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CISPLATIN is a brand name for Cisplatin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cisplatin Injection BP is indicated as palliative therapy, to be employed in addition to other modalities, or in established combination therapy with other chemotherapeutic agents in the following: • Metastatic Testicular Tumors: In patients who have already received appropriate surgical and/or radiotherapeutic and/or…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment The recommended dose of Cisplatin Injection BP in adults and children as single-agent therapy is 50 to 75 mg/m2 as a single intravenous dose every 3 to 4 weeks, or 15 to 20 mg/m2 intravenous daily for 5 days, every 3 to 4 weeks.
5 mg/100 mL and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets 100,000 cells/mm3, WBC 4,000 cells/mm3). Subsequent dose of Cisplatin Injection BP should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
When employed in combination with other antitumor drugs, the dose of Cisplatin Injection BP should be adjusted appropriately. 3 Reconstitution Preparation of intravenous solutions IV needles, syringes or sets having aluminum components should not be employed in preparation or administration of Cisplatin Injection BP solutions.
An interaction will occur between aluminum and platinum from cisplatin, causing formation of a black precipitate, which is visible in the reconstituted solution, and a loss of potency. 5 g of mannitol. Diluted Cisplatin Injection BP solution is suitable for intravenous infusion.
This solution is not preserved and it should be used within 24 hours. Any unused portion should be discarded after that time, in order to avoid risk of microbial contamination. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. 4 Administration Pre-treatment hydration with 1 to 2 L of fluid infused for 8 to 12 hours prior to a cisplatin dose is recommended.
5 g of mannitol, and infused over a 6 to 8-hour period. Adequate hydration and urinary output must be maintained during the following 24 hours. Cisplatin is a cytotoxic agent. Caution should be utilized during handling and preparation.
3 Reconstitution and 7 WARNINGS AND PRECAUTIONS, General and 12 SPECIAL HANDLING INSTRUCTIONS). If cisplatin solution contacts the skin, immediately wash thoroughly with soap and water. If cisplatin solution contacts mucous membranes, flush thoroughly with water.
) • Infections, such as sepsis, including fatal cases (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS) • Myelosuppression (including fatal cases) such as neutropenia, leukopenia, thrombocytopenia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS) • Neurotoxicity (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS): - Leukoencephalopathy, including fatal case - Peripheral neuropathy - Posterior reversible encephalopathy syndrome, including fatal cases • Renal toxicity (see 2 CONTRAINDICATIONS, 7 WARNINGS, AND PRECAUTIONS and 8 ADVERSE REACTIONS) • Cardiovascular toxicity, such as venous thromboembolic events and pulmonary embolism, including fatal cases (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS) • Administration of cisplatin prior to an infusion with paclitaxel may increase exposure to paclitaxel by 33% and can therefore intensify neutropenia and neurotoxicity.
2 Recommended Dose and Dosage Adjustment The recommended dose of Cisplatin Injection BP in adults and children as single-agent therapy is 50 to 75 mg/m2 as a single intravenous dose every 3 to 4 weeks, or 15 to 20 mg/m2 intravenous daily for 5 days, every 3 to 4 weeks.
5 mg/100 mL and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets 100,000 cells/mm3, WBC 4,000 cells/mm3). Subsequent dose of Cisplatin Injection BP should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.
When employed in combination with other antitumor drugs, the dose of Cisplatin Injection BP should be adjusted appropriately. 3 Reconstitution Preparation of intravenous solutions IV needles, syringes or sets having aluminum components should not be employed in preparation or administration of Cisplatin Injection BP solutions.
An interaction will occur between aluminum and platinum from cisplatin, causing formation of a black precipitate, which is visible in the reconstituted solution, and a loss of potency. 5 g of mannitol. Diluted Cisplatin Injection BP solution is suitable for intravenous infusion.
09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 13 8 ADVERSE REACTIONS ................................................................................................
14 9 DRUG INTERACTIONS ................................................................................................ 18 10 CLINICAL PHARMACOLOGY .......................................................................................
19 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 20 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 20 PART II: SCIENTIFIC INFORMATION .......................................................................................
