CIMETIDINE- cimetidine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

CIMETIDINE

Composition:

CIMETIDINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cimetidine tablets USP are indicated in: Cimetidine is contraindicated for patients known to have hypersensitivity to the product.

Product summary:

Cimetidine tablets USP, 400 mg are dark-green, oval-shaped, film-coated tablets, debossed with N vertical bisect 204 on one side and partial bisect 400 on the reverse. They are supplied as follows: Bottle of 30 - 68788-9064-3 Bottle of 60 - 68788-9064-6 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Canada By: TEVA CANADA LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. E 10/2015 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
CIMETIDINE TABLETS USP
8192
8204
8305
RX ONLY
DESCRIPTION
Cimetidine is a histamine H -receptor antagonist. Chemically it is
_N”_-cyano-_N_-methyl-_N’_-[2-[[(5-
methyl-1_H_-imidazol-4-yl)methyl]thio]-ethyl], guanidine.
The molecular formula for cimetidine is C
H N S; and the molecular weight is 252.35. The
structural formula for cimetidine is:
Cimetidine contains an imidazole ring, and is chemically related to
histamine. Cimetidine has a bitter
taste and characteristic odor.
SOLUBILITY CHARACTERISTICS
Cimetidine is soluble in alcohol, slightly soluble in water, very
slightly soluble in chloroform and
insoluble in ether.
Each tablet, for oral administration, contains 300 mg, 400 mg, or 800
mg cimetidine, USP. In addition,
each tablet contains the following inactive ingredients: corn starch,
magnesium stearate,
microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium
starch glycolate. The coating
for the tablets contains: carnauba wax, hypromellose, polyethylene
glycol, polysorbate 80, talc, titanium
dioxide, and triethyl citrate. The coating for the 300 mg and 400 mg
tablets also contains D&C Yellow
No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Yellow
No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
Cimetidine competitively inhibits the action of histamine at the
histamine H receptors of the parietal
cells and thus is a histamine H -receptor antagonist.
Cimetidine is not an anticholinergic agent. Studies have shown that
cimetidine inhibits both daytime and
nocturnal basal gastric acid secretion. Cimetidine also inhibits
gastric acid secretion stimulated by food,
histamine, pentagastrin, caffeine and insulin.
ANTISECRETORY ACTIVITY
2
10
16
6
2
2
_1) ACID SECRETION_
_NOCTURNAL_
Cimetidine 800 mg orally at bedtime reduces mean hourly H activity by
greater than 85% over an
eight-hour period in duodenal ulcer patients, with no effect on
daytime acid secretion. Cimetidine 1600
mg orally at bedtime produces 1