LOPRESOR Tablet, Solution for injection Ref.[50848] Active ingredients: Metoprolol

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2020  Publisher: Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149, Telephone: 0800 354 335

Product name and form

Lopresor 50 mg tablet.
Lopresor 100 mg tablet.
Lopresor 5 mg/5 mL solution for injection.
Slow Lopresor 200mg Modified release tablet (metoprolol tartrate).

Pharmaceutical Form

Lopresor Tablet 50mg

Pink heart shaped film-coated tablet with slightly convex faces.

Imprints: CIBA on one side and HM on other side.

Lopresor Tablet 100mg

Light blue, heart shaped, film-coated tablet with slightly convex faces.

Imprints: CIBA on one side and I/P with score on other side.

Lopresor 5mg/5ml solution injection

Clear colourless liquid contained in a 1 point glass ampoule.

Slow-Lopresor Tablet 200mg

Divitabs or scored sustained-release tablets of 200 mg.

Light yellow, capsule shaped, film-coated tablet with convex faces, slightly bevelled edges, and a deep breaking score on both sides.

Imprints: CG/CG on one side and CDC/CDC on other side.

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.

One 5 mL ampoule contains 5 mg metoprolol tartrate. One tablet contains 50 mg, 100 mg or 200 mg metoprolol tartrate.

For a full list of excipients, see Section 6.1 List of excipients.

Active Ingredient Description
Metoprolol

Metoprolol is a cardioselective beta-adrenergic blocking agent. It has a relatively greater blocking effect on beta1-receptors (ie those mediating adrenergic stimulation of heart rate and contractility and release of free fatty acids from fat stores) than on beta2-receptors, which are chiefly involved in broncho and vasodilation.
List of Excipients

Lopresor

Solution for injection:

Sodium chloride,
water for injection.

Tablets of 50 mg:

Silica aerogel,
cellulose,
lactose,
magnesium stearate,
polyvinylpyrrolidone,
sodium carboxymethyl starch,
hydroxypropyl methylcellulose,
red iron oxide (E 172),
polysorbate 80,
talc,
titanium dioxide (E 171).

Tablets of 100 mg:

Silica aerogel,
cellulose,
magnesium stearate,
sodium carboxymethyl starch,
hydroxypropyl methylcellulose,
polyvinylpyrrolidone,
shellac,
indico carmine,
titanium dioxide (E 171).

Slow Lopresor

Divitabs (divisible sustained-release tablets) of 200 mg:

Silica aerogel,
cellulose,
dibasic calcium phosphate,
copolymer based on polyacrylic/methacrylic esters,
magnesium stearate,
hydroxypropyl methylcellulose,
glycol palmitostearate,
yellow iron oxide (E 172),
polysorbate 80,
talc,
titanium dioxide (E 171).

Pack sizes and marketing

Lopresor 50mg: bottles containing 100 tablets.

Lopresor 100mg: bottles containing 60 tablets.

Slow Lopresor 200mg: blisters containing 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149, Telephone: 0800 354 335

Marketing authorization dates and numbers

9 September 1976

Drugs

Drug Countries
LOPRESOR Australia, Canada, Spain, Israel, Italy, Japan, Mexico, South Africa
 
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