Costarox

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

Costarox: instructions for use and reviews

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

Latin name: Kostarox

ATX code: M01AH05

Active ingredient: Etoricoxib (Etoricoxib)

Manufacturer: Kadila Pharmaceuticals, Ltd. (Cadila Pharmaceuticals, Ltd.) (India)

Description and photo updated: 2018-29-11

Prices in pharmacies: from 221 rubles.

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Costarox is a non-steroidal anti-inflammatory drug (NSAID); has anti-inflammatory, analgesic, antipyretic effect.

Release form and composition

The drug is available in the form of film-coated tablets: round, biconvex, dosage 30 mg - bluish green, dosage 60 mg - dark green, dosage 90 mg - white, dosage 120 mg - light green (in blisters: 7 pcs.., in a cardboard box 1 blister; 10 pcs., in a cardboard box 1, 2, 3, 5, 6, 9 or 10 blisters; 14 pcs., in a cardboard box 1, 2, 4, 6 or 7 blisters; each pack also contains instructions for the use of Costarox).

1 tablet contains:

active substance: etoricoxib - 30, 60, 90 or 120 mg;
auxiliary components: povidone K30, microcrystalline cellulose (MCC), calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate.
composition of the film shell: dosage 30 mg - Opadray II green 32K510001 [lactose monohydrate, hypromellose 15 cPs, triacetin, titanium dioxide, yellow iron oxide, indigo carmine aluminum varnish (3-5%)]; dosage 60 mg - Opadray II green 32K510002 [lactose monohydrate, hypromellose 15 cPs, triacetin, titanium dioxide, yellow iron oxide, indigo carmine aluminum varnish (3-5%)]; dosage 90 mg - Opadray II white 32K580000S (lactose monohydrate, hypromellose 15 cPs, triacetin, titanium dioxide); dosage 120 mg - Opadray II green 32K510003 [lactose monohydrate, hypromellose 15 cPs, triacetin, titanium dioxide, yellow iron oxide, indigo carmine aluminum varnish (3-5%)].

Pharmacological properties

Pharmacodynamics

Costarox is a non-steroidal anti-inflammatory drug. Its active ingredient is etoricoxib, which has anti-inflammatory, analgesic, antipyretic effects. It inhibits the biosynthesis of prostaglandins, when taken orally in a daily dose of up to 150 mg, etoricoxib has the ability to selectively inhibit type 2 cyclooxygenase (COX-2), without affecting COX-1. In therapeutic doses, selectively inhibiting COX-2, does not inhibit the synthesis of prostaglandins in the gastric mucosa and does not affect platelet function.

COX-2 is the main isoenzyme responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Fever induction and pain sensation is associated with the participation of COX-2 in the processes of ovulation, regulation of renal function, implantation and closure of the ductus arteriosus, and the cognitive function of the central nervous system. The anti-inflammatory effect of Costarox is due to an improvement in microcirculation, a decrease in vascular permeability and release of inflammatory mediators from cells, and suppression of the energy supply of the inflammatory process.

In the course of a study conducted to determine the optimal dose of etoricoxib for the treatment of osteoarthritis, it was found that against the background of a single use in a daily dose of 60 mg, there is a decrease in pain and an improvement in the condition of patients. The beneficial effect occurs on the second day of therapy and persists for a long time. Etoricoxib 30 mg daily showed less marked improvement; for the treatment of osteoarthritis of the joints of the hands, the effectiveness of this dose has not been studied.

In rheumatoid arthritis, a single dose of etoricoxib in a daily dose of 60 mg or 90 mg reduces pain, reduces inflammation, and improves joint mobility. The effect lasts for the entire period of treatment.

In acute gouty arthritis, after taking Costarox at a dose of 120 mg, a decrease in pain is noted after 4 hours. For moderate to severe joint pain, taking this dose once a day has an analgesic and anti-inflammatory effect.

With ankylosing spondylitis, the clinical efficacy of etoricoxib in a daily dose of 90 mg is achieved already from the second day of taking Costarox. There is a significant long-term decrease in pain and stiffness in the back, a decrease in inflammation, and an improvement in motor function.

