Imdex

Imdex

isosorbide mononitrate

Manufacturer:

CCM Pharma

Distributor:

Cosma Medical
Full Prescribing Info
Contents
Isosorbide 5-mononitrate.
Description
Imdex is a controlled release formulation of Isosorbide-5-mononitrate. The active substance is released independently of pH.
Each Imdex 60 mg CR tablet contains 60 mg Isosorbide-5-mononitrate.
Excipients/Inactive Ingredients: Iron oxide, titanium dioxide and quinoline yellow aluminum lake.
Action
Pharmacology: Pharmacokinetics: The principal pharmacological action of Isosorbide-5-mononitrate is relaxation of vascular smooth muscle, producing significant vasodilator activity, the strongest effect being exerted on the venous system and a lesser effect on the arterial circulation. As a consequence, the heart has less work to perform against diminished resistance and therefore oxygen requirement is reduced.
Isosorbide-5-mononitrate is readily absorbed from the gastro-intestinal tract and does not undergo first-pass hepatic metabolism and bioavailability is nearly 100%. The rate of absorption is slowed by food but overall bioavailability is unchanged. Kinetics of Isosorbide-5-mononitrate are not significantly influenced by advancing age, hepatic or renal disease.
Isosorbide-5-mononitrate is widely distributed with a large apparent volume of distribution. It undergoes nearly total elimination in the liver by denitration and conjugation to form Isosorbide and Isosorbide glucoronide as inactive metabolites. Only 2% of Isosorbide mononitrate is excreted unchanged in the urine with an elimination half-life of around 5 hours.
Indications/Uses
Imdex tablets are indicated for the prophylaxis and long-term treatment of angina pectoris due to coronary artery disease.
Dosage/Direction for Use
Adult dose: Imdex 60 mg, once daily to be taken in the morning. The dose may be increased to 120 mg once daily in the morning. To minimise the possibility of headache, treatment can be initiated with 30 mg for the first 2-4 days. Whole tablet of Imdex 60 mg and 30 mg tablets should be swallowed with half a glass of fluid. If required, the divided half of Imdex 60 mg should also be taken in the same manner. Care has to be taken to avoid crushing or chewing the tablet, in order for half tablet doses to be administered without affecting its sustained released properties.
Dosage of elderly: The dosage of nitrates in cardiovascular disease is usually determined by patient response and stabilisation. However, caution may be required in elderly patients who are known to be susceptible to the effects of hypotensive medication.
Children: The safety and efficacy of Imdex in children has not been established.
Overdosage
Acute Overdosage: Overdose symptoms include hypotension, tachycardia, warm flushed skin, headache, restlessness and nausea.
Treatment: Induce emesis or perform gastric lavage followed by charcoal administration. Hypotension is managed by elevating the legs and administration of intravenous fluids. If necessary an α-adrenergic agonist such as methoxamine or phenylephrine may be used.
Contraindications
Isosorbide-5-mononitrate is contraindicated in patients who are allergic to nitrates and in cases of low blood pressure, hypovolaemia, shock, marked anaemia, closed-angle glaucoma and raised intracranial pressure due to head trauma or cerebral haemorrhage. Imdex should also not be used in patients with hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac temponade, constrictive pericarditis, mitral stenosis and acute myocardial infarction with low left ventricular filling pressure.
Special Precautions
Imdex should be used with caution in patients with severe hepatic or renal impairment, hypothyroidism, malnutrition, hypothermia or with a recent history of myocardial infarction.
The use of Imdex during pregnancy and breast-feeding is not recommended due to lack of information.
Nitrate tolerance: Development of tolerance may occur with all forms of nitrate therapy particularly with the long acting nitrate preparations that maintain continuously high plasma nitrate concentration.
e.g. by taking more than 120 mg/day of Imdex and/or twice daily dosage, the risk of development of tolerance may occur. It is therefore very important that Imdex should be taken once a day in order to achieve a period of low nitrate concentration at night, reducing the risk of development of tolerance.
Withdrawal of nitrates should be gradual to avoid precipitation of acute angina.
Use in Elderly: Elderly patients may be more sensitive to the hypotensive effects of nitrates. In addition, they are more likely to have age-related renal function impairment, which may require caution in patients receiving nitrates.
Use In Pregnancy & Lactation
The use of Imdex during pregnancy and breast-feeding is not recommended due to lack of information.
Adverse Reactions
Most adverse effects are dose-related. Tachycardia, palpitations and orthostatic hypotension are common symptoms. These symptoms generally disappear during continued treatment. Headache may occur during initial treatment, but usually disappear with continued treatment.
Drug Interactions
Orthostatic hypotension may occur with the combined use of calcium channel blockers, antihypertensive agents, phenothiazines and tricyclic antidepressants. Use of alcohol with Isosorbide-5-mononitrate may produce severe hypotension and collapse.
Storage
Store below 30°C in a cool dry place.
Protect from light.
Keep medicines out of reach of children.
MIMS Class
ATC Classification
C01DA14 - isosorbide mononitrate ; Belongs to the class of organic nitrate vasodilators. Used in the treatment of cardiac disease.
Presentation/Packing
CR tab 60 mg (yellow, oval, biconvex, film coated, scored on one side and embossed with CCM on the other side) x 2 x 14's.
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