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Gemcitabine
Overview
What is Gemcitabine?
Gemcitabine is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl, USP is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).
The structural formula is as follows:
The empirical formula for Gemcitabine HCl, USP is CHFNO • HCl. It has a molecular weight of 299.66.
Gemcitabine HCl, USP is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.
The clinical formulation is supplied as a sterile solution for intravenous single vial use only. Vials of gemcitabine injection contain either 200 mg, 1 g, or 2 g of gemcitabine HCl, USP (expressed as free base). Each mL contains equivalent of 38 mg of gemcitabine in Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.
What does Gemcitabine look like?
What are the available doses of Gemcitabine?
Gemcitabine Injection is a clear and colorless to light straw-colored solution available in sterile
single-dose vials containing:
What should I talk to my health care provider before I take Gemcitabine?
How should I use Gemcitabine?
Gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Recommended Dose and Schedule
The recommended dose of gemcitabine injection is 1,000 mg/m as an intravenous infusion over
30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after gemcitabine injection administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.
Dose Modifications
Recommended gemcitabine injection dose modifications for myelosuppression are described in Table 1 and Table 2 . Refer to Dosage and Administration () for recommendations for non-hematologic adverse reactions.
Table 1: Dosage Reduction Guidelines for Gemcitabine Injection for Myelosuppression on Day of Treatment in Ovarian Cancer
Table 2: Gemcitabine Injection Dose Modification for Myelosuppression in Previous Cycle in Ovarian Cancer
What interacts with Gemcitabine?
Sorry No Records found
What are the warnings of Gemcitabine?
Sorry No Records found
What are the precautions of Gemcitabine?
Sorry No Records found
What are the side effects of Gemcitabine?
Sorry No records found
What should I look out for while using Gemcitabine?
Gemcitabine injection is contraindicated in patients with a known hypersensitivity to gemcitabine.
What might happen if I take too much Gemcitabine?
Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5,700 mg/m was administered by intravenous infusion over 30 minutes every 2 weeks to several patients in a dose-escalation study.
How should I store and handle Gemcitabine?
Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] [ ] Clindamycin Hydrochloride Capsules USP, 150 mgNDC 42292-018-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Dispense in a tight container with child-resistant closure. Clindamycin Hydrochloride Capsules USP, 150 mgNDC 42292-018-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Dispense in a tight container with child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate the deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (self-potentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands which eventually results in the initiation of apoptotic cell death.
Non-Clinical Toxicology
Gemcitabine injection is contraindicated in patients with a known hypersensitivity to gemcitabine.Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin . Because of possible clinical significance, these two drugs should not be administered concurrently.
In clinical trials evaluating the maximum tolerated dose of gemcitabine injection, prolongation of
the infusion time beyond 60 minutes or more frequent than weekly dosing resulted in an increased
incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia. The half-life of gemcitabine injection is influenced by the length of the infusion .
The following serious adverse reactions are discussed in greater detail in another section of the
label
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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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. 315.72Tips
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Interactions
Interactions
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