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Centrine

FDAH, Division of Wyeth

Centrine AMINOPENTAMIDEHYDROGEN SULFATEVeterinary Injection and Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

CENTRINE 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 Animal Amount to be Administered Every 8 to 12 hours
Dosage Injectable Volume Oral Tablets
10 lbs or less 0.1 mg 0.2 mL 1/2 Tab
11 lbs to 20 lbs 0.2 mg 0.4 mL 1 Tab
21 lbs to 50 lbs 0.3 mg 0.6 mL 1 1/2 Tabs
51 lbs to 100 lbs 0.4 mg 0.8 mL 2 Tabs
Over 100 lbs 0.5 mg 1.0 mL 2 1/2 Tabs

CAUTION

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

HOW 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

Centrine

aminopentamide sulfate INJECTION, SOLUTION

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:0856-2401
Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AMINOPENTAMIDE SULFATE AMINOPENTAMIDE 0.5 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0856-2401-10 10 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA043079 1970-09-05


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