Cisplatin Ebewe 50mg Novartis supports small and non -cell lung cancer treatment (100ml)

Dosage form Box X 100ml
Specifications Cisplatin
Ingredient Novartis

Ingredient

Composition information	Content
Cisplatin	0.5mg/ml

Uses

Indications

cisplatin "eBewe" indicated temporary mitigation for small cell lung cancer and no cells, testicular cancer, ovarian cancer, cervical cancer, endometrial cancer, prostate cancer, bladder cancer, melanoma, connective cancer, peony of pebbles.

Pharmacokic

cisplatin (CIS-DIAMMinedichloroplatium) is a heavy metal complex to treat cancer. The mechanism of action of this drug is like the compounds of the Alkyl group. The substrate causes the inhibition of DNA biosynthesis through short -term inhibition of RNA and protein biosynthesis.

The toxicity of the drug with the kidneys is significantly reduced if drinking plenty of water or using strong diuretic with mannitol. Non -specific drugs for any cell cycle. Only the cis form has anti -new birth and anti -tumor activity and the trans form does not have that effect.

Dynamic pharmacokinetics

After rapid infusion (in a short time) the drug is eliminated through two stages in plasma. The initial selling time is 25-50 minutes (with serum clearance about 50ml/1 minute) then the stage is slower, the half-life lasts 58-73 hours. Most of the drugs quickly attached to serum protein. Distribution into the tissue of the drug is very different: the highest concentration in the kidneys, liver, ovaries and uterus. The concentration in the central nervous system is very low. There is no selective concentration in cancer tissue. The drug excreted mainly through the kidneys at first quickly, then very slow. The speed of drug excretion depends mainly on the transmission time. Platinum can be detected in tissue after 4 months of treatment. Cisplatin has a high toxicity and is a strong anti -cancer. The drug has a genetic mutation, which has observed the effects that can cause teratogenic. Can not exclude the effect of fertility.

Before taking Cisplatin Ebewe 50mg Novartis supports small and non -cell lung cancer treatment (100ml)

How to use

cisplatin "eBewe" 0.5mg/ml of isothermal solution, only used by intravenous or artery, mainly in the north pass intravenously (by pass).

Do not direct intravenously unmininable solution.

Patients should be provided with enough water before transmitting 2 to 12 hours and after Cisplatin transmits at least 6 hours. For this reason, the recommendation of 0.9% NaCl solution or 0.45% NaCl solution and 5% glucose with a transfer rate of about 200ml/1 hour. The amount of urine after transmission must be from 100 - 200ml/1 hour, need to transmit manitol if less urine.

Transmission in a short time: Direct injection of 20% mannitol solution before cisplatin transmission, the amount of mannitol depends on the kidney function and the treatment dose (for example, 100ml of Mannitol solution 10 - 20% for 20mg of Cisplatin/m2 of body skin). Cisplatin is dissolved with 100ml of 0.9% NaCl solution and transmitted within 15 minutes.

If intravenously for hours: cisplatin is bridge intravenously with 1-2 liters of isothermal salt solution in the northern bridge line or can be directly mixed in the transmission bottle with 1-2 liter of isothermic salt solution and 150 ml of 20% (30 g) before starting transmission.

Patients need to drink plenty of water within 24 hours after transmission to ensure adequate amount of urine.

So far, there is no data on the cavalry between mannitol and cisplatin.

Dosage

The dose of the drug depends on the effectiveness of treatment and response on each individual. Common dosage for adults and children is recommended as follows:

The drug can be used for 1 treatment cycle:

1 time (every 4 weeks): 50 - 120mg Cisplatin/m2 body skin. Nhan.

cisplatin is mainly used in multi -chemotherapy but can also be used as single therapy.

Dosage in multi -chemotherapy is adjusted in accordance with the course.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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 dose to compensate for missed dose.

Side Effects

The unwanted effect of the drug depends on the dose.

With the urinary and kidney system: After a single medium -sized drug, a mild renal dysfunction and recovery disorders are often mild and may experience blood. Therefore, after using high doses or repeated doses in short time distance, it is possible to observe that renal dysfunction does not recover to the level of anuria and increased blood urea due to kidney necrosis.

