MAN-G composition, Dose, Use, Side Effect

MAN-G is a sex enhancement drug. It is used to treat erectile dysfunction in men. It produces some undesirable side effects. It is made by olive healthcare in Indian under license from darvinks international limited in England. In Nigeria, it is marketed by Elbe pharma nig ltd.

MAN-G

Composition Of MAN-G

Each film-coated tablet contains:

Sildenafil Citrate BP equivalent to Sildenafil.......100mg

Excipients q.s

Color: Brilliant Blue FCF

Pharmacokinetics

Absorption: Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). After oral dosing of sildenafil, AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg). When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in tmax of 60 minutes and a mean reduction in Cmax of 29%.

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Distribution: The mean steady state volume of distribution (Vd) for sildenafil is 105, indicating distribution into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%). Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM). Protein binding is independent of total drug concentrations. In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.

Biotransformation: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further metabolized, with a terminal half-life of approximately 4 h.

Elimination: The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).

Pharmacological Action

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the NO/CGMP pathway is activated, as occurs with sexual of PDE5 by sildenafil results in increased corpus cavernosum levels of CGMP. Therefore, sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.

Indications Of MAN-G

MAN-G is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

Dosage Of MAN-G

100 mg as a single dose once a day 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. If needed, the medical doctor may increase or decrease your daily dose.

MAN-G is not indicated for individuals below 18 years of age.

Method Of Administration

Swallow the tablet without chewing with a sip of water.

For oral use only.

Contraindications

MAN-G is contraindicated in patients with a known hypersensitivity to any component of the tablet.

Adverse Effects

Allergic reaction: Symptoms include sudden wheezing, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

Very common (may affect more than 1 in 10 people) is headache.

Common (may affect up to 1 to 10 people) are facial flushing, indigestion, effects on vision (including color tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision), stuffy nose and dizziness.

Uncommon (may affect up to in 1 to 100 people) are vomiting skin rash, bleeding at the back of the eyes, bloodshot eyes/red eyes, eye imitation, eye pain, double vision, abnormal sensation in the eye, watery eyes, pounding heartbeat, rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, penile bleeding, presence of blood in semen and/urine, chest pain and feeling tired.

Rare (may affect up to 1 in 1,000 people) are high blood pressure, low blood pressure, fainting, stroke, heart attack, irregular heartbeat, nosebleed and sudden decrease or loss of hearing.

Not known (frequency cannot be estimated from the available data): Additional side effects reported from post-marketing experience: Unstable angina (a heart condition), sudden death temporarily decreased blood flow to parts of the brain.

Special Warnings And Precautions For Use

• There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction including MAN-G should be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. MAN-G has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4 /5.5 mmHg).

• While this normally would be expected to be of little consequence in most patients, prior to prescribing MAN-G, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. There is no controlled clinical data on the safety or efficacy of MAN-G in the following groups; if prescribed this should be done with caution.

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• Patients who have suffered a myocardial infarction, stroke or life-threatening arrhythmia within the last 6 months.

• Patients with resting hypotension (BP 30/50) or hypertension (BP >170/110).

• Patients with cardiac failure or coronary artery disease causing unstable angina

• Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterase).

• Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of MAN-G. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Drug Interactions

The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). If MAN-G is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Visual disturbances occurred more commonly at higher levels of sildenafil exposure: Decreed blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg).

To decrease the chance of adverse events in patients taking ritonavir, a decrease in sildenafil dosage is recommended. A reduction in Sildenafil clearance occurs when it is co-administered with specific CYP 344 inhibitors such as ketoconazole, erythromycin, or itraconazole and with non-specific CYP inhibitors such as cimetidine. It can be expected that concomitant administration of CYP3A4 inducers, such an ampicillin, will decrease the plasma levels of Sildenafil.

Use In Pregnancy And Lactation

MAN G is not indicated for use by women. There are no adequate and well-controlled studies in pregnant or breast-feeding women.

Effects On Ability To Drive And Operate Machine

No studies on the effects on the ability to drive and use machines have been performed. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to MAN-G, before driving or operating machinery.

Overdosage

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.