Viagrazen 50 mg (Tablet)
Unit Price: ৳ 25.00 (1 x 6: ৳ 150.00)
Strip Price: ৳ 150.00
Medicine Details
Category | Details |
---|---|
Generic | Sildenafil citrate |
Company | Zenith pharmaceuticals ltd |
Also available as |
Title
- Viagrazen
Categories
- Medicine
- Drugs for Erectile Dysfunction
Description
- Selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5)
- Causes smooth muscle relaxation and inflow of blood into the penile tissues
Indications
- Treatment of men with erectile dysfunction
- Also indicated in pulmonary arterial hypertension
Mechanism of Action
- Inhibition of PDE5 by Viagrazen produces increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood into the penile tissues
Pharmacokinetics
- Rapidly absorbed after oral administration
- Mean absolute bioavailability of 41%
- Eliminated predominantly by hepatic metabolism
- Converted to an active metabolite with similar properties to the parent
Dosage & Administration
- Recommended dose for erectile dysfunction: 50 mg, taken approximately 1 hour before sexual activity
- May be increased to a maximum recommended dose of 100 mg or decreased to 25 mg based on effectiveness and toleration
- Maximum recommended dosing frequency is once per day
- Recommended dose for pulmonary arterial hypertension: 20 mg three times a day
Interactions
- Metabolism is mediated by the cytochrome P450 isoforms 3A4 and 2C9
- Inhibitors of these isoenzymes may reduce clearance, while inducers may increase clearance
Contraindications
- Hypersensitivity to any component of the medication
- Concomitant use with organic nitrates
Side Effects
- Includes various cardiovascular, digestive, hemic and lymphatic, nervous, respiratory, and urogenital adverse reactions
Pregnancy & Lactation
- Pregnancy category B
- Not indicated for use by women
Precautions & Warnings
- Caution advised when co-administered with alpha-blockers
- Potential for cardiac risk in patients with preexisting cardiovascular disease
Overdose Effects
- Adverse events similar to lower doses, but with increased incidence rates and severities
Storage Conditions
- Keep in a dry place, away from light and heat
- Keep out of the reach of children
Pharmacology
- Release of nitric oxide in the corpus cavernosum during sexual stimulation
- Activation of guanylate cyclase and increased levels of cGMP
- Rapidly absorbed, reaching maximum plasma concentrations within 30 to 120 minutes
- Cleared by hepatic microsomal isoenzymes
Special Populations
- Reduced clearance in healthy elderly volunteers (65 years or over)
Affecting Factors
- Age >65
- Hepatic impairment
- Severe renal impairment
- Concomitant use of potent cytochrome P450 3A4 inhibitors
Pharmacokinetics in Special Populations
- Reduced clearance in healthy elderly volunteers
Potential Drug Interactions
- Inhibitors or inducers of cytochrome P450 isoforms may affect clearance
Clinical Data
- No controlled clinical data on safety or efficacy in certain patient groups
Sensitivity
- Patients with left ventricular outflow obstruction
- Patients with severely impaired autonomic control of blood pressure
Additional Precautions
- Viagrazen has systemic vasodilatory properties that could affect patients with underlying cardiovascular disease
- Patients with certain conditions may be particularly sensitive to vasodilators
Risks
- Potential for symptomatic hypotension when co-administered with alpha-blockers
Cardiac Risk
- Use of Viagrazen in men for whom sexual activity is inadvisable due to underlying cardiovascular status should be carefully considered
Sensitive Patient Groups
- Patients with preexisting cardiovascular risk factors
- Patients with specific cardiovascular conditions
Long-term Effects
- No controlled clinical data on safety or efficacy in certain patient groups
Possible Adverse Outcomes
- Prolonged erection greater than 4 hours and priapism
- Adverse cardiac, cerebrovascular, and vascular events
Evaluation
- Evaluation of potential underlying causes of erectile dysfunction
- Identification of appropriate treatment following a complete medical assessment
Hypersensitive Reactions
- Possible allergic reaction to any component of the medication
Vasodilatory Effects
- Viagrazen has systemic vasodilatory properties
Symptomatic Hypotension
- Concomitant use with alpha-blockers may lead to symptomatic hypotension
Urogenital Adverse Reactions
- Includes cystitis, urinary frequency, abnormal ejaculation, and genital edema
Potential Risks for Patients
- Potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease
Blood Pressure-lowering Effects
- Vasodilators like Viagrazen and alpha-adrenergic blocking agents can have an additive effect on blood pressure
