Atasin EZ Tablet
Atorvastatin + Ezetimibe
20 mg+10 mg
ACI Limited
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 22.00 AED |
Available as:
Indications
Atasin EZ Tablet is used for:
Primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia, homozygous familial hypercholesterolemia (HoFH)
Adult Dose
Oral
Adult:
Hyperlipidemia
The dosage range is 10/10 mg/day through 10/80 mg/day.
Recommended starting dose is 10/10 mg/day or 10/20 mg/day.
Recommended starting dose is 10/40 mg/day for patients requiring a greater than 55% reduction in LDL-C.
Child Dose
Safety and efficacy not established
Renal Dose
Renal Impairment
A history of renal impairment may be a risk factor for statin-associated myopathy. These patients merit closer monitoring for skeletal muscle effects.
In patients with renal impairment, no dosage adjustment of Atorvastatin + Ezetimibe is necessary.
Administration
May be taken with or without food.
Contra Indications
Active liver disease or unexplained persistent elevations of hepatic transaminase levels.
Hypersensitivity to any component of Atorvastatin + Ezetimibe.
Women who are pregnant or may become pregnant.
Nursing mothers.
Precautions
Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness.
Atorvastatin + Ezetimibe should be discontinued immediately if myopathy is diagnosed or suspected.
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain CYP3A4 inhibitors, fibric acid derivatives, and cyclosporine. Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment.
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported.
Liver enzyme abnormalities: Persistent elevations in hepatic transaminase can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.
Other lipid-lowering medications: Use with fenofibrates or lipid modifying doses (>1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with Atorvastatin + Ezetimibe.
Fenofibrates: Combination increases the exposure of ezetimibe. If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.
Cholestyramine: Combination decreases exposure of ezetimibe.
Digoxin: Patients should be monitored appropriately.
Oral contraceptives: Values for norethindrone and ethinyl estradiol may be increased.
Rifampin should be simultaneously coadministered with Atorvastatin + Ezetimibe.
Pregnancy-Lactation
Pregnancy Category: X
Lactation: Because of the potential for adverse reactions in nursing infants, women taking this drug should not breast feed. Contraindicated in breastfeeding women.
Interactions
Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis with Atorvastatin
Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir), gemfibrozil: Avoid Atorvastatin + Ezetimibe
HIV protease inhibitor (lopinavir plus ritonavir): Use with caution and lowest dose necessary.
Clarithromycin, itraconazole, HIV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir): Do not exceed 10/20 mg Atorvastatin + Ezetimibe daily.
HIV protease inhibitor (nelfinavir), hepatitis C protease inhibitor (boceprevir): Do not exceed 10/40 mg Atorvastatin + Ezetimibe daily.
Potentially Fatal: Antacids decrease atorvastatin levels; colestipol decreases atorvastatin plasma levels; propranolol decreases the antihyperlipidaemic activity of atorvastatin.
Adverse Effects
Side effects of Atorvastatin + Ezetimibe :
1-10%
Increased ALT (5%),Increased AST (4%),Musculoskeletal pain (4%),Abdominal pain (3%),Nausea (3%),Arthralgias (3%),Muscle weakness (2%),Dizziness (2%),Hyperkalemia (2%),Hot flushes (2%),Coughing (2%),Bronchitis (2%),Sinusitis (2%)
Mechanism of Action
Atorvastatin competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate which is an early rate-limiting step in cholesterol biosynthesis. Ezetimibe inhibits the absorption of cholesterol from the intestine, thus decreasing the delivery of intestinal cholesterol to the liver.
Note
Atasin EZ 20 mg+10 mg Tablet manufactured by ACI Limited. Its generic name is Atorvastatin + Ezetimibe. Atasin EZ is availble in Bangladesh.
Farmaco BD drug index information on Atasin EZ Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.