In vitro studies: Sildenafil metabolism is principally mediated by the cytochrome P-450 (CYP) isoforms 3A4 (primary root) and 2C9 (minor root). But, inhibitors of these isoenzymes may reduce sildenafil clearance.
In vivo studies: Cimetidine (800mg), a known specific CYP inhibitor, caused a 56% increase in plasma sildenafil concentration when co-administered with sildenafil (50mg) to healthy volunteers.
Strong CYP3A4 inhibitors such as itraconazole or ketoconazole would be expected to have steel greater effects, and population data from patients in clinical trials did indicate a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors. It can be expected that concomitant management of CYP3A4 inducers, such rifampin, will decrease plasma level of sildenafil.
Ritonavir, highly potent P4-50 inhibitor, resulted in 300% increase in sildenafil C-max and 1000% increase in sildenafil plasma AUC.single doses of antacid (magnesium hydroxide, Aluminum hydroxide) did not affect the bioavailability of sildenafil.
Pharmacokinetic data from patients in clinical trials shown no effect on sildenafil pharmacokinetics of CYP2C9 inhibitors (such tolbutamide, warfarin), CYP2D6 inhibitors (such selective serotonin reuptake inhibitors, a tricyclic antidepressant), thiazide and related diuretics, ACE inhibitors and calcium channel brokers.
The AUC of the active metabolite, N-desmethyl generic sildenafil, increased 62% by the loop and potassium-sparing diuretics and 102% by known specific beta blockers. These effects on the metabolite are not envisaged to be of clinical consequences.
General Instructions
Always take this Extra Super P Force with a large glass of water.
Avoid large/ fatty meals close to when you intend to take the medication.
When Not to Use
There are no manage clinical data on the safety /efficacy of sildenafil of the following group, if prescribed, these should be done with caution.
Suffered who have suffered a myocardial infarction, stroke, life-threatening arrhythmia within the last six month.
Patients with resting hypertension (BP<90/50) or (BP>170/110)
Patients with cardiac failure or coronary arteries disease causing unstable angina.
Patients with retinitis a minority of these patients have genetic disorders or retinal phosphodiesterase(pigmentosa).
Currently, there is no documented drug-drug interaction associated with dapoxetine jelly. Coadministration of dapoxetine with ethanol did not produce any significant pharmacokinetic changes.
General warnings
Alcohol will reduce the effectiveness of Extra Super P Force medicine and if taken in excess could lead to drowsiness, decreased self-awareness, dizziness, and altered judgment.
Warnings for special population
Pregnancy:
There are no well-controlled studies and adequate of the combination of sildenafil and dapoxetine in pregnant women. It is not indicated in women.
Lactation:
Extra Super P Force drug is not indicated in nursing mother.
Pediatric use:
a combination of sildenafil and dapoxetine is not indicated in children.
