Bikana
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Prices in online pharmacies:
from 758 rub.
Buy
Bikana - antiandrogen; antineoplastic agent.
Release form and composition
Dosage form - film-coated tablets:
- 50 mg: oval, convex on both sides, light yellow in color; cross section - white core;
- 150 mg: diamond-shaped, convex on both sides, yellow; cross section - white core.
Packing of tablets: 7 pcs. in blisters, in a cardboard box 4 packs; 10 pcs. in blisters, in a cardboard box 3 packs; 14 pcs. in blisters, in a cardboard box 2 packages; 28 or 30 pcs. in polymer bottles, in a cardboard box 1 bottle.
Active ingredient: bicalutamide, in 1 tablet - 50 or 150 mg.
Inactive ingredients: magnesium aluminometasilicate, sodium carboxymethyl starch, magnesium stearate, ludipress, povidone, crospovidone, lactose monohydrate.
Shell composition:
- tablets 50 mg: Opadray II yellow 85F32771 (macrogol 3350, polyvinyl alcohol, titanium dioxide, talc, yellow iron oxide);
- tablets 150 mg: Opadray II yellow 85F32733 (macrogol 3350, polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow).
Indications for use
- therapy of advanced prostate cancer in combination with surgical castration or an analogue of gonadotropin-releasing hormone (GnRH);
- monotherapy for locally advanced prostate cancer;
- adjuvant therapy of locally advanced prostate cancer in combination with radiotherapy or radical prostatectomy (T1 – T2, N +, M0; T3 – T4, any N, M0);
- treatment of non-metastatic and locally advanced prostate cancer in cases where surgical castration or other methods of treatment are not applicable or contraindicated.
Contraindications
Absolute:
- use in combination with terfenadine, astemizole, cisapride;
- hypersensitivity to drug components.
Bikana is not used to treat women and children.
Carefully:
- impaired liver function;
- lactase deficiency, glucose-galactose malabsorption, lactose intolerance;
- concomitant use of drugs that inhibit microsomal oxidation of drugs (for example, ketoconazole, cimetidine), cyclosporine, slow calcium channel blockers.
Method of administration and dosage
Bikanu should be taken orally 1 time per day, swallowing the tablets whole with a sufficient amount of liquid.
Recommended daily doses:
- advanced prostate cancer - 50 mg (in combination with a GnRH analog or simultaneously with surgical castration);
- locally advanced non-metastatic prostate cancer - 150 mg.
Treatment is long-term, at least 2 years.
Side effects
- from the endocrine system: very often (≥ 10%) - breast tenderness, gynecomastia (may persist after discontinuation of the drug, especially in the case of long-term treatment); often (≥ 1% and <10%) - decreased sex drive, erectile dysfunction;
- from the gastrointestinal tract: very often - diarrhea; often - nausea, decreased appetite, flatulence, constipation, abdominal pain, dyspepsia;
- from the nervous system: very often - drowsiness; often - dizziness; when taken in a daily dose of 150 mg - depression;
- on the part of the hematopoietic organs: often - anemia;
- on the part of the cardiovascular system: often - flushing of the face; when using Bikana together with GnRH analogues - heart failure, myocardial infarction (fatal cases are known);
- on the part of metabolism and nutrition: often - anorexia / weight gain;
- from the respiratory system: often - chest pain; infrequently - interstitial pulmonary diseases (fatal cases are known);
- from the immune system: infrequently - hypersensitivity reactions, including urticaria, angioedema;
- from the kidneys and urinary tract: often - hematuria;
- on the part of the hepatobiliary system: often - a transient increase in the activity of hepatic transaminases, hepatotoxicity, jaundice, cholestasis (these changes in liver function decrease or completely disappear with continued treatment or after stopping therapy); rarely - liver failure (fatal cases have been reported);
- on the part of the skin and subcutaneous tissues: very often - skin rash; often - itchy skin; when taking the drug in a daily dose of 150 mg - restoration of hair growth / alopecia, dry skin, hirsutism;
- others: very often - asthenia; often - peripheral edema.
Bicalutamide is well tolerated by most patients. In rare cases, it is necessary to discontinue therapy due to the development of side effects.
special instructions
During treatment, liver function should be assessed periodically. In case of development of severe lesions, it is necessary to cancel Bikanu.
In patients receiving concomitantly coumarin anticoagulants, it is necessary to periodically monitor the prothrombin time.
When Bikana is used in combination with GnRH agonists, glucose tolerance may decrease, which may indicate the development of diabetes mellitus or a decrease in the level of glycemic control in pre-existing diabetes mellitus. For this reason, the serum glucose concentration must be monitored.
In the case of progression of the disease against the background of an increase in the concentration of prostate-specific antigen, the advisability of discontinuing therapy with bicalutamide should be considered.
Information for patients with lactose intolerance: 1 Bikan tablet in a dose of 50 mg contains 124.6 mg of lactose monohydrate, 1 tablet in a dose of 150 mg - 373.8 mg.
During treatment, it is recommended to be careful when driving and performing potentially hazardous types of work that require speed of reactions and increased attention. If side effects such as sleep disturbances, dizziness, headache and asthenia occur, these activities should be discarded.
Drug interactions
Bicalutamide inhibits the CYP3A4 isoenzyme, which may be of importance with the simultaneous use of drugs with a narrow therapeutic index, which are metabolized in the liver. In this regard, the combined use of bicalutamide with astemizole, terfenadine and cisapride is contraindicated.
To a lesser extent, bicalutamide affects the activity of isoenzymes CYP2D6, CYP2C9 and CYP2C19.
Care must be taken when using slow calcium channel blockers or cyclosporine in combination. In the event of side effects or increased action, it is necessary to reduce the dose of these drugs. After starting or discontinuing Bikana, it is recommended to control the concentration of cyclosporine in the blood and monitor the patient's clinical condition.
Drugs that inhibit microsomal oxidation of drugs (for example, ketoconazole and cimetidine) can increase the concentration of bicalutamide in blood plasma, which may lead to an increase in the frequency of side effects.
Bicalutamide enhances the effect of indirect anticoagulants of the coumarin series (including warfarin).
Terms and conditions of storage
Store in a dark place out of the reach of children at a temperature not exceeding 25 ° C.
The shelf life is 3 years.
Bikana: prices in online pharmacies
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Drug name Price Pharmacy |
|
Bikana 50 mg film-coated tablets 28 pcs. 758 RUB Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
