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| Drug class description : | Organic nitrates |
| Generic Name : | Isosorbide mononitrate |
| Drug description : | Prolonged Release Tablets Light yellow, biconvex, oval-shaped, prolonged release tablets, scored on both sides and marked "DX 31" on one side. |
| Presentation : | XISMOX 60 XL Prolonged Release Tablets also known as ISIB 60 XL Prolonged Release Tablets and CIBRAL 60 XL Prolonged Release Tablets - Isosorbide mononitrate 60.0 mg |
| Indications : | Prophylaxis of angina pectoris |
| Adult Dosage : | The recommended dose is one 60 mg tablet once daily to be taken in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated, by initiating treatment with 30 mg (half tablet) for the first 2-4 days to minimize the possibility of headache. There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important that the tablets are taken once a day to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development. When necessary the product may be used in combination with beta-adrenoreceptor blockers and calcium antagonists. Dose adjustments of either class of agent may be necessary. The tablets must not be chewed or crushed. They should be swallowed with half a glass of water. |
| Child Dosage : | The safety and efficacy in children has not been established. |
| Elderly Dosage : | No evidence of a need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency. |
| Contra Indications : | Hypersensitivity to isosorbide mononitrate, or to any of the excipients. Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contra-indicated. Isosorbide mononitrate is contraindicated in constrictive pericarditis and pericardial tamponade. |
| Special Precautions : | Use with extreme caution in hypotension with or without other signs of shock and in cases of cerebrovascular insufficiency. Other special warnings and precautions with Isosorbide mononitrate: Significant aortic or mitral valve stenosis. Hypertrophic obstructive cardiomyopathy. Anaemia. Hypoxaemia, Hypothyroidism. The tablets are not indicated for relief of acute angina attacks. Patients with rare hereditary problems of fructose or galactose intolerance, the Lapp lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medicine. |
| Interactions : | Isosorbide mononitrate may act as a physiological antagonist to noradrenaline, acetylcholine, histamine and many other agents. The effect of anti-hypertensive drugs may be enhanced. Alcohol may enhance the hypotensive effects of isosorbide mononitrate. The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil. The tablets should not be used during pregnancy and lactation. |
| Adverse Reactions : | Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated but usually disappears after continued treatment. Hypotension with symptoms such as dizziness and nausea has occasionally been reported. These symptoms generally disappear during long-term treatment. Less common are vomiting and diarrhoea. Uncommon is fainting. Skin rashes (dry rash, exfoliative dermatitis) and pruritus have been reported rarely with isosorbide mononitrate. Myalgia has been reported very rarely. |
| Manufacturer : | Genus Pharmaceuticals |
| Drug Availability : | (POM) |
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