Please email us at [email protected] with our item No, NDC#, UPC# or the product link if you have any quetions. We are located in Oceanside, California. Search over 110,000 items by Name, Item No., NDC, UPC (without dashes) or by Mfg.Name. Please note, Prescription items can only be ordered by a Drug Manufacturer, Wholesaler, Hospital, Governmental Medical Facility, VA, Pharmacy, Physician, Physician Assistant, Nurse Practitioner, Dentist, Podiatrist, Optometrist, Veterinarian, Naturopath, Licensed Lab, Physical Therapist & Pharmacist in their scope of practice. No order will ship, unless you you have provided us the Medical License (and DEA Lic. in case of controlled drug) and we had verified that. Rx items can only be shipped to AZ, AR, CA, CT, DE, FL, GA, GU, HI, IL, KS, KY, LA, ME, MA, MI, NJ, NY, PA, PR, TX, TN, VA, WA, WI and WV. If you are an International Physician or Pharmacist, please contact us before ordering.


Menu

Rx Item-Topotecan 4Mg 4 Ml Vial 4Ml By Sagent Pharma

NDC 25021-0236-04 UPC/GTIN No. Mfg.Part No.23604BRAND: TOPOTECAN NDC: 25021-0236-04,25021023604 UPC: , Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Topotecan 4Mg 4 Ml Vial 4Ml By Sagent Pharma

$180.00$205.71

Item No.: RX367813 NDC No.25021023604 UPC No.: NDC No. 25021-0236-04 UPC/GTIN No. MPN 23604 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx367813 Topotecan 4mg/4 ml Vial 4ml by Sagent Pharma Item No. 3367813 NDC No. 25021023604 UPC No. Other Name Hycamtin,Topotecan N+ Therapeutic Class Antineopl

Have a question?

TOPOTECAN- topotecan hydrochloride injection, solution, concentrate
Sagent Pharmaceuticals

WARNING: BONE MARROW SUPPRESSION

Topotecan can cause severe myelosuppression. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cells/mm 3 and platelet counts greater than or equal to 100,000 cells/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Small Cell Lung Cancer


Topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.

1.2 Cervical Cancer
Topotecan injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment.

2 DOSAGE AND ADMINISTRATION

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 Cancer
Recommended Dose and Schedule

The recommended dose of topotecan injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.

2.2 Cervical Cancer
Recommended Dose and Schedule

The recommended dose of topotecan injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 in combination with cisplatin 50 mg/m2 on Day 1, repeated every 21 days.

2.3 Dose Modifications
Hematologic Toxicities

For single-agent use, dose reduce topotecan injection to 1.25 mg/m 2 for:

neutrophil counts of less than 500 cells/mm3 , or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose of topotecan.
platelet counts less than 25,000 cells/mm3 during previous cycle.
For combination use with cisplatin, dose reduce topotecan injection to 0.60 mg/m 2 (and further to 0.45 mg/m 2 if necessary) for:

febrile neutropenia (defined as neutrophil counts less than 1,000 cells/mm3 with temperature of greater than or equal to 38�C (100.4�F), or administer G-CSF starting no sooner than 24 hours following the last dose of topotecan.
platelet counts less than 25,000 cells/mm3 during previous cycle.
Renal Impairment

For single-agent use, dose reduce topotecan injection to 0.75 mg/m2 in patients with moderate renal impairment (creatinine clearance [Clcr] = 20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment (Clcr less than 20 mL/min) to provide a dosage recommendation for topotecan injection [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 Preparation and Intravenous Administration
Topotecan injection is a cytotoxic drug. Follow applicable special handling and disposable procedures.1

Preparation and Administration

Dilute topotecan injection in either 0.9% Sodium Chloride, USP or 5% Dextrose in Water, USP prior to administration.

Stability

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 (36�F to 46�F)] conditions for no more than 12 hours.

3 DOSAGE FORMS AND STRENGTHS

Injection: 4 mg per 4 mL (1 mg per mL, topotecan free base equivalent) clear, light yellow to greenish solution in single-use vial.

4 CONTRAINDICATIONS

?Topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan.
ADVERSE REACTIONS

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

Bone Marrow Suppression [see Warnings and Precautions (5.1)]
Neutropenic Enterocolitis [see Warnings and Precautions (5.2)]
Interstitial Lung Disease [see Warnings and Precautions (5.3)]
Extravasation and Tissue Injury [see Warnings and Precautions (5.5)]
DESCRIPTION

Topotecan 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-1H -pyrano[3',4':6,7] indolizino [1,2-b ]quinoline-3,14-(4H ,12H)-dione 1.25 hydrochloride. It has the molecular formula C23 H23 N3 O5 �xHCl (x = 1.25) and a molecular weight of 467.02. It is soluble in water and melts with decomposition at 213�C to 218�C.
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.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
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 break
16.2 Storage and Handling
Store refrigerated between 2�C and 8�C (36�F and 46�F). Handle and dispose of topotecan injection consistent with recommendations for the handling and disposal of hazardous drugs1.

Protect from light. Retain in carton until time of use.

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free.

17 PATIENT COUNSELING INFORMATION

Bone Marrow Suppression
Inform patients that topotecan decreases blood cell counts such as white blood cells, platelets, and red blood cells. Advise patients to notify their healthcare provider promptly for fever, other signs of infection (e.g., chills, cough, or burning pain on urination), or bleeding. Inform patients that frequent blood tests will be performed while taking topotecan to monitor for the occurrence of bone marrow suppression.

Embryofetal Toxicity
Advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected during treatment with topotecan. Advise females of reproductive potential to use effective contraception during treatment and for 1 month after the last dose of topotecan. Advise males with a female sexual partner of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of topotecan [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)].

Lactation
Advise nursing mothers to discontinue breastfeeding during treatment with topotecan [see Use in Specific Populations (8.2)].

Infertility
Advise male and female patients of the potential risk for impaired fertility and possible family planning options [see Use in Specific Populations (8.3)].

Asthenia and Fatigue
Advise patients that topotecan may cause asthenia or fatigue. These symptoms may impair the ability to safely drive or operate machinery.

NDC 25021-0236-04 UPC/GTIN No. Mfg.Part No.23604
RX ITEM-Topotecan 4Mg 4 Ml Vial 4Ml By S
NDC 25021-0236-04 UPC/GTIN No. Mfg.Part No.23604

BRAND: TOPOTECAN NDC: 25021-0236-04,25021023604 UPC: ,
Topotecan 4Mg 4 Ml Vial 4Ml By Sagent Ph
BRAND: TOPOTECAN NDC: 25021-0236-04,25021023604 UPC: ,

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Hycamtin.
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.