cimetidine in sodium chloride- Cimetidine and Sodium Chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HOSPIRA, INC.

INN (International Name):

Cimetidine and Sodium Chloride

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

6 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cimetidine hydrochloride injection 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 five 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) Prevention of upper gastrointestinal bleeding in critically ill patients. (5) The treatment of pathological hypersecretory conditions

Product summary:

Cimetidine in 0.9% Sodium Chloride Injection, USP is supplied in a single-dose flexible container as follows: List No. Volume Total Cimetidine Content 7447 50 mL 300 mg Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F). ©Hospira 2004 EN-0499 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Summary of Product characteristics

CIMETIDINE IN SODIUM CHLORIDE- CIMETIDINE AND SODIUM CHLORIDE
INJECTION, SOLUTION
HOSPIRA, INC.
----------
CIMETIDINE
IN 0.9% SODIUM CHLORIDE INJECTION, USP
300 MG (6 MG/ML) CIMETIDINE
FLEXIBLE PLASTIC CONTAINER
FOR INTRAVENOUS INFUSION ONLY
Rx only
DESCRIPTION
Cimetidine in 0.9% Sodium Chloride Injection, USP is a sterile,
nonpyrogenic solution of cimetidine
hydrochloride in 0.9% sodium chloride injection. It is administered by
the intravenous route. Each mL
contains cimetidine HCl equivalent to 6 mg cimetidine and sodium
chloride 9 mg in water for injection.
The osmolar concentration is 356 mOsmol/L (calc.); pH is 6.0 (5.0 to
7.0). May contain hydrochloric
acid and/or sodium hydroxide for pH adjustment. The solution contains
no bacteriostat, antimicrobial
agent or added buffer and is intended only for use as a single-dose
administration. When smaller doses
are required, the unused portion should be discarded.
Cimetidine hydrochloride 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 Hydrochloride
Cimetidine contains an imidazole ring, and is chemically related to
histamine.
Cimetidine hydrochloride has a bitter taste and characteristic odor.
Sodium Chloride, USP is chemically designated NaCI, a white
crystalline compound freely soluble in
water.
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution
significantly. Solutions in contact with the plastic container may
leach out certain chemical components
from the plastic in very small amounts; however, biological testing
was supportive of the safety of the
plastic container materials. Exposure t