During the study, in the absence of an adequate clinical response to therapy with etoricoxib at a daily dose of 60 mg for 6 weeks, the patient was transferred to a daily dose of 90 mg, which showed an improvement in his condition.

In the period after dental operations, a noticeable decrease in pain occurs against the background of taking Costarox at a dose of 90 mg after 0.5 hours.

The results of an extensive controlled safety assessment for cardiovascular events showed that there were no significant differences in the incidence of cardiovascular thrombotic events with etoricoxib (60 mg or 90 mg) compared with diclofenac (150 mg). Against the background of Costarox, cardiorenal syndromes may occur more often. Withdrawal of therapy due to the development of hypertension, severe heart failure, or edema was more often performed in patients taking etoricoxib. The effect was dose-dependent; while taking Costarox at a dose of 60 mg, the severity of these phenomena was lower. Side effects from the gastrointestinal tract (GIT) and liver developed significantly more often when taking diclofenac, but serious undesirable effects (including those requiring discontinuation of treatment),were more common with etoricoxib.

The number of adverse events from the gastrointestinal tract included ulcers, bleeding (including complicated), obstruction, perforation.

In patients under the age of 75 years, the incidence of confirmed clinical adverse events from the upper gastrointestinal tract with etoricoxib is lower compared with diclofenac.

In the course of the study, therapy was canceled more often due to the development of adverse events from the liver while taking diclofenac. It should be noted that most of the resulting adverse reactions from the liver were not serious.

In additional clinical studies of the safety of the use of Costarox associated with thrombotic cardiovascular events, it was found that the difference between some NSAIDs in antiplatelet activity (COX-1 inhibitors and selective COX-2 inhibitors) in patients at risk of thromboembolic events may have clinical significance. … When compared with naproxen (500 mg twice daily), the incidence of severe thrombotic cardiovascular events was higher in patients receiving etoricoxib. Whereas the cumulative incidence of gastroduodenal ulcers is much lower when taking Costarox at a daily dose of 120 mg than that of naproxen (500 mg twice a day) or ibuprofen (800 mg three times a day).

It was found that when using etoricoxib for 15 days at a dose of 90 mg in elderly patients (60–85 years old) on a diet with limited sodium intake, a significant increase in systolic blood pressure (BP) was observed. The effect on sodium excretion by the kidneys is comparable to that of celecoxib and naproxen.

Pharmacokinetics

After oral administration, etoricoxib is rapidly absorbed. Its absolute bioavailability is 100%. The maximum concentration (Cmax) is reached after 1 hour. In adults, until an equilibrium is reached in blood plasma, it remains at a level of 3.6 μg / ml when using Costarox before meals at a dose of 120 mg once a day. The geometric mean area under the concentration-time curve (AUC) over 24 hours is 37.8 μg / h / ml. Etoricoxib pharmacokinetics are linear over the therapeutic dose range.

The simultaneous intake of food with a high fat content does not have a clinically significant effect on the degree of absorption of the drug, the absorption rate decreases, increasing the time to reach Cmax to 2 hours. This has no clinical significance, therefore, pills are indicated regardless of food intake.

Plasma protein binding - 92%.

The volume of distribution at equilibrium is about 120 liters.

It has been established that etoricoxib crosses the placental and blood-brain barrier in rats.

The main pathway of extensive metabolism of etoricoxib in the liver is the formation of 6'-hydroxymethylethoricoxib, which is catalyzed by enzymes of the cytochrome system, mainly by the isoenzyme CYP3A4. The participation of isoenzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 is assumed, but their quantitative effect in vivo has not been established. Of the five identified metabolites, 6'-carboxyacetylethoricoxib is the main one. It is formed as a result of further oxidation of 6'-hydroxymethylethoricoxib. Etoricoxib metabolites weakly inhibit COX-2 and do not inhibit COX-1.

It is excreted mainly in the form of metabolites, through the kidneys - 70%, through the intestines - 20%. Less than 2% is found unchanged, of which less than 1% is in the urine.

