Monivis
Generic Name
Monivisin Hydrochloride
Manufacturer
Apex Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
monivis 50 mg tablet | ৳ 6.75 | ৳ 67.50 |
Description
Overview of the medicine
Monivis 50 mg Tablet is an angiotensin receptor blocker (ARB) used to treat high blood pressure (hypertension) and to reduce the risk of cardiovascular events in certain patients. It works by relaxing blood vessels, allowing blood to flow more easily.
Uses & Indications
Dosage
Adults
Initial dose 50 mg once daily. The dose may be increased to a maximum of 100 mg once daily if needed, based on blood pressure response. Administer orally.
Elderly
No initial dosage adjustment required for elderly patients, but cautious monitoring recommended due to potential age-related decline in renal function.
Renal_impairment
No initial dosage adjustment for mild to moderate renal impairment. For severe impairment (CrCl <30 mL/min), consider a lower starting dose (e.g., 25 mg) and close monitoring of renal function and serum potassium.
How to Take
Monivis 50 mg Tablet may be taken with or without food. Administer orally once daily at approximately the same time each day to maintain consistent blood levels and maximize therapeutic effect.
Mechanism of Action
Monivisin selectively blocks the binding of angiotensin II to the AT1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland, kidney). This blockade prevents angiotensin II-mediated vasoconstriction, aldosterone secretion, and other effects, leading to a reduction in blood pressure.
Pharmacokinetics
Onset
Onset of action within 2 hours, maximal effect within 4-6 hours.
Excretion
Excreted primarily via feces (about 80%) and urine (about 20%) as unchanged drug and metabolites.
Half life
Elimination half-life approximately 6-9 hours.
Absorption
Well absorbed from the gastrointestinal tract, bioavailability around 30-40%. Peak plasma concentration typically reached within 1-2 hours.
Metabolism
Undergoes minimal hepatic metabolism, primarily by glucuronidation. No significant CYP450 involvement.
Side Effects
Contraindications
- Hypersensitivity to the active substance Monivisin or to any of the excipients
- Pregnancy (especially second and third trimesters) due to risk of fetal injury and death
- Concomitant use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (GFR <60 mL/min/1.73 m²)
Drug Interactions
NSAIDs
Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of ARBs and increase the risk of renal impairment, particularly in volume-depleted or elderly patients.
Lithium
Increased serum lithium concentrations and toxicity have been reported with concomitant use of ARBs and lithium. Monitor lithium levels carefully.
Diuretics
Co-administration with diuretics may result in an additive hypotensive effect, especially at the initiation of therapy.
Potassium-sparing diuretics/Potassium supplements
Concomitant use may lead to hyperkalemia, especially in patients with renal impairment. Monitor serum potassium levels.
Storage
Store below 30°C (86°F) in a dry place. Protect from light and moisture. Keep the tablets in their original packaging until use. Keep out of reach of children.
Overdose
Symptoms of overdose typically include hypotension and tachycardia; bradycardia could occur from parasympathetic stimulation. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage or administration of activated charcoal may be considered. Intravenous fluids and vasopressors may be administered for hypotension. Electrolyte and renal function should be closely monitored.
Pregnancy & Lactation
Pregnancy Category D: Monivis is contraindicated during pregnancy due to the risk of fetal injury and death. If pregnancy is detected, discontinue immediately. Lactation: It is not known whether Monivisin is excreted in human milk. Due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to the active substance Monivisin or to any of the excipients
- Pregnancy (especially second and third trimesters) due to risk of fetal injury and death
- Concomitant use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (GFR <60 mL/min/1.73 m²)
Drug Interactions
NSAIDs
Non-steroidal anti-inflammatory drugs (NSAIDs) may reduce the antihypertensive effect of ARBs and increase the risk of renal impairment, particularly in volume-depleted or elderly patients.
Lithium
Increased serum lithium concentrations and toxicity have been reported with concomitant use of ARBs and lithium. Monitor lithium levels carefully.
Diuretics
Co-administration with diuretics may result in an additive hypotensive effect, especially at the initiation of therapy.
Potassium-sparing diuretics/Potassium supplements
Concomitant use may lead to hyperkalemia, especially in patients with renal impairment. Monitor serum potassium levels.
Storage
Store below 30°C (86°F) in a dry place. Protect from light and moisture. Keep the tablets in their original packaging until use. Keep out of reach of children.
Overdose
Symptoms of overdose typically include hypotension and tachycardia; bradycardia could occur from parasympathetic stimulation. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage or administration of activated charcoal may be considered. Intravenous fluids and vasopressors may be administered for hypotension. Electrolyte and renal function should be closely monitored.
Pregnancy & Lactation
Pregnancy Category D: Monivis is contraindicated during pregnancy due to the risk of fetal injury and death. If pregnancy is detected, discontinue immediately. Lactation: It is not known whether Monivisin is excreted in human milk. Due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Patent expired
Clinical Trials
Extensive randomized, double-blind, placebo-controlled clinical trials (Phase I, II, III) demonstrated the efficacy and safety of Monivisin in reducing blood pressure and improving cardiovascular outcomes. Long-term post-marketing surveillance studies continue to monitor its profile.
Lab Monitoring
- Serum electrolytes (especially potassium) should be monitored periodically, particularly in patients with renal impairment or those taking potassium-sparing diuretics.
- Renal function (BUN, creatinine) should be assessed before starting therapy and periodically thereafter.
- Liver function tests may be monitored if clinically indicated.
Doctor Notes
- Advise patients on the importance of adherence to Monivis therapy and concomitant lifestyle modifications (diet, exercise, smoking cessation).
- Regularly assess renal function and serum potassium levels, especially in elderly, diabetic, or renally impaired patients, and adjust therapy as needed.
- Counsel female patients of childbearing potential on the significant risk of fetal harm if Monivis is used during pregnancy and ensure adequate contraception or alternative therapy is in place.
- Educate patients on symptoms of hypotension and hyperkalemia and when to seek medical attention.
Patient Guidelines
- Take Monivis regularly as prescribed by your doctor, even if you feel well. Do not stop taking the medicine without consulting your doctor.
- Monitor your blood pressure regularly at home and keep a record to share with your doctor.
- Report any unusual side effects, especially swelling of the face, lips, or tongue, immediately to your doctor.
- Avoid using potassium supplements or salt substitutes containing potassium without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Monivis may cause dizziness or fatigue, especially at the start of treatment or when the dose is increased. Patients should be advised to assess their reaction to the drug before driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet low in sodium and rich in fruits and vegetables.
- Engage in regular physical activity as advised by your doctor.
- Avoid smoking and excessive alcohol consumption, as these can negatively impact blood pressure.
- Manage stress effectively through relaxation techniques or hobbies.
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