Rostatin
Generic Name
Rosuvastatin
Manufacturer
Reputable Pharmaceutical Manufacturer
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rostatin 20 mg tablet | ৳ 14.00 | ৳ 196.00 |
Description
Overview of the medicine
Rostatin 20 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglycerides, reducing the risk of heart disease and stroke. It works by inhibiting an enzyme in the liver responsible for cholesterol production.
Uses & Indications
Dosage
Adults
Initial dose 5-10 mg orally once daily. Maximum dose 40 mg daily. The 20 mg dose is common for moderate to significant lipid reduction.
Elderly
Initial dose 5 mg once daily. No dosage adjustment based solely on age, but consider renal function.
Renal_impairment
Mild to moderate renal impairment: No dose adjustment. Severe renal impairment (CrCl < 30 mL/min, not on hemodialysis): Initial dose 5 mg once daily, maximum 10 mg once daily.
How to Take
Take orally once daily, with or without food, at any time of day, but preferably at the same time each day to maintain consistency. Do not crush or chew the tablet; swallow whole.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition reduces the production of mevalonate, a precursor to cholesterol. As a result, hepatic cholesterol synthesis decreases, leading to an upregulation of LDL receptors on the surface of liver cells, which increases the clearance of LDL-C from the blood.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 1 week, maximal effect within 2-4 weeks.
Excretion
Approximately 90% excreted unchanged in feces, 5-10% in urine (mainly as metabolites).
Half life
Approximately 19 hours.
Absorption
Peak plasma concentrations reached in 3-5 hours. Absolute bioavailability is approximately 20%.
Metabolism
Limited metabolism, primarily by CYP2C9 (10%) and to a lesser extent by CYP2C19. N-desmethyl rosuvastatin is the main metabolite.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy
- Lactation
- Severe renal impairment (CrCl < 30 mL/min) at doses of 40 mg
- Concomitant use with ciclosporin
Drug Interactions
Ciclosporin
Concomitant use is contraindicated; significantly increases rosuvastatin exposure.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration.
Erythromycin
Decreases rosuvastatin exposure.
Coumarin anticoagulants (e.g., Warfarin)
May increase INR; monitor INR closely.
Antacids (aluminum and magnesium hydroxide)
Decreases rosuvastatin plasma concentration; take antacids 2 hours after rosuvastatin.
Protease inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Significantly increase rosuvastatin exposure; dosage adjustment recommended.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, provide supportive and symptomatic treatment. Monitor liver function tests and CK levels.
Pregnancy & Lactation
Pregnancy Category X. Contraindicated in pregnancy and breastfeeding due to potential harm to the fetus/infant. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy
- Lactation
- Severe renal impairment (CrCl < 30 mL/min) at doses of 40 mg
- Concomitant use with ciclosporin
Drug Interactions
Ciclosporin
Concomitant use is contraindicated; significantly increases rosuvastatin exposure.
Gemfibrozil
Increases rosuvastatin exposure; avoid co-administration.
Erythromycin
Decreases rosuvastatin exposure.
Coumarin anticoagulants (e.g., Warfarin)
May increase INR; monitor INR closely.
Antacids (aluminum and magnesium hydroxide)
Decreases rosuvastatin plasma concentration; take antacids 2 hours after rosuvastatin.
Protease inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Significantly increase rosuvastatin exposure; dosage adjustment recommended.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, provide supportive and symptomatic treatment. Monitor liver function tests and CK levels.
Pregnancy & Lactation
Pregnancy Category X. Contraindicated in pregnancy and breastfeeding due to potential harm to the fetus/infant. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by FDA (USA) and DGDA (Bangladesh)
Patent Status
Generic versions available, patent expired for original formulation
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have demonstrated Rosuvastatin's efficacy in reducing LDL-C, total cholesterol, and triglycerides, as well as its role in cardiovascular risk reduction, including trials like JUPITER and STELLAR.
Lab Monitoring
- Liver function tests (ALT, AST) before initiation and as clinically indicated
- Lipid panel (Total-C, LDL-C, HDL-C, TG) regularly
- Creatine kinase (CK) levels if muscle pain or weakness occurs
Doctor Notes
- Emphasize lifestyle modifications (diet, exercise).
- Regular monitoring of lipid profile and liver function.
- Caution with concomitant medications that increase rosuvastatin exposure.
- Educate patients on symptoms of myopathy.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not stop taking this medicine without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness immediately to your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rosuvastatin is generally not expected to affect the ability to drive or operate machinery. However, if you experience dizziness, avoid such activities.
Lifestyle Advice
- Maintain a low-fat, low-cholesterol diet.
- Engage in regular physical activity.
- Avoid smoking and limit alcohol intake.
- Manage blood pressure and blood sugar if applicable.
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