Megafil 20 mg tab

Megafil 20 mg tab

DESCRIPTION

Tadalafil (MEGAFIL) an oral treatment for erectile dysfunction is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) .Penile erections during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle.

This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5.

Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by Tadalafil has no effect in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established.

COMPOSITION

MEGAFIL 5 : Each film-coated tablet contains Tadalafil INN 5 mg.

MEGAFIL 10 : Each film-coated tablet contains Tadalafil INN 10 mg.

MEGAFIL 20 : Each film-coated tablet contains Tadalafil INN 20 mg.

INDICATIONS

MEGAFIL (Tadalafil) is indicated for the treatment of-

 Erectile dysfunction.

 Benign Prostatic Hyperplasia

 Erectile Dysfunction and Benign Prostatic Hyperplasia

DOSAGE AND ADMINISTRATION

Erectile dysfunction:

The recommended starting dose of MEGAFIL (Tadalafil) in most patients is 10 mg, taken 30 minutes before sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.

MEGAFIL (Tadalafil) may be taken without regard to food.

Benign Prostatic Hyperplasia:

The recommended dose of Tadalafil for once daily use is 5 mg, taken at approximately the same time every day.

Erectile Dysfunction and Benign Prostatic Hyperplasia:

The recommended dose of Tadalafil for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE-EFFECTS

The side-effects of Tadalafil as mild or moderate in severity include dyspepsia, headache, flushing, dizziness, visual disturbances, raised intra-ocular pressure, nasal congestion, back pain and myalgia.

Hypersensitivity reactions (including rash), priapism, and painful red eyes have been reported.

CONTRAINDICATIONS

Tadalafil is contra-indicated in patients receiving nitrates or in patients in whom vasodilation or sexual activity are inadvisable. In the absence of information, manufacturers contra-indicate this drug in hypotension, recent stroke, unstable angina, myocardial infarction, moderate heart failure, uncontrolled arrhythmias and uncontrolled hypertension.

PRECAUTIONS

Tadalafil should be used with caution in cardiovascular disease, anatomical deformation of the penis (e.g. angulation, cavernosal fibrosis, Peyronie's disease), and in those with a predisposition to prolonged erection (e.g. in sickle-cell anaemia, multiple myeloma, or leukaemia). In hepatic impairment and in mild renal impairment maximum dose is 10 mg.

Use in children and adolescents

Tadalafil is not indicated for individuals below 18 years of age.

Use in Pregnancy & Lactation

Tadalafil is not indicated for use in women.

DRUG INTERACTIONS

Nitrates and Nicorandil: Tadalafil significantly enhances hypotensive effect of Nitrates and Nicorandil (avoid concomitant use)

Alpha-blockers: Enhanced hypotensive effect when Tadalafil is given with alpha-blockers (avoid concomitant use). Plasma concentration of Tadalafil is possibly increased by Saquinavir,

Clarithromycin, Erythromycin, Itraconazole, and Grapefruit juice. Plasma concentration of Tadalafil is increased by Ketoconazole and

Ritonavir and reduced by Rifampicin.

SUPPLY

MEGAFIL 5: Each box contains 5x4 tablets in blister strips.

MEGAFIL 10: Each box contains 5x4 tablets in blister strips.

MEGAFIL 20: Each box contains 5x2 tablets in blister strips.