Hematopoietic system: common leukopenia, platelet and red blood cells depend on mild levels and usually can recover. Seriously decreased bone marrow function after high doses of Cisplatin may occur (loss of granulocytes, bone marrow fiber). The highest leukopenia occurred about 14 days after using cisplatin, and the highest platelet reduction after about 21 days (recovery time after about 39 days).

Digestive system: often anorexia, reduces the feeling of taste, vomiting and nausea, abdominal pain and inflammation. Usually these symptoms disappear after 24 hours.

Toxicity on vestibular ear snails: Common hearing disorders with tinnitus symptoms, loss of hearing capacity, especially with sound in high frequency, deafness may also occur but rare. Listening dysfunctions can be recovered and often on one side.

Nervous system: peripheral neuropathy like losing the feeling of touching. In some cases, brain dysfunction may be confused, speech disorders, spasms, paralysis, and losing essential functions of the brain, but rarely occurs. These manifestations of this nerve toxicity may not be recovered and may occur after a single dose or after long -term treatment. Some rare cases may have visual disorders but can recover after the drug stopped. So far, a case of visual loss has been recorded due to the post -chemotherapy optic neuritis after the next chemotherapy and the next cisplatin.

hyperuric uric acid in the blood: Often arthritis occurs and floating in the leg.

Electrolyte disorders: hypoglycemia, hypogonodus and muscle spasms and/or changes in electrocardiograms rarely occur.

Anaphylactic reaction (increased heart rate, hypotension, shortness of breath and facial edema, allergic fever) may occur.

Liver: Liver dysfunction increases serum transaminase rarely occurs and recovers. Cirrhosis.

Reducing blood albumin may be due to cisplatin but rare.

Cardiac poisoning: Cardiac arrhythmia, electrocardiogram changes, rarely bradycardia or tachycardia, ineffective heart (cardiac arrest).

The immune system: There may be immunodeficiency reactions.

Change gums (gums) teeth: Metal deposits in gums (gums) tooth have been reported.

Local floating, rarely pain, rash as well as skin ulcers and localized venous inflammation may occur in the affected limb after the injecting of the artery and/or venous arteries.

Symptoms of bald hair, sperm disorders and eggs, large breasts in men. There are some cases of leukemia due to cisplatin.

Vascular disorders syndrome such as brain, coronary artery, vascular.

Notify the doctor with unwanted effects when using the drug.

Instructions on how to handle ADR:

Anaphylaxis usually appears within minutes after using cisplatin and can be overcome by epinephrin intravenous injection, corticosteroids and antihistamines.

Toxicity to the kidneys: Kidney failure due to accumulation and depending on the dose to limit cisplatin dose. Kidney toxicity usually appears in the second week after treatment, manifested by increased urea, uric acid and blood creatinine and reducing creatinine clearance. Transfusion before and after treatment will reduce the toxicity to the kidneys. Kidney function must be recovered to be used for further medication.

Bone marrow failure is also due to accumulation and depending on the dose. Platelets and leukocytes are most usually reduced after 18-23 days (about 7-45 days) and most patients recover after 39 days (about 13-62 days). Leukopenia and thrombocytopenia worse if the dose is over 50 mg/m2. Only reuse cisplatin when platelets over 100 000/mm3 and leukocytes above 4 000/mm3.

Anemia: Hemoglobin decreases over 2 g/100 ml of blood in a large number of patients, usually after several treatments. In severe cases, red blood cell transmission may be needed. There has been a report that hematuria is positive for Cisplatin. In sensitive people, using cisplatin the next batch can increase blood.

Nausea and vomiting: usually start 1-4 hours after taking the drug and may last up to a week. Nausea and vomiting occur in most patients treated with cisplatin and sometimes vomiting too much, so they have to reduce the dose or stop treatment. Can be reduced by anti -vomiting drugs.

Toxicity with hearing: usually occurs when the drug accumulates or takes high doses. Usually tinnitus and hearing loss, tinnitus often recover, only lasts a few hours to a week after stopping treatment. Hearing loss at 4 000 - 8 000 Hz, one ear or both sides; Sometimes normal conversation can not hear. Heavy ear toxicity in children. Frequency and intensity of hearing disorders increased during repetitive treatment. Severe lesions may not recover. Hearing tests should be tested to avoid toxic symptoms with hearing.

electrolyte and metabolic disorders: Magnesi hypoglycemia usually occurs, possibly due to renal tubular lesions, causing loss of magnesium ions; Then reduce blood calcium and cause cramps, shock, tremor or seizures; Therefore, electrolytes are needed.

