CIMETIDINE HYDROCHLORIDE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Akorn

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Cimetidine Hydrochloride Oral Solution is a clear yellow, orange flavored solution containing 300 mg of cimetidine hydrochloride per 5 mL (teaspoonful) supplied in 8 fl oz (237 mL) amber PET containers. Store at controlled room temperature, 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container. Rx only Manufactured by: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CIMETIDINE HYDROCHLORIDE- CIMETIDINE HYDROCHLORIDE SOLUTION
AKORN
----------
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION, 300 MG/ 5 ML RX ONLY
REV.966:00 02/19
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, methylparaben,
natural orange
flavor, 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
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
2
10
16
6
2
2
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 pa