Cisplatin-Teva injection for 0.5 mg ml 20 ml
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Active ingredients
Cisplatin
Release form
Solution
Composition
1 ml of 1 fl. cisplatin 500 mcg 10 mg. Excipients: microcrystalline cellulose - 136 mg, croscarmellose sodium - 32 mg, lactose monohydrate - 68 mg, magnesium stearate - 6 mg. The composition of the film shell: hypromellose - 9-12.6 mg, iron dye red oxide - 300-420 mcg, macrogol 4000 - 3-4.2 mg, titanium dioxide - 2.7-3.78 mg.
Pharmacological effect
Cisplatin (cis-diaminedichlorplatin) is an anticancer drug containing heavy metal platinum. Cisplatin has properties similar to those of bifunctional alkylating agents that form interstitial and intracellular crosslinks in DNA, thereby disrupting its function, leading to cell death. however, the drug does not have cyclic and phase specificity. It has immunosuppressive and radiosensitizing properties.
Indications
Cisplatin, usually in combination chemotherapy regimens, is widely used in the treatment of the following solid tumors: - germ cell tumors of women and men. - cancer of the ovaries and testicles. - lung cancer . - head and neck tumors. In addition, cisplatin has antitumor activity in the following types of tumors: - cervical cancer. - bladder cancer. - osteosarcomas. - melanoma. - neuroblastoma. - esophageal carcinoma.
Contraindications
- individual intolerance to cisplatin or other compounds containing platinum - impaired renal function (serum creatinine level more than 115 mcmol / liter) - inhibition of bone marrow hematopoiesis - heart failure - pregnancy and lactation - generalized infections.
Use during pregnancy and lactation
It is contraindicated to take the drug during pregnancy and lactation.
Dosage and administration
Cisplatin can be used both as monotherapy and in combination with other cytotoxic drugs in various doses, depending on the regimen. When individual dose should be guided by the data of special literature. Cisplatin is injected in / in or when indicated (intraperitoneal tumors) in the abdominal cavity. Cisplatin in monotherapy or in combination with other chemotherapy drugs is administered in a dose of 50-100 mg / m2 as an IV infusion every 3–4 weeks, or 15–20 mg / m2 IV dosage daily for 5 days every 3–4 weeks . In order to stimulate diuresis (up to 100 ml / h) and to minimize the nephrotoxic effect of the preparation, hydration is carried out.Before the introduction of Cisplatin, up to 2 liters of liquid (0.9% sodium chloride solution or 5% dextrose solution) is injected into the IV drip. After the end of the infusion, 400 ml of a 0.9% solution of sodium chloride or a 5% solution of dextrose is additionally injected. Excessive fluid intake and maintenance of diuresis must be observed for 24 hours. If intensive hydration is insufficient to maintain adequate diuresis, an osmotic diuretic (eg, mannitol) can be administered. Cisplastin is introduced into / into the drip at a rate not exceeding 1 mg / min. Long-term infusions are carried out for 6-8-24 hours, provided sufficient diuresis is administered before the administration and during the administration of the drug. Cisplatin is diluted in 0.9% sodium chloride solution to a concentration of 1 mg / ml. Cisplastin lyophilisate should first be dissolved in 10-25 ml of water for injection. Do not use dextrose (glucose) solutions to dilute Cisplatin. Note: Since aluminum reacts with cisplatin and inactivates it, and also causes precipitate formation, it is very important to avoid using needles and other equipment containing aluminum when preparing Cisplatin.
Side effects
On the part of the urinary system: nephrotoxicity (is cumulative in nature and is the main toxic factor limiting the dose of Cisplatin). Kidney damage, which is accompanied by damage to the renal tubules, may first be detected in the second week after a dose and manifest an increase in serum creatinine, urea, and uric acid and / or a decrease in creatinine clearance. Renal failure, as a rule, is insignificant or moderately severe and is reversible at ordinary doses of Cisplatin. On the part of the digestive system: nausea and vomiting, which usually begin during the first hour of therapy and last for 24 hours or more, occur in 65% of patients. These side effects are only partially eliminated by the use of standard antiemetic drugs. The severity of these symptoms can be reduced by dividing the total dose, calculated per cycle of therapy, into smaller doses, which are administered once a day for five days. Of the other frequently observed adverse events from the gastrointestinal tract, abdominal pain, diarrhea and constipation are noted. Minor and transient increases in serum AST and ALT levels may occur occasionally.On the part of the hemopoietic system: often - myelosuppression, (in most cases it is expressed slightly or moderately and at the use of ordinary doses is reversible). The lowest levels of leukocytes and platelets are usually detected after about 2 weeks. their initial level in most patients is restored within 4 weeks. Anemia may also occur. On the part of the hearing system: unilateral or bilateral tinnitus, with or without loss of hearing, occurs in approximately 10% of patients. usually this side effect is reversible. It has been established that damage to the organ of hearing is dose-dependent and cumulative, and this side effect is more often observed in patients of very young or old age. There are reports of the toxic effect of the drug on the vestibular apparatus. On the part of the central nervous system and peripheral nervous system: peripheral neuropathies occur infrequently. Usually they have a sensory nature (for example, paresthesias of the upper and lower extremities), but motor disturbances may also occur (decreased reflexes and weakness in the lower extremities). Vegetative neuropathy, convulsions, slurred