Tolevas (atorvastatin) coated tablets 20 mg. №30

Description

Tolevas (atorvastatin) coated tablets 20 mg. №30

Composition

active substance: atorvastatin;

1 tablet contains atorvastatin in the form of atorvastatin calcium trihydrate 10 mg or 20 mg, or 40 mg, or 80 mg;

Excipients: calcium carbonate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80, hydroxypropylcellulose, magnesium stearate;

film coating: Opadry AMB OY-B-28920: polyvinyl alcohol, titanium dioxide

(E 171), talc, lecithin (E 322), xanthan gum (E 415).

Dosage form

Coated tablets.

Main physical and chemical properties: oblong, coated, white tablets.

Pharmacotherapeutic group

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

Pharmacological properties

This medicine lowers 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

Tolevas coated tablets is used as an addition to the diet for 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 conduct myocardial revascularization

Contraindications

Tolevas coated 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

Tolevas is not used during these periods.

Method of administration and dosage

Before starting treatment, you should determine the level of total cholesterol in the blood.

The standard dose is 10–80 mg x 1 time / day at any time of the day, regardless of food intake.

It is recommended to follow a special diet during treatment.

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.