Romestin® 10 tablets are used for the following indications:
The active ingredient is rosuvastatin (one tablet contains rosuvastatin calcium in terms of rosuvastatin 10 mg).
Excipients: microcrystalline cellulose; calcium hydrogen phosphate anhydrous; lactose monohydrate; croscarmellose sodium; crospovidone; talc; stearic acid; Instacoat sol dye (hypromellose, polyethylene glycol, talc, titanium dioxide (E 171)); quinoline yellow (E 104).
The preparation is contraindicated:
Factors of this risk include:
The preparation can be taken at any time of the day, regardless of food intake.
Hypercholesterolemia treatment
The recommended starting dose is 5 or 10 mg orally once a day, both for patients who have not previously used statins and for patients who have previously used other HMG-CoA reductase inhibitors. When choosing an initial dose, one should take into account the cholesterol levels in each individual patient and the risk of cardiovascular disorders in the future, as well as the likelihood of developing adverse reactions. If necessary, the dose can be increased to the next level after 4 weeks. Considering that, against the background of the use of the preparation at a dose of 40 mg, adverse reactions occur more often than with lower doses, it is only necessary to finally titrate the dose to 40 mg in patients with severe hypercholesterolemia and a high risk of cardiovascular disorders (in particular, in patients with familial hypercholesterolemia), in whom the goal of treatment was not achieved with a dose of 20 mg and who will be monitored regularly. At the beginning of taking the preparation at a dose of 40 mg, specialist supervision is recommended.
Prevention of cardiovascular disorders
There is evidence that the preparation was used at a dose of 20 mg per day to reduce the risk of disorders of the cardiovascular system.
Children
The use of the preparation in children should be carried out only by a specialist.
Apply to children and adolescents aged 10 to 17 years (boys at developmental stage II and above according to Tanner and girls who started menstruating less than a year ago).
The initial daily dose for children and adolescents with heterozygous familial hypercholesterolemia is 5 mg per day. The preparation should usually be taken orally in doses from 5 mg to 20 mg once a day. The dose should be increased in accordance with the child's individual response to treatment and preparation tolerance, following the recommendations for the treatment of children.
Before starting rosuvastatin therapy, children and adolescents should be prescribed a standard cholesterol-lowering diet, which patients should also follow during treatment. The safety and efficacy of the preparation in doses greater than 20 mg in this population has not been studied.
Do not use 40 mg tablets in children.
The experience of treating children under the age of 10 years is limited to the use of the preparation in a small number of patients (aged 8 to 10 years) with homozygous familial hypercholesterolemia. Thus, the preparation is not recommended for use in children under 10 years of age.
Pregnant
The preparation is contraindicated during pregnancy or lactation.
Women of reproductive age must use appropriate contraception while taking this preparation.
Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the fetus, the potential risk of inhibition of HMG-CoA reductase outweighs the potential benefit from using the preparation during pregnancy. Animal studies have shown limited evidence of reproductive toxicity. If the patient becomes pregnant while using the preparation, treatment should be stopped immediately.
Rosuvastatin passes into the milk of rats. There is no data on the penetration of the preparation into breast milk in humans.
Drivers
Studies to determine the effect of rosuvastatin on the ability to drive vehicles and work with mechanisms have not been carried out. However, given its pharmacodynamic properties, it is unlikely that this preparation can interfere with this ability. When driving vehicles or working with mechanisms, you should take into account the possibility of dizziness during the treatment period.
There is no specific treatment for overdose. In case of an overdose, the patient should be treated symptomatically and, if necessary, supportive measures should be taken. It is necessary to monitor liver function and CK levels. Hemodialysis is unlikely to be effective.
Adverse events that occur with rosuvastatin are usually mild and temporary. Less than 4% of patients taking rosuvastatin in controlled clinical trials discontinued treatment due to the development of adverse reactions.
Below is a profile of adverse reactions to rosuvastatin according to clinical studies and extensive experience with post-registration use of rosuvastatin preparations. Adverse reactions are classified by frequency and systemic organ classes (SOC).
In terms of frequency, adverse reactions are distributed as follows: often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), rarely (≥ 1/10000 and <1/1000), very rarely ( <1/10000), unknown frequency (cannot be estimated from the available data).
On the part of the blood and lymphatic system: rarely - thrombocytopenia.
From the immune system: rarely - hypersensitivity reactions, including angioedema.
Endocrine disorders: often - diabetes mellitus.
Mental disorders: frequency unknown - depression.
From the nervous system: often - headache, dizziness; very rarely - polyneuropathy, memory loss; frequency unknown - peripheral neuropathy, sleep disorders (including insomnia and nightmares).
Respiratory, chest and mediastinal disorders: frequency unknown - cough, shortness of breath.
From the gastrointestinal tract: often - constipation, nausea, abdominal pain; rarely - pancreatitis; frequency unknown - diarrhea.
On the part of the digestive system: rarely - an increase in the level of hepatic transaminases; very rarely - jaundice, hepatitis.
On the part of the skin and subcutaneous tissue: infrequently - itching, rash, urticaria; frequency unknown - Stevens-Johnson syndrome.
On the part of skeletal muscles and connective tissue: often - myalgia, rarely - myopathy (including myositis), rhabdomyolysis; very rarely - arthralgia; frequency unknown - tendon disorders, sometimes complicated by ruptures, immune-mediated necrotizing myopathy.
From the side of the kidneys and urinary system: very rarely - hematuria.
From the reproductive system and mammary glands: rarely - gynecomastia.
General disorders and the condition of the injection site: often - asthenia; frequency unknown - edema.
Store in its original packaging at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life is 3 years.
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