Liptonorm

Liptonorm – hypolipidemic drug from group of statines.

Form of release and structure

Dosage form – tablets, coated: round, convex from two parties, white color; on a break – almost white or white color (on 14 pieces in the blister, on 2 blisters in a cardboard pack).

Active agent: аторвастатин (in the form of calcic salt), its contents in 1 tablet makes 10 or 20 mg.

Auxiliary components: twin 80, lactose, hydroxypropyl cellulose, cellulose microcrystallic, kroskarmelloza, calcium carbonate, magnesium stearate, polyethyleneglycol, titanium dioxide, gidroksipropilmetiltsellyuloz.

Indications to use

• Homozygous and heterozygous family hypercholesterolemia (as addition to a dietotherapy);
• Primary hypercholesterolemia;
• The mixed lipidemia.

Contraindications

Absolute:

• Cirrhosis of various etiology;
• Liver failure (the classes A and B according to a scale of Chayld-Pyyu);
• Active diseases of a liver, including active chronic hepatitis and chronic alcoholic hepatitis;
• Increase in activity of hepatic transaminases (more than by 3 times in comparison with the upper bound of norm) unspecified genesis;
• Age up to 18 years;
• Period of pregnancy and lactation;
• Hypersensitivity to medicine components.

Relative:

• Liver diseases in the anamnesis;
• Heavy disturbances of electrolytic balance;
• Endocrine and metabolic disturbances;
• Arterial hypotension;
• Alcoholism;
• Heavy acute infections (sepsis);
• Uncontrollable spasms;
• Injuries;
• Extensive surgical interventions.

Route of administration and dosage

Before Liptonorm's appointment of the patient transfer to the corresponding diet which provides decrease in maintenance of lipids in blood (it it is necessary to observe also the entire period of treatment).

Liptonorm it is necessary to accept in 1 times a day, irrespective of meal, but at the same time daily.

The initial dose, as a rule, makes 10 mg. Further the optimum dose is selected individually, based on the maintenance of level of cholesterol of lipoproteids of low density, expressiveness of a disease and efficiency of therapy. It is necessary to change a dose at least with 4 weeks intervals.

The highest admissible daily dose makes 80 mg in 1 reception.

Side effects

Frequency of side effects: often – more than in 2% of cases, it is rare – less than in 2% of cases.

• Central nervous system: often – dizziness and sleeplessness; seldom – drowsiness, dreadful dreams, an asthenic syndrome, emotional lability, hyperkinesias, paresthesias, an indisposition, a loss of consciousness, a headache, a depression, amnesia, an ataxy, a hyperesthesia, paralysis of a facial nerve, a peripheral neuropathy;
• Sense bodys: accommodation disturbance, a food faddism, loss of flavoring feelings, a parosmiya (loss of sense of smell), a ring in ears, deafness, an amblyopia, dryness of a conjunctiva, glaucoma, a hematopsia;
• Cardiovascular system: often – a stethalgia; seldom – migraine, increase in arterial pressure, a vazodilatation, arrhythmia, postural hypotension, stenocardia, heartbeat, phlebitis;
• Respiratory system: often – rhinitis and bronchitis; seldom – диспноэ, nasal bleeding, bronchial asthma, pneumonia;
• Alimentary system: often – a cheilitis, stomatitis, dryness in a mouth, bleeding of gums, erosive cankers of a mucous membrane of an oral cavity, a glossitis, abdominal pains, a meteorism, heartburn, an eructation, nausea, locks or diarrhea, anorexia or increase in appetite, a gastralgia, a melena, vomiting, a dysphagy, a gastroenteritis, an esophagitis, tenesmus, pancreatitis, a duodenum ulcer, hepatic colic, an abnormal liver function, hepatitis, cholestatic jaundice, rectal bleeding;
• Musculoskeletal system: often – arthritis; seldom – the bursitis, myotonia of legs, a myopathy, a miositis, an arthralgia, a wryneck, contractures of joints, tendosinovit, a muscle hyper tone, a mialgiya, рабдомиолиз;
• System of a hemopoiesis: lymphadenopathy, anemia, thrombocytopenia;
• Urinogenital system: often – peripheral hypostases, urogenital infections; seldom – a dysuria (including a delay of an urination or an incontience of urine, a nocturia, imperative desires on an urination, a pollakiuria), нефроуролитиаз, a hamaturia, nephrite, an epididymite, a metrorrhagia, vaginal bleeding, disturbance of an ejaculation, decrease in a libido, impotence;
• Dermatological reactions: often – the increased sweating, a xerodermia, eczema, ecchymomas, seborrhea, petechias, an alopecia;
• Allergic reactions: often – contact dermatitis, rash on skin and an itch; seldom – a face edema, an anaphylaxis, a Quincke's disease, a small tortoiseshell, a photosensitization, Stephens-Johnson's syndrome, a mnogoformny exudative erythema, a toxic epidermal necrolysis;
• Laboratory indicators: seldom – an albuminuria, a hypoglycemia, a hyperglycemia, increase in activity of an alkaline phosphatase, serumal kreatinfosfokinaza, alaninaminotranspherase (ALT) and aspartate aminotransferase (nuclear heating plant);
• Others: seldom – increase in body weight, an exacerbation of gout, a mastodynia, a gynecomastia.

