Capbize medicine 500mg Minh Hai treat colon cancer, breast cancer, stomach cancer (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Capecitabine
Ingredient Minh Hai Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Capecitabine	500mg

Uses

Indications

Breast cancer: Capbize in combination with Docetaxel is appointed to treat patients with breast cancer in place or metastases after failure with cytotoxic chemotherapy. Previous therapy includes anthracycline. Capbize is also indicated as single therapy for treatment of breast cancer patients on the spot or metastasis after failure with chemotherapy regimen including anthracycline and taxane or in patients who are not appointed anthracycline. Capbize is indicated for treatment of metastatic colorectal cancer patients, treatment support for patients after stage III colon cancer surgery (stage C of Dukes). Dynamic:

Capecitabine is a fluoropyrimidine carbamate derivative prepared for oral use, a cytotoxic drug activated by tumors and selected on the tumor. However, on Vivo, the drug is constantly transformed into a cellular root of 5-Fluorouracil (5-FU), which will be metabolized.

5-fu formation in the tumor thanks to the optimal catalyst of the vascular-related factor is Thymidine phosphorylase (DTHDPASE), thereby minimizing the level of healthy tissue with 5-fu in the body. (FDUMP) and 5-Fluorouridine Triphosphate (FUTP). These metabolites will damage cells with two mechanisms. First, FDUMP and homogeneous Folate N5-10-Methylenetetrahydrofolate associated with thymidylate synthase (TS) create a complex of three valence assimilizers. This cohesion will inhibit the formation of thymidylate from Uracil. Thymidylate is an essential precursor of thymidine triphosphate, an essential substance for DNA synthesis, so the deficiency of this compound can inhibit cell division. Secondly, the enzymes that copy the kernel can mistakenly combine Futp instead of Uridine Triphosphate (UTP) during RNA synthesis. This metabolic error may affect the synthesis of RNA and protein.

After drinking, Capecitabine is quickly and widely absorbed, then strongly converted into 5'-Fluorocytide (5'-dfcr) and 5'dfur. Used with food reduces capecitabine absorption rate, but only affects the area under the curve (AUC) of 5'dfur and its subsequent metabolites is 5-fu. With a dose of 1250mg/m2 on the 14th day after eating, plasma peak concentration (CMAX is in MCG/ml) for Capecitabine, 5'-SDCR, 5'-SFR, 5-FU and FBal, equivalent to 4.47, 3.05, 12,1, 0.95 and 5.46. The time to reach the plasma peak concentration (TMAX is calculated by hours), respectively, 1.50, 2.00, 2.00, 2.00, and 3.34. The value of AUC0-∞ in MCGH/mL is 7.75, 7.24, 24.6, 2.03 and 36.3.

Distribution: Mount with protein:

Plasma studies on Vitro have shown that the protein bonding rate of capecitabine, 5'-dfcr, 5'-dfur and 5-fu are 54%, 10%, 62%and 10%respectively, mainly associated with albumin.

Metabolism:

Capecitabine was first metabolized by the liver carboxy carboxy enzyme to 5'-dfcr, then converted to 5'-dfur by deaminase cytidine, mainly in liver tissue and tumors. Moreover, the catalytic activation of 5'-dfur then occurs by thymidine phosphorylase (thypase). The enzymes are involved in the catalytic activity that is found in tumor tissue but also in normal tissues, although often at a lower level. The sequential biological changes of the 5-Fu Capecitabine enzyme lead to high concentrations in tumor tissue. In the case of colorectal tumors, the 5-Fu generation seems to be largely localized in the cushion tumor cells. After the patient for colorectal cancer, the capecitabine oral cancer, the 5-fu concentration ratio in the colorectal tumors to the neighboring tissues is 3.2 (oscillating 0.9-8.0). The rate of concentration of 5-fu in serum tumor is 21.4 (oscillating 3.9-59.9, n = 8) while the ratio in serum healthy tissues is 8.9 (oscillating 3.0-25.8, n = 8). The thymidine phosphorylase activity is measured and found is 4 times larger in the main colorectal tumor in nearby normal tissues. According to immune studies, Thymidine Phosphorylase seems to be a largely localized in cushion tumor cells.

5-fu is continued by Catabolised the enzymes of dehydrogenase dihydropyrimidine (DPD) with more or less toxic dihydro-5-fluorouracil (FUH2). Dihydropyrimidinase isolated pyrimidin to carry 5-Fluoro-Allopopropionic acid (FUPA). Finally, it will separate ß-Me-proopionase fupa so that A-Fluoro- ß-Alanine (FBal) is excreted in urine. The activity of dihydropyrimidine dehydrogenase (DPD) is the step limit. Lack of DPD can lead to increased toxicity of capecitabine.

