Zilsart
Generic Name
Azilsartan Medoxomil
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zilsart 40 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Zilsart 40 mg Tablet is an Angiotensin II Receptor Blocker (ARB) used to treat high blood pressure (hypertension). It works by relaxing blood vessels, allowing blood to flow more easily.
Uses & Indications
Dosage
Adults
The recommended starting dose is 40 mg orally once daily. The dose may be increased to a maximum of 80 mg once daily if blood pressure is not adequately controlled.
Elderly
No initial dose adjustment is required for elderly patients (65 years or older). However, caution should be exercised in very elderly patients (75 years or older).
Renal_impairment
No initial dose adjustment is required for patients with mild to moderate renal impairment. For patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease on dialysis, a lower starting dose (e.g., 20 mg) may be considered, and careful monitoring is recommended.
How to Take
Zilsart tablets can be taken with or without food, preferably at the same time each day.
Mechanism of Action
Azilsartan medoxomil is a prodrug that is hydrolyzed to azilsartan, a selective AT1 subtype angiotensin II receptor antagonist. It blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues (e.g., vascular smooth muscle, adrenal gland). This leads to vasodilation and reduced blood pressure.
Pharmacokinetics
Onset
Antihypertensive effect observed within 1-2 hours; maximal effect within 2-3 weeks of therapy.
Excretion
Approximately 55% excreted in feces and 42% in urine.
Half life
Approximately 11 hours.
Absorption
Oral bioavailability of azilsartan is approximately 60% (azilsartan medoxomil is a prodrug). Peak plasma concentrations occur within 1.5-3 hours.
Metabolism
Minor metabolism by O-dealkylation to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to azilsartan or any component of the formulation.
- Pregnancy (especially second and third trimesters).
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).
- Severe hepatic impairment.
Drug Interactions
Lithium
Increased serum lithium concentrations and lithium toxicity have been reported with concomitant use of ARBs. Monitor serum lithium levels.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
May reduce the antihypertensive effect of ARBs and increase the risk of renal function deterioration, including acute renal failure, especially in elderly, volume-depleted, or renally impaired patients.
Dual blockade of the Renin-Angiotensin System (RAS)
Concomitant use of ARBs with ACE inhibitors or aliskiren is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure), particularly in patients with pre-existing renal impairment.
Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia). Monitor serum potassium levels.
Storage
Store below 25°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hypotension. Treatment should be symptomatic and supportive, including intravenous fluid administration for hypotension and close monitoring of vital signs.
Pregnancy & Lactation
Zilsart is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. It is not recommended during lactation as it is unknown whether azilsartan is excreted in human milk.
Side Effects
Contraindications
- Known hypersensitivity to azilsartan or any component of the formulation.
- Pregnancy (especially second and third trimesters).
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).
- Severe hepatic impairment.
Drug Interactions
Lithium
Increased serum lithium concentrations and lithium toxicity have been reported with concomitant use of ARBs. Monitor serum lithium levels.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
May reduce the antihypertensive effect of ARBs and increase the risk of renal function deterioration, including acute renal failure, especially in elderly, volume-depleted, or renally impaired patients.
Dual blockade of the Renin-Angiotensin System (RAS)
Concomitant use of ARBs with ACE inhibitors or aliskiren is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure), particularly in patients with pre-existing renal impairment.
Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium
May lead to increased serum potassium levels (hyperkalemia). Monitor serum potassium levels.
Storage
Store below 25°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hypotension. Treatment should be symptomatic and supportive, including intravenous fluid administration for hypotension and close monitoring of vital signs.
Pregnancy & Lactation
Zilsart is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. It is not recommended during lactation as it is unknown whether azilsartan is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
Clinical Trials
Azilsartan medoxomil has been extensively studied in various clinical trials demonstrating its efficacy and safety in the treatment of hypertension, including comparisons with other ARBs and ACE inhibitors.
Lab Monitoring
- Serum potassium levels (especially in patients with renal impairment, on potassium-sparing diuretics, or potassium supplements).
- Renal function tests (e.g., serum creatinine, BUN) periodically, especially in patients with pre-existing renal impairment or those receiving concomitant NSAIDs.
Doctor Notes
- Advise patients to report any signs of angioedema immediately.
- Regularly assess renal function and serum potassium, particularly in vulnerable populations (elderly, renally impaired, or those on interacting medications).
- Emphasize adherence to therapy and the importance of lifestyle modifications.
Patient Guidelines
- Take Zilsart as directed by your doctor, usually once daily.
- Do not stop taking this medicine without consulting your doctor, even if you feel well.
- Report any signs of swelling of the face, lips, tongue, or throat immediately.
- Avoid potassium supplements or salt substitutes containing potassium without consulting your doctor.
- Monitor your blood pressure regularly as advised by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Zilsart may cause dizziness or fatigue. Patients should be cautioned about driving or operating machinery until they know how this medication affects them.
Lifestyle Advice
- Maintain a healthy diet low in sodium.
- Engage in regular physical activity.
- Limit alcohol consumption.
- Quit smoking.
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