DEPONIT Transdermal patch Ref.[27650] Active ingredients: Glyceryl trinitrate

Posology

Adults

Treatment should be initiated with one patch daily. If necessary, the dosage may be increased to two patches. The maximum daily dose is 20 mg, any increases or decreases in dose should be made gradually.

Elderly population

No specific information on use in the elderly is available, however there is no evidence to suggest that an alteration in dose is required.

Paediatric population

The safety and efficacy of Deponit patch in children has not yet been established

Method of administration

Dermal.

It is recommended that the patch is applied to healthy, undamaged, relatively crease free and hairless skin. The best places to apply Deponit patches are the easily reached, fairly static areas at the front or side of the chest. However, Deponit patches may also be applied to the upper arm, thigh, abdomen or shoulder. Skin care products should not be used before applying the patch. The replacement patch should be applied to a new area of skin. Allow several days to elapse before applying a fresh patch to the same area of skin.

Tolerance may occur during chronic nitrate therapy. To avoid development of tolerance, the GTN patch should remain on the skin only for about 12-14 hours, to ensure a nitrate free interval of 10-12 hours. Additional anti-anginal therapy with drugs not containing nitro compounds should be considered for the nitrate-free interval if required.

As with any nitrate therapy, treatment with these patches should not be stopped abruptly. If the patient is being changed to another type of treatment, the two should overlap.

In view of the transdermal mode of delivery, an overdose of glyceryl trinitrate is unlikely to occur. However, in the unlikely event of an overdose, the symptoms could include the following:

• Fall in blood pressure ≤90 mmHg
• Collapse or syncope
• Paleness
• Sweating
• Weak pulse
• Reflex tachycardia
• Flushing
• Light-headedness on standing
• Headache
• Weakness
• Dizziness
• Nausea
• Vomiting
• Methaemoglobinaemia has been reported in patients receiving other organic nitrates. During glyceryl trinitrate biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It can not be excluded that an overdose of glyceryl trinitrate may cause this adverse reaction
• In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms

General procedure:

• Since these patches are applied to the skin, removing the patch immediately stops delivery of the drug.
• General procedures in the event of nitrate-related hypotension
• Patient should be kept horizontal with the head lowered and legs raised or, if necessary, compression bandaging of the patient’s legs.
• Supply oxygen
• Expand plasma volume
• For specific shock treatment admit patient to intensive care unit

Special procedure:

• Raising the blood pressure if the blood pressure is very low
• Treatment of methaemoglobinaemia

Treatment with intravenous methylene blue

• Initially 1 to 2 mg/kg, not exceeding 4 mg/kg of a 1% solution over 5 minutes.
• Repeat dose in 60 minutes if there is no response.
• Administer oxygen (if necessary)
• Initiate artificial ventilation

Treatment with methylene blue is contraindicated in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency or methaemoglobin reductase deficiency (see also section 4.4).

Where treatment with methylene blue is contraindicated or is not effective, exchange transfusion and/or transfusion of packed red blood cells is recommended.

Resuscitation measures:

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

Shelf life of the product as packaged for sale: 48 months.

Do not store above 25°C.

Multilaminate film/foil pouch with heat-sealed edges.

28 patches per carton.

The patch should be removed from the package just before application. After removal of the protective foil, the patch should be applied to unbroken, clean and dry skin that is smooth and with few hairs. The same area of skin should not be used again for some days.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.