Each ml contains:
Sildenafil (as Citrate)
Sildenafil Oral Suspension 10mg/1ml
Enafil suspension refers to a liquid form of sildenafil, the active ingredient commonly used to treat pulmonary arterial hypertension (PAH). It brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Enafil is a phosphodiesterase inhibitor used for the treatment of pulmonary arterial hypertension (PAH). In eliciting its mechanism of action, sildenafil ultimately prevents or minimizes the breakdown of cyclic guanosine monophosphate (cGMP) by inhibiting cGMP specific phosphodiesterase type 5 (PDE5)
Each 1 mL contains 10 mg Sildenafil.
Ideal for individuals who have difficulty swallowing pills, such as children, elderly patients, or those with swallowing disorders
The liquid form allows for precise, customizable doses, which can be beneficial for patients.
Enafil suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) when;
ENAFIL is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
The recommended dosage of ENAFIL is 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability.
For children 1-17 years <20kg is 10mg three times a day and for patients >20kg is 20 mg three times a day, higher than recommended doses should not be used in pediatric patients with PAH.
Note: Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL).
Refer to the detailed instructions below.
Tap the bottle to loosen the powder, Add 60 mL of water to the bottle.
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds.
Add another 30 mL of water to the bottle, Replace the cap and shake the bottle vigorously for a minimum of 30 seconds.
Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).
Recommended storage for reconstituted oral suspension: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.
ENAFIL is contraindicated in patients with:
Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension.
Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.
Known hypersensitivity to sildenafil or any component oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
After either oral, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
sildenafil is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25 to 63%). Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When enafil is taken with a high-fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%.
Body weight was shown to be a good predictor of drug exposure in children. Sildenafil plasma concentration half-life values were estimated to range from 2.9 to 4.4 hours for a range of 10 to 70 kg of body weight. Tmax was estimated at approximately 1 hour.
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