CIMETIDINE- cimetidine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIMETIDINE HYDROCHLORIDE (UNII: WF10491673) (CIMETIDINE - UNII:80061L1WGD)

Available from:

Pharmaceutical Associates, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cimetidine Hydrochloride Oral Solution is 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 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 disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for hea

Product summary:

Cimetidine Hydrochloride Oral Solution is supplied as a clear, light orange, berry flavored solution supplied in the following: NDC 0121-0649-08: 8 fl oz (237 mL) bottle NDC 0121-0649-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1298-93: 6.67 mL unit dose cup, in a tray of ten cups. 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. MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R11/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CIMETIDINE- CIMETIDINE HYDROCHLORIDE SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
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CIMETIDINE HYDROCHLORIDE ORAL SOLUTION
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 hydrochloride is C
H
N
S·HCl and the
molecular weight is 288.80. The structural formula of cimetidine
hydrochloride is:
Cimetidine contains an imidazole ring, and is chemically related to
histamine.
Cimetidine has a bitter taste and characteristic odor.
SOLUBILITY CHARACTERISTICS
Cimetidine hydrochloride is freely soluble in water, soluble in
alcohol, very slightly soluble
in chloroform and practically insoluble in ether.
Each 5 mL (1 teaspoonful), for oral administration, contains
cimetidine hydrochloride
equivalent to cimetidine, 300 mg; alcohol, 2.8%. In addition, the oral
solution contains
the following inactive ingredients: berry flavor, dibasic sodium
phosphate, FD&C Yellow
No. 6, methylparaben, propylene glycol, propylparaben, purified water,
saccharin
sodium, sodium chloride, and sorbitol. May contain sodium hydroxide
and/or
hydrochloric acid to adjust pH.
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 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 h.s.
2
10
16
6
2
2
produces 100% inhibition of mean hourly H+ activity over an eight-hour
period in
duodenal ulcer pati