Era:

Selling time (T1/2 is calculated by hours) of capecitabine, 5'-dfcr, 5'-dfur, 5 fu and fbal are 0.85, 1.11, 0.66, 0.76 and 3.23.

After drinking, the metabolites of capecitabine are found mainly in urine. 95.5% Capecitabine dose is found in urine. Excretion in stool is very little (2.6%). The main metabolites found in urine are fbal, accounting for 57% of the dose. About 3% of the dose is eliminated in urine in the form of constant drugs.

combined treatment mode

Capecitabine effects on phase assessment on the pharmacokinetics of or docetaxel or paclitaxel and vice versa show that Capecitabine does not impact the pharmacokinetics of Docetaxel or Paclitaxel (CMAX and AUC) and DOCETAXEL or Paclitaxel also does not affect the dynamic of 5'-dfur (the most important metabolic chemical of the most important metabolism of the most important metabolism of the most important metabolic metabolism capecitabine).

pharmacokinetics in special population

Population pharmacokinetic analysis is conducted after Capecitabine treatment in 505 patients (cancer) colorectal at 1250mg/m2 twice daily. Gender, with or without metastasis in the first liver, the function of functioning according to the Karnofsky, Bilirubin total, serum albumin, ASAT and ALAT have no statistical impact on the pharmacokinetics of 5'-dfur, 5-fu and fbal.

Patients with liver failure due to metastatic liver

Do not record the clinical impact of capecitabine on biological activity and pharmacokinetics in cancer patients with mild to moderate liver function due to metastasis in the liver. There is no pharmacokinetic data on patients with severe liver failure.

Patients with renal failure

Based on pharmacokinetic research on cancer patients with mild to severe renal failure, there is no evidence of the impact of creatinine clearance on the pharmacokinetics of primitive drugs and 5-fu. Research shows that the clearing of creatinine affects the level of body contact with 5'-dfur (AUC increases by 35% when the clearance decreases by 50%) and with FBal (AUC increases by 114% when the creatinine clearance decreases by about 50%). Fbal is a metabolic substance that does not have anti -proliferation activity; 5'-dfur is the direct precursor of 5-fu (see the special dose instructions).

Old people

Based on population pharmacokinetics analysis, including patients with wide age (from 27 to 86 years old) and including 234 (46%) of patients aged 65 or older, showing that age does not affect the pharmacokinetics of 5'-dfur and 5-fu. FBal's AUC increased with age (the age of 20% increased as an AUC of FBal increased by 15%). This increase may be due to renal function change.

race

Based on the population pharmacokinetic analysis of 455 white skin patients (90.1%), 22 black skin patients (4.4%) and 28 patients of other races or ethnic groups (5.5%), pharmacokinetic pharmacokinetics of non -physical black skin patients in whites strain.

Before taking Capbize medicine 500mg Minh Hai treat colon cancer, breast cancer, stomach cancer (3 blisters x 10 tablets)

How to use

should drink capbize with water for 30 minutes after eating.

Dosage

Standard dose

Single treatment: Colorectal cancer and breast cancer:

The recommended single dose of Capbize is 1250 mg/m2 used twice daily (morning and evening; equivalent to 2500mg/m2 total daily dose) for 14 days later is 7 days off.

Breast cancer: In the case of coordination with Docetaxel, Capbize's recommended starting dose is 1250mg/m2, twice a day for two weeks after a week of vacation, in combination with Docetaxel 75mg/m2 intravenously within 1 hour every three weeks. With oral corticosteroids like dexamethasone should be taken before using capecitabine combined with docetaxel. The biological drugs when treated in combination with capbize do not affect the starting dose of Capbize.

Capbize dose is calculated by body surface area. The following table shows the standard dose and reducing the dose for the starting dose of Capbize 1250 mg/m2 and 1000 mg/m2.

How to calculate the standard dose and reduce the dose according to the body surface area for the starting dose of Capbize 1250 mg/m2.

full dose 1250 mg/m2 (m2) Dosage each time (mg) 500 mg The dose of each use (mg) The dose of each use (mg) ≤1.26 1500 3 > 800

1.27 - 1.38 1650 3 1300

800 > 950 > 1000

1.79 - 1.92 2300 4 1800

1150 > 1300 > 1450

full dose 1250 mg/m2 (m2) Dosage each time (mg) 500 mg Dosage each time (mg) The dose of each use (mg) ≤1.26 1150 2 > 600

1.27 - 1.38 1300 2 > 750

> 800

1.79 - 1.92

1800

3 1400 900 > 1000

2.07 - 2.18 2150 4 1600 1050 > 1100

General adjustment:

Capbize toxicity can be controlled by symptomatic treatment and/or a change of Capbize dose (stop treatment or dose reduction). Once the dose has been reduced, it should not be increased later.

