Torvacard Cristal (atorvastatin) coated tablets 40 mg. №30

Description

Torvacard Cristal (atorvastatin) coated tablets 40 mg. №30

Composition

active substance: atorvastatin (in the form of atorvastatin calcium trihydrate);

1 tablet contains atorvastatin 10 mg (equivalent to atorvastatin calcium trihydrate 10.823 mg) or 20 mg (equivalent to atorvastatin calcium trihydrate 21.647 mg), or 40 mg (equivalent to atorvastatin calcium trihydrate 43.294 mg);

Excipients: calcium carbonate, microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropylcellulose, povidone K12, colloidal anhydrous silica, magnesium stearate; film coating: hypromellose, polyethylene glycol 6000, titanium dioxide (E 171), talc, iron oxide yellow (E 172), lactose monohydrate.

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

• 10 mg tablets: biconvex round tablets from white to almost white, film-coated;
• 20 mg tablets: biconvex, yellowish, film-coated round tablets;
• 40 mg tablets: biconvex round tablets from orange-yellow to yellow-orange, film-coated.

Pharmacotherapeutic group

Drugs that lower serum cholesterol and triglycerides. HMG-CoA reductase inhibitors.
ATX code C10A A05.

Pharmacological properties

This drug reduces the level of “harmful” fats in the blood. It is a selective competitive inhibitor of HMG-CoA reductase, which converts 3-hydroxy-3-methylglutaryl coenzyme A into mevalonic acid, a precursor of organic alcohol-sterols (including cholesterol). Reduces LDL by 41–61%, apolipoprotein B by 34–50%, triglycerides by 14–33%, cholesterol by 30–46%.

Indications

Torvacard Cristal tablets is used as an addition to the diet in the following conditions:

• elevated levels of LDL (low density lipoprotein), total cholesterol, apolipoprotein B, triglycerides – in order to increase the level of HDL (high density lipoprotein) in patients with primary hypercholesterolemia (familial or non-hereditary), combined hyperlipidemia (type IIa, ІІb);
• elevated triglyceride levels (type IV);
• dysbetalipoproteinemia (type III) – if the diet is ineffective;
• cardiovascular diseases (with / without dyslipidemia) in patients with risk factors (smoking, heredity, diabetes mellitus, low HDL cholesterol, arterial hypertension) in order to reduce the risk of myocardial infarction, stroke, angina pectoris, as well as if it is necessary to undergo myocardial revascularization.

Contraindications

Torvacard Cristal tablets is not prescribed:

• with a persistent unspecified increase in transaminase activity, exceeding the norm by three times;
• with active liver diseases;
• with allergies to components.

Application during pregnancy and lactation

Torvacard Cristal tablets is not used during these periods.

Method of application and dosage

• Hyperlipidemia and mixed dyslipidemia. The recommended starting dose of Torvacard® Crystal is 10 or 20 mg once daily. For patients who require a significant reduction in LDL cholesterol (more than 45%), therapy may be initiated at a dose of 40 mg once daily. The dose range of Torvacard Cristal tablets is from 10 to 80 mg once a day. The drug can be taken in a single dose at any time and regardless of meals. The starting and maintenance doses of Torvacard Cristal tablets l should be selected individually, depending on the purpose of treatment and response. After initiation of treatment and / or titration of the dose of Torvacard Cristal tablets , lipid levels should be analyzed over a period of 2 to 4 weeks and the dose adjusted accordingly.
• Heterozygous familial hypercholesterolemia in pediatric patients (10 to 17 years). The recommended starting dose of Torvacard Cristal tablets is 10 mg / day; the usual dose range is 10 to 20 mg orally once daily. Doses of the drug should be selected individually, according to the purpose of treatment. Dose adjustments should be made every 4 weeks or more.
• Homozygous familial hypercholesterolemia. The dose of Torvacard Cristal tablets for patients with homozygous familial hypercholesterolemia is 10 to 80 mg per day. Torvacard Cristal tablets should be used as an adjunct to other lipid-lowering treatments (eg LDL apheresis) or if hypolipidemic therapies are not available.
• Simultaneous lipid-lowering therapy. Torvacard Cristal tablets can be used with bile acid sequestrants. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.

Overdose

In case of an overdose, the following measures are taken: prevention of absorption of the active substance (gastric lavage, use of sorbents, laxatives), monitoring and maintenance of vital functions.
In exceptional cases, myopathy may develop with rhabdomyolysis (breakdown of muscle tissue), acute kidney failure. In this case, the drug is immediately canceled, diuretics are prescribed, sodium bicarbonate solution, hemodialysis is performed.

Side effects:

• Digestive disorders: pancreatitis, belching, vomiting, hepatitis, cholestatic jaundice, abdominal pain, constipation, nausea, diarrhea, dyspepsia, flatulence.
• Nervous system disorders: paresthesias, peripheral neuropathy, headache.
• Disorders of the musculoskeletal system: joint edema, myalgia, myopathy, neck pain, myositis, muscle cramps, tendopathy.
• General reactions: an increase in the level of transaminases, creatine phosphokinase in the biochemical blood test, asthenia.
• Respiratory system disorders: nosebleeds, pharyngolaryngeal pain.
• Metabolic disorders: hypoglycemia, anorexia, hyperglycemia.
• Mental disorders: nightmares, insomnia, depression.
• Skin changes: alopecia, rash, itching.
• Disorders of the organs of perception: impairment, blurred vision.
• Reproductive system disorders: sexual dysfunction, gynecomastia.
• Infections / invasions: nasopharyngitis.
• General: leukocyturia.