Equilibrium concentrations are achieved when Costarox is taken at a dose of 120 mg once a day for 7 days. The cumulation coefficient is about 2, the half-life is about 22 hours.

The pharmacokinetic parameters of etoricoxib in men and women are the same, and in patients over the age of 65 years, they are comparable to those in younger patients.

The safety and efficacy of using Costarox for the treatment of children has not been established.

With mild hepatic impairment (5-6 points on the Child-Pugh scale), taking etoricoxib at a daily dose of 60 mg causes an increase in AUC by about 16%.

With an average degree of hepatic impairment (7-9 points on the Child-Pugh scale), the AUC value against the background of using the drug at a dose of 60 mg every other day was similar to the AUC in healthy individuals who took etoricoxib at a daily dose of 60 mg daily. The efficacy and safety of etoricoxib 30 mg once daily has not been established in this group of patients.

There are no research results on the use of Costarox in severe hepatic failure (above 10 points on the Child-Pugh scale).

With moderate to severe renal failure or end-stage chronic renal failure requiring hemodialysis, there is no significant difference in pharmacokinetic parameters from those in healthy individuals after a single use of etoricoxib at a dose of 120 mg. Hemodialysis has little effect on drug excretion; clearance during dialysis is about 50 ml / min.

Indications for use

The use of Costarox is indicated for the symptomatic treatment of osteoarthritis, ankylosing spondylitis, rheumatoid arthritis, and acute gouty arthritis.

In addition, the drug is prescribed as a short-term treatment for moderate acute pain after dental surgery.

Contraindications

Absolute:

inflammatory bowel disease;
acute period of gastric ulcer and duodenal ulcer, active gastrointestinal bleeding;
bronchospasm, bronchial asthma, nasal polyposis, acute rhinitis, urticaria, allergic reactions or angioedema with the use of acetylsalicylic acid or other NSAIDs (including COX-2 inhibitors) in history;
severe liver dysfunction (above 10 points on the Child-Pugh scale);
renal failure with creatinine clearance (CC) less than 30 ml / min;
chronic heart failure II – IV functional class according to NYHA classification (New York Heart Association);
BP is consistently above 140/90 mm Hg with uncontrolled arterial hypertension;
peripheral artery disease, cerebrovascular disease and / or confirmed coronary artery disease;
lactase deficiency, glucose-galactose malabsorption syndrome, lactose intolerance;
hyperkalemia;
period of pregnancy;
breast-feeding;
age under 16;
hypersensitivity to the components of the drug.

It is recommended with caution to prescribe Costarox tablets to patients with a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, Helicobacter Pylori infection, dyslipidemia or hyperlipidemia, diabetes mellitus, arterial hypertension, heart failure, decompensated heart failure, impaired left ventricular function, fluid retention in the body, dehydration, smoking, liver failure (5-9 points according to the Child-Pugh classification), liver cirrhosis, impaired renal function with CC less than 60 ml / min [especially in old age, while taking angiotensin-converting enzyme inhibitors (ACE), angiotensin II receptor antagonists, diuretics]; with concomitant therapy with antiplatelet agents (including acetylsalicylic acid, clopidogrel), other NSAIDs,anticoagulants (including warfarin), drugs metabolized by sulfotransferases, as well as in old age.

Costarox, instructions for use: method and dosage

Costarox tablets are taken orally, regardless of food intake, with a sufficient amount of water. When taken on an empty stomach, the effect of the drug occurs faster.

To reduce the likelihood of developing cardiovascular complications during treatment with the drug, the minimum effective dose should be used for the shortest possible course.

Recommended dosage of Costarox:

osteoarthritis: 30 mg once a day, in the absence of the desired therapeutic effect, the daily dose of the drug can be increased to 60 mg. The maximum daily dose is 60 mg;
rheumatoid arthritis, ankylosing spondylitis: 60 mg once a day. In the absence of a sufficient clinical effect, the dose can be increased to 90 mg per day. After stabilization of the condition, Kostarox should be continued at the initial dose. The maximum daily dose is 90 mg, in the absence of signs of clinical improvement, it is necessary to consider the use of other methods of treatment;
acute gouty arthritis: 120 mg once a day. The duration of the course is no more than 8 days. The maximum daily dose is 120 mg;
acute pain syndrome after dental operations: 90 mg 1 time per day. The duration of the course of therapy is no more than 3 days. The maximum daily dose is 90 mg.

