FAMOTIDINE INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

FAMOTIDINE

Prieinama:

MYLAN PHARMACEUTICALS ULC

ATC kodas:

A02BA03

INN (Tarptautinis Pavadinimas):

FAMOTIDINE

Dozė:

10MG

Vaisto forma:

SOLUTION

Sudėtis:

FAMOTIDINE 10MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

2ML

Recepto tipas:

Prescription

Gydymo sritis:

HISTAMINE H2-ANTAGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0118722003; AHFS:

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2017-05-09

Prekės savybės

PRODUCT MONOGRAPH
PR
FAMOTIDINE INJECTION
10 MG/ML
HISTAMINE H
2
-RECEPTOR ANTAGONIST
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
June 24, 2014
Submission Control No: 174698
-2-
PRODUCT MONOGRAPH
Pr
Famotidine Injection
10 mg/mL
THERAPEUTIC CLASSIFICATION
Histamine H
2
-Receptor Antagonist
ACTIONS AND CLINICAL PHARMACOLOGY
Famotidine is a competitive inhibitor of histamine H
2
-receptors. The primary clinically important
pharmacologic activity of famotidine is inhibition of gastric juice
secretion. Famotidine reduces the
acid and pepsin content, as well as the volume, of basal, nocturnal,
and stimulated gastric secretion.
INDICATIONS AND CLINICAL USE
Famotidine Injection is indicated in some hospitalized patients with
pathological hypersecretory
conditions or intractable ulcers, or as an alternative to the oral
dosage form for short-term use in
patients who are unable to take oral medication.
-3-
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. Cross
sensitivity in this class of compounds
has been observed. Therefore, famotidine should not be administered to
patients with a history of
hypersensitivity to other H
2
-receptor antagonists.
PRECAUTIONS
PATIENTS WITH MODERATE OR SEVERE RENAL INSUFFICIENCY
Since CNS adverse effects have been reported in patients with moderate
and severe renal
insufficiency, longer intervals between doses or lower doses may need
to be used in patients with
moderate (creatinine clearance 30-50 mL/min) or severe (creatinine
clearance <30 mL/min) renal
insufficiency
to
adjust
for
longer
elimination
half-life
of
famotidine
(see
HUMAN
PHARMACOLOGY, Pharmacokinetics and DOSAGE AND ADMINISTRATION).
DRUG INTERACTIONS
Studies with famotidine in man, in animal models, and _in vitro_ have
shown no significant interference
with the disposition of compounds metabolized by the hepatic
microsomal enzymes, e.g., cytochrome
P450 system. Compounds tested in man have included warfarin,
theophylline, phenytoin, diazepam,
aminopyrine and antipy