SERC 8 MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAHISTINE HYDROCHLORIDE

Available from:

SOLVAY PHARMA INC

ATC code:

N07CA01

INN (International Name):

BETAHISTINE

Dosage:

8MG

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE HYDROCHLORIDE 8MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS THERAPEUTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0103555002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2005-02-07

Summary of Product characteristics

PRODUCT MONOGRAPH
SERC
†
(Betahistine Dihydrochloride)
8 mg, 16 mg, and 24 mg tablets
Anti-vertigo Agent
Date of Preparation:
October 15, 1996
Date of Revision:
August 7, 2003
†
Trademark used under licence by Solvay Pharma Inc.
2
PRODUCT MONOGRAPH
SERC
†
(Betahistine Dihydrochloride)
8 mg, 16 mg, and 24 mg tablets
THERAPEUTIC CLASSIFICATION
Anti-vertigo Agent
CLINICAL PHARMACOLOGY
Betahistine is a histamine H
1
-agonist with an intrinsic activity equal to that of histamine and an
H
1
-
agonistic activity of about 0.07 times that of histamine. This H
1
-agonist activity has been confirmed
in _in vivo_ studies where, like histamine, the hypotensive response
produced by betahistine could be
blocked by H
1
-receptor antagonists.
6,7,8
Betahistine also induces bronchoconstriction and increased
vasopermeability after parenteral administration, further confirming
its H
1
-agonistic properties.
3,6,8
In contrast to histamine, betahistine is virtually inactive at the H
2
-receptor. Only marginal increases
in gastric acid secretion are produced following very high parenteral
doses of betahistine.
11,12
The
3
compound did not produce relaxation in the rat uterus,
6
and no H
2
-agonist activity was noted in heart
muscle.
3
Receptor binding studies have shown that betahistine is a potent H
3
-receptor antagonist.
22,23
Orally administered doses of betahistine dihydrochloride are rapidly
and completely absorbed from
the gastrointestinal tract. The drug is rapidly metabolized to one
primary metabolite - 2-
pyridylacetic acid and excreted in the urine. Studies with
radio-labelled betahistine have
demonstrated a plasma half life of 3.4 hours and a urinary half life
of 3.5 hours for the radio-label.
Urinary excretion of the label was about 90% complete within 24 hours
of administration.
16,20
INDICATIONS AND CLINICAL USE
Serc (betahistine dihydrochloride) tablets are indicated for reducing
the episodes of recurrent
vertigo associated with Ménière’s disease.
CONTRAINDICATIONS
The use of Serc (betahistine dihydrochloride)