated that the parent drug Cmax and AUC values were comparable in the 2 groups, whereas the hydroxybupropion and threohydrobupropion metabolites had a 2.3– and 2.8–fold increase, respectively, in AUC for patients with end-stage renal failure. A second study, comparing normal subjects and patients with moderate-to-severe renal impairment (GFR 30.9 ± 10.8 mL/min) showed that exposure to a single 150-mg dose of sustained-release bupropion was approximately 2-fold higher in patients with impaired renal function while levels of the hydroxybupropion and threo/erythrohydrobupropion (combined) metabolites were similar in the 2 groups. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and subsequently excreted by the kidneys. WELLBUTRIN should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered as bupropion and the metabolites of bupropion may accumulate in such patients to a greater extent than usual. The patient should be closely monitored for possible adverse effects that could indicate high drug or metabolite levels.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with WELLBUTRIN and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions,” “Quitting Smoking, Quit-Smoking Medication, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions,”and “What Other Important Information Should I Know About WELLBUTRIN?” is available for WELLBUTRIN. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking WELLBUTRIN.

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment: Although WELLBUTRIN is not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN which is approved for this use. Patients should be informed that quitting smoking, with or without ZYBAN, may be associated with nicotine withdrawal symptoms (including depression or agitation), or exacerbation of pre-existing psychiatric illness. Furthermore, some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide when attempting to quit smoking while taking ZYBAN. If patients develop agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for them, or if patients develop suicidal ideation or behavior, they should be urged to report these symptoms to their healthcare provider immediately.

Bupropion-Containing Products: Patients should be made aware that WELLBUTRIN contains the same active ingredient found in ZYBAN, used as an aid to smoking cessation, and that WELLBUTRIN should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as WELLBUTRIN SR, the sustained-release formulation and WELLBUTRIN XL, the extended-release formulation).

Patients should be instructed to take WELLBUTRIN in equally divided doses 3 or 4 times a day to minimize the risk of seizure.

Patients should be told that WELLBUTRIN should be discontinued and not restarted if they experience a seizure while on treatment.

Patients should be told that any CNS-active drug like WELLBUTRIN may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Consequently, until they are reasonably certain that WELLBUTRIN does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery.

Patients should be told that the excessive use or abrupt discontinuation of alcohol or sedatives (including benzodiazepines) may alter the seizure threshold. Some patients have reported lower alcohol tolerance during treatment with WELLBUTRIN. Patients should be advised that the consumption of alcohol should be minimized or avoided.

Patients should be advised to inform their physicians if they are taking or plan to take any prescription or over-the-counter drugs. Concern is warranted because WELLBUTRIN and other drugs may affect each other’s metabolism.

Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy.

Laboratory Tests

There are no specific laboratory tests recommended.

Drug Interactions

Because bupropion is extensively metabolized, the coadministration of other drugs may affect its clinical activity. In vitro studies indicate that bupropion is primarily metabolized to hydroxybupropion by the CYP2B6 isoenzyme. Therefore, the potential exists for a drug interaction between WELLBUTRIN and drugs that are substrates of or inhibitors/inducers of the CYP2B6 isoenzyme (e.g., orphenadrine, thiotepa, cyclophosphamide, ticlopidine, and clopidogrel). In addition, in vitro studies suggest that paroxetine, sertraline, norfluoxetine, and fluvoxamine as well as ne

FML Forte Liquifilm

Generic Name: fluorometholone ophthalmic (FLURE oh METH oh lone)

Brand Names: Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.

What is FML Forte Liquifilm (fluorometholone ophthalmic)?

Fluorometholone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Fluorometholone ophthalmic (for the eyes) is used to treat eye swelling caused by infections, injury, surgery, or other conditions.

Fluorometholone ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about FML Forte Liquifilm (fluorometholone ophthalmic)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of viral or fungal eye infection, ocular herpes, tuberculosis, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, if you have herpes, or if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

Do not use fluorometholone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in. Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not stop using fluorometholone suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

What should I tell my healthcare provider before using FML Forte Liquifilm (fluorometholone ophthalmic)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of infection, especially:

• 
  

  a fungal eye infection;

  
  


• 
  

  any type of viral eye infection, such as ocular herpes;

  
  


• 
  

  tuberculosis; or

  
  


• 
  

  an untreated infection in your eye or elsewhere, including chickenpox.

  
  

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use fluorometholone.

FDA pregnancy category C. Fluorometholone ophthalmic may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fluorometholone ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use FML Forte Liquifilm (fluorometholone ophthalmic)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using your eye drops or ointment.

To apply the eye drops:

• Shake the bottle gently before each use to be sure the medicine is well mixed.


• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

To apply the ointment:

• 
  

  You may warm the ointment by holding the medicine tube in your hand for a few minutes before use. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

  
  

Do not stop using fluorometholone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

To be sure this medication is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

Store fluorometholone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube tightly capped. Do not allow this medicine to freeze.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of fluorometholone ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using FML Forte Liquifilm (fluorometholone ophthalmic)?

Do not wear any contact lens that has not been approved by your doctor.

Do not use fluorometholone ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Fluorometholone can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

FML Forte Liquifilm (fluorometholone ophthalmic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  pain behind your eyes, sudden vision changes, severe headache;

  
  


• 
  

  sudden eye irritation;

  
  


• 
  

  blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  
  


• 
  

  signs of new eye infection, such as swelling, draining, or crusting of your eyes.

  
  

Less serious side effects may include:

• 
  

  increased sensitivity to light; or

  
  


• 
  

  mild stinging, burning, itching, or irritation in your eyes.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect FML Forte Liquifilm (fluorometholone ophthalmic)?

Before using fluorometholone, tell your doctor if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

This list is not complete and there may be other drugs that can interact with fluorometholone ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More FML Forte Liquifilm resources

• FML Forte Liquifilm Side Effects (in more detail)
• FML Forte Liquifilm Use in Pregnancy & Breastfeeding
• FML Forte Liquifilm Drug Interactions
• FML Forte Liquifilm Support Group
• 1 Review for FML Forte Liquifilm - Add your own review/rating

• Flarex Prescribing Information (FDA)


• Flarex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluor-Op Prescribing Information (FDA)


• Fluor-Op MedFacts Consumer Leaflet (Wolters Kluwer)

Compare FML Forte Liquifilm with other medications

• Eye Dryness/Redness
• Eye Redness/Itching
• Eyelash Hypotrichosis

Where can I get more information?

• Your pharmacist can provide more information about fluorometholone ophthalmic.

See also: FML Forte Liquifilm side effects (in more detail)