Liptonorm - Instructions For Use, Reviews, Analogues, Price, 10 Mg, 20 Mg

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Liptonorm

Liptonorm: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacodynamics and pharmacokinetics
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Liptonorm

ATX code: C10AA05

Active ingredient: Atorvastatin (Atorvastatin)

Manufacturer: JSC Pharmstandard-Leksredstva, Russia M. J. Biopharm , India

Description and photo updated: 2019-30-07

Liptonorm is a hypolipidemic drug from the statin group.

Release form and composition

Dosage form - coated tablets: round, convex on both sides, white; at the break - almost white or white (14 pcs. in a blister, 2 blisters in a cardboard box).

Active ingredient: atorvastatin (in the form of calcium salt), its content in 1 tablet is 10 or 20 mg.

Auxiliary components: tween 80, lactose, hydroxypropyl cellulose, microcrystalline cellulose, croscarmellose, calcium carbonate, magnesium stearate, polyethylene glycol, titanium dioxide, hydroxypropyl methylcellulose.

Pharmacodynamics and pharmacokinetics

Liptonorm is a hypolipidemic drug from the statin group. The main mechanism of action of atorvastatin is to inhibit the activity of 3-hydroxy-3-methylglutaryl coenzyme A- (HMG-CoA) reductase. This enzyme catalyzes one of the initial stages of cholesterol synthesis - the process of converting HMG-CoA into mevalonic acid. The result of suppression of cholesterol synthesis by atorvastatin is an increased reactivity of low density lipoprotein (LDL) receptors in the liver and extrahepatic tissues. LDL particles bind to these receptors and are removed from the blood plasma, which lowers the level of LDL cholesterol in the blood.

Atorvastatin has an anti-sclerotic effect. The drug acts on blood components and vascular walls as follows:

• inhibits the synthesis of isoprenoids;
• improves endothelium-dependent vasodilation;
• reduces the content of triglycerides, cholesterol, apolipoprotein B, low density lipoproteins;
• increases the content of apolipoprotein A and HDL cholesterol (high density lipoprotein).

As a rule, the effect of Liptonorm develops after 2 weeks of admission. It takes 4 weeks to achieve maximum effect.

The absorption of the drug is high. It takes 1–2 hours to reach maximum concentration. In women, the maximum concentration is 20% higher than normal, and the AUC is 10% lower. In patients with alcoholic cirrhosis of the liver, the maximum concentration index exceeds the norm by 16 times, AUC - 11 times. Food intake slightly reduces the duration and rate of absorption of the drug (by 9% and 25%, respectively), however, the indicators of lowering LDL cholesterol are similar to those when using atorvastatin without food. When taken in the morning, the concentration of atorvastatin is approximately 30% higher than in the evening.

Bioavailability of Liptonorm is 14%, systemic bioavailability of inhibitory activity against HMG-CoA reductase is 30%. The decrease in the index of systemic bioavailability is influenced by the first pass metabolism in the mucous membrane of the fatty acid and the "first pass" through the liver.

The connection with plasma proteins is 98%, the average volume of distribution is 381 liters. The drug metabolism takes place mainly in the liver under the influence of cytochrome P450 CYP3A7, CYP3A5 and CYP3A4. As a result of this process, pharmacologically active metabolites (beta-oxidation products, ortho- and parahydroxylated derivatives) are formed. The inhibitory effect on HMG-CoA reductase is approximately 70% determined by the activity of circulating metabolites.

The drug does not undergo pronounced enterohepatic recirculation and is excreted together with bile after hepatic and / or extrahepatic metabolism.

The half-life of Liptonorm is 14 hours. Due to the presence of active metabolites, the inhibitory effect on HMG-CoA reductase lasts for about 20-30 hours. The drug is not excreted during hemodialysis. Less than 2% of the dose taken orally is determined in urine.

Indications for use

• Homozygous and heterozygous familial hypercholesterolemia (as an adjunct to dietary therapy);
• Primary hypercholesterolemia;
• Mixed hyperlipidemia.

Contraindications

Absolute:

• Liver cirrhosis of various etiologies;
• Liver failure (classes A and B according to the Child-Pugh scale);
• Active liver diseases, including active chronic hepatitis and chronic alcoholic hepatitis;
• Increase in the activity of hepatic transaminases (more than 3 times compared to the upper limit of the norm) of unknown origin;
• Age under 18;
• Pregnancy and lactation period;
• Hypersensitivity to the components of the drug.

