IPCA-Metoprolol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metoprolol tartrate 50mg

Available from:

Ipca Pharma (NZ) Pty Limited

INN (International Name):

Metoprolol tartrate 50 mg

Dosage:

50 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Metoprolol tartrate 50mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide red Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose Purified talc Sodium starch glycolate Starch Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Ipca Laboratories Limited

Therapeutic indications:

Disturbances of cardiac rhythm, including supraventricular and ventricular arrhythmias.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture

Authorization date:

2013-03-25

Summary of Product characteristics

NEW ZEALAND DATASHEET
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1 of 16
1.
PRODUCT NAME
IPCA-Metoprolol tablets 50 mg
IPCA-Metoprolol tablets 100 mg
_ _
_(metoprolol tartrate) _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is
Di-[(±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol]
L(+)-tartrate (metoprolol tartrate).
Metoprolol is an aryloxypropanolamine derivative.
For a full list of excipients, see Section 6.1 List of excipients.
3
PHAMACEUTICAL FORM
IPCA-METOPROLOL TABLETS 100 MG
White to off white, round, biconvex film-coated tablets with notch
break line on one
side and ‘100’ debossed on other side.
IPCA-METOPROLOL 50 MG TABLETS
Pink, round, biconvex film-coated tablets with notch break line on one
side and ‘50’
debossed on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All forms
Disturbances of cardiac rhythm, including supraventricular and
ventricular arrhythmias.
Oral forms only
Hypertension: as monotherapy or for use in combination with other
antihypertensives, for
example, a diuretic, peripheral vasodilator or angiotensin
converting-enzyme (ACE) inhibitor.
Angina pectoris: For long-term prophylaxis. Nitroglycerin should be
used, if necessary, for
alleviating acute attacks.
Hyperthyroidism (as adjunctive medication_)_.
Functional heart disorders with palpitation.
Prevention of migraine.
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral treatment, the tablets should be swallowed unchewed.
The dosage should be adapted to the requirements of the individual
patient. The following
dosage recommendations may be taken as a guide:
NEW ZEALAND DATASHEET
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 16
Disturbances of cardiac rhythm
The daily dose is 100 to 150 mg, given in 2 or 3 divided doses; if
necessary, the dailydose
can be increased to 300 mg.
Hypertension
The daily oral dose is 100 to 200 mg, given either as a single dose in
the morning or as 2
divided
doses