Details About Generic Salt ::  Cisplati

Main Medicine Class::    

(SIS-plat-in)

Platinol AQ

Solution for injection

1 mg/mL

Powder for injection

1 mg/mL

Class: Alkylating agent

 Indications Metastatic testicular or ovarian tumors, advanced bladder cancer.

Squamous cell carcinoma of the head and neck, cervix; lung carcinomas, osteogenic sarcoma, brain tumors; advanced esophageal, adrenal cortex, breast, endometrial, and liver carcinoma, bone marrow transplantation.

 Contraindications Preexisting renal impairment; myelosuppression; hearing impairment; history of allergic reactions to cisplatin or other platinum-containing compounds.

 Route/Dosage

Metastatic Testicular Tumors

ADULTS: IV Cisplatin 20 mg/m²/day IV for 5 days q 3 wk for 3 courses (combination regimen). Single doses of cisplatin up to 120 mg/m² in combination with other antineoplastics have been used.

Metastatic Ovarian Tumors (Cyclosphosamide Combination Therapy)

ADULTS: IV Cisplatin 75 to 100 mg/m² once q 4 wk. Cyclosphosamide 600 mg/m² once q 4 wk (day 1).

Metastatic Ovarian Tumors (Single Agent Therapy)

ADULTS: IV Administer as a single agent of 100 mg/m² IV/cycle once q 4 wk.

Advanced Bladder Cancer

Adults: IV Administer as a single agent. Give 50 to 70 mg/m² once q 3 to 4 wk, depending on prior radiation therapy or chemotherapy. For heavily pretreated patients, give an initial dose of 50 mg/m²/cycle repeated q 4 wk.

Repeat Courses

ADULTS: IV Do not give a repeat course until the serum creatinine is below 1.5 mg/dL or the BUN is below 25 mg/dL or until circulating blood elements are at an acceptable level (platelets at least 100,000/mm³, WBC at least 4000/mm³). Do not give subsequent doses until an audiometric analysis indicates that auditory acuity is within normal limits.

Renal Impairment

ADULTS: IV The manufacturer does not recommend the use of cisplatin in patients with renal impairment. Some clinicians recommend not giving cisplatin to patients with a Ccr below 30 mL/min.

Interactions

Aminoglycosides

Potentiation of nephrotoxicity is possible.

Lithium

Cisplatin may transiently decrease lithium serum levels.

Loop diuretics (eg, furosemide)

Potentiation of ototoxicity is possible.

Paclitaxel

Paclitaxel clearance decreases when cisplatin is given immediately prior to paclitaxel, resulting in increased hematologic toxicity.

Phenytoin

Cisplatin may decrease absorption or increase metabolism, resulting in lower serum levels of phenytoin.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: MI; cerebrovascular accident; cerebral arteritis; thrombotic microangiopathy. CNS: Peripheral sensory neuropathy with a glove-and-stocking distribution. GI: Nausea; vomiting; anorexia; transient LFT elevations. HEMATOLOGIC: Bone marrow suppression. HYPERSENSITIVITY: Anaphylactic reation. METABOLIC: Hypomagnesemia; hypocalcemia; hypokalemia; syndrome of inappropriate antidiuretic hormone secretion. RENAL: Dose-related and cumulative renal tubular damage. SPECIALSENSES: Tinnitus; high frequency hearing loss.

