CIMETIDINE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

STAT RX USA LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Cimetidine tablets are indicated in: (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to five years. (3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of l

Proizvod sažetak:

Cimetidine tablets are available containing 200 mg, 300 mg, 400 mg and 800 mg of cimetidine. The 200 mg tablets are film-coated green, five sided, house shaped, unscored tablets debossed with M on one side and 53 on the other side. They are available as follows: NDC 0378-0053-01 bottles of 100 tablets The 300 mg tablets are film-coated green, five sided, house shaped, unscored tablets debossed with M on one side and 317 on the other side. They are available as follows: NDC 0378-0317-01 bottles of 100 tablets NDC 0378-0317-05 bottles of 500 tablets The 400 mg tablets are film-coated green, five sided, house shaped, partially scored tablets debossed with M on one side and 372 on the other side. They are available as follows: NDC 0378-0372-01 bottles of 100 tablets NDC 0378-0372-05 bottles of 500 tablets The 800 mg tablets are film-coated green, oval, partially scored tablets debossed with M 541 across the partial score. They are available as follows: NDC 0378-0541-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2005 CIM:R12

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CIMETIDINE - CIMETIDINE TABLET, FILM COATED
STAT RX USA LLC
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CIMETIDINE TABLETS, USP
200 MG, 300 MG, 400 MG AND 800 MG
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. Its structural
formula 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 200 mg, 300 mg, 400 mg
or 800 mg cimetidine. Inactive
ingredients are: croscarmellose sodium, crospovidone, hypromellose,
lecithin, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, pregelatinized starch, sodium
alginate, sodium lauryl sulfate, titanium dioxide, triacetin,
vanillin, FD and C Blue #1 aluminum lake, FD
and C Yellow #6 aluminum lake and D and C Yellow #10 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
1) Acid SecretionNocturnal
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 h.s. produces 100% inhibition of mean hourly H activity over
an eight-hour period in
duodenal ulcer patients, but also reduces H activity by 35% for an
additional five hours into the
following morning. Cimetidine 400 mg b.i.d. and 300 mg q.i.d. decrease
no