Etoposid 100mg Bidiphar treatment for cancer cancer resistance, ovarian tumor, lymphoma (5ml)

Dosage form Box x 5ml
Specifications Etoposide

Ingredient

Composition information	Content
Etoposide	100mg

Uses

indicated

Etoposid is indicated for treatment:

Testicular cancer in the therapy combined with other chemotherapy agents. other).

pharmacokinetics

No data.

Before taking Etoposid 100mg Bidiphar treatment for cancer cancer resistance, ovarian tumor, lymphoma (5ml)

How to use

Etoposid is only used by slow intravenous line.

Be cautious when using:

Hypotension after rapid intravenous injection has been reported. Therefore, it is recommended to transmit Etoposid solution for 30 to 60 minutes. The longer transmission time may be necessary based on the patient's tolerance level. As well as other toxic compounds, it is necessary to be careful when processing and preparing Etoposid solution. Skin reactions are related to exposure to unintentional Etoposid. Recommendation of using gloves. If the Etoposid solution is in contact with the skin or mucosa, immediately wash this skin or mucosa with soap and water.

Etoposid Bidiphar is diluted for intravenous transmission with 5% defrose solution, or 0.9% sodium chloride solution to achieve the final concentration from 0.2 to 0.4 mg/ml. At higher concentrations, the precipitation of Etoposid may occur.

Dosage

The usual dose of Etoposid in the therapy combined with other chemotherapy agents, ranges from 100 - 120 mg/m2/day through continuous intravenous infusion for more than 30 minutes (no more than 2 hours) for 3 - 5 days, then stop treatment for 10-20 days.

Normally, 3 to 4 chemotherapy cycles should be conducted. Dosage and the number of treatment cycles must be adjusted according to the degree of bone marrow failure and the response of the tumor.

Dose adjustment:

The dose of Etoposid should be adjusted to consider the bone marrow inhibition effect of other drugs in combined therapy or the effects of X -rays or chemotherapy therapy that may have impaired bone marrow reserves.

Patients should not start a new treatment cycle with Etoposid if the neutral leukemia is less than 1,500 cells/mm3 or the number of platelets is less than 100,000 cells/mm3, unless it is caused by malignant disease.

Doses after initial doses should be adjusted if the number of neutrophils below 500 cells/mm3 occurs more than 5 days or related to fever or infection; If the number of platelets is below 25,000 cells/mm3 occurs; If any other group 3 or 4 toxicity progresses or if the renal clearance is less than 50 ml/min.

In combination therapy, the dose of Etoposid should be set up according to the appropriate treatment regimen.

The treatment time is considered by the doctor, paying attention to the existing disease, combined therapy is being treated (if appropriate) and cases of treatment for each patient. Etoposid should be stopped if the tumor does not respond to treatment and/or progresses or if the adverse effects occur.

Elderly: do not need to adjust the dose in elderly patients.

Children: Safety and efficiency in children and adolescents have not been established.

Patients with renal impairment: In patients with impaired renal function, it is necessary to consider adjusting the initial dose based on the measured creatinine clearance. Creatinin clearance is measured Dosage 15 - 50 ml/minute 75% dose

In patients with creatinine clearance

What to do when overdose?

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

Notify the physician the unwanted effects when using the drug.

Warnings

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

contraindicated

Hypersensitivity to active ingredients, podophyllotoxin or podophyllotoxin or any ingredients of the drug. The time of jaundice vaccine or other live vaccines in patients with immunodeficiency. Do not use for premature babies or infants.

Caution when using

Caution:

Etoposid should be used under the supervision of a professional doctor who has experience in the use of cancer chemotherapy agents. The reaction at the injection site may occur while using Etoposid. With the ability to escape, it is recommended to closely monitor the infusion position for the possibility of leakage during medication. It is unclear whether specific treatment for the exit reaction.

Severe marrow failure leads to infection or hemorrhage that may occur.

There have been reports of death bone marrow failure after using Etoposid. Patients being treated with Etoposid must be carefully monitored and regularly bone marrow failure, both during and after treatment. Bone marrow failure limits the dose is the most significant toxicity related to Etoposid therapy. The following studies should be conducted at the beginning of the therapy and before each next dose of Etoposid: platelet number, hemoglobin, number of white blood cells and each leukocyte. If radiation therapy or chemotherapy is used before starting treatment with Etoposid, it takes a suitable time to restore the bone marrow function.

Do not use Etoposid for patients with neutral leukemia below 1,500 cells/mm3 or platelet quantities below 100,000 cells/mm3 unless caused by malignancy.

Dosage after initial dose should be adjusted if the number of neutrophils is less than 500 cells/mm3 occurs more than 5 days or is related to fever or infection; If the number of platelets is below 25,000 cells/mm3 occurs; If any other group 3 or 4 toxicity progresses or if the kidney clearance is less than 50 ml/min. The dose adjustment should be considered to consider the bone marrow inhibition effect of other drugs in combined therapy or the effects of radiation therapy or previous chemotherapy therapy may have reduced bone marrow reserves.

The appearance of acute leukemia, which may occur with or without marrow dysplasma syndrome, has been described in patients who have been treated with Etoposid in chemotherapy regimens.