Relative:

• History of liver disease;
• Severe electrolyte imbalance;
• Endocrine and metabolic disorders;
• Arterial hypotension;
• Chronic alcoholism;
• Severe acute infections (sepsis);
• Uncontrolled seizures;
• Injuries;
• Major surgical interventions.

Instructions for use Liptonorm: method and dosage

Before prescribing the drug, the patient is transferred to an appropriate diet, which ensures a decrease in blood lipids (this must be observed for the entire period of treatment).

According to the instructions, Liptonorm should be taken orally 1 time per day, regardless of food intake, but at the same time every day.

The starting dose is usually 10 mg. In the future, the optimal dose is selected individually, based on the level of low-density lipoprotein cholesterol, the severity of the disease and the effectiveness of therapy. Dose changes should be made at least 4-week intervals.

The highest permissible daily dose is 80 mg in 1 dose.

Side effects

Frequency of side effects: often - in more than 2% of cases, rarely - in less than 2% of cases.

• Central nervous system: often - dizziness and insomnia; rarely - drowsiness, nightmares, asthenic syndrome, emotional lability, hyperkinesis, paresthesia, malaise, loss of consciousness, headache, depression, amnesia, ataxia, hyperesthesia, paralysis of the facial nerve, peripheral neuropathy;
• Sense organs: violation of accommodation, perversion of taste, loss of taste, parosmia (loss of smell), ringing in the ears, deafness, amblyopia, dryness of the conjunctiva, glaucoma, bleeding in the eye;
• Cardiovascular system: often - chest pain; rarely - migraine, increased blood pressure, vasodilation, arrhythmia, postural hypotension, angina pectoris, palpitations, phlebitis;
• Respiratory system: often - rhinitis and bronchitis; rarely - dyspnea, nosebleeds, bronchial asthma, pneumonia;
• Digestive system: often - cheilitis, stomatitis, dry mouth, bleeding gums, erosive and ulcerative lesions of the oral mucosa, glossitis, abdominal pain, flatulence, heartburn, belching, nausea, constipation or diarrhea, anorexia or increased appetite, gastralgia, melena, vomiting, dysphagia, gastroenteritis, esophagitis, tenesmus, pancreatitis, duodenal ulcer, hepatic colic, liver dysfunction, hepatitis, cholestatic jaundice, rectal bleeding;
• Musculoskeletal system: often - arthritis; rarely - bursitis, leg muscle cramps, myopathy, myositis, arthralgia, torticollis, joint contractures, tendosynovitis, muscle hypertonia, myalgia, rhabdomyolysis;
• Hematopoietic system: lymphadenopathy, anemia, thrombocytopenia;
• Genitourinary system: often - peripheral edema, urogenital infections; rarely - dysuria (including urinary retention or urinary incontinence, nocturia, urge to urinate, pollakiuria), nephrourolithiasis, hematuria, nephritis, epididymitis, metrorrhagia, vaginal bleeding, ejaculation disorders, decreased libido, impotence;
• Dermatological reactions: often - increased sweating, xeroderma, eczema, ecchymosis, seborrhea, petechiae, alopecia;
• Allergic reactions: often - contact dermatitis, skin rash and itching; rarely - facial edema, anaphylaxis, angioedema, urticaria, photosensitivity, Stevens-Johnson syndrome, exudative erythema multiforme, toxic epidermal necrolysis;
• Laboratory indicators: rarely - albuminuria, hypoglycemia, hyperglycemia, increased activity of alkaline phosphatase, serum creatine phosphokinase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST);
• Others: rarely - an increase in body weight, exacerbation of gout, mastodynia, gynecomastia.

Overdose

In case of an overdose, the development of symptoms included in the list of side effects is possible, but with greater severity.

There is no specific antidote for Liptonorm, therefore, in case of an overdose, the following measures are recommended:

• preventing further absorption of the drug (taking activated charcoal, gastric lavage);
• support for the work of vital functions of organs;
• symptomatic therapy.

Hemodialysis in such cases is ineffective.

special instructions

During treatment, careful monitoring of clinical and laboratory indicators of body functions is required. If any significant pathological changes are detected, the dose of the drug should be reduced or treatment discontinued.

