Product Dossier
BETALOC
Product Dossier for BETALOC (metoprolol tartrate, AstraZeneca). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: AstraZeneca
- Active ingredient: metoprolol tartrate
- Therapeutic area: Cardiology
- Related brand: TN-METOPROLOL
- Related brand: MYOTAR
- Related brand: MINAX
- Same area: ATOZET
- Same area: OPSUMIT
What it is
BETALOC contains metoprolol tartrate. The tablets are available in 50 mg or 100 mg strength and contain inactive ingredients including lactose monohydrate, cellulose microcrystalline, colloidal anhydrous silica, sodium starch glycollate, povidone and magnesium stearate. An injection solution is also available containing 1 mg/mL metoprolol tartrate with sodium chloride and water for injections.
Approved indications
**Oral therapy** — Hypertension. — Angina pectoris prophylaxis. — Suspected or definite myocardial infarction. — Migraine prophylaxis. **Intravenous therapy** — Disturbances of cardiac rhythm, in particular supraventricular tachyarrhythmias.
Dosing overview
Key safety warnings
Beta-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in increased airways resistance. Blood pressure and ECG should be monitored during intravenous treatment. Parenteral administration should be conducted by experienced staff with suitable monitoring and resuscitating equipment available. The safety and efficacy in children have not been established.
Contraindications
Bronchospasm is a contraindication.
Regulatory history
BETALOC metoprolol tartrate 50 mg tablets, 100 mg tablets and 5 mg/5 mL injection ampoules were first registered on the ARTG on 13 August 1991.