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
Amber Tablet 5 mg
Amber Tablet 5 mg

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 disease

Dosage

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 treatment

Interaction

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 mothers

Special 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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*** Taking medicines without doctor's advice can cause long-term problems.
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