Name:
Atorvastatin-lf. Forms of release Tablets. MNNA torvastatin.
Description:
Pills, coated, pink, with a biconvex surface. Composition 1 tablet contains: Active substance: atorvastatin (in the form of atorvastatin calcium trihydrate) – 10 mg, 20 mg or 40 mg; Excipients: calcium carbonate, crospovidone (type B), sodium lauryl sulfate, anhydrous colloidal silicon dioxide, talc, microcrystalline cellulose; Shell composition: Opadry II pink (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000/PEG, talc, yellow iron oxide, red iron oxide, black magnetite/iron oxide). Pharmacotherapeutic group Hypolipidemic agents. HMG-CoA reductase inhibitors. ATX code: C10AA05 Indications for use Atorvastatin-LF belongs to a group of medicines called statins that regulate blood lipid levels. Atorvastatin-LF is used to lower blood lipids such as cholesterol and triglycerides in adults, adolescents, and children 10 years of age and older when a low-fat diet and lifestyle changes alone have not been effective. Atorvastatin-LF may also be used to reduce the risk of heart disease even when cholesterol levels are normal. During treatment with Atorvastatin-LF, it is necessary to follow a standard diet aimed at lowering cholesterol levels. Dosage and Administration Before starting treatment, your doctor will prescribe you a low-cholesterol diet, which you will also need to follow while taking Atorvastatin-LF. The standard starting dose of Atorvastatin-LF is 10 mg once daily in adults and children 10 years of age and older. If necessary, your doctor may increase the dose of the drug until you receive the dose that you need. Dose adjustments will be made by the attending physician at intervals of 4 weeks or more. The maximum dose of Atorvastatin-LF is 80 mg once daily. Atorvastatin-LF tablets should be swallowed whole with water. The drug Atorvastatin-LF can be taken at any time of the day, regardless of the meal. However, try to take your tablets at the same time each day. In all cases, you should strictly follow the instructions of the doctor. If you have any doubts about taking the drug, consult your doctor. The duration of taking Atorvastatin-LF is determined by your doctor. If you miss one dose of the drug, take the next dose according to your usual schedule at the proper time. Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this drug or want to stop treatment, contact your doctor. Side effects Like all medicines, this medicine can sometimes have side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking the drug and tell your doctor immediately or go to the nearest hospital or emergency room. Rare: may affect up to 1 in 1,000 people – severe allergic reactions with swelling of the face, tongue and throat that can cause severe breathing difficulties. – severe skin lesions with severe flaking and swelling, blistering of the skin, mouth, eyes, genitals and fever. A rash on the skin in the form of pink-red spots, especially on the palms of the hands or soles of the feet, which may turn into blisters. – muscle weakness, soreness or pain in the muscles, especially if it is accompanied by poor health and high body temperature. This condition may be due to the pathological destruction of muscle tissue (rhabdomyolysis). Pathological destruction of muscle tissue does not always resolve on its own, even after discontinuation of atorvastatin, can be life-threatening and can lead to impaired renal function. Very rare: may occur in up to 1 in 10,000 people – unexpected or unusual bleeding or hemorrhage, which may indicate a violation of the liver. You should consult with your doctor as soon as possible. Other possible side effects of atorvastatin Common: may affect up to 1 in 10 people with sinus inflammation, sore throat, nosebleeds; allergic reactions; increased blood glucose levels (if you are diabetic, continue careful monitoring of blood glucose levels), increased blood creatine kinase levels; headache; nausea, constipation, flatulence, indigestion, diarrhea; joint pain, muscle pain, and back pain; deviation in the results of a blood test, indicating a possible violation of liver function. Uncommon: may affect up to 1 in 100 people with anorexia (loss of appetite), weight gain, low blood glucose (if you have diabetes, keep monitoring your blood glucose closely); nightmares, insomnia; dizziness, numbness or tingling in the fingers and toes, decreased sensation of pain or touch, change in taste perception, memory loss; blurred vision; ringing in the ears and / or head; vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas causing pain in the abdomen); hepatitis (inflammation of the liver); rash, skin rash and itching, hives, hair loss; neck pain, muscle fatigue; fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (edema), fever; a positive test result for the presence of leukocytes in the urine. Rare: may affect up to 1 in 1,000 people with visual impairment; unexpected bleeding or bruising; cholestasis (yellowing of the skin and mucous membranes of the eyes); tendon injury. Very rare: may affect up to 1 in 10,000 people with an allergic reaction – symptoms may include sudden shortness of breath, pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue and throat, difficulty breathing, fainting; hearing loss; gynecomastia (enlargement of the mammary glands in men and women). Not known: frequency cannot be estimated from the available data: persistent muscle weakness. Possible side effects reported with the use of some statins (drugs of the same type): sexual dysfunction; depression; breathing problems, including persistent cough and/or shortness of breath or fever; diabetes mellitus, the development of which is most likely with an increase in the level of glucose and fats in the blood, overweight and high blood pressure. Your doctor will monitor your health while you are taking this drug. Contraindications The use of Atorvastatin-LF is contraindicated: if you are hypersensitive (allergic) to atorvastatin or any of the other ingredients of this drug; if you have had or are currently suffering from a disease that causes liver dysfunction; if you have unexplained pathological abnormalities in the biochemical parameters of liver function (an increase in the activity of transaminases in the blood serum by more than 3 times compared to the upper limit of the norm); if you are a woman of reproductive age who does not use reliable contraception; if you are pregnant or planning to