Correction of the dosage regimen for elderly patients is not required.

Recommended dosage of Costarox for patients with impaired liver function (regardless of the indication for use):

mild severity (5-6 points on the Child-Pugh scale): no more than 60 mg once a day:
moderate severity (7-9 points on the Child-Pugh scale): no more than 30 mg once a day.

In case of impaired renal function with a CC of 30 ml / min and higher, dose adjustment of Costarox is not required.

Side effects

from the gastrointestinal tract: very often - abdominal pain; often - nausea, vomiting, constipation, diarrhea, flatulence, gastroesophageal reflux (heartburn), dyspepsia (epigastric discomfort), oral ulcer, esophagitis, gastritis; infrequently - dry mouth, bloating, irritable bowel syndrome, changes in peristalsis, pancreatitis, gastric ulcer (including perforation, bleeding), gastroduodenal ulcer;
infectious and parasitic diseases: often - alveolar osteitis; infrequently - upper respiratory tract infections, gastroenteritis, urinary tract infections;
from the immune system: infrequently - hypersensitivity reactions; rarely - angioedema, anaphylactic or anaphylactoid reactions, including shock;
from the lymphatic system and blood: infrequently - leukopenia, thrombocytopenia, anemia (more often caused by gastrointestinal bleeding);
from the heart: often - arrhythmia, palpitations; infrequently - tachycardia, atrial fibrillation, angina pectoris, chronic heart failure, nonspecific changes in electrocardiography, myocardial infarction;
from the side of the vessels: often - arterial hypertension; infrequently - flushes of blood to the skin, vasculitis, transient ischemic attack, cerebrovascular accident, hypertensive crisis;
on the part of metabolism and nutrition: often - fluid retention, edema; infrequently - decreased or increased appetite, increased body weight;
from the nervous system: often - headache, dizziness; infrequently - insomnia, drowsiness, paresthesia, hypesthesia, impaired taste;
on the part of the psyche: infrequently - anxiety, decreased clarity of thinking, depression, hallucinations; rarely - confusion, anxiety;
on the part of the organ of vision: infrequently - conjunctivitis, blurred vision;
on the part of the organ of hearing and labyrinth disorders: infrequently - vertigo, ringing in the ears;
from the respiratory system, chest and mediastinal organs: often - bronchospasm; infrequently - nosebleeds, cough, shortness of breath;
from the hepatobiliary system: often - an increase in the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST); rarely - jaundice, hepatitis, liver failure;
dermatological reactions: often - ecchymosis; infrequently - itching, rash, facial swelling, erythema, urticaria; rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, fixed drug erythema;
from the musculoskeletal and connective tissue: infrequently - muscle spasm or cramps, musculoskeletal pain and / or stiffness;
from the urinary system: infrequently - increased serum creatinine concentration, proteinuria, renal failure;
general disorders: often - asthenia or weakness, flu-like syndrome; infrequently - chest pain;
laboratory parameters: infrequently - hyperkalemia, increased activity of creatine phosphokinase, increased concentration of uric acid, blood urea nitrogen; rarely, hyponatremia.

Overdose

Symptoms: with a single dose of etoricoxib up to 500 mg or for 21 days at a dose of up to 150 mg, no clinically significant toxic effects were found. In acute overdose, the most common adverse reactions from the gastrointestinal tract, cardiorenal phenomena.

Treatment: immediate gastric lavage or artificial vomiting in order to remove the drug from the digestive tract that has not had time to be absorbed. Careful monitoring of the patient's condition, the appointment of supportive therapy.

