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OUR PRODUCTS

atorvastatin+ezetimibe
Commercial name
ATOMIBE
Category
lipid-lowering drugs
Chemical composition

Each film coated tablet contains 10 mg ezetimab + 10.9 atorvastatin calcium (equivalent to 10 mg atorvastatin).

Each film coated tablet contains 10 mg ezetimab + 21.7 atorvastatin calcium (equivalent to 20 mg atorvastatin).

Each film coated tablet contains 10 mg ezetimab + 43.4 atorvastatin calcium (equivalent to 40 mg atorvastatin).

Each film coated tablet contains 10 mg ezetimab + 86.8 atorvastatin calcium (equivalent to 80 mg atorvastatin).

Dosage Form
film - coated tablets
Pharmaceutical group
LIPID-LOWERING DRUGS.
Contraindications

- Active liver disease or persistent, unexplained elevations of liver transaminases.

- Hypersensitivity to any of the active ingredients or excipients used.

- Women who are pregnant or who may become pregnant. Atomib may cause fetal harm when administered to a pregnant woman.

-   nursing mothers. It is not known whether atorvastatin passes into breast milk. However, a small amount of another medicine in this class passes into breast milk. Because statins have the potential to cause serious adverse reactions in infants, women who require atomaib therapy should not breastfeed their infants.

Drug interactions

- Strong inhibitors of cytochrome P450 3A4: Atorvastatin is metabolized by cytochrome P450 3A4. Concomitant administration of atorvastatin with potent inhibitors of CYP3A4 can lead to an increase in plasma concentrations of atorvastatin.

- Clarithromycin: The AUC of atorvastatin was significantly increased when 80 mg atorvastatin was co-administered with clarithromycin (500 mg twice daily) compared to atorvastatin alone.

- Combination Protease Inhibitors: The concomitant use of atomib should be avoided in patients taking the HIV protease inhibitor tipranavir in addition to ritonavir, or telaprevir, a protease C inhibitor,

- Itraconazole: In patients taking itraconazole, do not use an atomib dose higher than 10/20 mg

- Cyclosporine: Atorvastatin and its metabolites are substrates of the OATP1B1 transporter. Cyclosporine is an inhibitor of this transporter, which significantly increases the bioavailability of atorvastatin.

Also, the simultaneous use of ezetimibe and cyclosporine increased the concentration of both substances. The degree of increase in exposure to ezetimibe may be greater in patients with severe renal insufficiency.

- Digoxin: The plasma concentration of digoxin increases with multiple doses of atorvastatin and digoxin.

- Oral contraceptives: Chronic administration of atorvastatin with oral contraceptives increases the concentration of ethinyl estradiol and norethindrone.

- Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin in combination with colchicine

Dosage and usage

 

- Atomib contains two different medicines. One is (ezetimibe) and the other is atorvastatin (atorvastatin calcium trihydrate). Atomib reduces high total cholesterol, bad cholesterol and triglycerides and increases good HDL cholesterol

- Atomib works by decreasing the absorption of cholesterol in the small intestine and by decreasing the amount of cholesterol produced in the liver. It has been used in people whose cholesterol and triglyceride levels are too high and when diet alone cannot adequately lower these levels.

Recommended Dosages:

- The dose of atomib ranges from 10/10 mg/day to 10/80 mg/day. The recommended starting dose of atomib is 10/10 mg/day or 10/20 mg/day. Atomib can be taken as a single dose at any time of the day, with or without food. The recommended starting dose for patients requiring a greater reduction in LDL-C (greater than 55%) is 10/40 mg/day. After initiation and/or upon titration of Atomib, lipid levels should be analyzed within two weeks or more and the dose adjusted accordingly.

- Patients should swallow Atomaib tablets whole. The tablets should not be crushed, dissolved or chewed.

- Patients with homozygous familial hypercholesterolemia:

The dose of atomib in patients with homozygous familial hypercholesterolemia is 10/40 mg/day or 10/80 mg/day. Atomib should be used as an adjunct to other lipid-lowering therapies (eg, LDL apheresis) in these patients or if these treatments are unavailable.

Side Effect

The most common adverse side effects are rhabdomyolysis and myopathy, abnormal liver enzymes, increased ALT, increased AST, musculoskeletal pain, abdominal pain.

Marketing authorization number(s)

Atomib (10/10) Film Coated Tablets…………..(30/2021)

Atomib (20/20) Film Coated Tablets…………..( 31/2021)

Atomib (10/40) Film Coated Tablets………….. (32/2021)

Atomib (80/10) Film Coated Tablets…………… (33/2021)

The nature and content of the packaging

A carton box containing 3blisters, each one contains 10 f.c.tablets