MONOREM Tablet Ref.[27870] Active ingredients: Isosorbide mononitrate

Posology

Adults

One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day.

The dosage may be increased up to 120 mg per day.

Dosage regime should be designed according to the clinical response of the patient. Tablets should be taken after meals, unchewed with a little fluid.

The lowest effective dose should be used.

In patients taking one tablet twice daily, the second dose should be taken 8 hours after the 1st dosage. If the dose is one tablet three times daily, take one every 6 hours and ensure 12 hours treatment-free interval every 24 hours.

Elderly

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

Paediatric population

The safety and efficacy of Monorem has yet to be established in children.

Treatment with Monorem, 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

For oral administration.

Animal experience

In rats and mice, significant lethality at oral doses of 1965 mg/kg and 2581 g/kg, respectively, was observed.

Human experience

Symptoms:

• fall of blood pressure ≤90 mmHg.
• paleness.
• sweating.
• weak pulse.
• tachycardia.
• light-headedness on standing.
• headache.
• weakness.
• dizziness.
• nausea.
• vomiting.
• diarrhea.

Methaemoglobinaemia 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.

General procedure:

• stop intake of the drug.
• general procedures in the event of nitrate-related hypotension:
  • patients should be kept horizontal with the head lowered and legs raised.
  • 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 of methaemoglobinaemia:
  • reduction therapy of choice with vitamin C, methylene-blue or toluidine-blue.
  • administer oxygen (if necessary).
  • initiate artificial ventilation.
  • hemodialysis (if necessary).
• resuscitation measures.

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

3 years.

Store below 25°C. Protect from light and moisture.

PVC/Aluminium blisters. Pack sizes of 50, 100 and 1000 tablets.

No special requirements.