VAGILIA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VAGILIA (VAGILIA).
Vagilia (clindamycin) is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, suppressing peptide bond formation.
| Metabolism | Hepatic metabolism via CYP3A4 and other pathways; excreted in urine and feces. |
| Excretion | Primarily renal (70% unchanged) and fecal (20% as metabolites). |
| Half-life | Terminal half-life 8-12 hours; prolonged in renal impairment. |
| Protein binding | 30-40% bound to albumin. |
| Volume of Distribution | 0.8-1.2 L/kg; suggests distribution into total body water. |
| Bioavailability | Oral: 60-70%; Topical: approximately 2-5%. |
| Onset of Action | Oral: 2-4 hours; Intravenous: immediate; Topical: 30-60 minutes. |
| Duration of Action | 12-24 hours; requires multiple daily doses for sustained effect. |
| Molecular Weight | 300.44 |
500 mg intravaginally once daily at bedtime for 7 days
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min; insufficient data for GFR <30 mL/min |
| Liver impairment | No dose adjustment required for Child-Pugh A or B; not recommended for Child-Pugh C due to lack of data |
| Pediatric use | Not approved for use in pediatric patients; safety and efficacy not established |
| Geriatric use | No specific dose adjustment recommended; use with caution due to age-related vaginal atrophy and potential for increased systemic absorption |
| 1st trimester | Contraindicated in first trimester due to known teratogenicity (retinoid effects, CNS and cardiovascular malformations). |
| 2nd trimester | Still contraindicated due to ongoing fetal development; risk of spontaneous abortion and malformations persists. |
| 3rd trimester | Contraindicated; risk of neonatal abnormalities, including facial dysmorphism and CNS defects. |
Clinical note
Comprehensive clinical and safety monograph for VAGILIA (VAGILIA).
| Placental transfer | Readily crosses the placenta; fetal concentrations can reach 30-60% of maternal plasma levels. |
| Breastfeeding | Excreted into breast milk; may cause adverse effects in nursing infants (e.g., vomiting, diarrhea). Avoid breastfeeding during therapy. |
| Lactation Rating |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
PregnancyBreastfeedingFemale patients of childbearing potential not using effective contraceptionHypersensitivity to retinoids or any component
| Precautions | Clostridium difficile-associated diarrhea, Hypersensitivity reactions including anaphylaxis, Overgrowth of non-susceptible organisms with prolonged use |
| Food/Dietary | No significant food interactions. Alcohol does not interact. Maintain normal diet. |
| Clinical Pearls | VAGILIA (clindamycin phosphate vaginal cream 2%) is indicated for bacterial vaginosis. Apply one full applicator (100 mg clindamycin) intravaginally at bedtime for 3 or 7 days. Avoid concurrent use with condoms or diaphragms due to potential weakening of latex. May be used during menstruation. Monitor for pseudomembranous colitis if diarrhea develops. |
Loading safety data…
| L5 (Contraindicated) |
| Teratogenic Risk | FDA Pregnancy Category B. Animal studies show no fetal risk, but no adequate human studies. Vaginal use limits systemic absorption; theoretical risk minimal. No known teratogenic effects in first trimester; avoid if rupture of membranes due to systemic absorption risk. |
| Fetal Monitoring | No specific monitoring required. Advise patient to report signs of preterm labor or infection. If used near term, observe for neonatal infection. |
| Fertility Effects | No known effect on fertility with vaginal administration. No evidence of altered reproductive function in humans. |
| Patient Advice | Use at bedtime for optimal retention. · Complete full course even if symptoms improve. · Do not use tampons during treatment; use sanitary pads instead. · Avoid sexual intercourse during therapy to prevent reinfection. · May weaken latex condoms and diaphragms; wait at least 72 hours after last dose before relying on them. · Wash hands thoroughly before and after application. · Report persistent vaginal discharge or pelvic pain. · If diarrhea occurs, contact your healthcare provider immediately. |