Sianem

Sianem

imipenem + cilastatin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Imipenem (anhydrous) 500 mg, cilastatin 500 mg
Indications/Uses
Treatment of serious infections caused by susceptible microorganisms in the conditions: Lower resp tract infections; UTI (complicated & uncomplicated); intra-abdominal infections; gynecologic infections; bone & joint infections; skin & skin structure infections; bacterial septicemia; endocarditis caused by Staphylococcus aureus (penicillinase-producing); polymicrobic infections.
Dosage/Direction for Use
Adult w/ normal renal function (CrCl ≥70 mL/min/1.73 m2) & w/ body wt of at least 70 kg Fully susceptible organisms: Mild infection 250 mg every 6 hr. Total daily dose: 1 g. Moderate 500 mg every 8 hr or every 6 hr. Total daily dose: 1.5 or 2 g. Severe life-threatening 500 mg every 6 hr. Total daily dose: 2 g. Uncomplicated UTI 250 mg every 6 hr. Total daily dose: 1 g. Complicated UTI 500 mg every 6 hr. Total daily dose: 2 g. Moderately susceptible organisms, primarily some strains of Pseudomonas aeruginosa: Mild infection 500 mg every 6 hr. Total daily dose: 2 g. Moderate 500 mg every 6 hr or 1 g every 8 hr. Total daily dose: 2 or 3 g. Severe life-threatening 1 g every 8 hr or 6 hr. Total daily dose: 3 or 4 g. Uncomplicated UTI 250 mg every 6 hr. Total daily dose: 1 g. Complicated UTI 500 mg every 6 hr. Total daily dose: 2 g.
Contraindications
Hypersensitivity to carbapenem antibiotics. Meningitis, childn w/ CNS infections.
Special Precautions
Patients w/ CNS disorders, renal impairment. Monitor patients w/ history of epilepsy that may be necessary to co-administer w/ anticonvulsants. Patients w/ previous hypersensitivity reactions to β-lactam antibiotics. Evaluate periodically during prolonged therapy the renal, hepatic & hematologic systems. Seizure may occur in neonates & childn ≤3 mth. Superinfection may occur in prolonged use. Clostridium difficile-associated diarrhea & colitis. Na-restricted patients. Childn <30 kg w/ renal impairment.
Adverse Reactions
Nausea, vomiting, diarrhea, pseudomembranous colitis, hemorrhagic colitis, staining of the teeth &/or tongue, gastroenteritis, abdominal pain, glossitis, papillar hypertrophy of the tongue, heartburn, pharyngeal pain, increased salivation & taste perversion. Fever, seizure, dizziness, somnolence, tremor, confusion, myoclonus, paresthesia, vertigo, headache, myoclonus, encephalopathy, psychic disturbances including hallucinations. Rash, pruritus, urticaria, allergic dermatitis, erythema multiforme, Stevens-Johnson syndrome, angioedema, toxic epidermal necrolysis, flushing, cyanosis, candidiasis, hyperhidrosis, pruritus vulvae, pain & erythema at inj site, phlebitis. Eosinophilia, leucopenia, neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, bone marrow depression, hemolytic anemia. Increases in BUN &/or serum creatinine conc, oliguria/anuria, polyuria, discoloration of urine, proteinuria, acute renal failure. Increases in serum conc of AST, ALT, alkaline phosphatase, LDH & bilirubin, jaundice, hepatitis. Chest discomfort, dyspnea, hyperventilation, thoracic spine pain. Hypotension, palpitation, tachycardia. Hearing loss, tinnitus, polyarthralgia.
Drug Interactions
Aminoglycosides, cyclosporine, gancyclovir, probenecid.
MIMS Class
ATC Classification
J01DH51 - imipenem and cilastatin ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.
Presentation/Packing
Form
Sianem powd for inj
Packing/Price
1's
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