speech, loss of taste and memory loss can also occur. The development of Lermitte’s syndrome (spinal column myelopathy and autonomic neuropathy) has been reported in the literature. Treatment should be discontinued when these symptoms first appear. On the part of the immune system: sometimes there are allergic reactions, manifested in the form of redness and swelling of the face, wheezing in the lungs, tachycardia and a decrease in blood pressure. These reactions can occur within a few minutes after the start of cisplatin administration. In rare cases, urticaria and maculopapular skin rash may occur. On the part of the vision system: in rare cases, neuritis of the optic nerve, edema of the optic nerve head, and cortical blindness are noted. Changes in the perception of colors can also be observed, especially in the yellow-blue part of the spectrum. The only change in the fundus can be irregular pigmentation of the retina in the area of the yellow spot. These side effects are usually reversible and disappear after discontinuation of the drug. Disorders of electrolyte balance: hypomagnesaemia, hypocalcemia and hypokalemia.Hypomagnesemia and / or hypocalcemia may manifest clinically increased muscle sensitivity or seizures, tremor, carpopedal spasm (cramps in the hands and feet), and / or tetany. Possible hyponatremia due to inadequate production of antidiuretic hormone syndrome. Local reactions: if the drug gets under the skin, the development of phlebitis, cellulite and skin necrosis is possible. Others: cardiovascular disorders (coronary heart disease, congestive heart failure, arrhythmias, orthostatic hypotension, thrombotic microangiopathy, etc.), hyperuricemia, minor alopecia, myalgia, fever and platinum gum line. Reported cases of spermatogenesis and azoospermia.
special instructions
On the part of the urinary system: nephrotoxicity (is cumulative in nature and is the main toxic factor limiting the dose of Cisplatin). Kidney damage, which is accompanied by damage to the renal tubules, may first be detected in the second week after a dose and manifest an increase in serum creatinine, urea, and uric acid and / or a decrease in creatinine clearance. Renal failure, as a rule, is insignificant or moderately severe and is reversible at ordinary doses of Cisplatin. On the part of the digestive system: nausea and vomiting, which usually begin during the first hour of therapy and last for 24 hours or more, occur in 65% of patients. These side effects are only partially eliminated by the use of standard antiemetic drugs. The severity of these symptoms can be reduced by dividing the total dose, calculated per cycle of therapy, into smaller doses, which are administered once a day for five days. Of the other frequently observed adverse events from the gastrointestinal tract, abdominal pain, diarrhea and constipation are noted. Minor and transient increases in serum AST and ALT levels may occur occasionally. On the part of the hemopoietic system: often - myelosuppression, (in most cases it is expressed slightly or moderately and at the use of ordinary doses is reversible).The lowest levels of leukocytes and platelets are usually detected after about 2 weeks. their initial level in most patients is restored within 4 weeks. Anemia may also occur. On the part of the hearing system: unilateral or bilateral tinnitus, with or without loss of hearing, occurs in approximately 10% of patients. usually this side effect is reversible. It has been established that damage to the organ of hearing is dose-dependent and cumulative, and this side effect is more often observed in patients of very young or old age. There are reports of the toxic effect of the drug on the vestibular apparatus. On the part of the central nervous system and peripheral nervous system: peripheral neuropathies occur infrequently. Usually they have a sensory nature (for example, paresthesias of the upper and lower extremities), but motor disturbances may also occur (decreased reflexes and weakness in the lower extremities). Vegetative neuropathy, convulsions, slurred speech, loss of taste and memory loss can also occur. The development of Lermitte’s syndrome (spinal column myelopathy and autonomic neuropathy) has been reported in the literature. Treatment should be discontinued when these symptoms first appear. On the part of the immune system: sometimes there are allergic reactions, manifested in the form of redness and swelling of the face, wheezing in the lungs, tachycardia and a decrease in blood pressure. These reactions can occur within a few minutes after the start of cisplatin administration. In rare cases, urticaria and maculopapular skin rash may occur. On the part of the vision system: in rare cases, neuritis of the optic nerve, edema of the optic nerve head, and cortical blindness are noted. Changes in the perception of colors can also be observed, especially in the yellow-blue part of the spectrum. The only change in the fundus can be irregular pigmentation of the retina in the area of the yellow spot. These side effects are usually reversible and disappear after discontinuation of the drug. Disorders of electrolyte balance: hypomagnesaemia, hypocalcemia and hypokalemia. Hypomagnesemia and / or hypocalcemia may manifest clinically increased muscle sensitivity or seizures, tremor, carpopedal spasm (cramps in the hands and feet), and / or tetany.Possible hyponatremia due to inadequate production of antidiuretic hormone syndrome. Local reactions: if the drug gets under the skin, the development of phlebitis, cellulite and skin necrosis is possible. Others: cardiovascular disorders (coronary heart disease, congestive heart failure, arrhythmias, orthostatic hypotension, thrombotic microangiopathy, etc.), hyperuricemia, minor alopecia, myalgia, fever and platinum gum line. Reported cases of spermatogenesis and azoospermia.