The use of hemodialysis is inappropriate, the effectiveness of peritoneal dialysis has not been established.

special instructions

Against the background of the use of NSAIDs, the likelihood of developing adverse events from the gastrointestinal tract, including perforations, ulcers or bleeding, including fatal ones, increases. Therefore, it is recommended to be especially careful when prescribing Costarox to patients with a history of gastrointestinal ulcers or gastrointestinal bleeding. In addition, the risk group includes elderly patients who simultaneously use acetylsalicylic acid or other NSAIDs.

In order to prevent cardiovascular complications, the appointment of Costarox should be performed in the minimum effective daily dose with the shortest possible duration of treatment. It is necessary to periodically assess the need and response of the patient to symptomatic therapy, especially in patients with osteoarthritis.

The use of Costarox in arterial hypertension, hyperlipidemia, diabetes mellitus, smoking and other established risk factors for the development of cardiovascular complications is indicated only in cases where the expected therapeutic effect for the patient is higher than the potential risk.

During the period of treatment, you should not stop taking acetylsalicylic acid for the prevention of cardiovascular diseases and other antiplatelet drugs.

Consideration should be given to the increased risk of renal impairment in patients with impaired renal function, hepatic cirrhosis, or a history of uncompensated heart failure, and treatment should be accompanied by careful monitoring of renal function.

The use of Costarox can cause fluid retention, edema, arterial hypertension, the development or recurrence of chronic (congestive) heart failure. Therefore, with the appearance of clinical signs of deterioration in patients with arterial hypertension, a history of heart failure, left ventricular dysfunction, with already existing edema of any etiology, the advisability of continuing therapy with etoricoxib should be considered.

During the period of use of Costarox, it is recommended to monitor blood pressure, in case of a significant increase, it is required to cancel etoricoxib.

If laboratory parameters of liver function are three times higher than the upper limit of the norm or signs of liver failure are found, the pill should be stopped immediately.

Before using Costarox in patients with dehydration, it is necessary to take appropriate measures to replenish fluid in the body.

At the first signs of hypersensitivity, including skin rash and mucosal lesions, Costarox should be canceled.

It should be borne in mind that the use of the drug can mask signs of inflammatory processes in the body and fever.

Influence on the ability to drive vehicles and complex mechanisms

If, against the background of the use of Costarox, the patient develops dizziness, drowsiness, weakness and other undesirable phenomena that reduce the speed of psychomotor reactions and attention, it is recommended to refrain from driving and working with complex mechanisms.

Application during pregnancy and lactation

The use of Costarox is contraindicated during gestation and during breastfeeding.

In case of conception during treatment, the drug must be canceled.

Etoricoxib is not recommended for women planning a pregnancy.

Pediatric use

The appointment of Costarox is contraindicated in children under the age of 16.

With impaired renal function

The use of Costarox is contraindicated for the treatment of patients with severe renal failure (CC less than 30 ml / min).

Etoricoxib should be prescribed with caution in patients with impaired renal function (CC less than 60 ml / min), especially in elderly patients, if necessary, the simultaneous use of ACE, angiotensin II receptor antagonists, diuretics.

In case of impaired renal function with a CC of 30 ml / min and higher, dose adjustment of Costarox is not required.

For violations of liver function

The use of Costarox is contraindicated for the treatment of patients with severely impaired liver function (above 10 points on the Child-Pugh scale).

Etoricoxib should be taken with caution in liver failure (5-9 points according to the Child-Pugh classification), liver cirrhosis.

Use in the elderly

With caution, it is recommended to prescribe Costarox to elderly patients, especially with impaired renal function.

Correction of the dosage regimen for elderly patients is not required.

Drug interactions

With the simultaneous use of Costarox:

