CIMETIDINE HYDROCHLORIDE ORAL SOLUTION solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Akorn Operating Company LLC

INN (International Name):

CIMETIDINE HYDROCHLORIDE

Sammensetning:

CIMETIDINE 300 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers NDC 50383-050-08 and 16 fl oz (473 mL) amber PET containers NDC 50383-050-16. Store at controlled room temperature, 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. Rx Only Distributed by: Akorn Operating Company LLC Gurnee, IL 60031

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CIMETIDINE HYDROCHLORIDE ORAL SOLUTION- CIMETIDINE HYDROCHLORIDE ORAL
SOLUTION SOLUTION
AKORN OPERATING COMPANY LLC
----------
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION
RX ONLY
Rev. 050:05 08/22
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•HCI 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: FD&C Yellow No. 6, hydrochloric
acid, methylparaben,
natural orange flavor, polyoxyethylene, polyoxypropylene glycol,
propylene glycol,
propylparaben, purified water, saccharin sodium, sodium chloride,
dibasic sodium
phosphate anhydrous, and sorbitol. The pH range is 5.1 to 5.7.
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
2
10
16
6
2
2
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. pr