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UNIKET ® 40 mg. ISOSORBIDE-5-MONONITRATE
COMPOSITION
Each tablet contains:
Isosorbide-5-mononitrate (I.N.N.) ………… 40 mg.
Excipients: Lactose, talc, colloidal silicon dioxide, potato starch, microcrystalline cellulose, aluminium stearate, magnesium stearate, q.s.
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PROPERTIES
Isosorbide-5-mononitrate is the main active metabolite of isosorbide dinitrate. The extent of bioavailability of isosorbide-5-mononitrate is 100% after oral administration and it is metabolised very slowly, therefore it has a very prolonged action (more than 12 hours). Like other nitrates, isosorbide-5-mononitrate reduces the demand of the myocardium for oxygen, thus improving myocardial oxygen balance. The action of isosorbide-5-mononitrate is the relaxation of vascular smooth muscle producing vasodilation of both veins (intense) and peripheral arteries (moderate). This vasodilation simultaneously reduces cardiac preload and afterload thereby reducing the workload of the heart, resulting in a decreased myocardial oxygen requirement and an improved oxygen demand / supply balance in the myocardium, this change is the basis of the manifestations of ischemic heart disease.
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INDICATIONS
For the prophylaxis and treatment of angina pectoris.
POSOLOGY
The usual recommended dose is 20 mg. (1/2 tablet) twice or three times per day. The dose may be increased to 40 mg. (1 tablet) twice per day if there is no satisfactory response. For patients that do not receive nitrate therapy regularly it is convenient that they initiate treatment with a low dose and increase it gradually. In any case, when prophylactic nitrate derivative therapy has already been established, the patient can be directly switched to therapeutic doses of isosorbide-5-mononitrate, taking into account the patients need for nitrates.
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CONTRAINDICATIONS
UNIKET should not be given to patients with a known hypersensitivity to this medication or to isosorbide dinitrate. It should not be administered in cases of shock, cardiovascular collapse, marked hypotension or acute myocardial infarction with low filling pressure. It should not be used in patients with marked anaemia, a head trauma and cerebral haemorrhage.
Patients taking this medication must not concomitantly take products that contain sildenafil (medications used for male erectile dysfunction). For more information please consult your doctor or pharmacist.
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PRECAUTIONS
It is convenient that this preparation be administered in a seated position, especially at the beginning of the treatment, particularly when taking high doses or in the case of elderly patients. Long term therapy should not be stopped suddenly. Both the dosage and frequency should be tapered gradually. This medicinal product contains lactose. Even though intolerance to this ingredient has been reported in children and adolescents, the quantity present in this medication is probably not sufficient to cause symptoms of intolerance. If you experience diarrhoea you should consult your doctor.
Use during pregnancy and lactation. UNIKET should not be taken during the first 3 months of pregnancy, the drug should only be administered to pregnant women if, in the opinion of the physician, the clinical benefits outweigh the potential risks. It is not known whether the active substance passes into the breast milk.
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INTERACTIONS
Due to the possible enhanced hypotensive effect of UNIKET, caution should be taken when it is administered concomitantly with antihypertensive agents (calcium antagonists, ?-blockers, diuretics) and phenothiazines. The consumption of alcohol may impair the patient's ability to react. Nitrates may interfere with the Zlatkis-Zak color reaction causing a false report of decreased serum cholesterol.
Concomitant administration of isosorbide-5-mononitrate and preparatations that contain sildenafil (medications used for male erectile dysfunction) may impair the action this medication has on the heart (see CONTRAINDICATIONS).
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SIDE EFFECTS
In certain cases, especially at high doses or at the start of therapy, orthostatic hypotension may occur. The consumption of alcoholic beverages may potentiate this effect. In patients that are particularly sensitive, hypotension may lead to syncope, which may be mistaken for symptoms of acute myocardial infarction. Treatment should be instituted gradually, especially in patients taking diuretics or another antihypertensive agent or in subjects with systolic blood pressure below 90 mmHg.
Other side effects are: headache, rubor or facial flushing, dizziness, palpitations and fatigue. All these side effects, including hypotension, generally disappear during continued treatment or when reducing the dose. Like other nitrates, isosorbide-5-mononitrate may on rare occasions cause skin rash and / or exfoliative dermatitis.
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WARNINGS
Treatment with isosorbide-5-mononitrate may impair reflex response time. The patient should therefore be advised that if affected, they should not drive or operate dangerous machinery. This effect may be increased by the concomitant ingestion of alcohol (see INTERACTIONS).
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OVERDOSE AND ITS TREATMENT
The main symptom of massive ingestion is likely to be hypotension. Gastric lavage should be carried out. Usually, placing the patient in supine position with legs raised is sufficient to correct a fall in blood pressure. If other overdose symptoms occur appropiate symptomatic treatment should be given. For more information in case of an overdose or accidental ingestion, consult your local poison centre
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