The toxicity considered by the treating doctor is almost non -serious or life -threatening, the treatment may be continued at the original dose without reducing or stopping the dose. Do not recommend changing the dose for adverse effects level 1. Should stop treatment with Capbize if the adverse effects of level 2 or 3 occur. When the adverse effects are recovered or decreased to degree 1, it is recommended to be re -treated with Capbize with the original dose or adjust the dose according to Table 3. If the adverse effects occur, it is necessary to temporarily stop or permanently stop treatment until the adverse effects are recovered or decreased to degree 1, and can be treated later with the dose equal to 50% of the original dose. Patients who use capbize should be notified of immediately stopping treatment if the average or worse toxicity appears. Do not replace the unused Capbize dose because of toxicity.

Hematology: Capbize should not be treated in patients with initial neutrophils

The following table shows the recommended dose change after the toxicity appears with Capbize:

toxicity according to ncic* Dosage

* Degree 2 75%

first appeared stopped until recovery to level 0-1. Vien. 0-1.

Adjust the dose of Capbize due to toxicity when Capbize combined with other drugs should be based on Table 3 above for Capbize and according to the prescription information of other drugs in the most appropriate way. A treatment process of toxicity considered by the doctor is not related to Capbize (for example, nerve toxicity, ear toxicity, sensory nerve toxicity, fluid retention (pleural effusion, pericardium or ascites, bleeding, gastrointestinal puncture, proteinuria, hypertension), Capbize treatment should be continued and adjust the dose of other drugs based on the prescription information. Capbize treatment must be stopped permanently.

Patients with liver failure: The available data is not safe and effective enough to propose to adjust the dose. There is no information on liver or hepatitis. The starting point of treatment, it is recommended to reduce 75% for a starting dose of 1250 mg/m2. In patients with mild renal failure (creatinine clearance is 51-80 ml/min) without adjusting the initial dose. Should suspend the treatment of capbize, if the creatinine clearance is reduced below 30 ml/min. Adjust the dose for patients with renal failure average applicable to both treatment and combination.

The patient is the elderly:

Patient ≥ 60 years old does not need to adjust the dose in the single therapy.

Patient ≥ 60 years old when using the dose in combination with Docetaxel should reduce the starting dose of capecitabine to 75% (950 mg/m2 twice a day). If the toxicity is not observed in patients ≥60 years of treatment by reducing the starting dose of capecitabine in a combination with Docetaxel, the Capecitabine dose can be used carefully up to 1250 mg/m2 twice a day.

Patients with children: Do not use capecitabine in children in colon, colorectal, stomach and breast cancers.

What to do when overdose?

Expressions of acute overdose include nausea, vomiting, diarrhea, mucous inflammation, stimulation and gastrointestinal bleeding, and myeloma.

Management:

Overdose treatment should include conventional treatment and supportive medical interventions to treat clinical symptoms present and prevent possible complications.

What to do when you forget 1 dose?

Side Effects

Summary of reports related to ADRS in patients treated with single therapy capecitabine.

Body system

very popular

All levels

popular

All levels

rare

Serious and/ or life-threatening (level 3-4)

rare/ very rare

infected with herpes virus, nasopharyngitis, lower respiratory tract infections.

Blood infection, urinary tract infection, cellular inflammation, tonsillitis, sore throat, Candida mouth, influenza, gastritis, fungal infection, infection, tooth abscess.

lipoma.

leukopenia, anemia.

leukopenia fever, reduced hemorrhage, granular leukemia, thrombocytopenia, leukopenia, hemolytic anemia.

hypersensitivity.

anorexia.

dehydration, weight loss.

diabetes, hypokalemia, malnutrition, increased blood triglycerides.

insomnia, weakness.

Mind, panic, depressed mood.

headache, drowsiness dizzy.]

White degeneration in the brain (very rare).

Increased tears, conjunctiva, eye irritation.]

Rare (rare) tumor stenosis, (rare) corneal disorders (rare) keratitis (rare), with doting of keratitis (rare).

dizziness, ear pain.

unstable angina, chest pain, myocardial ischemia, atrial fibrillation, arrhythmia, tachycardia, fast sinus rhythm, brush.]

