Wandara IM/IV Injection
Ertapenem
1 gm/vial
Incepta Pharmaceuticals Ltd.
| Pack size | 1gm vial |
|---|---|
| Unite Price | 3,200.00 BDT |
Indications
Wandara IM/IV Injection is used for:
Intra-abdominal infections, Community-acquired pneumonia, Skin and skin structure infections, Urinary tract infections, Pyelonephritis, Surgical infections, Diabetic foot infections, Septic abortion
Adult Dose
Community-Acquired Pneumonia
1 g/day IV/IM up to 14 days; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Complicated Urinary Tract Infections (Including Pyelonephritis)
1 g/day IV/IM up to 14 days; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Acute Pelvic Infections
1 g/day IV/IM for 3-10 days
Complicated Intra-abdominal Infections
1 g/day IV/IM for 5-14 days
Complicated Skin/Skin Structure Infections
1 g/day IV/IM for 7-14 days; may be continued up to 4 weeks for diabetic foot infections, depending on severity of infection and response to therapy (treatment excludes diabetic foot infections with osteomyelitis)
Child Dose
Community-Acquired Pneumonia, Complicated Urinary Tract Infections (Including Pyelonephritis)
3-12 years: 15 mg/kg IV/IM q12hr up to 14 days; not to exceed 1 g q12hr; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
>12 years: 1 g/day IV/IM up to 14 days; after ?3 days of parenteral therapy, may be switched to appropriate PO regimen if patient improves clinically
Complicated Intra-abdominal Infections, Complicated Skin/Skin Structure Infections
3-12 years: 15 mg IV/IM q12hr for 7-14 days
>12 years: 1 g/day IV/IM for 7-14 days
<3 years: Safety and efficacy not established
Renal Dose
Renal impairment
CrCl >30 mL/min/1.73 m²: Dosage adjustment not necessary
CrCl <30 mL/min/1.73 m² and end-stage renal disease (ESRD): 500 mg/day IV
Dialysis: 500 mg/day IV; if given ?6 hr before dialysis, supplemental dose of 150 mg afterward
Administration
IV Preparation
Reconstitute 1 g vial with 10 mL SWI, NS, or BWI; shake well; transfer to 50 mL NS
IV Administration
Infuse over 30 minutes
IM Preparation
Reconstitute 1 g vial with 3.2 mL of 1% lidocaine injection (without epinephrine); shake well; use within 1 hour after preparation
IM Administration
Make sure patient does not have allergy to lidocaine or another amide anesthetic
Administer by deep IM injection into large muscle mass (eg, gluteal muscle or lateral part of thigh)
Do not administer IM preparation or drug reconstituted for IM administration IV
Contra Indications
Hypersensitivity; lactation.
Precautions
Hypersensitivity to penicillins, cephalosporins or other beta-lactams (possibility of cross-sensitivity). Renal impairment; CNS disorders e.g. epilepsy. Pregnancy.
Lactation: Drug distributed in breast milk; use with caution
Pregnancy-Lactation
Pregnancy
Available data from a small number of postmarketing cases with use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
In animal reproduction studies after intravenous administration of ertapenem during period of organogenesis, there was no evidence of developmental malformations in rats at systemic exposures (AUC) up to approximately 1.2 times the human exposure at maximum recommended human dose (MRHD) and in mice at doses up to approximately 3 times MRHD based on body surface area comparison; in pregnant rats administered ertapenem during organogenesis through lactation, fetal toxicity, developmental delays, and impaired reproduction did not occur in first generation offspring at systemic exposures (AUC) approximately 1.2 times the human exposure at MRHD
Lactation
Ertapenem is present in human milk; there are no data on effects on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Interactions
May decrease plasma levels of valproic acid thus, increasing the risk of seizures. Increased plasma concentrations w/ probenecid.
Side Effects
Side effects of Ertapenem :
>10%
Diarrhea (2-12%)
1-10%
Elevated liver function tests (LFTs) (7-9%), Nausea (6-9%), Headache (6-7%), Infused vein complications (5-7%), Increased platelet count (4-7%), Increased alkaline phosphatase (4-7%), Altered mental status (3-5%), Fever (2-5%), Abdominal pain (4%), Vomiting (4%), Constipation (3-4%), Insomnia (3%), Swelling or edema (3%), Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) (2-3%), Rash (2-3%), Vaginitis (1-3%), Dizziness (2%), Phlebitis or thrombophlebitis (1.5-2%), Pruritus (1-2%), Tachycardia (1-2%), Acid regurgitation (1-2%), Eosinophilia (1-2%), Hypotension (1-2%), Erythema (1-2%), Hypertension (0.7-2%), Chest pain (1%), Dyspepsia (1%), Fatigue (1%), Anxiety (0.8-1%), Oral candidiasis (0.1-1%)
Potentially Fatal: Pseudomembranous colitis, Stevens-Johnson syndrome.
Mode of Action
Ertapenem acts similarly to penicillins by bacterial cell wall inhibition. It is active against many gram-negative and aerobic and anaerobic organisms. It is stable to hydrolysis by beta-lactamases.
Note
Wandara 1 gm/vial IM/IV Injection generic name is Ertapenem. Wandara 1 gm/vial IM/IV Injection is manufactured by Incepta Pharmaceuticals Ltd.Wandara is availble in all over Bangladesh.
Mes BD drug index information on Wandara IM/IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.