become pregnant; if you are breastfeeding. Overdose If you accidentally take too many Atorvastatin-LF tablets (more than your usual daily dose), contact your doctor or the nearest hospital. There is no specific antidote for the treatment of atorvastatin overdose. In case of overdose, if necessary, symptomatic and supportive treatment should be carried out. It is necessary to monitor liver function indicators, as well as the level of creatine kinase in the blood serum. Given the active binding of the drug to plasma proteins, hemodialysis is unlikely to significantly accelerate the clearance of atorvastatin. Precautions: Talk to your doctor before taking Atorvastatin-LF: if you have severe respiratory failure; if you are taking or have taken in the past 7 days a medicine called fusidic acid (used to treat a bacterial infection), by mouth or by injection. The combined use of fusidic acid and the drug Atorvastatin-LF can lead to serious muscle problems (rhabdomyolysis); if you have had a hemorrhagic stroke in the past or if you have small cysts in the brain due to previous strokes; if you have kidney problems; if you have an underactive thyroid gland (hypothyroidism); if you have recurring or unexplained muscle pain or have had muscle problems in your family; if you have previously developed muscle problems while taking other lipid-lowering drugs (for example, other statins or fibrates); if you regularly drink alcohol in large quantities; if you have a history of liver disease; if you are over 70 years old. If any of the above conditions apply to you, your doctor will need to order a blood test before you start using Atorvastatin-LF and possibly during treatment to determine if you may develop adverse reactions due to muscle disorders. It is known that the risk of developing side effects associated with muscles (for example, rhabdomyolysis) increases with the simultaneous use of certain drugs (see section “Interaction with other drugs”). Also tell your doctor if you have persistent muscle weakness. Additional examinations and drugs for diagnosis and treatment may be required. If you have diabetes or are at risk of developing diabetes, you will be under close medical supervision during treatment with this medicine. If you have high blood sugar and fat levels, if you are overweight and have high blood pressure, you are more likely to develop diabetes. Use during pregnancy and lactation Do not take Atorvastatin-LF if you are pregnant or planning to become pregnant. You should not take Atorvastatin-LF if you are able to become pregnant and are not using reliable methods of contraception. You should not take Atorvastatin-LF if you are breastfeeding. The safety of Atorvastatin-LF during pregnancy and lactation has not been established. Before using any medicine, consult your doctor. Influence on the ability to drive a car and work with mechanisms As a rule, the drug does not affect the ability to drive vehicles and work with mechanical equipment. However, do not drive a car if this drug affects your ability to drive. Do not use any tools or equipment if this drug affects your ability to do these things. Interaction with other medicinal products Tell your doctor if you are currently taking, have recently taken or may take any other medicines. Some drugs may change the way atorvastatin works, or atorvastatin may affect how these drugs work. This type of interaction may reduce the effectiveness of one or both drugs and may increase the risk or severity of adverse reactions, including a serious muscle wasting condition called rhabdomyolysis, which is described in the section “Side effects”: drugs that affect on the immune system (for example, cyclosporine); certain antibiotics or antifungals (eg, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid); other drugs that affect lipid levels (eg gemfibrozil, other fibrates, colestipol); certain calcium channel blockers used to treat angina or high blood pressure (eg, amlodipine, diltiazem); medicines for the treatment of cardiac arrhythmias (eg, digoxin, verapamil, amiodarone); medicines for the treatment of HIV infection (eg ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir combination, etc.); certain medicines used to treat hepatitis C (for example, telaprevir); other drugs known to interact with atorvastatin: ezetimibe (lowers cholesterol), warfarin (lowers blood clotting), oral contraceptives, styripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat heartburn and peptic ulcer) diseases), phenazone (pain reliever), colchicine (used to treat gout), antacids (medications for indigestion containing aluminum or magnesium), and boceprevir (used to treat liver diseases such as hepatitis C); medicines sold without a doctor’s prescription: preparations containing St. John’s wort; if you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking atorvastatin. Your doctor will let you know when it is safe to start taking Atorvastatin-LF. Taking atorvastatin with fusidic acid can, in rare cases, lead to muscle weakness, muscle tenderness when touched, or pain (this phenomenon is called “rhabdomyolysis”). For more information regarding rhabdomyolysis, see the “Side Effects” section. Effects of Food and Drinks on Atorvastatin-LF Pay attention to the following: Grapefruit Juice Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may interfere with the effect of Atorvastatin-LF. Alcohol Do not drink large amounts of alcohol while taking this drug. See the Precautions section for details. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the package. Packaging Dosage 10 mg: 10 or 15 tablets in a blister pack made of PVC film and aluminum foil. Three or six blister packs of 10 tablets, two or four blister packs of 15 tablets with instructions for medical use in a cardboard pack. Dosage 20 mg: 10 tablets in a blister pack made of PVC film and aluminum foil. Three or six blister packs with instructions for medical use in a pack of cardboard. Dosage 40 mg: 10 tablets in a blister pack made of PVC film and aluminum foil. Three blister packs with instructions for medical use in a cardboard pack. Conditions of release By prescription. Buy Atorvastatin-LF tablets p/o 40mg No. 10×3 Price for Atorvastatin-LF tablets p/o 40mg No. 10×3
INN | Atorvastatin |
---|---|
The code | 129 940 |
Barcode | 4 812 608 011 359 |
Active substance | Atorvastatin |
Manufacturer | Lekpharm SOOO, Belarus |
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