Nitren.doc

PACKAGE LEAFLET
NITROLONG
ATC code: C01DA05
PHARMACOTHERAPEUTIC GROUP
Vasodilators for heart diseases. Organic nitrates. COMPOSITION
Pentaerythrityl tetranitrate 10 mg in one tablet. Nitrolong is a nitropreparation with prolonged antistenocardial action. It induces relaxation of the smooth muscles mainly of the venous vessels, reducing the venous reflux to the heart, the central venous pressure and the diastolic ventricular filling. The preloading of the heart and to a weaker degree the after loading decreases. The work of the myocardium is relieved, its oxygen needs diminish and the oxygen supply of the heart is improved. The preparation induces redistribution of coronary blood circulation towards the ischemic subendocardial zones of the myocardium. Venous pressure in the pulmonary In oral administration nitrolong is absorbed comparatively well. Therapeutic action begins within 30 min after ingestion and lasts 4-5 hours. The drug is excreted mainly through the kidneys, almost entirely in the form of metabolites. INDICATIONS
Ischemic heart disease - for prophylaxis of attacks of angina pectoris; post- myocardial infarction conditions; chronic congestive cardiac insufficiency - in the CONTRAINDICATIONS
Hypersensitivity to nitropreparations; pronounced anemia; fresh head injuries; cerebral hemorrhages; hypotension; shock conditions; constrictive pericarditis; glaucoma; severe hepatic insufficiency (risk of methaemoglobinaemia); hypertrophic cardiomyopathy; fresh myocardial infarction (in case of risk of developing of hypotension, cardiogenic shock and/or left ventricular cardiac ADVERSE REACTIONS/SIDE EFFECTS
Usually the side effects are short-lived and do not necessitate discontinuation of treatment but only temporary reduction of the dose. Undesirable reactions (dose- dependent) such as reddening of the face and/or the neck, headache, tachycardia, noise in the ears, hypotension, dizziness and palpitations are fairly common. Less often diarrhea, rashes and itching may occur. DRUG AND NON-DRUG INTERACTIONS
Nitrolong potentates the action of all antihypertensive agents such as beta- adrenoblockers, calcium antagonists and ACE-inhibitors. Combination with other vasodilators, alcohol, diuretics and opioid narcotics may provoke orthostatic hypotension. Concomitant usage with acetylholine and histamine reduces their therapeutic effect. Sympathomimetics may weaken the antianginose effect of nitrolong. Parallel administration with Sildenafil (Viagra) is contra-indicated. PRECAUTIONS AND WARNINGS
Due to the risk of orthostatic hypotension and strong headache the dose should be increased gradually until optimum amount is attained. In case of high dose administration the abrupt withdrawal of the drug is contra-indicated. Nitrolong administration in children is not recommended since controlled studies proving the drug’s efficacy and safe employment have not been carried out. Elderly patients are more sensitive to the hypotensive action of the preparation and more easily develop orthostatic hypotension. If headache or reddening of the face occur temporary reduction of the dose and following gradual increase is recommended. In case of cyanosis without data for accompanying pneumopatia the level of Nitrolong is not suitable for treatment of attacks of angina pectoris. Patients sensitive to other nitropreparations may prove so to nitrolong as well. In gastrointestinal hypermotility or malabsorptional syndrome the desired plasma levels may not be attained (in which case an increase of the dose would be In hypertrophic cardiomyopathy nitropreparations, including nitrolong, can The drug should be used with caution in patients with severe dehydration (in intensive diuretic therapy etc) due to the risk of hypotension. In long-term treatment a tolerance to the effect of the drug is developed which can be prevented by regular 10-12 hour interruption intervals in nitrolong intake 1- PREGNANCY AND BREAST-FEEDING
It is recommended that nitrolong is administered with caution in pregnancy and during the period of lactation. The drug has not been reported to pass into the EFFECTS ON ACTIVE ATTENTION, DRIVING ABILITY AND
OPERATION OF MACHINERY
Adverse effects on the active attention, reflexes and motor activity have not been MODE OF ADMINISTRATION AND DOSAGE
Nitrolong is taken orally. Treatment starts with 1 tablet 2-3 times daily. The dose can be increased according to the individual needs of the patient up to 2 tablets 3-4 times daily. The usual maintenance dose is 1 tablet 3 times daily in a long- term treatment determined by a specialist. OVERDOSAGE
Symptoms: severe hypotension, headache, tachycardia or bradycardia; nausea, vomiting and diarrhea; reddening and warming of the skin of the face and neck; cyanosis of the lips, the fingernails or the palms of the hands; dizziness; sense of intense tension in the head; superficial tachypnoea; weak and quick pulse; unusual weakness and fatigue; fever and convulsions. Treatment: gastric lavage, raising of the patient’s legs in order to improve the venous reflux, hospitalization, symptomatic therapy and monitoring of In methaemoglobinaemia over 0.8 g/100 ml methylene blau is administered intravenously 1-2 mg/kg or 50 mg/kg orally in lighter cases. DOSAGE FORM AND PACKAGES
In a dry place protected from light at 15-25oC.

Source: http://www.actavis.bg/nr/rdonlyres/8fbeb81f-fafa-4584-b76d-faf6f627f56a/0/nitrolong_eng.pdf