Each film coated tablet contains:
Equivalent to Atorvastatin 40 mg
Colour: Titanium Dioxide BP
Therapeutic Category: Lipid lowering agent
For the relief of signs and symptoms of:
For the hypercholesterolaemia
Prevention of cardiovascular disease
It is contraindicated in patients:
i) With hypersensitivity to the active substance or to any or the excipients of this medicinal product.
ii) With active liver disease or unexplained persistent elevations of serum transaminase exceeding 3 times the upper limit of normal.
iii) During pregnancy, while breast-feeding and in women of childbearing potential not using appropriate contraceptive measures.
Warning & Precautions:
Rare case of rhabdomyolysis with acute renal failure secondary to myoglobinuria have bean reported and with other drugs in this
class. A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for skeletal muscle effects.
Pregnancy and Lactation:
There are no data on the excretion of atorvastatin into human milk; however, a small amount of another drug in this class does pass into breast milk. It is contraindicated in nursing woman. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, it is recommended that mothers discontinue nursing prior to initiation of therapy with atorvastatin.
Myopathy with elevation or creatinine kinase (CK) and rhabdomyolysis are the most serious side effect, although rare at <1%.
Headache is the most common side effect , occurring in more than 10% of patients.
Side effects that occur in 1-10% of patients taking atorvastatin include:
- Insomnia and dizziness
- Chest pain and peripheral edema
- Abdominal pain constipation, diarrhea, dyspepsia, flatulence, nausea
- Urinary tract infection
- Arthralgia, myalgia, back pain, arthritis
- Sinusitis, pharyngitis, bronchitis, rhinitis
- Infection,flu-like syndrome, allergic reaction