Roxera - instructions for use, doses, side effects, contraindications, price, where to buy

Roxera®

Renal dysfunction

In patients receiving high doses of rosuvastatin (particularly 40 mg/day), tubular proteinuria was observed, which was detected using test strips and in most cases was intermittent or short-term. Such proteinuria does not indicate acute illness or progression of concomitant renal disease. The incidence of serious renal dysfunction observed in post-marketing studies of rosuvastatin is higher when taking a dose of 40 mg/day.

In patients taking Roxera® at a dose of 30 or 40 mg/day, it is recommended to monitor kidney function indicators during treatment (at least once every 3 months).

Effect on the musculoskeletal system

The following musculoskeletal effects have been reported with rosuvastatin at all doses, but particularly at doses greater than 20 mg/day: myalgia, myopathy, and in rare cases, rhabdomyolysis. Very rare cases of rhabdomyolysis have been reported with the simultaneous use of HMG-CoA reductase inhibitors and ezetimibe. This combination should be used with caution, as pharmacodynamic interactions cannot be excluded.

As with other HMG-CoA reductase inhibitors, the incidence of rhabdomyolysis with post-marketing use of rosuvastatin is higher when using a dose of 40 mg/day.

Determination of serum CPK activity

Serum CPK activity cannot be determined after intense physical exercise and in the presence of other possible reasons for an increase in its activity; this may lead to incorrect interpretation of the results obtained. If the initial serum CPK activity is significantly exceeded (5 times higher than the upper limit of normal), a repeat analysis should be performed after 5-7 days. Therapy should not be started if the results of a repeat analysis confirm the initial high serum CPK activity (more than 5 times the upper limit of normal).

Before starting therapy

Depending on the daily dose, Roxera® should be administered with caution to patients with existing risk factors for myopathy/rhabdomyolysis.

These factors include:

renal dysfunction,
hypothyroidism,
history of muscle diseases (including family history),
history of myotoxic effects when taking other HMG-CoA reductase inhibitors or fibrates,
excessive alcohol consumption,
age over 65 years,
conditions in which the concentration of rosuvastatin in the blood plasma may increase,
simultaneous use of fibrates.

In such patients, it is necessary to evaluate the risks and possible benefits of therapy. Clinical monitoring is also recommended. If the initial serum CPK activity is more than 5 times higher than the upper limit of normal, therapy with Roxera® cannot be started.

During drug therapy

The patient should be informed to immediately report to the doctor if muscle pain, muscle weakness or spasms occur unexpectedly, especially in combination with malaise and fever. In such patients, serum CPK activity should be determined. Therapy should be discontinued if serum CPK activity is significantly increased (more than 5 times the upper limit of normal), or if muscle symptoms are severe and cause daily discomfort (even if serum CPK activity is no more than 5 times the upper limit of normal). exceeds the upper limit of normal). If symptoms disappear and serum CPK activity returns to normal, consideration should be given to resuming the use of Roxera® or other HMG-CoA reductase inhibitors in lower doses with careful medical supervision. Monitoring serum CPK activity in the absence of symptoms is impractical.

Very rare cases of immune-mediated necrotizing myopathy have been reported with clinical manifestations in the form of persistent weakness of the proximal muscles and increased CPK activity in the blood serum during therapy or upon discontinuation of the use of HMG-CoA reductase inhibitors, including rosuvastatin. Additional studies of the muscular and nervous system, serological studies, and therapy with immunosuppressive drugs may be required.

There were no signs of increased effects on skeletal muscles when taking rosuvastatin and concomitant therapy. However, an increase in the number of cases of myositis and myopathy has been reported in patients taking other HMG-CoA reductase inhibitors in combination with fibric acid derivatives (for example, gemfibrozil), cyclosporine, nicotinic acid in lipid-lowering doses (more than 1 g / day), antifungals - azole derivatives, HIV protease inhibitors and macrolide antibiotics.

When used simultaneously with certain HMG-CoA reductase inhibitors, gemfibrozil increases the risk of developing myopathy. Thus, the simultaneous use of Roxera® and gemfibrozil is not recommended. The benefits of further changes in plasma lipid concentrations with the combined use of Roxera® with fibrates or nicotinic acid in lipid-lowering doses must be carefully weighed taking into account the possible risks. Roxera® at a dose of 30 mg/day is contraindicated for combination therapy with fibrates.

Roxera® should not be used simultaneously or within 7 days after stopping therapy with systemic fusidic acid preparations. In patients in whom the use of fusidic acid is considered necessary, statin therapy should be discontinued for the entire duration of fusidic acid therapy. There have been reports of rhabdomyolysis (including death in some cases) in patients receiving fusidic acid concomitantly with statins. The patient should seek immediate medical attention if any symptoms of muscle weakness, pain, or tenderness occur.

Therapy with Roxera® can be resumed 7 days after the last dose of fusidic acid.

In exceptional cases, when long-term use of systemic fusidic acid is required, for example, in the treatment of severe infections, the need for simultaneous use of Roxera® and fusidic acid should be considered individually and subject to careful medical supervision.