• Cisplatin Injection BP is contraindicated in patients with pre-existing renal impairment and hearing impairment, unless in the judgment of the physician and patient, the possible benefits of treatment outweigh the risks. • Cisplatin Injection BP should not be employed in myelosuppressed patients • Cisplatin Injection BP is contraindicated in individuals who have demonstrated a previous hypersensitivity to it or other platinum-containing compounds or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
When used as indicated, the physician must carefully weigh the therapeutic benefit versus risk of toxicity which may occur.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This solution is not preserved and it should be used within 24 hours. Any unused portion should be discarded after that time, in order to avoid risk of microbial contamination. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. 4 Administration Pre-treatment hydration with 1 to 2 L of fluid infused for 8 to 12 hours prior to a cisplatin dose is recommended.
5 g of mannitol, and infused over a 6 to 8-hour period. Adequate hydration and urinary output must be maintained during the following 24 hours. Cisplatin is a cytotoxic agent. Caution should be utilized during handling and preparation.
3 Reconstitution and 7 WARNINGS AND PRECAUTIONS, General and 12 SPECIAL HANDLING INSTRUCTIONS). If cisplatin solution contacts the skin, immediately wash thoroughly with soap and water. If cisplatin solution contacts mucous membranes, flush thoroughly with water.
5 OVERDOSAGE CAUTION SHOULD BE USED TO PREVENT INADVERTENT OVERDOSAGE WITH CISPLATIN INJECTION BP. Acute overdosage with this drug may result in kidney failure, liver failure, deafness, ocular toxicity (including detachment of the retina), significant myelosuppression, intractable nausea and vomiting and/or neuritis.
In addition, death can occur following overdosage. No proven antidote has been established for cisplatin overdosage. Hemodialysis, even when initiated for hours after overdosage, appears to have little effect on removing platinum from the body because of rapid and high degree of protein binding of cisplatin.
Management of overdosage should include general supportive measures to sustain the patient through the period of toxicity that may occur. Patients should be monitored for 3-4 weeks in case of delayed toxicity. For management of a suspected drug overdose, contact your regional poison control centre.
PrCisplatin Injection BP – Product Monograph Page 7 of 31 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Cisplatin Injection BP, 1 mg / mL, is supplied as a sterile aqueous solution for intravenous use, available in amber glass ONCO-TAIN® vials of 50 mL and 100 mL.
Each single-use vial is individually packaged in a carton. Cisplatin Injection BP is preservative-free. 7 WARNINGS AND PRECAUTIONS See 3 WARNINGS AND PRECAUTIONS BOX General CISPLATIN INJECTION BP IS A CYTOTOXIC DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS.
BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE TAKEN REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN. Cisplatin Injection BP should be administered under the supervision of a qualified physician experienced with the use of antineoplastic therapy.
The benefit to patient versus risk of toxicity must be carefully weighed. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. An interaction will occur between aluminum and platinum from cisplatin, causing a black precipitate which is […]
21 13 PHARMACEUTICAL INFORMATION ............................................................................ 21 14 CLINICAL TRIALS ........................................................................................................
21 15 MICROBIOLOGY ........................................................................................................ 21 16 NON-CLINICAL TOXICOLOGY .....................................................................................
21 PATIENT MEDICATION INFORMATION .................................................................................. 23 PrCisplatin Injection BP – Product Monograph Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Cisplatin Injection BP is indicated as palliative therapy, to be employed in addition to other modalities, or in established combination therapy with other chemotherapeutic agents in the following: • Metastatic Testicular Tumors: In patients who have already received appropriate surgical and/or radiotherapeutic and/or chemotherapeutic procedures.
• Metastatic Ovarian Tumors: As secondary therapy in patients refractory to standard chemotherapy. • Advanced Bladder Cancer: As a single agent for patients with transitional cell bladder cancer. 3 Special Populations – Pediatrics). 2 Geriatrics Geriatric patients, patients with baseline renal impairment, patients who are taking other nephrotoxic drugs, or patients who are not well hydrated may be more susceptible to nephrotoxicity.
Geriatric patients may be more susceptible to myelosuppression. Geriatric patients may be more susceptible to peripheral neuropathy. 4 Special Populations – Geriatric. 2 CONTRAINDICATIONS • […]