Medicinal Products

DINITRATE ISOSORBIDE TEVA LP 60 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Isosorbide dinitrate
laboratory: Teva Classics

Sustained-Release Capsule
Box of 30
All forms

Indication

- Preventive treatment of the angina crisis.
Treatment of left or global heart failure, in combination with other usual therapies.

Dosage DINITRATE ISOSORBIDE TEVA LP 60 mg Prolonged-release capsule Box of 30

Mode of administration :
- Oral way.
- The capsules must be swallowed directly without opening them.
Dosage :
Nitrate derivatives are administered discontinuously on the nycthemeron by providing a daily free interval in order to avoid the well-established therapeutic escape phenomenon when the nitrated derivatives are administered continuously.
- This free interval will be chosen in the period when the patient does not present a crisis.
The schedule for the associated anti-anginal treatment (betablocker and / or calcium antagonist) should be chosen to ensure therapeutic coverage during the free interval. The duration of the free interval is approximately 12 hours.
- The methods of administration are the same in the preventive treatment of the angina attack and in the treatment of left or global heart failure.
- 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. From the beginning of the treatment, the most adapted forms are those with prolonged release. Conventional forms may be used if the dosage does not exceed 60 mg per day.
- In heart failure, the escape phenomenon was also observed. It can be at least partially countered by adjuvant therapies (diuretics, IEC). It is possible that its clinical significance is lower when high doses of nitrates are used.
- Preventive treatment of the angina attack:
. Initial dose :
It is advisable to start the treatment with the lowest dosages of nitrates.
. Dose of maintenance :
The dose will then be adjusted according to the desired clinical effect and the individual response of each patient. The usual dose varies from 10 to 80 mg per 24 hours. When a 60, 80 or 120 mg extended-release form is used, it should be taken at one time, in order to respect a free range.
- Left or global heart failure:
. Initial dose :
It is advisable to start the treatment with the lowest dosages of nitrates.
. Dose of maintenance :
The dose will then be adjusted according to the desired clinical effect and the individual response of each patient. The usual dose varies from 10 to 80 mg per 24 hours. When a 60, 80 or 120 mg extended-release form is used, it should be taken at one time, in order to respect a free range.
- Refractory heart failure:
Because of the precarious hemodynamic balance of these patients, the doses should be increased very gradually up to the maximum dose of 240 mg per 24 hours. The high doses are intended for exceptional cases of patients generally hospitalized and therefore under close clinical supervision.
The sustained-release forms are particularly suitable for this type of patient because they make it possible to reach the effective plasma concentrations in a very progressive manner.

Against indications

CONTRAINDICATED:
This medicine MUST NEVER be prescribed in the following cases:
- hypersensitivity to nitrates,
- 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 having a first anginal episode after the sexual activity, it is advisable to search by questioning the possible taking of sildenafil (most often, in the hour preceding the sexual activity) and if so, 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.
- Due to the presence of lactose and sucrose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome, lactase deficiency, fructose intolerance or sucrase-deficiency. isomaltase.
NOT RECOMMENDED :
This medicine SHOULD NOT BE USED in case of:
- obstructive cardiomyopathy,
- lower seat myocardial infarction with extension to the right ventricle, in the acute phase,
- intracranial hypertension,
- if 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. In clinical studies, there are currently no data of sufficient relevance to evaluate the possible malformative or foetotoxic effect of isosorbide dinitrate when administered during pregnancy. Therefore, except in acute situation, the use of isosorbide dinitrate is not recommended during pregnancy.

Adverse effects Dinitrate Isosorbide Teva LP

- Headache dose-dependent, frequent at the beginning of treatment and most often transient, or may require a decrease in dosage.
- Hypotension, sometimes orthostatic, especially reported in the elderly or in combination with other vasodilators. These hypotensions may be associated with reflex tachycardia and be accompanied by dizziness, lipothymia, or syncope exceptionally.
- Skin vasodilation with erythema and hot flashes.
- Digestive disorders (nausea and vomiting).

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