Due to the increased risk of rhabdomyolysis, Roxera® should not be used in patients with acute conditions that may lead to myopathy or conditions predisposing to the development of renal failure (for example, sepsis, arterial hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders, uncontrollable seizures).

2-4 weeks after the start of treatment and/or when increasing the dose of Roxera®, monitoring of lipid metabolism parameters is necessary (dose adjustment is required if necessary).

Liver

Depending on the daily dose, Roxera® should be used with caution in patients with excessive alcohol consumption and/or in patients with a history of liver disease, or its use is contraindicated (see sections “Contraindications” and “With caution”).

It is recommended to determine liver function tests before the start of therapy and 3 months after its start. The use of Roxera® should be discontinued or the dose of the drug should be reduced if the activity of “liver” transaminases in the blood serum is 3 times higher than the upper limit of normal.

In patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome, treatment of underlying diseases should be carried out before starting treatment with Roxera®.

Ethnic characteristics

During pharmacokinetic studies, an increase in the plasma concentration of rosuvastatin was noted in representatives of the Mongoloid race compared to representatives of the Caucasian race.

Interstitial lung disease

Isolated cases of interstitial lung disease have been reported with the use of certain HMG-CoA reductase inhibitors, especially over long periods of time. Manifestations of the disease may include shortness of breath, non-productive cough and deterioration in general health (weakness, weight loss and fever).

If interstitial lung disease is suspected, therapy with HMG-CoA reductase inhibitors should be discontinued.

Diabetes mellitus type 2

In patients with glucose concentrations between 5.6 and 6.9 mmol/L, rosuvastatin therapy was associated with an increased risk of developing type 2 diabetes mellitus.

HIV protease inhibitors

Concomitant use of the drug with HIV protease inhibitors is not recommended (see section “Interaction with other drugs”).

Special information on excipients

Roxera® contains lactose and is therefore contraindicated in patients with lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.

Compound

One Roxer tablet contains 5, 10, 15, 20, 30 or 40 mg of rosuvastatin in the form of rosuvastatin calcium and auxiliary components:

microcrystalline cellulose;
lactose anhydrous;
crospovidone;
anhydrous colloidal silicon dioxide;
magnesium stearate.

The shell that covers the tablets contains:

butyl methacrylate, dimethylaminoethyl methacrylate and methyl acrylate copolymer in a ratio of 1:2:1;
macrogol 6000;
titanium dioxide;
lactose monohydrate.

Side effects

During treatment with Roxera, the following side effects may occur:

dysfunction of the immune system , including reactions caused by hypersensitivity to rosuvastatin or other ingredients of the drug, including the development of angioedema ;
dysfunction of the digestive system , expressed in the form of frequent constipation, pain in the epigastric region, attacks of nausea; pancreatitis may develop ;
disorders arising from the skin and subcutaneous tissues and expressed in the form of skin rashes, itching, urticaria ;
dysfunction of skeletal muscles, which manifests itself as myalgia (often) and sometimes myopathy and rhabdomyolysis ;
general disorders, the most common of which is asthenia ;
dysfunction of the kidneys and urinary tract , which are most often accompanied by an increase in the concentration of protein in the urine.

Rocker may influence changes in laboratory parameters. Thus, after taking the drug, the activity of creatine kinase , the concentrations of glucose , bilirubin , the liver enzyme gamma-glutamyl transpeptidase , alkaline phosphatase , and the plasma concentrations of thyroid .

The frequency and severity of side effects are dose-dependent.

Analogues of Roxers

Level 4 ATX code matches:
Akorta

Atomax

Lipitor

Pravastatin

Simvastol

Owencore

Simgal

Tulip

Lovastatin

Liptonorm

Rozulip

Zokor

Rosart

Tevastor

Atorvastatin

Liprimar

Simvastatin

Atoris

Basilip

Rosecard

Analogs of the drug that have the same ATC code, active substance and release form as Roxera are:

Klyvas 10;
Klyvas 20;
Crestor;
Mertenil;
Rovics;
Rosart;
Rozvator;
Rosuvastatin Sandoz;
Rosecard;
Rozulip;
Romazik;
Fastong.

The price of Roxera analogues in Ukraine varies from 65 to 595 hryvnia, on the Russian pharmaceutical market - from 220 to 2100 rubles.

Indications for use

Rocker shown:

For the treatment of patients suffering from primary type hypercholesterolemia (including familial hypercholesterolemia type II-A Fredrickson ) or dyslipidemia (type II-b). It is advisable to prescribe the drug when the expected therapeutic effect cannot be achieved by prescribing non-drug treatment methods: diet, correction of the patient’s weight, physical exercise, etc.
For the treatment of patients diagnosed with familial homozygous hypercholesterolemia . Roxera is prescribed as an addition to therapy, the purpose of which is to lower lipid , as an addition to the diet, and also in cases where previously prescribed treatment does not produce positive results.
For the treatment of patients diagnosed with atherosclerosis . The drug is used as a supplement to the prescribed diet to slow the progression of the disease, as well as to reduce total cholesterol and low-density lipoprotein cholesterol to the required level.
As a prophylactic agent to prevent the development of complications of heart and vascular in patients with a predisposition to the development of atherosclerotic vascular lesions .

