SPECTROBID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SPECTROBID (SPECTROBID).
Spectrobird (bacampicillin) is a prodrug of ampicillin, a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
| Metabolism | Bacampicillin is hydrolyzed by esterases in the intestinal wall and liver to active ampicillin. Ampicillin is partially metabolized by the liver and renal excretion is the primary route of elimination. |
| Excretion | Renal: ~75-85% unchanged drug; fecal/biliary: ~15-25% as metabolites and unchanged drug. |
| Half-life | Terminal elimination half-life: 1.5-2 hours in normal renal function; prolonged to 6-10 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | 15-25% bound to serum albumin. |
| Volume of Distribution | Vd: 0.3-0.4 L/kg; distributes primarily into extracellular fluid. |
| Bioavailability | Oral: 90-100% (as bacampicillin); IM: nearly 100% (as ampicillin sodium). |
| Onset of Action | Oral: 1-2 hours; Intramuscular: 30-60 minutes; Intravenous: immediate. |
| Duration of Action | Oral: 6-8 hours; IM/IV: 6-12 hours; clinical duration may be extended in renal impairment. |
400 mg orally twice daily or 200 mg orally four times daily for 10-14 days. For acute exacerbations of chronic bronchitis: 400 mg orally twice daily for 10 days.
| Dosage form | FOR SUSPENSION |
| Renal impairment | CrCl >80 mL/min: no adjustment. CrCl 50-80 mL/min: 400 mg orally every 12 hours. CrCl <50 mL/min: 400 mg orally every 24 hours. |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution. |
| Pediatric use | Children ≥8 years: 4-8 mg/kg/day orally in 2 divided doses, not to exceed 400 mg/day. For uncomplicated skin infections: 200 mg orally twice daily. Duration: 7-14 days. |
| Geriatric use | No specific dose adjustment based solely on age. Consider renal function; if CrCl <50 mL/min, adjust per renal guidelines. Monitor for increased risk of adverse effects such as QT prolongation and Clostridium difficile infection. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SPECTROBID (SPECTROBID).
| Breastfeeding | Bacampicillin is excreted into breast milk in small amounts. The milk-to-plasma (M/P) ratio for ampicillin (active metabolite) is approximately 0.01 to 0.04. The dose received by the infant is estimated to be less than 1% of the maternal weight-adjusted dose. Considered compatible with breastfeeding; however, monitor for potential infant effects such as diarrhea, rash, or candidiasis. Use only if clearly needed. |
| Teratogenic Risk | Spectrobid (bacampicillin) is a prodrug of ampicillin. Generally, penicillins are considered low risk during pregnancy. Animal studies have not shown teratogenic effects. In humans, adequate studies in pregnant women have not been conducted, but data from extensive use of ampicillin do not indicate an increased risk of congenital malformations. First trimester: limited data, but no evidence of teratogenicity. Second and third trimesters: considered safe when clinically indicated. Risk category: B (U.S. FDA). |
■ FDA Black Box Warning
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
| Serious Effects |
Hypersensitivity to penicillins or cephalosporins. Infectious mononucleosis (due to high risk of erythematous rash).
| Precautions | Serious hypersensitivity reactions (including anaphylaxis) may occur. Prolonged use may result in superinfection. Caution in patients with renal impairment (dose adjustment required). May cause antibiotic-associated colitis. Use cautiously in patients with mononucleosis due to high incidence of rash. |
Loading safety data…
| Fetal Monitoring | Monitor maternal renal function (creatinine clearance) as dosage adjustment may be needed in severe renal impairment. No specific fetal monitoring required; routine prenatal care including fetal growth assessment as per standard guidelines. Observe for signs of maternal hypersensitivity reactions or gastrointestinal disturbances. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impaired fertility at therapeutic doses. Limited human data, but penicillins are generally not associated with fertility impairment. |