Imipenem and Cilastatin

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Overview

What is Imipenem and Cilastatin?

Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP (I.V.) is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by . Its chemical name is (5,6)-3-[[2-(formimidoylamino)ethyl]thio]-6[()-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is CHNOS•HO, and its structural formula is:

Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium ()7[[()-2-amino-2-carboxyethyl]thio]-2-[()-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is CHNOSNa, and its structural formula is:

Imipenem and Cilastatin for Injection, USP (I.V.) is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. Each Imipenem and Cilastatin for Injection, USP (I.V.) 250 mg/250 mg vial contains imipenem USP 250 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 250 mg cilastatin and each 500 mg/500 mg vial contains imipenem USP 500 mg (anhydrous equivalent) and cilastatin sodium USP equivalent to 500 mg cilastatin. In addition, the 250 mg/250 mg vial contains 10 mg of sodium bicarbonate and the 500 mg/500 mg vial contains 20 mg of sodium bicarbonate. The sodium content of the 250 mg/250 mg vial is 18.8 mg (0.8 mEq) and the sodium content for the 500 mg/500 mg vial is 37.5 mg (1.6 mEq). Solutions of Imipenem and Cilastatin for Injection, USP (I.V.) range from colorless to yellow. Variations of color within this range do not affect the potency of the product.

What does Imipenem and Cilastatin look like?

What are the available doses of Imipenem and Cilastatin?

For Injection: Imipenem and Cilastatin for Injection (I.V.) is a sterile powder mixture for reconstitution in single-dose vials containing:

What should I talk to my health care provider before I take Imipenem and Cilastatin?

How should I use Imipenem and Cilastatin?

Imipenem and Cilastatin for Injection, USP (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of (penicillinase-producing isolates), species, species, , , , species, .

For Intravenous Injection Only

Table 1: Dosage of Imipenem and Cilastatin for Injection (I.V.) in Adult Patients with Creatinine Clearance Greater than or Equal to 90 mL/min

What interacts with Imipenem and Cilastatin?

Sorry No Records found

What are the warnings of Imipenem and Cilastatin?

Sorry No Records found

What are the precautions of Imipenem and Cilastatin?

Sorry No Records found

What are the side effects of Imipenem and Cilastatin?

Sorry No records found

What should I look out for while using Imipenem and Cilastatin?

Imipenem and Cilastatin for Injection (I.V.) is contraindicated in patients who have shown hypersensitivity to any component of this product.

What might happen if I take too much Imipenem and Cilastatin?

In the case of overdosage, discontinue Imipenem and Cilastatin for Injection (I.V.), treat symptomatically, and institute supportive measures as required. Imipenem and Cilastatin for Injection (I.V.) is hemodialyzable.

How should I store and handle Imipenem and Cilastatin?

Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with “5729” on one side and “TEVA” on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid storage of famotidine tablets at temperatures above 40°C (104°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured In Croatia By: PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. E 5/2016

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Imipenem and Cilastatin for Injection (I.V.) is a combination of imipenem and cilastatin. Imipenem is a penem antibacterial drug . Cilastatin sodium is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem.

Non-Clinical Toxicology

Imipenem and Cilastatin for Injection (I.V.) is contraindicated in patients who have shown hypersensitivity to any component of this product.

No drug interactions have been identified. Studies with famotidine in man, in animal models, and have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.

There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam. Before initiating therapy with Imipenem and Cilastatin for Injection (I.V.), careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to Imipenem and Cilastatin for Injection (I.V.) occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. • Hypersensitivity Reactions • Seizure Potential • Increased Seizure Potential Due to Interaction with Valproic Acid • -Associated Diarrhea (CDAD) • Development of Drug-Resistant Bacteria

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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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Review

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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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