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THERAPEUTIC INDICATIONS: Maxifort is indicated for the treatment of erectile dysfunction, which is the inability to achieve or maintain sufficient erection of the penis for satisfactory sexual performance. For Maxifort to be effective it is necessary that there is sexual stimulation. PHARMACOKINETICS AND PHARMACODINAMIA IN HUMANS. Pharmacodynamic properties Maxifort is an oral solution for erectile dysfunction disorders consisting of Maxifort citrate salt, which is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific for phosphodiesterase type 5 (PDE5). Mechanism of action: The physiological mechanism responsible for the erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. As a result, nitric oxide activates the enzyme guanylate cyclase, resulting in increased concentrations of cyclic guanosine monophosphate (cGMP), resulting in relaxation of the smooth muscle of the corpus cavernosum, favoring blood flow. Maxifort does not exert a direct relaxing effect on the isolated human corpus cavernosum but increases the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for the degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local NO release, inhibition of PDE5 by action of Maxifort causes an increase in cGMP concentrations in the corpus cavernosum, resulting in smooth muscle relaxation and increased blood flow to the corpus cavernosum. At recommended doses, Maxifort has no effect in the absence of sexual stimulation. In vitro studies have shown that Maxifort is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (80 times for PDE1, 1,000 times over PDE2, PDE3 and PDE4). The approximately 4,000-fold selectivity for PDE5 compared to PDE3 is important because PDE is involved in the control of cardiac contractility. Minor and transient differences in color discrimination tests (blue-green) were observed in some subjects using the Farns-worth-Mensell 100 dye test at 60 minutes after taking a dose of 100 mg without observing Evidence of effects 120 minutes after taking the medicine. The mechanism postulated for this change in color discrimination is related to the inhibition of PDE6, which is involved in the phototransduction cascade of the retina. In vitro studies demonstrate that Maxifort is 10-fold less potent against PDE6 than against PDER5. Maxifort has no effect on studies of visual acuity, contrast sensitivity, electroretinograms, intraocular pressure or pupillometry. Clinical studies: The administration of single doses of oral Maxifort up to 100 mg did not cause clinically significant changes in ECG studies in healthy male volunteers. After administration of a 100 mg dose by oral route, the mean maximum decrease in systemic blood pressure in dorsal decubitus was 8.4 mmHg. While the corresponding change in diastolic blood pressure figures was 5.5 mmHg. Significant but also transient changes in blood pressure figures were recorded in patients who were simultaneously receiving concomitant nitrate treatment (see Contraindications and drug and other drug interactions). The efficacy and safety of Maxifort were studied in 21 randomized, double-blind, placebo-controlled studies lasting up to 6 months. Maxifort was administered to more than 3,000 patients aged 19-87 years, with erectile dysfunction of various etiologies (organic, psychogenic and mixed). Efficacy was studied by means of a general evaluation questionnaire, erectile log diary, the International Erectile Function Index (IIFE, validated questionnaire for sexual function) and a questionnaire for the sexual partner.

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Brand(s): Vikalis VX

Sold as: Generic Cialis

Manufacturer: Shree Venkatesh

Strength: 5mg / 10mg / 20mg / 40mg /60mg

Packaging: Blister of 10 Tablets