Romestin 10, 10mg 30 tablets — Made in India — Free Delivery

Product description

Romestin® 10 tablets are used for the following indications:

• treatment of hypercholesterolemia (adults, adolescents and children over 10 years of age with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IІb) as an adjunct to the diet, when adherence to the diet and the use of other non-pharmacological agents (for example exercise, weight loss) is insufficient; with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid-lowering preparations  (for example, LDL apheresis) or in cases where such treatment is inappropriate);
• prevention of cardiovascular disorders (prevention of significant cardiovascular disorders in patients who are estimated to be at high risk of a first case of cardiovascular disorder, in addition to correcting other risk factors).

Compound

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).

Contraindications

The preparation is contraindicated:

• patients with hypersensitivity to rosuvastatin or to any of the excipients of the preparation;
• patients with active liver disease, including persistent elevations in serum transaminases of unknown etiology and any elevations in serum transaminases, which is three times higher than the upper limit of normal (ULN);
• patients with severe renal impairment (creatinine clearance <30 ml / minute);
• patients with myopathy;
• patients who are simultaneously receiving cyclosporine;
• during pregnancy and lactation, as well as women of reproductive age who do not use proper contraception.
• The 40 mg dose is contraindicated in patients with a tendency to myopathy / rhabdomyolysis.

Factors of this risk include:

• moderate renal impairment (creatinine clearance <60 ml / minute);
• hypothyroidism;
• a personal or family history of hereditary muscle diseases;
• a history of myotoxicity while using other inhibitors of HMG-CoA reductase or fibrates;
• alcohol abuse;
• situations that can lead to an increase in the concentration of the preparation in the blood plasma;
• belonging to the Mongoloid race;
• simultaneous use of fibrates.
• Mode of application
• Before starting treatment, the patient should be prescribed a standard cholesterol-lowering diet, which should be followed during treatment. The dose should be selected individually, depending on the goal of therapy and the effectiveness of treatment, guided by the recommendations of the current generally accepted instructions.

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.

Application features

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.

Overdose

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.

Side effects

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.

Storage conditions

Store in its original packaging at a temperature not exceeding 30 ° C, out of the reach of children.

Shelf life is 3 years.