warfarin and other oral anticoagulants: An increase in the International Normalized Ratio (INR) or prothrombin time is associated with a 120 mg daily dose of etoricoxib in patients on chronic warfarin. Therefore, if it is necessary to use Costarox in patients on therapy with oral anticoagulants, control of prothrombin time should be ensured at the beginning of treatment or when the dose of the drug is changed;
diuretics: the therapeutic effect of diuretics and other antihypertensive drugs may be weakened;
ACE inhibitors, angiotensin II receptor antagonists: additional deterioration of renal function is possible, including the development of acute renal failure, in patients with an initial impairment of renal function (including dehydration, old age), treatment should be accompanied by careful monitoring of renal function;
acetylsalicylic acid: acetylsalicylic acid can be taken only in doses prescribed for the prevention of cardiovascular diseases. It should be borne in mind that in this case, the likelihood of an increase in the frequency of complications, including ulcerative lesions of the gastrointestinal tract, increases in comparison with monotherapy with etoricoxib;
cyclosporine, tacrolimus: the nephrotoxic effect of cyclosporine or tacrolimus may increase, therefore, if necessary, this combination requires monitoring of renal function;
ketoconazole: taking ketoconazole, which is a potent inhibitor of the isoenzyme CYP3A4, for 11 days, at a daily dose of 400 mg in healthy individuals does not cause a clinically significant effect on the pharmacokinetics of etoricoxib at a dose of 60 mg;
voriconazole, miconazole: oral voriconazole or miconazole gel for topical administration causes a slight increase in the exposure of etoricoxib;
rifampicin: administration of rifampicin (a powerful inducer of the cytochrome system) can cause a 65% decrease in the concentration of etoricoxib in blood plasma and lead to a relapse of symptoms of the disease;
antacids: antacids have no clinically significant effect on the pharmacokinetics of etoricoxib;
lithium preparations: as against the background of other NSAIDs, the excretion of lithium by the kidneys decreases, which leads to an increase in the level of lithium in the blood plasma;
methotrexate: at a dose of 60 mg or 90 mg, etoricoxib does not affect the renal clearance of methotrexate and its plasma concentration over a dose range of 7.5 mg to 20 mg. When using a dose of 120 mg etoricoxib, it is recommended to control the possible occurrence of toxic effects of methotrexate;
oral contraceptives: oral contraceptives containing ethinylestradiol and norethindrone may increase the incidence of adverse events, including venous thromboembolism, in women at risk;
hormone replacement therapy (HRT): etoricoxib at a dose of 120 mg affects the exposure of conjugated estrogens, an increase in estrogen concentration may increase the likelihood of developing adverse events associated with hormone therapy in the postmenopausal period;
prednisone, prednisolone: a clinically significant violation of the pharmacokinetics of prednisone or prednisolone has not been established;
digoxin: it is possible to increase the Cmax of digoxin by about 33%;
minoxidil, salbutamol for oral administration and other drugs metabolized by human sulfotransferases: it is possible to increase the concentration of ethinyl estradiol in the blood serum when combined with these drugs.

In addition, it is assumed that etoricoxib will not affect the activity of drugs whose metabolism occurs under the influence of cytochrome P ₄₅₀ (CYP) isoenzymes 1A2, 3A4, 2C9, 2C19, 2D6 or 2E1.

Analogs

Analogues of Costarox are: Arcoxia, Denebol, Dinastat, Exineph, Ranselex, Celebrex, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Costarox

Reviews about Costarox are mostly positive. Patients indicate the effectiveness of the drug, improvement in the condition in most cases occurs after the first day of therapy. Some patients experienced the development of adverse events. Many consider the high cost of tablets to the disadvantages of Costarox.

Costarox price in pharmacies

The price of Costarox per pack containing 28 tablets at a dose of 90 mg can range from 798 rubles.

Costarox: prices in online pharmacies

Drug name

Price

Pharmacy

Costarox 90 mg film-coated tablets 7 pcs.

221 r

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Costarox tablets p.p. 90mg 7 Pcs.

280 RUB

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Costarox 60 mg film-coated tablets 14 pcs.

288 r

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Costarox 120 mg film-coated tablets 7 pcs.

RUB 300

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Costarox tablets p.p. 60mg 14 Pcs.

366 r

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Costarox tablets p.o. 120mg 7 Pcs.

399 RUB

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Costarox 60 mg film-coated tablets 28 pcs.

RUB 400

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Costarox 90 mg film-coated tablets 28 pcs.

RUB 500

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Costarox tablets p.p. 60mg 28 pcs.

RUB 608

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Costarox tablets p.o. 90mg 28 Pcs.

747 RUB

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!