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Logo MONICOR SR 60 mg SLOW RELEASE TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

MONICOR SR 60 mg SLOW RELEASE TABLETS

COMPOSITION:
Each slow release tablet contains 60 mg
Isosorbide-5-mononitrate.

PHARMACOLOGICAL CLASSIFICATION:
A 7.1.4 Vasodilators –coronary and other medicines used in angina pectoris.

PHARMACOLOGICAL ACTION:
Isosorbide-5-mononitrate is an active metabolite of isosorbide dinitrate. It relaxes vascular smooth muscle, producing vasodilation of both the arteries and veins (predominantly). This effect is dose-dependent. Low plasma concentrations lead to venous dilatation, resulting in peripheral pooling of blood, decreased venous return and reduction in left ventricular end-diastolic pressure (preload). High plasma concentrations also dilates the arteries reducing systemic vascular resistance and arterial pressure leading to a reduction in cardiac afterload. Isosorbide-5-mononitrate may also have a direct dilatory effect on the coronary arteries. By reducing the end diastolic pressure and volume, isosorbide-5-mononitrate lowers the intramural pressure, thereby leading to an improvement in the subendocardial blood flow. The net effect is therefore a reduced workload of the heart and an improved oxygen supply/demand balance in the myocardium.
Pharmacokinetics:
The elimination half-life is about 5 hours. Only about 2% of isosorbide-5-mononitrate is excreted unchanged in the urine. Monicor SR 60 mg is a slow release formulation of isosorbide-5-mononitrate. The active substance is released independently of pH over a 10 hour period. The absorption phase of Monicor SR 60 mg is prolonged and the duration of effect is extended.

INDICATIONS:
Prophylactic treatment of angina pectoris.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Severe hypotension, hypovolaemia, marked anaemia, heart failure due to obstruction (including constrictive pericarditis), or raised intracranial pressure due to head trauma or cerebral haemorrhage.
Patients with angle closure glaucoma as Monicor SR 60 mg may increase intra-ocular pressure.
Sildenafil and other phosphodiesterase type 5 inhibitors (PDE5) must not be given Monicor SR 60 mg (see Interactions).

WARNINGS:
Caution should be observed in patients with severe cerebral arteriosclerosis and hypotension (See Contra-indications).

INTERACTIONS:
The hypotensive effects of Monicor SR 60 mg may be enhanced by alcohol, and by vasodilators and other medicines with hypotensive actions.
Concomitant administration with sildenafil and other phosphodiesterase type 5 inhibitors (PDE5) can potentiate the effect of Monicor SR 60 mg with the potential result of serious adverse effects such as hypotension, syncope or myocardial infarction.

PREGNANCY AND LACTATION:
The safety during pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
The recommended dosage is 60 mg daily (one tablet), in the morning. This dosage may be increased to 120 mg (two tablets), once daily in the morning. Treatment may be initiated with 30 mg (half a tablet) for the first two to four days, to minimize the possibility of headache. Monicor SR 60 mg tablets may be broken in half, but should not be chewed or crushed and should be taken with half a glass of water.
NOTE:
Monicor SR 60 mg tablets are not indicated for the relief of acute anginal attacks. Sublingual or buccal nitroglycerin tablets should be used in these situations.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Cardio-vascular disorders:
Incidence more frequent: Tachycardia; hypotension; syncope; headache
Incidence less frequent: Severe or prolonged headache; bradycardia
Nervous system disorders:
Incidence more frequent: Dizziness; restlessness
Gastro-intestinal disorders:
Incidence more frequent: Vomiting
Skin disorders:
Incidence more frequent: Flushing of the face
Incidence less frequent: Cyanosis
Eye disorders:
Incidence less frequent: Blurred vision
Other disorders:
Incidence less frequent: Methaemoglobinaemia; impairment of respiration
Precautions:
Monicor SR 60 mg
, may increase intra-ocular pressure in patients with angle-closure glaucoma (see Contra-indications). It should be used with caution in patients with severely impaired renal or hepatic function, hypothyroidism, malnutrition or hypothermia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and Special Precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Cream oval tablets, half scored on both sides, marked with “60”on one side.

PRESENTATION:
White polypropylene securitainers containing 30 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep well closed. Protect from light.
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
37/7.1.4/0340

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Marketed by PHARMA DYNAMICS (PTY) LTD for:
CompuPharm (Pty) Ltd
476 Kings Highway
Lynnwood
Pretoria

DATE AND PUBLICATION OF THE PACKAGE INSERT:
17 January 2005

New addition to this site: April 2008
Source: Pharmaceutical Industry

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