Slow (rare), vascular (rare).

intravenous inflammation.

venous thrombosis, high blood pressure, hemorrhage, hypotension, peripheral cold.

Difficulty breathing, nosebleeds, cough, runny nose.]

diarrhea, vomiting, nausea, stomatitis, abdominal pain.

Gastrointestinal bleeding, constipation, abdominal pain, digestive disorders, flatulence, dry mouth.]

hyperlirubin blood, abnormal liver function tests.

jaundice.

Rare (rare) liver failure (rare).]]]]

]

water stasis, uncontrolled urinary, hematuria, night urination, blood creatinin increased.

vaginal bleeding.

fatigue, weakness.

Fever, peripheral edema, discomfort, chest pain.

edema, chills, chills, body temperature increases.

Warnings

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

contraindicated

Capbize is contraindicated in patients known as hypersensitivity to capecitabine or with any component of the drug. Like the fluoropyrimidine, Capbize is contraindicated in patients known as DPD deficiency (dihydropyrimidine dehydrogenase). Severe liver failure. weight.

Caution when using

diarrhea: Capbize can cause diarrhea, sometimes heavy. Patients with severe diarrhea should be carefully monitored and if dehydrated, water and electrolyte should be monitored. Standard diarrhea should start (eg Loperamide), with appropriate drugs as soon as possible. NCIC CTC level 2 diarrhea is defined as an increase of 4-6 times/day or stool at night, degree 3 diarrhea increases 7-9 times inecast/day or uncontrolled and unprecedened. Grade 4 diarrhea increases ≥10 times/day or less bloody diarrhea or bowel support needs. Dosage reduction should be applied when necessary. Patients with anorexia, weakness, nausea, vomiting or diarrhea may quickly dehydrate. If dehydration of level 2 (or higher) appears, Capbize should be stopped immediately and need to be adjusted dehydration. Do not treat it until the patient is still dehydrated and any causes must be adjusted or controlled. The dose should be adjusted for adultery effects when necessary. These toxicity include myocardial infarction, angina, arrhythmia, cardiac arrest, heart failure and an electrocardiogram change. These adverse effects are more common in patients with a history of coronary artery disease. Cardiac arrhythmia (including ventricular vibration, torsion, and slow heartbeat), angina, myocardial infarction, heart failure and myocardial disease have been reported in patients using capecitabine. Caution should be prudent in patients with a history of serious heart disease, arrhythmia and angina. Caution should be careful in patients with reduced or hyperactive blood calcium. Be cautious in patients with central or peripheral nervous system disease, such as brain metastasis or neurological disease. Caution should be careful in patients with diabetes or electrolyte disorders, as they can deteriorate during Capecitabine treatment. Capecitabine permanently stopped in patients who have experienced a serious skin reaction during treatment. DPD, an enzyme associated with Fluorouracil recession, is at risk of increasing serious side effects, life -threatening or killing Fluorouracil. Although the deficiency of DPD cannot be defined correctly, it is known that the patient has a number of homosexuality mutations or some of the DPYD gene positions, which can cause the absence of DPD enzyme activity (determined from laboratory tests), which are at high risk of life -threatening or fatal poisoning and not should be treated with capecitabine. There is no safety dose for patients with DPD deficiency. There is not enough data to recommend a specific dose in patients with a partial deficiency of DPD. Treatment of eye disorders should start as soon as possible. For patients with metastases that are treating Capbize alone, the median time to appear toxicity is 79 days (in the range of 11 to 360 days), the degree from degree 1 to 3. Hand-foot syndrome of the leg 1 is determined by numbness, sensory disorders, ants, or erythema in the hands and/or/or/or not feel comfortable but does not affect normal activities. Degree 2 is identified as an erythema and swelling of hands and/or legs causing pain and/or uncomfortable affecting the activities of the patient's daily life. Degree 3 is identified as peeling skin, ulcers, blisters or pain in the arms and/or legs and/or very uncomfortable that the patient cannot work or perform normal activities daily. If the hand-foot-legged hand syndrome occurs, the Capbize should be stopped until recovery or decreases to level 1. When using a combination of capbize and cisplatin, the use of vitamin B6 (pyridoxine) is not recommended for symptoms or secondary backup treatment of hand-foot-legged hand syndrome, because the reported reports can reduce the effectiveness of cisplatin. There are some evidence that dexpanthenol is effective to prevent hand-syndrome in patients treated with capecitabine. Capbize should be stopped if bilirubin increases> 3.0 x ULN (above normal limits) related to treatment or aminotransferase liver enzymes (ALT, AST) increases> 2.5 x Uln related to treatment. It is possible to start treating again when bilirubin drops to ≤ 3.0 x Uln or aminotransferase liver drops to ≤ 2.5 x ULN. These results show that drug interactions may be due to capecitabine inhibiting the isenzyme cytochrome P450 2C9. Patients using Capbize in combination with Coumarin's derivative anticoagulant drugs must be carefully monitored for the anticoagulant effect of the drug (Inr or prothrombin time) and adjust the anticoagulant dose accordingly.

