APO METHAZIDE 15 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHYLDOPA; HYDROCHLOROTHIAZIDE

Available from:

APOTEX INC

ATC code:

C02LB01

INN (International Name):

METHYLDOPA (LEVOROTATORY) AND DIURETICS

Dosage:

250MG; 15MG

Pharmaceutical form:

TABLET

Composition:

METHYLDOPA 250MG; HYDROCHLOROTHIAZIDE 15MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

CENTRAL ALPHA-AGONISTS

Product summary:

Active ingredient group (AIG) number: 0200050001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-05-04

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
APO-METHAZIDE - 15
(Methyldopa 250 mg and Hydrochlorothiazide 15 mg)
Pr
APO-METHAZIDE - 25
(Methyldopa 250 mg and Hydrochlorothiazide 25 mg)
TABLETS
Antihypertensive Agent
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
January 21, 2013
Toronto, Ontario M9L 1T9
Control number: 159404
2
NAME OF DRUG
Pr
APO-METHAZIDE - 15
(Methyldopa 250 mg and Hydrochlorothiazide 15 mg)
Pr
APO-METHAZIDE - 25
(Methyldopa 250 mg and Hydrochlorothiazide 25 mg)
TABLETS
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
ACTION
Methyldopa reduces both supine and standing blood pressure. Effective
lowering of the supine
pressure with less frequent symptomatic postural hypotension can be
obtained with methyldopa.
In patients treated with methyldopa exercise hypotension and diurnal
blood pressure variations
rarely occur. Morning hypotension can be prevented by adjustment of
dosage, without
sacrificing control of afternoon blood pressure.
Methyldopa when used in effective doses, usually has not reduced
glomerular filtration rate,
renal blood flow, or filtration fraction. Cardiac output is usually
maintained with no cardiac
acceleration, in some patients the heart rate is slowed.
Hydrochlorothiazide is also an effective drug in the treatment of
hypertension. This diuretic is
mildly antihypertensive, with a sustained blood pressure-lowering
effect on continued
administration. Greatest effectiveness however, is seen when the drug
is given in conjunction
with other anti-hypertensive agents.
Hydrochlorothiazide complements the action of methyldopa. The
concomitant use of these two
agents, as provided in Apo-Methazide frequently produces a more
pronounced antihypertensive
response than when either compound is the only therapeutic agent.
Particularly in those cases of
hypertensive vascular disease associated with sodium and water
retention, the
hydrochlorothiazide component of Apo-Methazide will help control the
fluid imbalance.
In severe essential hypertension and in malignant hyper-tension
Apo-Methazide may achieve
effective l