ISOSORBIDE MONONITRATE / CARMIL / MONOMIL Tablet Ref.[6936] Active ingredients: Isosorbide mononitrate

Adults

One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. For patients not already receiving prophylactic nitrate therapy it is recommended that the initial dose of isosorbide mononitrate be 20mg twice a day. The dosage may be increased to 120mg per day. The lowest effective dose should be used.

Paediatric population

The safety and efficacy of Isosorbide Mononitrate 20mg tablets in children has not been established.

Elderly

There is no evidence to suggest that an adjustment of the dosage is necessary.

Treatment with Isosorbide mononitrate tablets, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.4).

Method of administration

The tablet should be swallowed whole, and not chewed or crushed.

Symptoms and signs

Fall of blood pressure ≤90 mmHg, headache, paleness, weak pulse, light headedness on standing, weakness, dizziness, diarrhoea, hypotension, nausea, vomiting, sweating, tachycardia, vertigo, restlessness, warm flushed skin, blurred vision and syncope. A rise in intracranial pressure with confusion and neurological deficits can sometimes occur. Methaemoglobinaemia (cyanosis, hypoxaemia, restlessness, respiratory depression, convulsions, cardiac arrhythmias, circulatory failure, raised intracranial pressure) has been reported in patients receiving other organic nitrates. During isosorbide mononitrate biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It cannot be excluded that an overdose of isosorbide mononitrate may cause this adverse reaction.

In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.

Management

General Procedure:

• Stop intake of the drug.
• General procedures in the event of nitrate-related hypotension:
  • Consider oral activated charcoal if ingestion of a potentially toxic amount has occurred within 1 hour. Observe for at least 12 hours after the overdose. Monitor blood pressure and pulse. Correct hypotension by raising the foot of the bed and/or by expanding the intravascular volume. Other measures as indicated by the patient’s clinical condition. If severe hypotension persists despite the above measures consider use of inotropes.
  • Supply oxygen.
  • Expand plasma volume (i.v. fluids).
  • Specific treatment for shock (admit patient to intensive care unit).

Special Procedure:

• Raising the blood pressure if the blood pressure is very low.
  • Treatment with methaemoglobinaemia: If methaemoglobinaemia (symptoms or >30% methaemoglobin), IV administration of methylene blue or toluidine-blue 1-2mg/kg body-weight. If therapy fails with second dose after 1 hour or contraindicated, consider red blood cell concentrates or exchange transfusion. In case of cerebral convulsions, diazepam or clonazepam IV, or if therapy fails, phenobarbital, phenytoin or propofol anaesthesia.
  • Reduction therapy of choice with vitamin C.
  • Administer oxygen (if necessary).
  • Initiate artificial ventilation.
  • Haemodialysis (if necessary).
• Resuscitation measures.

In case of signs of respiratory and circulatory arrest, initiate resuscitation measures immediately.

3 years.

Do not store above 25°C.

PVC/Aluminium foil blisters on a cardboard carton.

Each sheet of blisters contains 10 tablets and there are six sheets of ten tablets per carton (60’s pack).

Each strip of blister contains 14 tablets and there are four such strips per carton (56’s pack).

Not applicable.