It is unclear the accumulated risk factors as well as the factors that are related to the progression of secondary leukemia. The roles of the use plan and the accumulated doses of the proposed Etoposid, but have not been clearly defined.

A 11Q23 chromosome abnormal has been observed in some cases of secondary leukemia in patients who have used epiPodophyllotoxin. This abnormal also occurred in patients with secondary progression of leukemia after being treated with chemotherapy regimens that did not contain epiPodophyllotoxin and leukemia occurred. Another feature that is related to secondary leukemia in patients who used epiPodophyllotoxin seemed to be a short -hidden period, with average medium time to progress leukemia about 32 months.

Doctors should pay attention to the possibility of anaphylactic reactions caused by Etoposid, with a chills, fever, tachycardia, bronchospasm, shortness of breath and lowering blood pressure, which can be fatal. Symptomatic treatment. Immediately stop the infusion, followed by the use of hypertension agents, corticosteroids, antihistamine drugs, or agents that increase volume depending on the doctor's decision.

Etoposid should only use slow intravenous lines (usually for a period of 30 to 60 minutes) to avoid hypotension and bronchospasm. No injection in arteries, pleura or peritoneal.

In all cases when considering using Etoposid in chemotherapy therapy, the doctor must assess the need and the benefits of Etoposid with the risk of adverse reactions. Most of these adverse reactions can recover if detected early. If the reaction occurs, the dose should be reduced or stop using the drug and the appropriate treatment must be taken based on the clinical assessment of the doctor. The start of re -using Etoposid should be careful, fully reviewed the need for the drug and pay attention to the recurrence of toxicity.

In patients with lower serum albumin levels, the risk of toxicity caused by Etoposid may increase. Before starting treatment, during treatment and before each treatment, peripheral blood examination (leukemia, platelet, hemoglobin), kidney function, liver function and nerve functions. The phases of therapy with Etoposid should be performed only when the patient's liver and kidney function. If the patient's liver or kidney function is disordered, the liver and kidney function should be monitored regularly due to the risk of accumulation. Moreover, the treatment with Etoposid should only be performed if the function of the peripheral nervous system is normal.

Bacterial infections must be controlled before treatment with Etoposid. Caution should be used when using Etoposid for patients who have or have been infected with herpes zoster.

Etoposid causes mutations and cancer. This should be noted when conducting long -term treatment.

With the mutant of Etoposid, it is necessary to take effective contraception for both men and women patients during treatment and up to 6 months after the end of treatment. It is recommended to advise genetic advice if the patient wants to have children after the end of treatment. Because Etoposid can reduce the fertility of men, it is possible to consider sperm preservation.

Children: Safe and effective of Etoposid in children who have not been systematically studied. There have been reports of anaphylactic reactions occurring in children when using Etoposid injecting.

Etoposid Bidiphar contains polysorbat 80 excipients. In premature babies, a life -threatening syndrome caused by liver and kidney failure, lung damage, platelet and ascites are associated with a vitamin E product used to contain polysorbate 80.

Etoposid Bidiphar contains 30.8% (TT/TT) of absolute ethanol. Each 5 ml vial contains up to 1.54 ml (1.22 g) absolute ethanol. This can be harmful to people with liver disease, alcoholism, epilepsy, brain injury or brain disease as well as for children and pregnant women. Ethanol may also change or increase the effects of other drugs.

Etoposid Bidiphar contains alcohol Benzylic, so it can cause toxic reactions and anaphylactic reactions in infants and children up to 3 years old.

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

There has been no research on the effect of Etoposid when driving and operating machinery. However, if patients have side effects such as fatigue, drowsiness, avoid driving and operating machinery.

Use drugs for women during pregnancy and lactation

Used for pregnant and lactating women:

Pregnant women and pregnant women: Etoposid can be harmful to the fetus when used for pregnant women. Etoposid has been shown to cause teratogenic rats and rats. There is no adequate and well -controlled research in pregnant women. Women who are likely to be pregnant should be recommended to avoid pregnancy. If these drugs are used during pregnancy, or if the patient is pregnant while receiving these drugs, the patient needs to be known to the potential risk to the fetus.

contraceptive in men and women:

With the mutant potential of Etoposid, it is necessary to have an effective contraceptive method for both men and women during treatment and up to 6 months after the end of treatment. It is recommended to advise genetic advice if the patient wants to have children after the end of treatment. Because Etoposid can reduce male fertility, sperm preservation.

breastfeeding women:

It is not clear whether these drugs are excreted in breast milk or not. Because many drugs are excreted through breast milk and due to the possibility of serious adverse reactions in infants from Etoposid, it is necessary to decide to stop breastfeeding or stop taking the drug, which should consider the importance of the drug for the mother.

Alcohol Benzylic is capable of being excreted in breast milk and can be absorbed by oral in infants.

Drug interaction

drug interactions can affect the activity of the drug or cause side effects.

Patients should notify the doctor or pharmacist a list of the drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

Expiry date after preparation: When dilute Etoposid, should use the drug immediately, otherwise, should store the mixed solution for no more than 12 hours at 15 - 250C unless diluted under aseptic condition.

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