Tylenol Pm
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Uses
Topotecan Injection is indicated for the treatment of chemotherapy-sensitive small cell lung cancer (SCLC) after failure of first-line chemotherapy. Chemotherapy-sensitive SCLC is defined as responding to first-line chemotherapy but subsequently progressing at least 60 days after chemotherapy.
Topotecan Injection, in combination with cisplatin, is indicated for the treatment of stage IVB, recurrent or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
History
There is currently no drug history available for this drug.
Other Information
Topotecan is a topoisomerase I-inhibitor that is a semi-synthetic derivative of camptothecin.
The chemical name for topotecan free base is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7] indolizino [1,2-b]quinoline-3,14-(4H ,12H)-dione. It has the molecular formula C23H23N3O5 and a molecular weight of 421.45. The hydrochloride salt of topotecan is freely soluble in water and melts with decomposition at 213°C to 218°C.
As formulated in Topotecan Injection, topotecan hydrochloride has the following structural formula:
Topotecan Injection is supplied as a sterile, non-pyrogenic, clear, light yellow to greenish solution in single-use vials at a topotecan free base concentration of 4 mg per 4 mL (1 mg per mL).
Each mL contains topotecan hydrochloride (equivalent to 1 mg of topotecan free base), 12 mg of mannitol, USP, and 5 mg of tartaric acid, NF. It may also contain hydrochloric acid and sodium hydroxide to adjust the pH. The solution pH ranges from 2.0 to 2.5.
Sources
Tylenol Pm Manufacturers
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Mcneil Consumer Healthcare Div Mcneil-ppc, Inc
![Tylenol Pm (Acetaminophen And Diphenhydramine Hydrochloride) Tablet, Film Coated [Mcneil Consumer Healthcare Div Mcneil-ppc, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tylenol Pm | Sagent Pharmaceuticals
Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)].
2.1 Small Cell Lung CancerRecommended Dosage: The recommended dose of Topotecan Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily on days 1 to 5 of each 21-day cycle until disease progression.
Dosage Modification Guidelines: Recommended dose modifications in patients with bone marrow suppression or renal impairment are provided in the table below [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1. Recommended Dose Modifications in Patients with Small Cell Lung Cancer Adverse Reaction or Laboratory Values Recommended Dose Modification On Day 1 of first cycle
--neutrophil count of ≤ 1,500 cells/mm3 or
--platelet count ≤ 100,000 cells/mm3 or
--serum creatinine > 1.5 mg/dL Delay initiation of Topotecan Injection until hematologic or renal recovery On Day 1 of subsequent cycles (cycle 2 and beyond)
--neutrophil count of ≤ 1,000 cells/mm3 or
--platelet count ≤ 100,000 cells/mm3 or
--hemoglobin < 9.0 gm/dL or
--serum creatinine > 1.5 mg/dL Delay next cycle of Topotecan Injection until hematologic or renal recovery For neutropenia < 500 cells/mm3 in preceding cycle Permanently reduce Topotecan Injection dose to 1.25 mg/m2 or administer prophylactic granulocyte colony-stimulating factor during subsequent cycles. For platelets < 25,000 cells/mm3 in preceding cycle Permanently reduce Topotecan Injection dose to 1.25 mg/m2 For creatinine clearance 20-39 mL/min Reduce the Topotecan Injection dose to 0.75 mg/m2 2.2 Cervical CancerRecommended Dosage: The recommended dose of Topotecan Injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3 of each 21-day cycle. Administer cisplatin 50 mg/m2 by intravenous infusion on day 1 of each 21-day cycle.
Dosage Modification Guidelines: Recommended dose modifications in patients with bone marrow suppression or renal impairment are provided in the table below [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. See manufacturer's prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity.
Table 2. Recommended Dose Modifications in Patients with Cervical Cancer Adverse Reaction or Laboratory Values Recommended Dose Modification On Day 1 of first cycle
--neutrophil count of ≤ 1,500 cells/mm3 or
--platelet count ≤ 100,000 cells/mm3 or
--serum creatinine > 1.5 mg/dL Delay initiation of Topotecan Injection until hematologic or renal recovery On Day 1 of subsequent cycles (cycle 2 and beyond)
--neutrophil count of ≤ 1,000 cells/mm3 or
--platelet count ≤ 100,000 cells/mm3 or
--hemoglobin < 9.0 gm/dL or
--serum creatinine > 1.5 mg/dL Delay next cycle of Topotecan Injection until hematologic or renal recovery For the first occurrence of febrile neutropenia [ < 1,000 neutrophils/mm3 with fever ≥ 38.0°C (≥ 100.4°F) in preceding cycle Permanently reduce the daily Topotecan Injection dose to 0.60 mg/m2 or administer prophylactic granulocyte colony-stimulating factor (G-CSF) during subsequent cycles. For re-occurrence of febrile neutropenia [< 1,000 neutrophils/mm3 with fever ≥ 38.0°C (≥ 100.4°F) in preceding cycle despite use of G-CSF Permanently reduce the daily Topotecan Injection dose to 0.45 mg/m2 For platelet nadir < 25,000 cells/mm3 in preceding cycle Permanently reduce the daily Topotecan Injection dose to 0.60 mg/m2 For serum creatinine > 1.5 mg/dL in subsequent cycles Permanently discontinue cisplatin and Topotecan Injection 2.3 Instructions for Handling, and Preparation for Intravenous AdministrationUse procedures for proper handling and disposal of anticancer drugs [see References (15)].
Dilute Topotecan Injection in either 0.9% Sodium Chloride USP or 5% Dextrose USP. Store diluted Topotecan Injection solutions at approximately 20°C to 25°C (68°F to 77°F) for no more than 4 hours or under refrigerated (2°C to 8°C) conditions for no more than 12 hours.
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