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GEMCITABINE HYDROCHLORIDE

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Overview

What is GEMCITABINE HYDROCHLORIDE?

Gemcitabine for Injection, USP is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows:

The empirical formula for gemcitabine HCl is CHFNO • HCl. It has a molecular weight of 299.66.

Gemcitabine HCl is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.

Gemcitabine for Injection, USP is supplied in a sterile form for intravenous use only. Vials of Gemcitabine for Injection, USP contain either 200 mg or 1 g or 2 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g or 2 g respectively) and sodium acetate (12.5 mg or 62.5 mg or 125 mg respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.



What does GEMCITABINE HYDROCHLORIDE look like?



What are the available doses of GEMCITABINE HYDROCHLORIDE?

Gemcitabine for Injection, USP is a white to off-white lyophilized powder available in sterile single-use vials containing 200 mg or 1 g or 2g gemcitabine.

What should I talk to my health care provider before I take GEMCITABINE HYDROCHLORIDE?

How should I use GEMCITABINE HYDROCHLORIDE?

Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated:

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2.3

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2.4


What interacts with GEMCITABINE HYDROCHLORIDE?

Sorry No Records found


What are the warnings of GEMCITABINE HYDROCHLORIDE?

Sorry No Records found


What are the precautions of GEMCITABINE HYDROCHLORIDE?

Sorry No Records found


What are the side effects of GEMCITABINE HYDROCHLORIDE?

Sorry No records found


What should I look out for while using GEMCITABINE HYDROCHLORIDE?

           Patients with a known hypersensitivity to gemcitabine. ()


What might happen if I take too much GEMCITABINE HYDROCHLORIDE?

Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5700 mg/mwas 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 HYDROCHLORIDE?

Store at 20˚ to 25˚C (68˚ to 77˚F)Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415Benztropine Mesylate Tablets, USP, for oral use, are supplied in the following forms:As 0.5 mg: Compressed tablet, white, 1/4" diameter, flat beveled edge; one side scored and debossed 832 and BM05, one side plain, in bottles of 100 (NDC 0832-1080-00).As 1 mg: Compressed tablet, white, 0.231" x 0.420", oval; one side scored and debossed 832 and BM1, one side plain, in bottles of 100 (NDC 0832-1081-00) and 1000 (NDC 0832-1081-10).As 2 mg: Compressed tablet, white, 9/32" diameter, flat beveled edge; one side scored and debossed 832 and BM2, one side plain, in bottles of 100 (NDC 0832-1082-00) and 1000 (NDC 0832-1082-10).Store at controlled room temperature 15 - 30° C (59 - 86° F).Dispense in well-closed containers as defined in the USP.Keep out of reach of children.-------------------------*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. : 1963-1965, Nov. 25, 1968. Manufactured by Maple Grove, MN 55369 Revised 0415


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Clinical Information

Chemical Structure

No Image found
Clinical 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 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
           Patients with a known hypersensitivity to gemcitabine. ()

Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see ).

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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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Tips

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Interactions

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).