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 Staph 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, SJS, angioedema, TEN, 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
Other Beta-Lactams
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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