CIMETIDINE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Mylan Pharmaceuticals Inc.

INN (International Name):

CIMETIDINE

구성:

CIMETIDINE 200 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 tablets 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 cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of 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 tablets 400 mg at bedtime for periods of up to 5 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 lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas). Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product.

제품 요약:

Cimetidine Tablets, USP are available containing 200 mg, 300 mg, 400 mg or 800 mg of cimetidine, USP. The 200 mg tablets are green, film-coated, 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 green, film-coated, 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 The 400 mg tablets are green, film-coated, 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 The 800 mg tablets are green, film-coated, 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 Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75069095 Revised: 8/2019 MXA:CIM:R1

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CIMETIDINE- CIMETIDINE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
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, USP. Inactive ingredients are: croscarmellose sodium,
crospovidone,
hypromellose, lecithin, magnesium stearate, microcrystalline
cellulose, polydextrose,
polyethylene glycol, povidone, pregelatinized starch (corn), sodium
alginate, sodium
lauryl sulfate, titanium dioxide, triacetin, vanillin, FD&C Blue No. 1
Aluminum Lake, FD&C
Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.
CLINICAL PHARMACOLOGY
Cimetidine tablets 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 tablets
inhibit both daytime and nocturnal basal gastric acid secretion.
Cimetidine tablets also
inhibit gastric acid secretion stimulated by food, histamine,
pentagastrin, caffeine and
insulin.
ANTISECRETORY ACTIVITY
_1) ACID SECRETION_
_Nocturnal_
An 800 mg oral dose of cimetidine tablets at bedtime reduces mean
hourly H activity by
2
2
2
+
greater than 85% over an 8-hour period in duodenal ulcer patients,
with no effect on
daytime acid secretion. A 1,600 mg oral dose of cimetidine tablets at
bedtime produces
100% inhibition of mean hourly H activity over an 8-hour period in
duodenal ulcer
patients, but also reduces H activity by 35% for an additional 5 hours
into the following
morning. Cimetidine tablets given as 400 mg tw