INDICATION AND USAGE:
Sildenafil is indicated for the treatment of erectile dysfunction. The studies that established benefits demonstrated improvements in success rates for sexual intercourse compared with placebo.
Use of sildenafil is contraindicated in patients with a known hypersensitivity to any components of the tablet.
Consistent with its known effects on the nitric oxide/cGMP/ pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contraindicated .
When sildenafil was taken as recommended (no an as-needed basis) the following adverse events were reported:
Headache 16 %, Rushing 10 %, Dyspepsia 7 %, Nasal Congestion 4 %, Urinary Tract Infection 3 %, Abnormal Vision 3 %, Diarrhea 3 %, Dizziness 2 %, Rash 2 %. Other adverse reactions occurred at rate of > 2 % such as respiratory tract infection, back pain, flu syndrome and arthralgia.
Sildenafil caused some rare cases such as: face odema, photosensitivity reaction, migraine, tachycardia, angina pectoris. palpitation, heart failure, abnormal electrocardiogram , glossitis, stomatitis, vomiting, anemia, leukopenia, thirst, gout, arthritis, myalgia, neuralgia, paresthesia, tremor, vertigo, depression, dyspenea, laryngitis, pharyngitis, pruritis, dermatitis, nocturia, unnary frequency, urinary incontinence , genital odema.
In studies with healtiy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses at incidence rates were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.
DOSAGE AND ADMINISTRATION:
For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.However, TIGRAN may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day. The following factors are associated with increased plasma levels pf sildenafil: ade > 65 (40 % increase in AUC), hepatic impairment (e.g. cirrhosis, 80%), severe renal impairment (creatinine clearance < 30 mL/min, 100 %), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, 200 %). Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.
TIGRAN was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated .
A pack contains 4 film-coated tablets.
The drug is indicated only by a prescription dated no more than two weeks. The prescription should be sealed by the pharmacist's seal.