 Precautions

Pregnancy: Category D. Lactation: Reported to be found in breast milk. Do not breastfeed. Children: Safety and efficacy not established. Electrolyte disturbances: Hypomagnesemia, hypocalcemia, hyponatremia, hypokalemia, and hypophosphatemia have occurred and are probably related to renal tubular damage. Extravasation risk: Local irritation or phlebitis may occur. Refer to your institution specific protocol. GI: Marked nausea and vomiting occur in almost all patients and are occasionally so severe that the drug must be discontinued. Hematologic: Myelosuppression occurs in 25% to 30% of patients. Leukopenia and thrombocytopenia are more pronounced at doses above 50 mg/m². Anemia (decrease of 2 g hemoglobin/dL) occur at the same frequency and with the same timing as leukopenia and thrombocytopenia. Hepatotoxicity: Transient elevations of liver enzymes, especially AST, as well as bilirubin have been reported. High/Cumulative doses: Muscle cramps, defined as localized painful, involuntary skeletal muscle contractions of sudden onset and short duration have occurred. Hyperuricemia: Occurs at about the same frequency as increase in BUN and serum creatinine. It is more pronounced after doses above 50 mg/m². Hypersensitivity: Anaphylactic-like reactions have occurred. Neuropathies: Neurotoxicity, usually characterized by peripheral neuropathy, have occurred. Severe neuropathies have occurred in patients receiving higher doses of cisplatin or greater dose frequencies than those recommended, or after prolonged therapy. Discontinue therapy when symptoms are observed. Ophthalmic effects: Optic neuritis, papilledema, and cerebral blindness have occurred infrequently in patients receiving recommended cisplatin doses. Ototoxicity: Has occurred in no more than 31% of patients given a single dose of 50 mg/m² dose. It is manifested by tinnitus or loss of high frequency hearing, and occasionally deafness. Renal toxicity: Dose-related and cumulative renal insufficiency is the major dose-limiting toxicity. This is manifested by elevations in BUN and creatinine, serum uric acid, or a decrease in Ccr. Renal toxicity becomes more severe and prolonged with repeated courses; therefore, renal function must return to normal before another dose can be given. Amifostine can be used to reduce renal toxicity in patients with advanced ovarian cancer receiving repeated doses of cispaltin. Vascular toxicities: These events are rare and coincident with the use of cisplatin in combination with other antineoplastic agents. These events may include MI, cerebrovascular accident, thrombotic microangiopathy, or cerebral arteritis.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Store at 15° to 25°C. Protect unopened container from light. Do not refrigerate. The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.
• Cisplatin powder reconstituted with Bacteriostatic Water for Injection is chemically stable for 3 days at room temperature with protection from light.
• If not protected from light, reconstituted cisplatin solution is stable for 6 hr at room temperature.
• Administer by IV over 6 to 8 hr. More rapid administration rates (30 min to 2 hr) are commonly used
• Cisplatin degrades and forms a black precipitate on contact with aluminum. Although needles and administration sets rarely contain aluminum, consider this interaction if a black precipitate is observed.
• Reconstitute powder with 50 mL of sterile Water for Injection or Bacteriostatic Water for Injection for a final concentration of 1 mg/mL. The resulting solution should be clear and colorless.
• Skin reactions associated with accidental exposure may occur. Use gloves. If solution contacts skin or mucosa, wash immediately and thoroughly with soap and water, and flush mucosa with water.
• Cisplatin and fluorouracil admixtures are stable in 0.9% Normal Saline for 1 hr.
• The manufacturer recommends further dilution in 2 L of solution containing 37.5 g mannitol, using 5% Dextrose with 0.45% Sodium Chloride. More concentrated solutions, up to a max concentration of 0.7 mg/mL have been used. Cisplatin (up to 200 mg) may also be diluted in 500 mL of 0.9% Sodium Chloride with 12.5 to 25 g mannitol.
• Exercise caution to prevent inadvertent cisplatin overdose. Doses above 100 mg/m²/cycle once q 3 to 4 wk are rarely used. Care must be taken to avoid cisplatin overdose because of confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.
• The administration of cisplatin using a 6- to 8-hr infusion with IV hydration and mannitol has been used to reduce nephrotoxicity.

Pretreatment hydration

• Adequately hydrate patients before and for 24 hr after administration of cisplatin to increase urine output and minimize nephrotoxicity. The manufacturer recommends hydrating patients with 1 to 2 L of fluid infused for 8 to 12 hr before cisplatin administration. Patients may be given 1 L of 0.9% Sodium Chloride (with or without Potassium Chloride) over 2 to 4 hr prior to cisplatin administration to establish good urine output.

