NaPifit Tablet is a prescription medicine used to treat erectile dysfunction (impotence) in men. It works by increasing blood flow to the penis. This helps men to get or maintain an erection. It belongs to a group of medicines known as phosphodiesterase type 5 (PDE 5) inhibitors.

NaPifit Tablet may be taken on an empty stomach or with a meal. It should be strictly taken as advised by your doctor. You should take about 1 hour before you plan to have sex. The amount of time it takes to work varies from person to person, but it normally takes between 30 minutes and 1 hour. This medicine will only help you to get an erection if you are sexually stimulated. However, you should not take this medicine if you do not have erectile dysfunction. It should not be taken more than once a day.

The most common side effects of this medicine are flushing (sense of warmth), headache, dizziness, blurred vision, muscle pain, stomach upset, and rash. Talk to your doctor if any of the side effects bother you or do not go away.

This medicine is not intended for use by women and men should avoid using any other medicines to treat impotence without talking to a doctor first. It can be dangerous to take it along with medicines called nitrates (often given for chest pain or angina). Do not take this medicine if you have severe heart or liver problems, have recently had a stroke or heart attack or if you have low blood pressure. Let your doctor know if you suffer from these or any other health problems before taking it. You should not drive if this medicine makes you feel dizzy. Avoid drinking alcohol while taking this medicine as it increases the chances of side effects.

Composition

• Each NaPifit 50 mg film coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
• Each NaPifit 75 mg film coated tablet contains sildenafil citrate equivalent to 75 mg sildenafil.
• Each NaPifit 100 mg film coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.

Inactive ingredients: Hydroxy propyl cellulose LF (Klucel LF), croscarrnellose sodium , microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, sodium starch glycollate and purified water.

• NaPifit 50 mg tab, NaPifit 75 mg tab: Opadry Blue, Opadry Silver.
• NaPifit 100 mg tab: Opdary Red, Opadry Silver.

Indications

Napifit is indicated for the treatment of erectile dysfunction.

Dosage and administration

For most patients, the recommended dose is 50 mg taken as needed approximately 1 hour before sexual activity. However, NaPifit may betaken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

Side effects

Headache, flushing. dyspepsia, nasal congestion, urinary tract infection, diarrhea, dizziness, rash. Abnormal vision: Mild and transient, predominantly colour tinge to vision, but also increased sensitivity to light or blurred vision.

Adverse effects which occur at a rate of > 2%: Respiratory tract infection, back pain, flu syndrome, and arthralgia.

Rare side effects which occur in < 2% of patients such as: Photosensitivity reaction, vomiting, glossitis, anaemia, myalgia, bone pain, abnormal dreams, urticaria, pruritus, sweating.

Pharmacodynamics

NaPifit, sildenafi I, is a phosphodiesterase type-5 inhibitor (PDE5). Its effect is more potent on PDE5 than on other known phosphodiesterases.

Sildenafil enhances the effect of nitric oxide (NO), released during sexual stimulation, by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavemosum.

Increased levels of cGMP cause smooth muscle relaxation and allow inflow of blood in the corpus cavemosum.

Pharmacokinetics

Sildenafil is rapidly absorbed after a dose by mouth, with a bioavailability of about 40% Peak plasma concentrations are reached within 30 to 120 minutes; The rate of absorption is reduced when sildenaftl is taken with food.

It is widely distributed into tissues and is about 96% bound to plasma proteins.

It is metabolised in the liver mainly by cytochrome P450 isoenzymes CYP3A4 (the major route) and CYP2C9. The major metabolite, N-desmethylsildenafil also has some activity.

The terminal half-lives of both sildenafil and the N-desmethylsildenafil metabolite are about 4 hours. It is excreted as metabolites, mainly in the faeces, and to a lesser extent in the urine.

Clearance may be reduced in the elderly and in patients with hepatic or severe renal impairment.

Contraindications

In patients with a known hypersensitivity to any component of the tablet, patients receiving nitrates, ischemic, optic neuropathy, hypotension, recent stroke, unstable angina and myocardial infarction.

Drug-drug interactions

• Organic nitrates: Sildenafil or other phosphodiesterase type-5 inhibitors may potentiate the hypotensive effects of organic nitrates, and are therefore contraindicated in patients receiving such drugs.
• Alpha blockers: Symptomatic hypotension may occur when phosphodiesterase type-5 inhibitors are given with alpha blockers.
• Drugs that inhibit the cytochrome P450 isoenzyme CYP3A4, such as cimetidine, erythromycin, itraconazole, ketoconazole, and HIV-protease inhibitors, may reduce the clearance of phosphodiesterase type-5 inhibitors, necessitating a reduction in dosage.
• Grapefruit juice should be avoided with sildenafil or other phosphodiesterase type-5 inhibitors as it may increase their plasma concentrations.
• Inducers of CYP3A4, such as rifampicin, are likely to decrease plasma concentrations of phosphodiesterase type-5 Inhibitors.

Pregnancy and Lactation

Not indicated

Precautions

Caution is required in patients with hepatic or severe renal impairment, and dosage reduction of sildenafil may be necessary. Care is also needed in patients with anatomical deformation of the penis or haematological disorders that may predispose them to priapism.

Patients who experience dizziness or visual disturbances should not drive or operate hazardous machinery. Caution in patients with a recent history of stroke, myocardial infarction, or life-threatening arrhythmia, unstable angina, heart failure.

Presentation

• NaPifit 50 mg is supplied in wallet of 2 tablets each.
• NaPifit 75 mg is supplied in wallet of 2 tablets each.
• NaPifit 100 mg is supplied in box of 4 tablets each.

Store at temperature not exceeding 30° C in a dry place.

Manufactured by: GLOBAL NAPI PHARMACEUTICALS – October City – EGYPT.

NaPifit Tablet – Information Leaflet

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Egypt – Brands of Sildenafil Citrate 50mg film coated tablets 

1. VIRECTA 50MG 30 F.C. TAB.
2. BLUVISA® United Pharmaceutical
3. VIGOREX 50MG 4 F.C.TAB.
4. VIGORAN 50MG 4 F.C.TAB.
5. VIGORAMA 50 MG 4 F.C.TABS.
6. VIGOR 50MG 1 F.C.TAB.
7. VIAGRA 50 MG 4 F.C.TABS.
8. VETOYAGRA 50 MG 5 F.C. TABS.
9. V-GONE 50 MG 10 F.C. TAB.
10. ANDAGRA 100 MG 4 F.C. TABS.
11. SILDEN 50 MG 4 F.C. TABS.
12. NAPIFIT 50MG F.C. 1TAB.
13. EZEQUEL 50 MG 4 F.C.TAB
14. ECTAGOR 50 MG 4 F.C. TABS.