Vega Asia 100 Composition, Use, Dose, Side Effect
Vega Asia 100 is popularly known and called rocket in Nigeria. This is because of the rocket on its pack. It is made by Vee Excel Drugs And Pharmaceuticals Pvt. Ltd, India and marketed by Donhelens Pharmaceutical Company, Nigeria.
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Vega Asia 100 |
It is one of the many drugs that are fake everywhere. For this reason, the company has launched different packages recently to spell out the original from the fake. The latest introduction is the mobile authentication service for each product.
Composition Of Vega Asia 100
Each film- coated tablet contains:
Sildenafil Citrate USP eq. to Sildenafil 100 mg.
Pharmacological Classification
Phosphodiesterase type 5 inhibitor, vasodilator agents.
Mechanism Of Action
The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide (NO) then activates the enzyme guanylate cyclase, which results in increased level of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
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Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of CGMP in the corpus cavernosum. When sexual stimulation causes local release of nitric oxide (NO), inhibition of PDE5 by Sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle ralaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended dose has no effect in the absence of sexual stimulation.
Pharmacokinetics
Sildenafil is rapidly absorbed after oral administration, with absolute bioavailability of about 40%. Peak plasma concentrations are attained within 30 to 120 minutes; the rate of absorption is reduced when Sildenafil is administered with food. Sildenafil is widely distributed in two tissues and is approximately 96% bound to plasma proteins.
It is metabolized in the liver primarily by cytochrome p450 isoenzymes CYP3A4 (the major route) and CYP2C9. The major metabolite, N Desmethyl-sildenafil, also has some activity. The terminal half-life of Sildenafil and the N Desmethyl metabolite are about 4 hours. Sildenafil is excreted predominantly as metabolites, in the faces, and to a lesser extent in urine. Clearance may be reduced in the elderly and in patients with hepatic or severe renal impairment.
Indications Of Vega Asia 100
Vega Asia 100 is indicated for the treatment of erectile dysfunction (ED).
Contraindications
Consistent with its own effects on the nitric oxide/cGMP pathway, vega Asia 100 was shown to potentiate the hypotensive effects of nitrates, and it's administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.
Warnings
There is a potential for cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. Therefore, treatment for erectile dysfunction, including Vega Asia 100, should not be regularly use in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
Vega Asia 100 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 will be expected to be of little consequence in most patients, prior to prescribing Vega Asia 100, 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.
Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators including Vega Asia 100- those with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.
-There is no controlled clinical data on the safety or efficacy of Vega Asia 100 in the following groups; if prescribed this should be done with caution.
-Patients who have suffered a myocardial infarction, stroke or life-threatening arrhythmias within the last 6 months
-Patients with resting hypotension (BP<90/50 mmHg) or hypertension (BP<170/110 mmHg);
-Patients with cardiac failure or coronary artery disease causing unstable angina;
-Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retina phosphodiesterases).
In the event of an erection that persists longer than four hours, the patients should seek immediate medical assistance. If priapism is not treated immediately, tissue damage and permanent loss of potency could result.
The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of Sildenafil (11-fold increase in AUC). If Vega Asia 100 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.
Decreased 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.
Dosage And Direction For Use Of Vega Asia 100
For most patients, the recommended dose is 100mg taken, as needed, approximately 1 hour before sexual activity. However, Vega Asia 100 may be taken 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 decrease to 25 mg. The maximum recommended dosing frequency is once per day.
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The following factors are associated with increased plasma levels of sildenafil: age >65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 80%), severe renal impairment (creatine in clearance <30 ml/min, 100%), and concomitant use of potent cytochrome p450 3A4 inhibitors [ketoconazole, itraconazole, erythromycin (182%), and saquinavir (210%)]. Since, higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.
Side Effects And Special Precautions
Side Effect
The most common side effects are headache or facial flushing and less commonly indigestion, dizziness, stuffy nose, pounding heart beat, or effects on vision (including color tinge to vision, increased brightness of light or blurred vision). Since its introduction on the market, the following events have been reported in men taking sildenafil: vomiting, allergic reactions, skin rash, bloodshot eyes, eye pain, rapid heartbeat or nosebleeds.
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes have been reported. Sudden decrease or loss of hearing has been reported. Prolong and sometimes painful erections are being reported after taking sildenafil.
Precautions
Caution is advised when phosphodiesterase type 5 (PDE5) inhibitors are co-administered with alpha blockers. PDE5 inhibitors, including sildenafil and alpha adrenergic blocking agents are both vasodilators with blood pressure lowering effects.
When vasodilators are used in combination, an addictive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypertension (e.g. dizziness, lightheadedness, fainting). Consideration should be given to the following:
-Patients should be stable on alpha blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypertension with concomitant use of PDE5 inhibitors.
-In those patients who are stable on alpha blocker therapy, PDE5 inhibitors should be initiated at the lowest dose.
-In those patients already taking an optimized dose of a PDE5 inhibitor, alpha blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha blocker may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
-Safety of combined use of PDE5 inhibitors and alpha blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.
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-Vega Asia 100 has systemic vasodilatory properties and augments the blood pressure-lowering effect of other antihypertensive medications.
Known Symptoms Of Overdosing And Particulars Of Its Treatment
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.
Can A Woman Take Vega Asia 100
Women who take it might also have increased blood flow to the genitals. That may help increase sensitivity, arousal, and orgasmic function. Studies on its effectiveness in women have had mixed results.
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