Ipca-Propranolol

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Propranolol hydrochloride 40mg

Tilgjengelig fra:

Ipca Pharma (NZ) Pty Limited

INN (International Name):

Propranolol hydrochloride 40 mg

Dosering :

40 mg

Legemiddelform:

Tablet

Sammensetning:

Active: Propranolol hydrochloride 40mg Excipient: Sunset Yellow FCF Aluminium lake Cl15985 Brilliant Blue FCF Aluminium lake Cl42090 Lactose monohydrate Magnesium stearate Maize starch Povidone Quinoline yellow Sodium starch glycolate

Resept typen:

Prescription

Produsert av:

Ipca Laboratories Limited

Indikasjoner:

Management of angina pectoris.

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, White HDPE bottle with white polypropylene child resistant cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Autorisasjon dato:

2014-06-27

Preparatomtale

NEW ZEALAND DATA SHEET
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 9
1.
PRODUCT NAME
IPCA-PROPRANOLOL 10 MG AND 40 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS 10 MG OR 40 MG PROPRANOLOL HYDROCHLORIDE
Chemical Structure:
Chemical Name:
2-propanol, 1-[(1-methyl-ethyl)amino]-3-(1-naphthalenyloxy),
hydrochloride, (±).
Molecular Formula:
C
16
H
21
NO
2
,HCl
Molecular Weight:
295.8
CAS Registry Number:
318-98-9.
EXCIPIENT(S) WITH KNOWN EFFECT : LACTOSE.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
IPCA-PROPRANOLOL 10mg tablets :Orange coloured, round, biconvex
tablets, embossed
with "P" and "10" on either side of the breakline on one side and
plain on the other side.
IPCA-PROPRANOLOL 40 mg tablets: Green coloured, round, biconvex
tablets, embossed
with "P" and "40" on either side of the breakline on one side and
plain on the other side.
The score line is not intended for breaking the tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Management of angina pectoris.
•
Long term prophylaxis after recovery from acute myocardial infarction.
•
Control of most forms of cardiac dysrhythmias.
•
Control of essential and renal hypotension
•
Prophylaxis of migraine.
•
Control of anxiety and anxiety tachycardia
•
Management of essential tremor.
•
Adjunctive management of thyrotoxicosis and thyrotoxic crisis.
•
Management of hypertrophic obstructive cardiomyopathy.
•
Management of phaeochromocytoma (with an alpha-adrenoreceptor blocking
medicine).
NEW ZEALAND DATA SHEET
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 9
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS
:
HYPERTENSION:
A starting dose of 80 mg twice a day may be increased at weekly
intervals according to
response. The usual dose range is 160-320 mg per day. With concurrent
diuretic or other
anti-hypertensive drugs a further reduction of blood pressure is
obtained.
ANGINA, ANXIETY, MIGR