Special instructions

During treatment careful control of clinical and laboratory indicators of functions of an organism is necessary. At identification of any considerable pathological changes it is necessary to reduce a dose of drug or to stop treatment.

Function of a liver needs to be controlled before administration of drug, in 6 and 12 weeks of therapy, after each increase in a dose, and also periodically during treatment, for example, each 6 months. Within the first 3 months of use of Liptonorm change of activity of liver enzymes is usually noted.

In case of increase in activity of hepatic transaminases patients have to be under careful control until recovery of normal level. If value of nuclear heating plant or ALT more than by 3 times exceeds the upper bound of norm, it is necessary to lower a dose of drug or to stop treatment.

Patients with a diffusion mialgiya, weakness and slackness of muscles and/or substantial increase of a kreatinfosfokinaza treat risk group of development of a myopathy. At emergence of inexplicable pains or weakness in muscles, especially if they are followed by fever or an indisposition, it is necessary to see a doctor immediately.

Liptonorm's use needs to be stopped or to suspend temporarily at development of any serious condition which can potentially be a consequence of a myopathy, and also with risk factors which can lead to an acute renal failure owing to a rabdomioliz, such as disturbances of electrolytic balance, heavy endocrine and metabolic disturbances, arterial hypotension, an acute heavy infection, an injury, extensive surgical intervention.

In need of Liptonorm's appointment in a combination with derivatives of fibroyevy acid, niacin (in the doses causing hypolipidemic effect), immunodepressants, cyclosporine, klaritromitsiny, erythromycin, antifungal drugs (derivatives of azoles) it is necessary to compare the expected advantage of therapy and a risk degree. During treatment, especially in the first months and at increase in a dose of any of drugs, it is necessary to control a condition of the patient in case of weakness, slackness or muscular pains.

Cases of a negative impact of Liptonorm on the speed of psychophysical reactions and ability of the person to concentration of attention are not known.

Women of childbearing age during treatment need to use reliable methods of contraception. When planning pregnancy drug should be cancelled at least in 1 month.

Medicinal interaction

Antiacid funds for 35% reduce concentration of an atorvastatin, however influence on the content of cholesterol of lipoproteins of low density does not change.

Liptonorm in a daily dose of 80 mg increases for 20% concentration in blood of at the same time applied oral contraceptives containing ethinylestradiol and norethindrone and digoxin.

At use of drug in combination with warfarin in the first days the prothrombin time decreases. This indicator usually is normalized 15 days later. Follows the patients receiving this combination more often than usually to control a prothrombin time.

The protease inhibitors which are CYP3A4 inhibitors promote increase in concentration of an atorvastatin in a blood plasma.

At simultaneous use of antifungal drugs (derivative azoles), the klaritromitsina, erythromycin, niacinamide, fibrat, immunodepressants, cyclosporine increases concentration of an atorvastatin in a blood plasma and the risk of development of a myopathy increases.

At use of a combination of Liptonorm with kolestipoly the hypolipidemic effect surpasses that for each drug separately.

Grapefruit juice can increase concentration of an atorvastatin in a blood plasma therefore during treatment it is recommended to refrain from the use of this drink.

Terms and storage conditions

To store at a temperature up to 25 ºС in dry, protected from light, the place, unavailable to children.

Period of validity – 2 years.