SERC 8 MG TABLET

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

BETAHISTINE HYDROCHLORIDE

থেকে পাওয়া:

SOLVAY PHARMA INC

এটিসি কোড:

N07CA01

INN (International Name):

BETAHISTINE

ডোজ:

8MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

BETAHISTINE HYDROCHLORIDE 8MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

MISCELLANEOUS THERAPEUTIC AGENTS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2005-02-07

পণ্য বৈশিষ্ট্য

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)