Nomosic 50 mg Tablet

Indications

Atova is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.

- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.

Pharmacology

Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to Atorvastatin dose. The absolute bioavailability of Atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%. Mean volume of distribution of Atorvastatin is approximately 381 liters. Atorvastatin is 98% bound to plasma proteins. Atorvastatin is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products. Atorvastatin and its metabolites are eliminated primarily in bile following hepatic and/or extra-hepatic metabolism. Mean plasma elimination half-life of Atorvastatin in humans is approximately 14 hours.

Dosage & Administration

Primary hypercholesterolaemia and combined hyperlipidaemia-

- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.

Familial hypercholesterolaemia-

- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily.

Prevention of cardiovascular events-

- Adults: Initially 10 mg once daily adjusted according to response.

The recommended starting dose of Atorvastatin is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. Atorvastatin can be administered as a single dose at any time of the day, with or without food.

Side Effects

Atova is generally well-tolerated. The most frequent side effects related to Atova are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Precautions & Warnings

Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atova should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atova therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

Contraindications

Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.

Pregnancy & Lactation

Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult your physician or pharmacist before starting any medication.