Larringy 50mg Davipharm medicine supports the treatment of prostate cancer (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Bicalutamide

Ingredient

Composition information	Content
Bicalutamide	50mg

Uses

Indications

Prostate cancer treatment in combination with substances that are similar to Lutien Chemical Liberation Hormone (LHRH) or testicular removal surgery.

Pharmacokology

Pharmacological group: Ant androgen drug.

ATC code: L02BB03.

bicalutamid is an anti -androgen agent of non -steroid group, without other hormonal activity. Bicalutamid is associated with androgen receptors without manifesting gene activation and thus inhibits androgen stimulation. The regression of tumors in the prostate is due to this inhibition. Clinically, stop taking bicalutamids can lead to anti -antagonistic cessation syndrome in some patients. Bicalutamid is a racemic isomer with anti -androgen activity, this activity is almost only available in the opposite isomer (R).

Pharmacokinetics

absorption

Bicalutamid absorbs well after drinking. Food does not affect the bioavailability of the drug.

Distribution

bicalutamid strongly connected with protein (96%racemic isomers, R-bicalutamid> 99%) and strongly metabolized (through oxidation and glucoronylation): The metabolites are excreted through the kidney and bile at the same proportion.

Metabolism and elimination

Optimal isomers (S) are eliminated faster than optical contrast (R), optical contrast (R) has a semi -exhaust time in plasma about 1 week.

With daily dosage bicalutamid, optical isomers (R) accumulated in plasma is about 10 times due to long -selling time, which is suitable for the only dose of the day.

The concentration of optical isomers (R) in plasma in a stable state is about 9 mcg/ml when taking the dose of 50 mg of bicalutamid per day. In a stable state, optical contrast (R) has the main activity that accounts for 99% of the total optical isomers in plasma.

In the clinical trial of the average concentration of R-bicalutamid in the province's translation province of drugs is 4.9 Ug/ ml. The amount of bicalutamid can be switched to a female partner when having low sex and external for approximately 0.3 ng/ kg. This drug is lower than the amount needed to touch the fertility in animal tests.

Special subjects

Age, kidney failure or mild or medium liver failure does not affect the pharmacokinetics of optical isomers (R). In patients with severe hepatic impairment, optical contrast (R) eliminates slower plasma.

Before taking Larringy 50mg Davipharm medicine supports the treatment of prostate cancer (4 blisters x 7 tablets)

How to use

Drink whole tablets with water or not with food. Should take the drug at the same time every day (morning or evening).

Dosage

Men's adults including the elderly: 50 mg x 1 time/ day. Starting for treatment with bicalutamid at least 3 days before performing treatment with substances with similar structures LHRH, or at the same time with testicular removal surgery.

Patients with renal failure: No need to adjust the dose for patients with renal impairment.

Patients with liver failure: No need to adjust the dose for patients with mild liver failure. There may be accumulation increases in patients with severe to severe liver failure.

Children: Contraindicated using bicalutamid in children.What do

do when using overdose? There is no specific antidote, so symptomatic treatment should be overdosed.

Hemolysis may not be effective, because bicalutamid is strongly connected to protein and is not found in a constant form in the urine. Should take care of general support, including regular monitoring of life signs.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

Unwanted effects are separated by frequency and organ system

Very common, ADR> = 1/10

Blood and lymphatic system: Anemia.

Neurology: dizziness.

Blood vessels: hot.

Digestive: abdominal pain, constipation, nausea.

Kidney and urinary: urinating bleeding.

Genital and mammary glands: Female mammary glands and breast pain.

Body and sugar use: weakness, edema.

Common, 1/100

Metabolism and nutrition: reduce appetite.

Mental: Reduce libido, depression.

Neuroscope: Sleep.

Heart: myocardial infarction (case of death has been reported), heart failure.

digestive: indigestion, flatulence.

liver - bile: liver poisoning, jaundice, hypernipate blood.

Skin and subcutaneous tissue: Hair loss, hair, hair developed abnormally, dry skin, itching, rash.

Genital and mammary glands: erectile dysfunction.

Body and sugar use: chest pain.

Testing: weight gain.

less common, 1/1,000

Immune: Hypersensitivity, angioedema and urticaria.

Respiratory, chest and mediastinum: interstitial lung disease (case of death has been reported).

Rare, 1/10,000

liver - bile: liver failure (case of death has been reported).