Reviews about Roxer

Roxer tablets - reviews left on forums by patients taking the drug confirm this fact - are an effective means for lowering cholesterol .

The main advantages of the drug, many of them include a pronounced result, which is observed in a shorter time than when taking drugs similar to Roxera in their pharmacological action.

At the same time, an improvement in the clinical picture often occurs against the background of prescribing an order of magnitude lower dose compared to analogues (for example, Sigmal ).

Release form

Roxer is available in the form of tablets coated with a white film coating, which differ in appearance depending on the concentration of the active substance in them:

Tablets containing rosuvastatin in a dose of 5, 10 or 15 mg are round, biconvex, and chamfered. On one side there is a marking corresponding to the dose of the active substance: “5”, “10” and “15”, respectively.
Tablets containing rosuvastatin at a dose of 20 mg are round, biconvex, with a chamfer.
Tablets containing rosuvastatin at a dose of 30 mg are biconvex, capsule-shaped and scored on both sides.
Tablets containing rosuvastatin at a dose of 40 mg are biconvex and capsule-shaped.

On the cut of the tablet, two layers are clearly visible, the inner one is white.

pharmachologic effect

The pharmacological action of the drug Roxera is aimed at:

Suppression of the activity of the microsomal enzyme hydroxymethylglutaryl-CoA reductase , which acts as a catalyst for the rate-limiting early stage of cholesterol .
Normalization of lipid profile indicators ( hypolipidemic effect ) by reducing the concentration of total cholesterol , triglycerides , lipoproteins the blood , as well as increasing the concentration of lipoproteins .

The medicine belongs to the pharmacological group “ Statins ”.

Overdose

Clinical manifestations that may occur when the recommended dose of the drug is exceeded are not described. After a single dose of Roxera at a dose several times greater than the established daily dose, no clinically significant changes in the pharmacokinetics of rosuvastatin were observed.

In case of overdose and the appearance of symptoms of intoxication of the body, symptomatic treatment and, if necessary, a set of supportive measures are prescribed.

It is also recommended to monitor the level of creatine kinase and perform a test to assess liver .

The feasibility of prescribing hemodialysis is considered unlikely.

Rocker price

The price of Roxera depends on the dose of the active substance contained in it and the number of tablets in the package.

So, for example, tablets containing rosuvastatin 5 mg can be purchased on average for 295-450 Russian rubles per pack of 30 pieces. A package containing 90 Roxer 5 mg tablets will cost an average of 850-1100 Russian rubles.

The price of Roxera 10 mg is:

395-590 Russian rubles for a pack of 30 pieces;
1026-1500 Russian rubles per pack of 90 pieces.

The price of Roxera 20 mg is:

585-980 Russian rubles for a pack of 30 pieces;
1500-2175 Russian rubles per pack of 90 pieces.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

ZdravCity

Roxera tab.
p/o captivity. 5mg No. 30 Krka-Rus LLC 469 rub. order
Roxera tab. p/o captivity. 10mg No. 30Krka-Rus LLC
RUR 567 order
Roxera tab. p/o captivity. 5mg No. 90 Krka-Rus LLC
1015 rub. order
Roxera tab. p/o captivity. 10 mg No. 90 Krka-Rus LLC
RUB 1,306 order
Roxera tablets p.p.o 15 mg 90 pcs. Krka-Rus LLC
RUB 1,512 order

Pharmacy Dialogue

Roxera tablets 20 mg No. 30KPKA
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Roxera tablets 15 mg No. 30KPKA
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Roxera tablets 15 mg No. 90KPKA
RUB 1,458 order
Roxera tablets 5 mg No. 90KPKA
996 RUR order
Roxera tablets 10 mg No. 30KPKA
RUR 581 order

Pharmacy24

Roxera 40 mg No. 30 tablets KPKA, d.d., Novo mesto, Slovenia
250 UAH. order
Roxera 30 mg No. 90 tablets KPKA, d.d., Novo Mesto, Slovenia
370 UAH. order
Roxera 10 mg N90 tablets KPKA, d.d., Novo Mesto, Slovenia
298 UAH order
Roxera 20 mg No. 30 tablets KPKA, d.d., Novo Mesto, Slovenia
166 UAH order
Roxera 15 mg N30 tablets KRKA, Slovenia
98 UAH order

PaniPharmacy

Roxera tablets Roxera tablets 10 mg No. 30 Slovenia, KRKA dd Novo Mesto
134 UAH order
Roxer table 5mg No.90
219 UAH. order
Roxera tablets Roxera tablets. 30 mg No. 90 Slovenia, KRKA dd Novo Mesto
396 UAH. order
Roxera tablets Roxera tablets 15 mg No. 30 Slovenia, KRKA dd Novo Mesto
112 UAH order
Roxera tablets Roxera tablets 20 mg No. 30 Slovenia, KRKA dd Novo Mesto
194 UAH order