 Assessment/Interventions

• Monitor serum uric acid. Minimize effects with hydration, urinary alkalinization, and allopurinol.
• Monitor peripheral blood counts weekly and liver function periodically. Measure serum creatinine, BUN, Ccr, magnesium, sodium, calcium, and potassium levels prior to initiating therapy and to each subsequent course. Do not give more frequently than once q 3 to 4 wk at the recommended dosage.
• Perform neurologic and auditory examinations regularly. Carefully perform audiometry before starting therapy and prior to subsequent doses.
• Delayed emesis typically occurs 24 to 72 hr after cisplatin administration. Severity may be reduced by administration of a prophylactic regimen of dexamethasone in combination with metaclopramide or prochlorperazine. Begin prophylactic therapy 16 to 24 hr after cisplatin administration and continue for a total of 4 days. Add additional antiemetics if breakthrough nausea and vomiting occur.
• Amifostine may decrease the risk of cumulative renal toxicity with repeated courses in ovarian cancer patients.

OVERDOSAGE: SIGNS & SYMPTOMS   Kidney failure, liver failure, deafness, ocular toxicity, significant myelosuppression, intractable nausea and vomiting, neuritis, death

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
• Advise patient, family, or caregiver that medication may be used in combination with other agents to achieve maximum benefit possible.
• Review dosing schedule with patient, family, or caregiver.
• Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; difficulty breathing; fever, chills or other signs of infection; sores in mouth; unusual bleeding or bruising.
• Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting or appetite loss; persistent or worsening general body weakness; changes in hearing or ringing in the ears; dizziness or feeling of whirling motion; abnormal skin sensations; any other unexplained sensation; pain, redness or swelling at injection site.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised by the health care provider.
• Instruct women of childbearing potential to notify the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Advise patient that frequent follow-up visits, hearing tests, and laboratory tests will be required to monitor therapy, and to keep appointments.

Medicscientist Drug Facts

Drugs Class ::

Indications for Drugs ::

 Indications Metastatic testicular or ovarian tumors, advanced bladder cancer.

Squamous cell carcinoma of the head and neck, cervix; lung carcinomas, osteogenic sarcoma, brain tumors; advanced esophageal, adrenal cortex, breast, endometrial, and liver carcinoma, bone marrow transplantation.

Drug Dose ::

 Route/Dosage

Metastatic Testicular Tumors

ADULTS: IV Cisplatin 20 mg/m²/day IV for 5 days q 3 wk for 3 courses (combination regimen). Single doses of cisplatin up to 120 mg/m² in combination with other antineoplastics have been used.

Metastatic Ovarian Tumors (Cyclosphosamide Combination Therapy)

ADULTS: IV Cisplatin 75 to 100 mg/m² once q 4 wk. Cyclosphosamide 600 mg/m² once q 4 wk (day 1).

Metastatic Ovarian Tumors (Single Agent Therapy)

ADULTS: IV Administer as a single agent of 100 mg/m² IV/cycle once q 4 wk.

Advanced Bladder Cancer

Adults: IV Administer as a single agent. Give 50 to 70 mg/m² once q 3 to 4 wk, depending on prior radiation therapy or chemotherapy. For heavily pretreated patients, give an initial dose of 50 mg/m²/cycle repeated q 4 wk.

Repeat Courses

ADULTS: IV Do not give a repeat course until the serum creatinine is below 1.5 mg/dL or the BUN is below 25 mg/dL or until circulating blood elements are at an acceptable level (platelets at least 100,000/mm³, WBC at least 4000/mm³). Do not give subsequent doses until an audiometric analysis indicates that auditory acuity is within normal limits.

Renal Impairment

ADULTS: IV The manufacturer does not recommend the use of cisplatin in patients with renal impairment. Some clinicians recommend not giving cisplatin to patients with a Ccr below 30 mL/min.

Contraindication ::

 Contraindications Preexisting renal impairment; myelosuppression; hearing impairment; history of allergic reactions to cisplatin or other platinum-containing compounds.

