Topotecan hydrochloride

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Overview

What is Topotecan hydrochloride?

Topotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1-pyrano[3’,4’:6,7] indolizino [1,2-]quinoline-3,14-(4,12)-dione monohydrochloride. It has the molecular formula CHNO•HCl and a molecular weight of 457.9. It is soluble in water and melts with decomposition at 213°C to 218°C.

Topotecan hydrochloride has the following structural formula:

Topotecan Hydrochloride for Injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. The reconstituted solution ranges in color from yellow to yellow-green and is intended for administration by intravenous infusion.

Inactive ingredients are mannitol, 48 mg, and tartaric acid, 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5.

What does Topotecan hydrochloride look like?

What are the available doses of Topotecan hydrochloride?

4 mg (free base) lyophilized powder in single-dose vial. ()

What should I talk to my health care provider before I take Topotecan hydrochloride?

How should I use Topotecan hydrochloride?

Topotecan Hydrochloride for Injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.

Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously .

What interacts with Topotecan hydrochloride?

Sorry No Records found

What are the warnings of Topotecan hydrochloride?

Sorry No Records found

What are the precautions of Topotecan hydrochloride?

Sorry No Records found

What are the side effects of Topotecan hydrochloride?

Sorry No records found

What should I look out for while using Topotecan hydrochloride?

To

potecan

Topotecan hydrochloride

can cause severe myelosuppression. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cells/mm and platelet counts greater than or equal to 100,000 cells/mm. Monitor blood cell counts .

What might happen if I take too much Topotecan hydrochloride?

Overdoses (up to 10-fold of the prescribed dose) occurred in patients treated with intravenous topotecan. The primary complication of overdosage is bone marrow suppression. The observed signs and symptoms of overdose are consistent with the known adverse reactions associated with topotecan hydrochloride for intravenous use . In addition, elevated hepatic enzymes and mucositis have been reported following overdose. One patient received a single dose of 40 mg/m of intravenous topotecan and developed gastrointestinal toxicity, skin toxicity, and myelosuppression leading to septic shock. Another patient received a single dose of 35 mg/m and experienced severe, reversible neutropenia.

There is no known antidote for overdosage with topotecan hydrochloride. If an overdose is suspected, monitor the patient closely for bone marrow suppression and institute supportive-care measures (such as the prophylactic use of G-CSF and antibiotic therapy) as appropriate.

How should I store and handle Topotecan hydrochloride?

Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000Sulindac Tablets USP, 150 mg are yellow, round tablets, bisected and debossed with “Є” to the left of bisect and “10” to the right of bisect on one side, and plain on the other side. They are supplied as follows: NDC 42806-018-01 in bottles of 100.NDC 42806-018-05 in bottles of 500.NDC 42806-018-10 in bottles of 1000.Sulindac Tablets USP, 200 mg are yellow, oval-shaped tablets, bisected and debossed with “Є” to the left of bisect and “11” to the right of bisect on one side, and plain on the other side. They are supplied as follows:NDC 42806-011-01 in bottles of 100.NDC 42806-011-05 in bottles of 500.NDC 42806-011-10 in bottles of 1000.StorageStore in a well-closed container at 20° to 25° C (68 to 77° F) [See USP Controlled Room Temperature].Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF018REV01/16OE1000

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents re-ligation of these single-strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I, and DNA. Mammalian cells cannot efficiently repair these double-strand breaks.

Non-Clinical Toxicology

To

potecan

Topotecan hydrochloride

can cause severe myelosuppression. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cells/mm and platelet counts greater than or equal to 100,000 cells/mm. Monitor blood cell counts .

Bone marrow suppression (primarily neutropenia) is the dose-limiting toxicity of topotecan hydrochloride. Neutropenia is not cumulative over time. Severe myelotoxicity has been reported when topotecan hydrochloride is used in combination with cisplatin .

Neutropenia

Thrombocytopenia

Anemia

Administer topotecan hydrochloride only to patients with a baseline neutrophil count of greater than or equal to 1,500 cells/mm and a platelet count greater than or equal to 100,000/mm. Monitor peripheral blood counts frequently during treatment with topotecan hydrochloride. Refer to Section 2.4 for dose modification guidelines for hematological toxicities in subsequent courses. Do not treat patients with subsequent courses of topotecan hydrochloride until neutrophils recover to greater than 1,000 cells/mm, platelets recover to greater than 100,000 cells/mm, and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary).

The following serious adverse reactions are described below and elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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