Liptonorm is a lipid-lowering agent from the group of statins.
Release form and composition
Liptonorm is produced in the form of tablets: coated white, round, biconvex; on a break - white or almost white (14 pieces in blisters, 2 blisters in a carton box).
The active ingredient of the drug is atorvastatin (in the form of calcium salt). 1 tablet contains 10 or 20 mg.
Excipients: crosscarmelose, hydroxypropylcellulose, magnesium stearate, tween 80, lactose, hydroxypropylmethylcellulose, microcrystalline cellulose, titanium dioxide, calcium carbonate, polyethylene glycol.
Indications for use
- Mixed hyperlipidemia;
- Primary hypercholesterolemia;
- Heterozygous and homozygous familial hypercholesterolemia (in addition to diet therapy).
Strict contraindications to the use of Liptonorm are:
- Hepatic insufficiency (grades A and B according to the Child-Pugh scale);
- Increased activity of hepatic transaminases (more than 3 times compared with congenital adrenal hyperplasia) of unclear genesis;
- Active liver disease (including chronic hepatitis in the active phase and chronic alcoholic hepatitis);
- Cirrhosis of the liver of various etiologies;
- Age up to 18 years;
- Hypersensitivity to the drug.
With extreme caution Liptonorm prescribed in the following cases:
- A history of liver disease;
- Endocrine and metabolic disorders;
- Severe electrolyte imbalance;
- Uncontrolled seizures;
- Severe acute infections (sepsis);
- Chronic alcoholism;
- Extensive surgery.
Dosing and Administration
Before the appointment of Liptonorm and the entire period of its use, the patient should follow a dietary diet that provides a reduction in the content of lipids in the blood.
The drug is taken orally 1 time per day, regardless of meals, at the same time.
The initial daily dose is usually 10 mg. Further, the dose is adjusted individually, based on the cholesterol content of low-density lipoprotein. Intervals between dose changes should not be less than 4 weeks. The maximum permissible daily dose is 80 mg.
Possible side effects of the drug (often more than 2%, rarely less than 2%):
- Central nervous system: often - dizziness, insomnia; rarely - malaise, asthenic syndrome, drowsiness, headache, nightmares, emotional lability, peripheral neuropathy, ataxia, paresthesias, facial nerve paralysis, hyperesthesia, hyperkinesia, amnesia, depression, loss of consciousness;
- Cardiovascular system: often - chest pain; rarely - postural hypotension, arrhythmia, vasodilation, increased heart rate, angina, increased blood pressure, phlebitis;
- Sense organs: dryness of the conjunctiva, glaucoma, hemorrhage in the eye, amblyopia, disturbance of accommodation, parosmia, tinnitus, deafness, taste perversion, loss of taste;
- Respiratory system: often - rhinitis, bronchitis; rarely - nosebleeds, pneumonia, bronchial asthma, dyspnea;
- Digestive system: often - cheilitis, bleeding gums, erosive and ulcerative lesions of the oral mucosa, stomatitis, glossitis, dry mouth, tenesmus, constipation or diarrhea, heartburn, flatulence, nausea, gastralgia, belching, abdominal pain, vomiting, dysphagia , esophagitis, anorexia or increased appetite, duodenal ulcer, hepatic colic, gastroenteritis, hepatitis, abnormal liver function, cholestatic jaundice, pancreatitis, melena, rectal bleeding;
- Urogenital system: often - peripheral edema, urogenital infections; rarely - hematuria, nephritis, nephrolourithiasis, dysuria (including urinary incontinence or urinary retention, nocturia, pollakiuria, imperative urination to urinate), metrorrhagia, vaginal bleeding, epididymitis, impaired ejaculation, decreased libido, impotence;
- Musculoskeletal system: often - arthritis; rarely - tendosynovitis, bursitis, myositis, myalgia, arthralgia, torticollis, leg muscle cramps, joint contractures, muscle hypertonus, myopathy, rhabdomyolysis;
- Hematopoietic system: lymphadenopathy, anemia, thrombocytopenia;
- Dermatological and allergic reactions: rarely - increased sweating, seborrhea, xeroderma, eczema, petechiae, ecchymosis, alopecia, pruritus, skin rash, contact dermatitis; rarely - facial edema, angioedema, urticaria, photosensitivity, exudative erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylaxis;
- Laboratory indicators: rarely - albuminuria, hypoglycemia, hyperglycemia, increased activity of alkaline phosphatase, serum creatinine phosphokinase and hepatic transaminases;
- Other: rarely - mastodynia, gynecomastia, weight gain, exacerbation of gout.
Throughout the entire period of treatment, careful monitoring of clinical and laboratory parameters of body functions is necessary. In the event of significant pathological changes, you should reduce the dose of Liptonorm or stop taking it altogether.
Before prescribing the drug, then 6 and 12 weeks after the start of therapy, after each dose increase, and periodically during the entire treatment period (for example, every 6 months), it is necessary to monitor liver function. Changes in the activity of enzymes are usually observed in the first 3 months of taking Liptonorm. In the case of increased activity of hepatic transaminases, patients should be under close medical supervision until recovery of indicators. If the value of alanine aminate transferase (ALT) or aspartate aminotransferase (AST) is more than 3 times higher than the same indicator for congenital adrenal hyperplasia, it is recommended to reduce the dose or stop the drug.
It is necessary to compare the expected benefits and the degree of risk when Liptonorm is prescribed to a patient receiving cyclosporine, erythromycin, clarithromycin, immunosuppressants, fibric acid derivatives, nicotinic acid (in doses that have a lipid-lowering effect), antifungal agents derived from azole. If signs of muscle pain, weakness or lethargy appear, especially during the first few months of treatment or when the dose of any of the drugs is increased, the patient’s condition should be especially carefully monitored.
If there are risk factors for the development of acute renal failure as a result of rhabdomyolysis (for example, arterial hypotension, severe metabolic and endocrine disorders, acute severe infection, trauma, extensive surgical intervention, electrolyte imbalance), as well as in the case of a serious condition that may indicate the development of myopathy, Liptonorm must be temporarily or completely canceled.
The patient should be warned about the need to immediately consult a doctor if weakness or unexplained pain in the muscles, and especially if they are accompanied by indisposition and / or fever.
Reports of the negative impact of Liptonorm on the ability to drive vehicles and perform work requiring concentration of attention, were not received.
Immunosuppressants, antifungals derived from azole, fibrates, cyclosporin, erythromycin, clarithromycin, nicotinamide increase atorvastatin plasma levels and the risk of myopathy.
The level of the active substance Liptonorm also increase CYP3A4 inhibitors.
Antacid drugs reduce the atorvastatin concentration by 35%, but do not affect the cholesterol content of low-density lipoproteins.
When taking Liptonorm in a daily dose of 80 mg simultaneously with digoxin, the concentration of the latter in the blood increases by about 20%.
Liptonorm, taken in a daily dose of 80 mg, increases the concentration of oral contraceptives containing ethinyl estradiol or noretidron by 20%.
The lipid-lowering effect of the combination of atorvastatin with colestipol exceeds the effects inherent to each drug separately.
In the case of simultaneous use of warfarin in the first days of treatment, the prothrombin time decreases, but after 15 days, this figure, as a rule, normalizes. For this reason, patients receiving this combination should be monitored for prothrombin time more often than usual.
During treatment, it is not recommended to use grapefruit juice, since it may contribute to an increase in plasma atorvastatin concentration.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C in a dry, dark and protected from children place.
Shelf life - 2 years.