KX-50

KX-5050mg

Type:Tablet

Generic Name:Sildenafil

Manufacturer:Kemiko Pharmaceuticals Ltd.

Price:30.09

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Indication

Erectile dysfunction, Pulmonary arterial hypertension

Administration

May be taken with or without food.

Adult Dose

Oral Erectile dysfunction Adult: 50 mg about 1 hr before sexual intercourse. May adjust dose depending on penile response. Max: 100 mg/dose and not to be taken > once in 24 hr. Elderly: >65 yr: Lower initial dose at 25 mg. Hepatic impairment: Initially, 25 mg. Pulmonary Arterial Hypertension 20 mg 3 times daily, administered 4-6 hours apart

Renal Dose

Renal impairment: CrCl (ml/min) Dosage Recommendation <30 Initially, 25 mg.

Contraindication

Hypersensitivity. Patients concurrently or intermittently using organic nitrates in any form.

Mode of Action

Sildenafil inhibits phosphodiesterase type-5 (PDE5) which is responsible for cGMP degradation in the corpus cavernosum. Inhibition of PDE5 increases cGMP levels in the corpus cavernosum which results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.

Precaution

Caution when used in patients with anatomical deformation of penis or conditions that may predispose them to priapism (e.g. sickle cell anaemia, myeloma, or leukaemia). Mild, transient, dose-related impairment of colour discrimination (blue/green) may occur. Hepatic or severe renal impairment, bleeding disorders, active peptic ulceration, hypotension, recent history of stroke, MI, arrhythmias, unstable angina, heart failure or retinal disorders. May cause sudden loss or decrease in hearing.

Side Effect

>10% Headache (7-16%) 1-10% Flushing (4-10%),Epistaxis (8%),Dyspepsia (4-8%),Insomnia (6%),Erythema (5%),Diarrhea (4%),Dizziness (2%),Skin rash (2%)

Interaction

Inhibitors of CYP3A4 such as cimetidine and erythromycin are likely to reduce sildenafil clearance. CYP3A4 inducers such as rifampicin may decrease the plasma concentrations of sildenafil. Symptomatic hypotension when used with beta-blockers. Plasma concentrations are increased by ritonavir. Potentially Fatal: May potentiate hypotensive effects of of organic nitrates and nicorandil.

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