Monday, 10 September 2012

Centrine





Dosage Form: FOR ANIMAL USE ONLY
Centrine®

AMINOPENTAMIDE

HYDROGEN SULFATE

Veterinary Injection and Tablets

Centrine Description


Centrine (aminopentamide hydrogen sulfate) is a potent antispasmodic agent. As a cholinergic blocking agent for smooth muscle, its action is similar to atropine.



ACTION


Centrine effectively reduces the tone and amplitude of colonic contractions to a greater degree and for a more extended period than does atropine.


Centrine effects a reduction in gastric secretion, a decrease in gastric acidity and a marked decrease in gastric motility.


The mydriatic and salivary effects of Centrine are less than those produced by atropine at similar dosage, permitting the control of vomiting and diarrhea with less distress to the animal due to dryness of the mouth and blurred vision.



INDICATIONS


Centrine is indicated in the treatment of acute abdominal visceral spasm, pylorospasm or hypertrophic gastritis and associated nausea, vomiting and/or diarrhea.



Contraindications


Centrine should not be used in animals with glaucoma because of the occurrence of mydriasis.



Warning


FOR USE IN DOGS AND CATS ONLY.



Precautions


Dryness of the mouth is the most commonly reported side effect. Blurring of vision may occur and dryness of the eyes may occur if larger (greater than therapeutic) doses are used. Centrine should be used cautiously, if at all, in pyloric obstruction because of its action in delaying gastric emptying. These effects frequently decrease with continued administration of the drug. Disturbances in urination are relatively infrequent. They vary from slightly hesitancy in initiating urination to complete inability to urinate; the latter is an indication for discontinuing the drug. After a day or two, it may be resumed at a lower dosage level.



DOSAGE


Centrine (aminopentamide hydrogen sulfate) may be administered by subcutaneous or intramuscular injection or by oral tablets according to the following schedule. If the desired effect is not obtained, the dosage may be gradually increased up to a maximum of 5 times the doses listed. When the condition has been brought under control by parenteral medication, treatment can be continued, if desired, with 0.2 mg scored tablets according to the dosage schedule.



























Weight of AnimalAmount to be Administered Every 8 to 12 hours
DosageInjectable VolumeOral Tablets
10 lbs or less0.1 mg0.2 mL1/2 Tab
11 lbs to 20 lbs0.2 mg0.4 mL1 Tab
21 lbs to 50 lbs0.3 mg0.6 mL1 1/2 Tabs
51 lbs to 100 lbs0.4 mg0.8 mL2 Tabs
Over 100 lbs0.5 mg1.0 mL2 1/2 Tabs

CAUTION


Federal law restricts this drug to use by or on the order of a licensed veterinarian.



How is Centrine Supplied


0.5 mg/mL Centrine (aminopentamide hydrogen sulfate) VETERINARY INJECTION, 10 mL vials.


0.2 mg Centrine (aminopentamide hydrogen sulfate) VETERINARY TABLETS, bottles of 100.


NDC 0856-2401-10 – 0.5 mg/mL – 10 mL vials.

NDC 0856-2400-60 – 0.2 mg – bottles of 100.



Store at controlled room temperature 15° to 30°C (59° to 86°F).



Fort Dodge Animal Health

Fort Dodge, Iowa 50501 USA


92686

Rev. September 1996

4260F


NADA 43-079, Approved by FDA

NADA 43-078, Approved by FDA



PRINCIPAL DISPLAY PANEL - 10 mL Vial Label


NDC 0856-2401-10


Centrine®

AMINOPENTAMIDE

HYDROGEN SULFATE

Veterinary Injection


FORT DODGE®


contains 0.5 mg/mL

aminopentamide hydrogen sulfate


10 mL


CAUTION: Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.


NADA 43-079, Approved by FDA










Centrine 
aminopentamide sulfate  injection, solution










Product Information
Product TypePRESCRIPTION ANIMAL DRUGNDC Product Code (Source)0856-2401
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULARDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aminopentamide sulfate (aminopentamide)aminopentamide sulfate0.5 mg  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10856-2401-1010 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA04307909/05/1970


Labeler - FDAH, Division of Wyeth (149957656)
Revised: 07/2010FDAH, Division of Wyeth



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