Used in special subjects:

Older people: Among patients with colorectal cancer aged 60-79 received a simple Capbize treatment for distant metastasis, and the same gastrointestinal toxicity in the common population. Patients 80 years old or more, have a larger rate than the adverse effects of gastrointestinal tract level 3, level 4, such as diarrhea, nausea and vomiting. When treating Capbize in combination with other drugs, an older ≥ 65 -year -old patient who has had adverse drug reactions (ADRS) of degree 3 and degree 4 more than young patients, ADRS will lead to suspension of treatment. When treating Capbize in combination with Docetaxel, the percentage of adverse effects is related to treatment of level 3 or 4, serious adverse effects and early treatment of treatment due to increased adverse effects are recorded in patients 60 years old or more, compared to patients younger than 60 years old. As seen with 5 FU excluding the adverse effects of level 3, level 4 related to treatment is more in patients with average renal impairment (the clearance of the creatinine 30-50 ml/min). Hepatic failure is not due to liver metastases or severe liver failure due to the impact of Capbize is not known.

The effect of the drug on the ability to drive and operate machinery

avoid using the drug when driving and operating machinery because Capbize can cause dizziness, fatigue and nausea.

Use drugs for women during pregnancy and lactation

Pregnant women:

affect pregnant women d. However, based on pharmacological and toxic properties, it can be seen that Capbize can be harmful to the fetus if used for pregnant women. In animal reproductive toxicity studies, using Capbize causes embryo death and teratogen. These evidence can occur in the derivatives of fluoropyrimidine. Capbize is said to be likely to cause teratogenicity in humans. Contraindicated using capbize for pregnant women. If using capbize during pregnancy or if the patient is pregnant while taking this medication, it is necessary to notify the patient the potential risk for the fetus. Women should be recommended for pregnancy during treatment with Capbize.

breastfeeding women:

Do not know whether the drug is excreted through breast milk or not. In a study for nursing mice to drink single dose, a significant amount of metabolites of capecitabine are excreted in milk. Should stop breastfeeding during the Capbize treatment process.

Interactive drug

Coumarin anticoagulant drugs: have recorded changes in blood clots and/or bleeding in patients using capbize along with anticoagulant drugs such as Warfarin and Phenprocoumon. These side effects occur for a few days and last up to several months after the Capbize treatment and in a few cases, in a month after the Capbize stops. In a clinical interactive study, after using a single-dose Warfarin 20mg, the Capbize treatment increases the AUC of S-Warfarin about 57% and the Inr value increased by 91%. Patients who use anticoagulant drugs of Coumarin along with capbize should be carefully monitored about changes in their blood coagulation parameters (PT or INR) and must adjust the anticoagulant dose accordingly. P450 2C9. Should be carefully monitored when Capbize is used with these drugs. No drug interactive studies have been conducted in official drugs, but the drug interaction mechanism is considered to be Capbize inhibiting the isoenzyme CYP2C9 system (see the part of anticoagulant drugs). Patients who use Phenytoin along with Capbize should be carefully monitored because of the increased plasma concentration of phenytoin. Plasma concentrations of capecitabine and a metabolite (5'DFCR) increase small; No impact on three main metabolites (5'dfur, 5-fu and fbal). However, Leucovorin has an impact on Capbize and Leucovorin's pharmacies that may increase the toxicity of Capbize. This interaction leads to increased toxicity of dihydropyrimidine dehydrogenase, which can be life -threatening. Therefore, Capbize should not be used with Sorivudine or similar drugs related to chemical, like Brivudine. It is necessary to wait at least 4 weeks after the end of treatment with sorivudine or similar drugs related to chemicals like Brivudine before starting treatment with capbize. There is Bevacizumab. 3000 mg/ m2 per day when Capbize is used alone. With the ability to reduce the effectiveness of 5-fu. Elimurinol simultaneous use with Capbize.

Storage

Store at temperatures below 30 ° C, cool dry place, avoid light.

to be out of reach of children.

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