Drug Precautions ::

 Precautions

Pregnancy: Category D. Lactation: Reported to be found in breast milk. Do not breastfeed. Children: Safety and efficacy not established. Electrolyte disturbances: Hypomagnesemia, hypocalcemia, hyponatremia, hypokalemia, and hypophosphatemia have occurred and are probably related to renal tubular damage. Extravasation risk: Local irritation or phlebitis may occur. Refer to your institution specific protocol. GI: Marked nausea and vomiting occur in almost all patients and are occasionally so severe that the drug must be discontinued. Hematologic: Myelosuppression occurs in 25% to 30% of patients. Leukopenia and thrombocytopenia are more pronounced at doses above 50 mg/m². Anemia (decrease of 2 g hemoglobin/dL) occur at the same frequency and with the same timing as leukopenia and thrombocytopenia. Hepatotoxicity: Transient elevations of liver enzymes, especially AST, as well as bilirubin have been reported. High/Cumulative doses: Muscle cramps, defined as localized painful, involuntary skeletal muscle contractions of sudden onset and short duration have occurred. Hyperuricemia: Occurs at about the same frequency as increase in BUN and serum creatinine. It is more pronounced after doses above 50 mg/m². Hypersensitivity: Anaphylactic-like reactions have occurred. Neuropathies: Neurotoxicity, usually characterized by peripheral neuropathy, have occurred. Severe neuropathies have occurred in patients receiving higher doses of cisplatin or greater dose frequencies than those recommended, or after prolonged therapy. Discontinue therapy when symptoms are observed. Ophthalmic effects: Optic neuritis, papilledema, and cerebral blindness have occurred infrequently in patients receiving recommended cisplatin doses. Ototoxicity: Has occurred in no more than 31% of patients given a single dose of 50 mg/m² dose. It is manifested by tinnitus or loss of high frequency hearing, and occasionally deafness. Renal toxicity: Dose-related and cumulative renal insufficiency is the major dose-limiting toxicity. This is manifested by elevations in BUN and creatinine, serum uric acid, or a decrease in Ccr. Renal toxicity becomes more severe and prolonged with repeated courses; therefore, renal function must return to normal before another dose can be given. Amifostine can be used to reduce renal toxicity in patients with advanced ovarian cancer receiving repeated doses of cispaltin. Vascular toxicities: These events are rare and coincident with the use of cisplatin in combination with other antineoplastic agents. These events may include MI, cerebrovascular accident, thrombotic microangiopathy, or cerebral arteritis.

Drug Side Effects ::

 Adverse Reactions

CARDIOVASCULAR: MI; cerebrovascular accident; cerebral arteritis; thrombotic microangiopathy. CNS: Peripheral sensory neuropathy with a glove-and-stocking distribution. GI: Nausea; vomiting; anorexia; transient LFT elevations. HEMATOLOGIC: Bone marrow suppression. HYPERSENSITIVITY: Anaphylactic reation. METABOLIC: Hypomagnesemia; hypocalcemia; hypokalemia; syndrome of inappropriate antidiuretic hormone secretion. RENAL: Dose-related and cumulative renal tubular damage. SPECIALSENSES: Tinnitus; high frequency hearing loss.

Drug Mode of Action ::  

Drug Interactions ::

Interactions

Aminoglycosides

Potentiation of nephrotoxicity is possible.

Lithium

Cisplatin may transiently decrease lithium serum levels.

Loop diuretics (eg, furosemide)

Potentiation of ototoxicity is possible.

Paclitaxel

Paclitaxel clearance decreases when cisplatin is given immediately prior to paclitaxel, resulting in increased hematologic toxicity.

Phenytoin

Cisplatin may decrease absorption or increase metabolism, resulting in lower serum levels of phenytoin.

