ISOKET RETARD Prolonged release tablet Ref.[28019] Active ingredients: Isosorbide dinitrate

Posology

Adults

One tablet to be taken twice daily without chewing and with a sufficient amount of fluid. The second dose should be given 6 to 8 hours after the first dose. For patients with higher nitrate requirements the dose may be increased to one tablet three times daily, but ensuring a 12 hours treatment free interval every 24 hours.

Elderly population

Clinical experience has not necessitated alternative advice for use in elderly patients.

Paediatric population

The safety and efficacy of Isoket Retard has yet to be established.

Method of administration

For oral administration.

Symptoms:

• Fall of blood pressure ≤ 90mm Hg, paleness, sweating, weak pulse, tachycardia, light-headedness on standing, headache, weakness, dizziness, nausea and vomiting.
• During isosorbide mononitrate biotransformation nitrite ions are released, which may include methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It can not be excluded that an overdose of isosorbide dinitrate may cause this adverse reaction.
• In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.

Supportive measures:

• Stop intake of the drug
• General procedures in the event of nitrate-related hypotension:
  • Patient should be kept horizontal with the head lowered and legs raised
  • Supply oxygen
  • Expand plasma volume
  • For specific shock treatment admit patient to intensive care unit

Specific Procedures:

• Raising the blood pressure if the blood pressure is very low
• Treatment of methaeglobinaemia
  • 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.

5 years.

No special precautions.

Cartons of blister strips of polypropylene (PP) and aluminium or of PP/PP.

Pack sizes 50, 56, 60, 84 and 90 tablets.

Only the pack sizes marked in bold are currently marketed.

No special requirements.