doripenem monohydrate

doripenem monohydrate

Doribax

Pharmacologic class: Carbapenem

Therapeutic class: Anti-infective

Pregnancy risk category B

GI: nausea, diarrhea, oral candidiasis, Clostridium difficile-associated diarrhea

Action

Acts against aerobic and anaerobic gram-positive and gram-negative bacteria

Availability

Powder for reconstitution for infusion: 500 mg single-use vials

Indications and dosages

Complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus, and Peptostreptococcus micros; complicated urinary tract infections (UTIs), such as pyelonephritis caused by E. coli (including cases with concurrent bacteremia), K. pneumoniae, Proteus mirabilis, P. aeruginosa, and Acinetobacter baumannii

Adults ages 18 and older: 500 mg q 8 hours by I.V. infusion over 1 hour; continue for 5 to 14 days for complicated intra-abdominal infections and 10 days for complicated UTIs, with possible extension to 14 days for patients with concurrent bacteremia

Dosage adjustment

• Renal impairment

Contraindications

• Serious hypersensitivity to drug or other carbapenems
• History of anaphylactic reactions to beta-lactams

Precautions

Use cautiously in:
• renal impairment
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

Don't use constituted suspension for direct injection; dilute further before giving by I.V. infusion.
• To prepare 500-mg dose, constitute vial with 10 ml sterile water for injection or normal saline solution for injection, and shake gently to form suspension; resulting concentration is 50 mg/ml. Withdraw suspension using syringe with 21G needle, and add it to infusion bag containing 100 ml normal saline solution or 5% dextrose; shake gently until clear. Final infusion solution concentration is 4.5 mg/ml.
• To prepare 250-mg dose, constitute vial with 10 ml sterile water for injection or normal saline solution for injection, and shake gently to form suspension. Resulting concentration is 50 mg/ml. Withdraw suspension using syringe with 21G needle, and add it to infusion bag containing 100 ml normal saline solution for injection or 5% dextrose; shake gently until clear. Remove 55 ml of this solution from bag and discard. Infuse remaining solution, which contains 250 mg (4.5 mg/ml).
• To prepare infusions in Baxter Minibag Plus infusion bags, see infusion bag manufacturer's instructions.
• Know that infusion solutions range from clear and colorless to clear and slightly yellow. Color variations within this range don't affect product potency.
• Don't mix with or physically add to solutions containing other drugs.
• Don't administer by inhalation.

Adverse reactions

CNS: headache

CV: phlebitis

GI: nausea, diarrhea, oral candidiasis, Clostridium difficile-associated diarrhea

GU: vulvomycotic infection

Hematologic: anemia

Respiratory: pneumonitis (with inhalation use)

Skin: rash, allergic or bullous dermatitis, erythema, macular and papular eruptions, urticaria, erythema multiforme

Other: hypersensitivity reactions (including anaphylaxis)

Interactions

Drug-drug.Probenecid: reduced doripenem renal clearance

Valproic acid: decreased valproic acid level and loss of seizure control

Drug-diagnostic tests.ALT, AST, liver enzymes, transaminases: increased levels

Patient monitoring

• Closely monitor patient for diarrhea.

If allergic reaction occurs, discontinue drug and intervene for serious anaphylactic reactions by giving epinephrine and taking other emergency measures as ordered and needed, including oxygen, I.V. fluids and antihistamines, corticosteroids, pressor amines, and airway management.
• Monitor renal function in patients with moderate to severe renal impairment.

Patient teaching

Tell patient to immediately report rash, diarrhea, or difficulty breathing.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.