Skin and subcutaneous tissue: light sensitive reaction.

unknown frequency

Heart: extends the range of qt.

The drug can cause other unwanted effects, advising patients to notify unwanted effects when taking the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

hypersensitivity to bicalutamid or any ingredients of the drug.

Women, children and teenagers.

Used in combination with terfenadin, Astemizol or Cisaprid.

Caution when using

Starting treatment should be performed under the supervision of experts.

bicalutamid metabolizes in the liver. The information shows that the elimination of the drug may be slower in the object of severe liver failure and this can lead to increased drug accumulation. Therefore, be cautious when using bicalutamid in patients with severe to severe liver failure.

Periodically check the liver function as there may be changes in the liver. Most of the changes occur within the first 6 months of treatment with bicalutamid.

Severe liver changes and rare liver failure when using bicalutamid, and death have been reported. Should stop the drug if the serious changes.

Reducing glucose tolerance has been found in men using Lhrh transport owner. This condition may manifest such as diabetes or reduced blood glucose control in patients with diabetes. Therefore, consider monitoring blood glucose in patients using bicalutamid in collaboration with the LHRH transport drug owner.

Bicalutamid inhibits Cytochrom P450 (CYP3A4), so be careful when used with the most metabolic drugs that are mainly equal to CYP3A4.

Androgen deficiency treatment can cause a long range of qt

In patients with a history or risk factor that extends the QT interval and the patient with combination of drugs can cause a QT range, so assessing the risk benefits including the risk of torsion before using bicalutamid.

Androgen resistance can cause sperm's morphology. Although the effects of sperm mortamid have not been evaluated and there is no report on this effect in patients using bicalutamid, patients and/ or their partners should take appropriate contraceptive measures when taking bicalutamid and 130 days after stopping the drug.

Warning related to excipients

The drug contains lactose, patients with rare genetic diseases galactose, Lapp Lactase deficiency or glucose - galactose absorption disorders should not use this drug.

The effect of the drug on driving and operating machinery

bicalutamid does not impair the ability to drive or operate the patient's machine. However, it should be noted that sleepiness may occur. Any patient who is affected should be cautious.

Use drugs for women during pregnancy and lactation

bicalutamid contraindicated in women and not for pregnant or lactating women.

Interactive drug

There is no evidence of pharmacokinetic or pharmacokinetics between bicalutamid and substances with similar structure LHRH.

In vitro studies show that R-bicalutamid is a CYP 3A4 inhibitor, with a weaker inhibitor on CYP 2C9, 2C19 and 2D6.

Although clinical studies use antipipin as a substance that marks the activity of Cytochrom P450 (CYP), there is no drug interaction with Bicalutamid, Midazolam's average AUC increases by 80% after use with bicalutamid in 28 days. For drugs with narrow treatment index, this increase should be paid to this increase. Therefore, contraindicated use of bicalutamid simultaneously with terfenadin, astemizol, cisaprid and cautious when using bicalutamid with compounds such as ciclosporin and calcium channel blockers. The dose of these drugs should be reduced, especially if unwanted effects increase. For cyclosporin, plasma concentration should be carefully monitored and clinical status after the beginning of treatment or after stopping bicalutamid.

Be careful when prescribing bicalutamid with drugs that can inhibit oxidation such as cimetidine and ketoconazole. In theory, this simultaneous use can increase bicalutamid levels in plasma and may increase unwanted effects.

In vitro studies show that Bicalutamid can occupy the place of coagulants of coumarin and warfarin in locations associated with protein. Therefore, it is advisable to closely monitor prothrombin when starting with bicalutamid in patients who are taking coagulants of COMARIN, so carefully monitor prothrombin time.

Vì điều trị thiếu hụt androgen có thể gây kéo dài khoảng QT, nên cẩn thận đánh giá khi sử dụng chung bicalutamid với các thuốc gây kéo dài khoảng QT hoặc thuốc có thể gây xoắn đỉnh nhữ thuốc chống loạn nhịp nhóm IA (như quinidin, disopyramid) hoặc nhóm III (như amiodaron, sotalol, dofetilid, ibutilid), methadon, moxifloxacin, Anti -psychotic drugs, ...

Children

Interactive research is only done on adults.

Storage

In a dry place, the temperature does not exceed 30 ° C.

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