Rosebac 500 mg/vial (IV Injection or Infusion)

500 mg vial: ৳ 700.00

Medicine Details

Category	Details
Generic	Meropenem trihydrate
Company	Concord pharmaceuticals ltd
Also available as	Rosebac 1 gm injection

Indications

Pneumonia and Nosocomial Pneumonia
Urinary Tract Infections
Intra-abdominal Infections
Gynaecological Infections
Skin and Skin Structure Infections
Meningitis
Septicaemia
Pulmonary infections in cystic fibrosis
Empiric treatment for presumed infections in patients with febrile neutropenia

Pharmacology

Exerts bactericidal action by interfering with bacterial cell wall synthesis, potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria

Dosage

Adults:
- 500 mg to 1 gm by intravenous administration every 8 hours
- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours
- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours
- Intra-abdominal infections: 500 mg to 1 gm every 8 hours
- Cystic fibrosis: Up to 2 gm every 8 hours
- Meningitis: 2 gm IV every 8 hours
Children:
- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours
- Intra-abdominal infections: 20 mg/kg every 8 hours
- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours
- Meningitis: 40 mg/kg IV every 8 hours
- Febrile neutropenia: 20 mg/kg every 8 hours
- Children over 50 kg weight: use adult dosage
- No experience in children with hepatic or renal impairment

Administration

Administered by intravenous infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes

Interaction

Probenecid competes with Rosebac for active tubular secretion and thus inhibits the renal excretion, may reduce serum valproic acid levels

Contraindications

Hypersensitivity to the product

Side Effects

Inflammation
Thrombophlebitis
Pain at the site of injection
Skin reactions like rash, pruritus, urticaria
Abdominal pain
Nausea
Vomiting
Diarrhea
Headache

Pregnancy & Lactation

Category B. Use during pregnancy only if clearly needed. Caution when administered to a nursing woman

Precautions & Warnings

Discontinue if allergic reaction occurs, careful monitoring of transaminase and bilirubin levels in hepatic disease patients

Use in Special Populations

Renal impairment: Dosage reduction in patients with creatinine clearance less than 51 ml/min
Hepatic impairment: No dosage adjustments necessary
Elderly: No dosage adjustments necessary unless creatinine clearance is less than 51 ml/min
Children: Efficacy and tolerability in infants under 3 months not established

Overdose Effects

Accidental overdose could occur during therapy, treatment should be symptomatic, rapid renal elimination in normal individuals, haemodialysis may be necessary in subjects with renal impairment

Therapeutic Class

Other beta-lactam Antibiotics

Reconstitution

Intravenous bolus Administration: Reconstitute with sterile water for injection, shake to obtain clear solution
Intravenous infusion administration: May be directly constituted with a compatible infusion fluid and then further diluted with the compatible infusion fluid
Compatible infusion fluids:
- 0.9% sodium chloride intravenous infusion
- 5% or 10% glucose intravenous infusion
- 5% glucose intravenous infusion with 0.02% sodium bicarbonate
- 5% glucose and 0.9% sodium chloride intravenous infusion
- 5% glucose with 0.225% sodium chloride intravenous infusion
- 5% glucose with 0.15% potassium chloride intravenous infusion
- 2.5% and 10% mannitol intravenous infusion
- normosol-M in 5% glucose intravenous infusion
Recommended shelf life of reconstituted solution: Up to 3 hours at up to 25°C or 13 hours at up to 5°C

Storage Conditions

Store in a cool, dry place (below 30°C), away from light & moisture, Keep out of the reach of children