CIMETIDINE HYDROCHLORIDE solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Cimetidine Hydrochloride (UNII: WF10491673) (Cimetidine - UNII:80061L1WGD)

Dostupné z:

Morton Grove Pharmaceuticals, Inc.

INN (Medzinárodný Name):

Cimetidine Hydrochloride

Zloženie:

Cimetidine 300 mg in 5 mL

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CIMETIDINE HYDROCHLORIDE- CIMETIDINE HYDROCHLORIDE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
CIMETIDINE HYDROCHLORIDE ORAL SOLUTION
300 MG/5 ML
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 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 of 5 mL (1 teaspoonful) contains: Cimetidine hydrochloride
equivalent to cimetidine 300 mg and
alcohol 2.8%. The pH range is between 5.3 and 6.2.
Inactive Ingredients: FD&C Yellow No. 6; Methylparaben, NF; Natural
and Artificial Peach Flavor;
Propylene Glycol, USP; Propylparaben, NF; Purified Water, USP;
Saccharin Sodium, USP; Sodium
Chloride, USP; Sodium Phosphate Dibasic, USP and Sorbitol Solution,
USP. IT MAY ALSO CONTAIN
Sodium Phosphate Monobasic, USP 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 8-
2
10
16
6
2
2
+
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
8-hour period in duoden