Makmaul-Sanagra
Generic Name
Sildenafil Citrate 100 mg
Manufacturer
Makmaul Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| makmaul sanagra 100 mg tablet | ৳ 45.00 | ৳ 180.00 |
Description
Overview of the medicine
Makmaul-Sanagra 100 mg Tablet is an oral medication used to treat erectile dysfunction (ED) in adult men. It helps increase blood flow to the penis, allowing an erection to occur in response to sexual stimulation.
Uses & Indications
Dosage
Adults
For most patients, the recommended dose is 50 mg taken approximately 1 hour before sexual activity. The dose may be increased to 100 mg or decreased to 25 mg based on efficacy and tolerability. Maximum recommended dosing frequency is once per day.
Elderly
No dosage adjustment is required for elderly patients (≥65 years).
Renal_impairment
For patients with severe renal impairment (creatinine clearance <30 mL/min), a starting dose of 25 mg should be considered. Based on efficacy and tolerability, the dose may be increased to 50 mg and then to 100 mg.
How to Take
Oral administration. Take approximately 1 hour before sexual activity. Can be taken with or without food, but a high-fat meal may delay the onset of action.
Mechanism of Action
Sildenafil selectively inhibits phosphodiesterase type 5 (PDE5), an enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. By inhibiting PDE5, sildenafil increases cGMP levels, leading to smooth muscle relaxation and increased blood flow into the penis, resulting in an erection upon sexual stimulation.
Pharmacokinetics
Onset
Typically within 30-60 minutes after administration.
Excretion
Eliminated predominantly as metabolites in the feces (approximately 80% of administered oral dose) and, to a lesser extent, in the urine (approximately 13% of administered oral dose).
Half life
Approximately 3-5 hours.
Absorption
Rapidly absorbed. Absolute bioavailability is about 41%. Peak plasma concentrations are reached within 30-120 minutes (median 60 minutes) of oral dosing in the fasted state.
Metabolism
Primarily metabolized by CYP3A4 (major route) and CYP2C9 (minor route) in the liver. The major circulating metabolite, N-desmethyl sildenafil, has about 50% of the potency of the parent drug.
Side Effects
Contraindications
- Concomitant use with nitrates (e.g., nitroglycerin, isosorbide dinitrate) in any form, as it may potentiate hypotensive effects.
- Hypersensitivity to sildenafil or any component of the tablet.
- Patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION).
- Severe cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months.
Drug Interactions
Nitrates
Potentiation of hypotensive effects, leading to severe hypotension. Contraindicated.
Riociguat
Concomitant use is contraindicated due to risk of severe hypotension.
Alpha-blockers (e.g., Doxazosin)
Risk of symptomatic hypotension. Initiate sildenafil at 25 mg and ensure patient is hemodynamically stable on alpha-blocker therapy.
CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole, Erythromycin)
Increased plasma levels of sildenafil. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In volunteers, single doses up to 800 mg were associated with similar adverse reactions as seen at lower doses, but with increased incidence and severity. In cases of overdose, standard supportive measures should be adopted as required.
Pregnancy & Lactation
Makmaul-Sanagra is not indicated for use in women. Therefore, information regarding use during pregnancy and lactation is not applicable.
Side Effects
Contraindications
- Concomitant use with nitrates (e.g., nitroglycerin, isosorbide dinitrate) in any form, as it may potentiate hypotensive effects.
- Hypersensitivity to sildenafil or any component of the tablet.
- Patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION).
- Severe cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months.
Drug Interactions
Nitrates
Potentiation of hypotensive effects, leading to severe hypotension. Contraindicated.
Riociguat
Concomitant use is contraindicated due to risk of severe hypotension.
Alpha-blockers (e.g., Doxazosin)
Risk of symptomatic hypotension. Initiate sildenafil at 25 mg and ensure patient is hemodynamically stable on alpha-blocker therapy.
CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole, Erythromycin)
Increased plasma levels of sildenafil. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In volunteers, single doses up to 800 mg were associated with similar adverse reactions as seen at lower doses, but with increased incidence and severity. In cases of overdose, standard supportive measures should be adopted as required.
Pregnancy & Lactation
Makmaul-Sanagra is not indicated for use in women. Therefore, information regarding use during pregnancy and lactation is not applicable.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA
Patent Status
Generic available, original patent expired
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of sildenafil in treating erectile dysfunction across various patient populations.
Lab Monitoring
- No specific lab monitoring is routinely required for sildenafil use for ED in healthy individuals.
Doctor Notes
- Thorough patient history and physical examination are essential to diagnose ED and determine underlying causes before prescribing.
- Advise patients on nitrate contraindication and potential for priapism.
Patient Guidelines
- Take approximately 1 hour before sexual activity.
- Do not take more than one dose per day.
- Seek immediate medical attention if an erection lasts longer than 4 hours (priapism).
- Avoid alcohol consumption while taking this medication as it may increase side effects.
Missed Dose Advice
This medicine is taken as needed, so you are not on a regular dosing schedule. Do not take more than one dose per day.
Driving Precautions
May cause dizziness or visual disturbances. Patients should be aware of how they react to Makmaul-Sanagra before driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, which can improve overall cardiovascular health and potentially aid erectile function.
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