Absorption and Distribution: 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. When sildenafil 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 C max of 29%.
Luv-69 is indicated for the treatment of erectile dysfunction in men.
Use of Luv-69 is contraindicated in patients with a known hypersensitivity to any component of the jelly. Consistent with its known effects of the nitric oxide/ cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contraindicated Luv-69 is not indicated for use to women and individuals below 18 years of age.
DOSAGE AND METHOD OF ADMINISTRATION:
For most patients, the recommended dose is 50 mg taken, as needed approximately I hour before sexual activity. However, Luv-69 may be taken anywhere from 4 hours to 5 hours before sexual activity. Based on effectiveness and tolerance, 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.
WARNINGS AND PRECAUTIONS :
A through medical history and physical examination should be undertaken to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment. There is a degree of cardiac risk associated with sexual activity, therefore physicians should consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction. Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation cavernosal fibrosis or peyronie's patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple mycloma, or leukemia). There is no safety information on the administration of sildenafil to patients with bleeding disorder or active peptic ulceration. Therefore it should be administered with caution to these patients.
Pregnancy and Lactation: There is no adequate and well-controlled studies of sildenafil in pregnant women Sildenafil is not indicated in pregnant women. Sildenafil is not indicated for nursing mothers .
Alpha-blockers, amlodipine (eg, doxazosin)
Administration may result in an additional decrease in BP
Sildenafil plasma concentrations may be prolonged; however, data are conflicting. HMG-CoA reductase inhibitors (cg, simvastatin)
At least 1case of rhabdomyolysis has been reported during coadministration of sildenafil and simvastatin.
Inducers of CYP3A4 (eg rifampin) May decrease sildenafil levels. Inhibitors of CYP3A4 (cg, cimetidine, erythromycin, itraconazole, ketoconazole protease inhibitors [cg; ritonavir, saquinavir], tacrolimus)
Sildenafil plasma levels may be elevated, increasing the risk of adverse reactions Nitrates
H Hypotension (see Contraindications).
Administration of opiod analgesics (eg. Dihydrocodeine) may prolong, the effect of sildenafil resulting in prolonged erections following orgasm.
Approximately 15% of persons taking sildenafil experience side effects. The most common side effects are facial flushing (1 in 10), headaches (1 in 6), stomach pain, nasal congestion, nausea, diarrhea, and an inability to differentiate between the colors green and blue. Rare cases of sudden loss of hearing have been reported with phosphodiesterase inhibitors such as sildenafil, sometimes with ringing in the ears and dizziness. If changes in hearing occur, patients should discontinue their sildenafil and seek immediate medical attention.
In studies with healthy volunteers a single dose up to 800 mg, resulted in reactions adverse similar to those seen with lower doses but incidence rates were increased. 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 is not eliminated in the urine.
Not to be taken more than 1 dose in 24 hr period.
Store below 300 C . Keep out of reach of children.
3 years from the date of manufacturing.
LUV-69 is available in 5gm sachets in a carton.