There may be hyperuricemia, especially when taking high doses over 50 mg/m2. The highest uric acid concentration occurs about 3-5 days after taking the drug. Using alopurinol can reduce uric acid levels in serum.

Neurotic toxicity: Neurological manifestations are commonly seen after prolonged treatment (4-7 months), including abnormalities, vibration, muscle weakness, loss of taste, cramps, convulsions in some patients. Lesions may not recover. If the above symptoms begin to occur, the drug must be stopped.

Eye: Visuality decreases with different degrees after using cisplatin, especially when combined with other anti -cancer drugs. Most vision is recovered after stopping cisplatin.

Toxicity to the liver: cisplatin into the liver and toxic to the liver: AST and alkaline phosphatase increases. Be cautious when the liver is injured.

Warnings

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

contraindicated

"Ebewe" cisplatin drugs contraindicated in the following cases:

Hypersensitivity to cisplatin or other platinum compounds, pregnant, during breastfeeding, severe bone marrow failure, severe renal failure, dehydration, chickenpox, herpes zoster (shingles), gout, uRat stones, recent infections, peripheral neuropathy due to cisplatin.

Particularly cautious in patients with mild renal impairment, mitigating the function of hemorrhage system and hearing organs, patients who had previously treated chemotherapy, or radiation, and peripheral neuropathy by cisplatin. It is necessary to consider exactly the interest-mechanical ratio in these cases.

Cases of pregnancy and lactation are absolute contraindications. Need to ensure strict contraception for female patients as well as male patients.

Caution when using

cisplatin is an anti -cancer chemical and must be used under the guidance of a doctor who has experience in cancer specialist.

Do not use chelate substances during the medication period. Do not leave the drug in contact with aluminum tools (needles, syringes ...).

Kidney toxicity can be greatly reduced if there is enough water. During and after the treatment process with cisplatin, the patient must drink enough water.

Before, during and after treatment and before each treatment cycle, the kidney function, blood formula, calcium toxicity, liver function, neurological and hearing function. Need to check the blood formula per week throughout the course. Only continue the treatment cycle after the agency function returns to normal.

Anti -vomiting drugs can help reduce side effects on the digestive system such as vomiting and nausea.

Hyperglycemia can be adjusted by allopurinol.

Magnesi and blood calcium can be adjusted by using additional supplements.

Anaphylactic reactions are controlled by sympathetic stimulants, corticosteroids and antihistamines.

During and after the cisplatin course, it is necessary to use thorough contraception, both male and female patients.

Only use the drug on the condition that the solution remains clear and expiryly. The drug is only used once.

The effect of drugs on driving and operating machinery

cisplatin may impair centralized ability, vehicle control or operating machinery.

Using drugs for women during pregnancy and lactation

Pregnancy:

Consult genetic experts if deciding to become pregnant after treatment.

Breastfeeding period:

Consult genetic experts if deciding to become pregnant after treatment.

Drug interaction

diagnosed drug interactions: Bun, creatinine and uric acid, Ca, Mg, PO4, K. increase serum iron concentration occasionally occur.

If combined with bone marrow inhibitors or after radiation therapy, the toxicity on the bone marrow may increase. Coordinating with iFostamid may increase the toxicity on the ear.

During the drug treatment, the use of kidney and ear toxic drugs (cephalosporin and aminoglycoside increases the toxicity of cisplatin. In these cases, avoiding the medications should be avoided.

The activity of cisplatin is impaired by penicillamin and other chelate.

Protein will increase if used simultaneously with ifosfamid. Forced diuretic is not allowed to be done with diuretics such as Furosemide because of the risk of renal tubular damage as well as increasing toxicity on the ear.

If using cisplatin during treatment with Allopurinol, Colchicin, Probenecid or SulfinPyrazon, the dose of the above drugs to be adjusted because cisplatin causes increased uric acid toxicity in the blood.

If simultaneously used cisplatin with antihistamine, bulizine, cyclizine, loxapine, meclizine, phenothiazine, thioxanthen or trimetho benzamide may increase symptoms of dizziness such as dizziness or tinnitus.

Vaccinative vaccine should be done at least after 3 months of stopping the drug.

Storage

Stored at room temperature no more than 25 ° C and avoid light.

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