Liver function should be monitored before starting the drug, after 6 and 12 weeks of therapy, after each dose increase, and also periodically during treatment, for example, every 6 months. During the first 3 months of using Liptonorm, there is usually a change in the activity of liver enzymes.

In the case of an increase in the activity of hepatic transaminases, patients should be closely monitored until the normal level is restored. If the AST or ALT value is more than 3 times higher than the upper limit of the norm, the dose of the drug should be reduced or treatment stopped.

Patients with diffuse myalgia, muscle weakness and lethargy and / or a significant increase in creatine phosphokinase are at risk of developing myopathy. If you develop unexplained muscle pain or weakness, especially if it is accompanied by fever or malaise, you should see your doctor right away.

The use of Liptonorm should be discontinued or temporarily suspended if any serious condition develops that can potentially be a consequence of myopathy, as well as in the presence of risk factors that can lead to acute renal failure due to rhabdomyolysis, such as electrolyte imbalance, severe endocrine and metabolic disorders, arterial hypotension, acute severe infection, trauma, major surgery.

If it is necessary to prescribe Liptonorm in combination with derivatives of fibric acid, nicotinic acid (in doses causing a hypolipidemic effect), immunosuppressants, cyclosporine, clarithromycin, erythromycin, antifungal drugs (derivatives of azoles), the expected benefits of therapy and the degree of risk should be compared. During treatment, especially in the first months and with an increase in the dose of any of the drugs, it is necessary to monitor the patient's condition in case of weakness, lethargy or muscle pain.

Cases of the negative influence of Liptonorm on the speed of psychophysical reactions and a person's ability to concentrate are not known.

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

Application during pregnancy and lactation

Liptonorm is forbidden to use during pregnancy and breastfeeding. It is not recommended to prescribe the drug to women of childbearing age who do not use reliable methods of contraception. At least one month before the planned pregnancy, you must stop using the drug.

Pediatric use

It is forbidden to use in the treatment of children and adolescents under 18 years of age.

For violations of liver function

The drug is prescribed with caution if there is a history of liver disease.

Liptonorm is contraindicated in the following cases:

• active phase of liver disease (for example, with active chronic hepatitis, chronic alcoholic hepatitis);
• an increase in the activity of hepatic transaminases (exceeding the upper limit of the norm by at least 3 times compared with VGN) of unclear etiology;
• cirrhosis of the liver of various etiologies;
• liver failure (classes A and B on the Child-Pugh scale).

Use in the elderly

When treating this category of patients, dose adjustment is not required.

Drug interactions

Antacids reduce the concentration of atorvastatin by 35%, but the effect on low-density lipoprotein cholesterol does not change.

Liptonorm in a daily dose of 80 mg increases by 20% the concentration in the blood of simultaneously used oral contraceptives containing ethinyl estradiol and norethindrone, and digoxin.

When using the drug in combination with warfarin in the first days, the prothrombin time decreases. This indicator normalizes usually after 15 days. Patients receiving this combination should monitor prothrombin time more often than usual.

Protease inhibitors, which are inhibitors of CYP3A4, increase the concentration of atorvastatin in blood plasma.

With the simultaneous use of antifungal drugs (derivatives of azoles), clarithromycin, erythromycin, nicotinamide, fibrates, immunosuppressants, cyclosporine, the concentration of atorvastatin in the blood plasma increases and the risk of myopathy increases.

When using a combination of Liptonorm with colestipol, the lipid-lowering effect is superior to that for each drug separately.

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

Analogs

Liptonorm analogs are: Anvistat, Atokord, Atomax, Atorvastatin, Atorvastatin-Teva, Liprimar, Ator, Lipoford, Lipona, Vasator, Torvakard.

Terms and conditions of storage

Store at temperatures up to 25 ºС in a dry, protected from light, out of reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Liptonorm

In general, the reviews about Liptonorm are positive. At the same time, there are reports that without dieting (refusal of fried and fatty foods, alcohol), the effectiveness of the drug is significantly reduced.

The price of Liptonorm in pharmacies

The price of a package of Liptonorm 10 mg of 28 tablets is about 200 rubles, a package of 28 Liptonorm 20 mg tablets is about 390 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!