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ATORVASTATIN + FENOFIBATE
Contents: Each film-coated tablet contains: Atorvastain (as calcium) 10mg, Fenofibrate 160mg.
The fixed dose combination of Atorvastatin and Fenofibrate is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B and TG levels abd to increase HDL-C in patients with mixed hyperlipidemia.
Indications: Relief of nasal congestion, headache, body ache, & fever associated w/ common cold, allergic rhinitis, influenza, acute & chronic sinusitis & other resp tract infections.
Dosage: Adults and Elderly: Start with Atorvastatin 10mg plus Fenofibrate 160mg (or Atorvastatun 10mg plus Fenofibrate 160mg) once daily.
Children: No data is available on the use of the fixed dose combination of Atorvastatin and Fenofibrate in patients under the age of 18 years.
Contraindications: The fixed dose combination of Atorvastatin and Fenofibrate is contraindicated in patients with: hypersensitivity to either componenet; severe hepatic or renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality, unexplained and persistent elevations of serum transaminases exceeding three times the upper limit of normal; pre-existing gallbladder disease. Pregnancy and Lactation.
Special Precautions: Diabetes, high BP, heart disease, thyroid disease, depression, difficulty in urination. May affect ability to drive or operate machinery. Pregnancy & lactation.
Adverse Drug Reactions: There is no data available on undersirable effects of this combination. However, side effects have been reported with individual molecules.
Drug Interactions: May enhance or reduce metabolic clearance w/ other drugs & substance. May induce ventricular fibrillation w/ inhalational anesth eg cyclopropane & halothane. Sedative agents & antidepressants; drugs that increase action of liver enzymes. May accelerate absorption w/ metoclopramide. May affect excretion & alter plasma conc w/ probenecid.
MIMS Class: Dyslipidaemic Agents
ATC Classification: C10AB05- Fenofibrate; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
C10AA05- Atorvastatin; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
C10BA- Combinations of various lipid modifying agents; Used in thetreatment of hyperlipidemia..
Regulatory Classification: Rx |
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