Drug Assesment ::

 Assessment/Interventions

• Monitor serum uric acid. Minimize effects with hydration, urinary alkalinization, and allopurinol.
• Monitor peripheral blood counts weekly and liver function periodically. Measure serum creatinine, BUN, Ccr, magnesium, sodium, calcium, and potassium levels prior to initiating therapy and to each subsequent course. Do not give more frequently than once q 3 to 4 wk at the recommended dosage.
• Perform neurologic and auditory examinations regularly. Carefully perform audiometry before starting therapy and prior to subsequent doses.
• Delayed emesis typically occurs 24 to 72 hr after cisplatin administration. Severity may be reduced by administration of a prophylactic regimen of dexamethasone in combination with metaclopramide or prochlorperazine. Begin prophylactic therapy 16 to 24 hr after cisplatin administration and continue for a total of 4 days. Add additional antiemetics if breakthrough nausea and vomiting occur.
• Amifostine may decrease the risk of cumulative renal toxicity with repeated courses in ovarian cancer patients.

Drug Storage/Management ::

 Administration/Storage

• Store at 15° to 25°C. Protect unopened container from light. Do not refrigerate. The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.
• Cisplatin powder reconstituted with Bacteriostatic Water for Injection is chemically stable for 3 days at room temperature with protection from light.
• If not protected from light, reconstituted cisplatin solution is stable for 6 hr at room temperature.
• Administer by IV over 6 to 8 hr. More rapid administration rates (30 min to 2 hr) are commonly used
• Cisplatin degrades and forms a black precipitate on contact with aluminum. Although needles and administration sets rarely contain aluminum, consider this interaction if a black precipitate is observed.
• Reconstitute powder with 50 mL of sterile Water for Injection or Bacteriostatic Water for Injection for a final concentration of 1 mg/mL. The resulting solution should be clear and colorless.
• Skin reactions associated with accidental exposure may occur. Use gloves. If solution contacts skin or mucosa, wash immediately and thoroughly with soap and water, and flush mucosa with water.
• Cisplatin and fluorouracil admixtures are stable in 0.9% Normal Saline for 1 hr.
• The manufacturer recommends further dilution in 2 L of solution containing 37.5 g mannitol, using 5% Dextrose with 0.45% Sodium Chloride. More concentrated solutions, up to a max concentration of 0.7 mg/mL have been used. Cisplatin (up to 200 mg) may also be diluted in 500 mL of 0.9% Sodium Chloride with 12.5 to 25 g mannitol.
• Exercise caution to prevent inadvertent cisplatin overdose. Doses above 100 mg/m²/cycle once q 3 to 4 wk are rarely used. Care must be taken to avoid cisplatin overdose because of confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.
• The administration of cisplatin using a 6- to 8-hr infusion with IV hydration and mannitol has been used to reduce nephrotoxicity.

Pretreatment hydration

• Adequately hydrate patients before and for 24 hr after administration of cisplatin to increase urine output and minimize nephrotoxicity. The manufacturer recommends hydrating patients with 1 to 2 L of fluid infused for 8 to 12 hr before cisplatin administration. Patients may be given 1 L of 0.9% Sodium Chloride (with or without Potassium Chloride) over 2 to 4 hr prior to cisplatin administration to establish good urine output.

Drug Notes ::

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
• Advise patient, family, or caregiver that medication may be used in combination with other agents to achieve maximum benefit possible.
• Review dosing schedule with patient, family, or caregiver.
• Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; difficulty breathing; fever, chills or other signs of infection; sores in mouth; unusual bleeding or bruising.
• Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting or appetite loss; persistent or worsening general body weakness; changes in hearing or ringing in the ears; dizziness or feeling of whirling motion; abnormal skin sensations; any other unexplained sensation; pain, redness or swelling at injection site.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised by the health care provider.
• Instruct women of childbearing potential to notify the health care provider if becoming pregnant, planning on becoming pregnant, or are breastfeeding.
• Advise patient that frequent follow-up visits, hearing tests, and laboratory tests will be required to monitor therapy, and to keep appointments.

Medicscientist Drug Facts

Disclaimer ::

The Information available on this site is for only Informational Purpose , before any use of this information please consult your Doctor .Price of the drugs indicated above may not match to real price due to many possible reasons may , including local taxes etc.. These are only approximate indicative prices of the drug.