Itavas Tablets / Film-coated
Pitavastatin
4mg
Neopharma
| Pack size | 30’s (10’s Blister × 3) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | NEW MEDICAL CENTRE |
| Retail Price | 90.50 AED |
Available as:
Indications
Itavas Tablets / Film-coated is used for:
Hypercholesterolaemia, Hyperlipidaemias, Mixed dyslipidaemia, Cardiovascular disease,
Adult Dose
Oral
Hypercholesterolemia
Adult: 2 mg once daily.
May increase to 4 mg qDay if necessary.
Hepatic Impairment
Contraindicated in active liver disease or unexplained transaminase elevations
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment: Moderate to severe (CrCl 15-60 mL/min, not on haemodialysis) and ESRD (on haemodialysis): Initial: 1 mg once daily. Max: 2 mg once daily.
Administration
May be taken with or without food.
Contra Indications
Patients with a known hypersensitivity to any component of this products. Pitavastatin is contraindicated in patients with active liver disease , which may include unexplained persistent elevations of hepatic transaminase levels.
Precautions
Patient w/ predisposing factors for myopathy; alcoholism. Renal impairment. Monitoring Parameters Monitor lipid panel (total cholesterol, HDL, LDL, triglycerides), hepatic transaminase levels; creatine phosphokinase (CPK).
Lactation: Contraindicated
Pregnancy-Lactation
Pregnancy
Contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy during pregnancy; therapy should be discontinued as soon as pregnancy is recognized
May cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during therapy
Lactation
Contraindicated during breastfeeding; there is no available information on effects of drug on breastfed infant or effects of drug on milk production; however, another drug in this class passes into human milk; because of potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment
Interactions
Increased bioavailability w/ erythromycin and rifampicin. Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil, colchicine, niacin and other fibrates.
Potentially Fatal: Ciclosporin significantly increases pitavastatin exposure.
Adverse Effects
Side effects of Pitavastatin :
Liver enzyme abnormalities, myalgia, muscle spasm, back pain, diarrhoea, constipation, pain in extremities, arthralgia, headache, dizziness, influenza, nasopharyngitis, abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, malaise, fatigue, hepatitis, jaundice, hypoaesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction, cognitive impairment (e.g. memory loss and impairment, confusion, forgetfulness, amnesia).
Potentially Fatal: Myopathy and rhabdomyolysis w/ acute renal failure secondary to myoglobinuria; hepatic failure.
Mechanism of Action
HMG-CoA reductase inhibitor, inhibits rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase
Note
Itavas 4mg Tablets / Film-coated manufactured by Neopharma. Its generic name is Pitavastatin. Itavas is availble in United Arab Emirates.
Farmaco UAE drug index information on Itavas Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.