Amber Tablet 5 mg
Amber Tablet 5 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Trade Name | Amber Tablet 5 mg |
Generic | Rosuvastatin Calcium |
Weight | 5 mg |
Type | Tablet |
Therapeutic Class | Other Anti-anginal & Anti-ischaemic drugs, Statins |
Manufacturer | Desh Pharmaceuticals Ltd. |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
Uses
Rosuvastatin is indicated in- Heterozygous Hypercholesterolemia (Familial and Non familial) Homozygous Hypercholesterolemia (Familial) Mixed Dyslipidemia (Fredrickson Type IIa and IIb) Primary prevention of cardiovascular diseaseDosage
Amber Tablet 5 mg dosage
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mgHoFH: Starting dose 20 mg/day.Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age. Rosuvastatin can be taken with or without food, at any time of day.Side Effects
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.Precaution
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Liver enzymes should be monitored before and during treatmentInteraction
Remarkable drug interactions of Rosuvastatin are- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily. Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily. Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily. Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy. Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.Pregnancy & Breastfeeding use
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.Contraindication
Rosuvastatin is contraindicated if- Known hypersensitivity to product components Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels Pregnant women and women who may become pregnant Nursing mothersSpecial Warning
Use in children: The safety and effectiveness in pediatric patients have not been established.Storage Condition
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.Innovators Monograph
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