Recommendations
- Initiation of PDE5 inhibitors at the lowest dose in stable alpha-blocker therapy
Considerations
- Consideration should be given to certain patient groups, including those with bleeding disorders and active peptic ulceration
Potential Cardiac Risk
- Viagrazen should not be generally used in men for whom sexual activity is inadvisable due to underlying cardiovascular status
Drug Combinations
- Safety and efficacy of combinations with other treatments for erectile dysfunction have not been studied
Cardiac Risk of Sexual Activity
- There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease
Coronary Artery Disease
- Viagrazen should not be generally used in patients with coronary artery disease causing unstable angina
Resting Hypotension
- Viagrazen safety is unknown in patients with resting hypotension (BP <90/50) or hypertension (BP >170/110)
Contraindications in Patients
- Viagrazen should be used with caution in patients with anatomical deformation of the penis
- Contraindicated in patients using organic nitrates
Overdose
- Standard supportive measures should be adopted as required
- Renal dialysis not expected to accelerate clearance due to high plasma protein binding
Animal Studies
- Animal study shows no evidence of teratogenicity or embryotoxicity
Plasma Levels
- Hepatic metabolism plays a significant role in determining plasma levels
Adverse Events
- Incidence rates and severities of adverse events increase with higher doses
Clinical Trials
- Patients on multiple antihypertensive medications were included in the pivotal clinical trials for Viagrazen
Potential for Adverse Events
- Decrease the chance of adverse events by decreasing Viagrazen dosage when prescribed to patients taking ritonavir
Safety and Efficacy
- No controlled clinical data on safety or efficacy in certain patient groups
Unstudied Groups
- No controlled clinical data on safety or efficacy in certain patient groups
Incidence Rates
- Adverse events at higher doses have increased incidence rates
Binding to Plasma Proteins
- Highly bound to plasma proteins, leading to slow clearance
Potentiation of Hypotensive Effects
- Viagrazen potentiates the hypotensive effects of nitrates
Drug Metabolism
- Viagrazen metabolism is principally mediated by specific cytochrome P450 isoforms
Erectile Dysfunction Therapy
- Recommended evaluation and identification of potential underlying causes
Phosphodiesterase Type 5 Inhibitors
- Caution is advised when co-administered with alpha-blockers
Vasodilatory Properties
- Viagrazen has systemic vasodilatory properties
Effects on Blood Pressure
- Combination with alpha-blockers may lead to additive effects on blood pressure
Vascular Events
- Reports of serious cardiovascular, cerebrovascular, and vascular events post-marketing
Blood Pressure-lowering Effect
- Concomitant use with other antihypertensive medications may lead to additional blood pressure reduction
Vascular Risk
- Reports of serious cardiovascular, cerebrovascular, and vascular events post-marketing
Pre-existing Risk Factors
- Patients with preexisting cardiovascular risk factors may be at increased risk of adverse events
Risk of Prolonged Erection
- Potential for prolonged erection greater than 4 hours and priapism
Interaction with Alpha-blockers
- Caution advised when Viagrazen is co-administered with alpha-blockers, leading to potential for symptomatic hypotension
Effect on Blood Pressure
- Viagrazen has been shown to lead to transient decreases in supine blood pressure in healthy volunteers
Reduction of Blood Pressure
- Combination with amlodipine led to additional blood pressure reduction in hypertensive patients
Secondary Effects
- Adverse events at higher doses have increased incidence rates and severities
Precautionary Measures
- Recommendation for initiation at the lowest dose in patients taking optimized doses of PDE5 inhibitors
Combination with Antihypertensive Medications
- Viagrazen has systemic vasodilatory properties and may augment the blood pressure-lowering effect of other antihypertensive medications
Age-related Factors
- Reduced clearance in healthy elderly volunteers
Hepatic Metabolism
- Predominantly eliminated by hepatic metabolism, particularly by cytochrome P450 3A4
Plasma Clearance
- Cytochrome P450 inhibitors or inducers may affect plasma clearance of Viagrazen
Blood Pressure-lowering Interaction
- Potential for blood pressure-lowering interaction with alpha-blockers
Blood Pressure Control
- Caution advised when combining with other anti-hypertensive drugs
Blood Pressure Reduction
- Combination with other antihypertensive medications may lead to additional blood pressure reduction