Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Trinitrin
laboratory: Pierre Fabre Medicament
Box of 100 Sachets of 1
Preventive treatment of the angina attack
Dosage DIAFUSOR 5 mg / 24 hours transdermal patch Box of 100 Sachets of 1
Reserved for adults . Dosage:
- Nitrate derivatives are administered discontinuously on the nycthemeron by providing a daily free interval to avoid the phenomenon of therapeutic escape, well established when nitrates are administered continuously.
- This free interval will be chosen in the period when the patient does not present a crisis.
The duration of the free interval is at least 8 hours.
The schedule for the associated anti-anginal treatment (betablocker and / or calcium antagonist) should be chosen to ensure therapeutic coverage during this free interval.
- In the preventive treatment of the angina attack, the escape phenomenon is well established. A control of the prescription modalities respecting a free interval ensures that nitrated derivatives have a recognized therapeutic efficacy. The application and withdrawal schedules of the transdermal patch must be clearly indicated on the prescription.
The response to nitrates varies from patient to patient and the lowest effective dose should be prescribed at the start of treatment.
- The therapeutic scheme is as follows : setting up a device per day, starting with the least dosed device, ie 5 mg / 24 h per day.
In case of insufficient efficacy, the dosage will be increased to a transdermal patch 10 mg / 24 h per day or 0.4 mg per hour, then if necessary to a transdermal patch 15 mg / 24 h per day, or 0.6 mg per hour. Method of administration: - The device must be glued on the skin in a healthy, dry and clean place where the hairiness is rare (lateral wall of the thorax for example). For a good adhesiveness, it is useful to apply the system well by pressing ten seconds with the palm of the hand.
- After the prescribed application time, remove and dispose of the system, and then apply the new system to another location. Do not glue a system in the same place until after several days, to avoid local irritation.
- In the case of spontaneous detachment, a new system (at another location) must be reinstalled.
This medicine MUST NEVER BE USED in the following cases:
- hypersensitivity to nitrates or any of the other ingredients,
- shock, severe hypotension.
- in combination with sildenafil (see interactions and warnings):
. in any patient treated with a nitrate derivative, in any form, sildenafil should not be prescribed as long as the patient is under the action of the nitrate derivative.
. when treated with sildenafil, nitrates are contraindicated in any form. In particular, all coronary patients should be warned that, if they present anginal pain during the sexual act, they should under no circumstances take a nitrate derivative of immediate action.
Similarly, in the patient without a coronary history presenting a first anginal episode after the sexual activity, it is advisable to search by the interrogation the possible taking of sildenafil (most often in the hour preceding the sexual activity) and if this is the case, refrain from any nitrate treatment.
In general, based on the available data, the time to be given before administering a nitrate derivative to a patient exposed to sildenafil is not precisely known, but can be estimated at a minimum of 24 hours.
NOT RECOMMENDED :
- Reserved for adults.
- THIS MEDICINE SHOULD NOT BE USED IN CASE OF:
. obstructive cardiomyopathy,
. lower seat myocardial infarction with right ventricular extension, acute phase,
. intracranial hypertension,
. in case of breastfeeding: in the absence of data on the passage into breast milk, breastfeeding is not recommended during the course of treatment.
- Pregnancy: There are no reliable data on teratogenesis in animals. Clinically, there are currently no data of sufficient relevance to evaluate the possible malformative or foetotoxic effect of trinitrin when administered during pregnancy. Therefore, except in acute situation, the use of trinitrin is not recommended during pregnancy.
Diafusor side effects
- Headache dose-dependent, frequent at the beginning of treatment and most often transient, or may require a decrease in dosage.
- Hypotension, sometimes orthostatic, especially seen in the elderly or in combination with other vasodilators. These hypotensions may be associated with reflex tachycardia and may be accompanied by dizziness, lipothymia or, exceptionally, syncope.
- Skin vasodilation with erythema and hot flashes.
- Pruritus and erythema at the site of application of the device.
- Digestive disorders (nausea, vomiting).