PERIOGARD
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PERIOGARD (PERIOGARD).
Chlorhexidine gluconate is a cationic bisbiguanide that disrupts microbial cell membrane integrity, leading to leakage of intracellular contents and cell death. It exhibits broad-spectrum antimicrobial activity against gram-positive and gram-negative bacteria, fungi, and viruses.
| Metabolism | Chlorhexidine is not significantly absorbed systemically following oral topical application; minimal metabolism occurs in the liver, with primary excretion via feces. |
| Excretion | Primarily renal (70-80% unchanged via glomerular filtration); minor biliary/fecal (20-30%). |
| Half-life | 6-7 hours (prolonged in renal impairment; no dosage adjustment for topical oral use). |
| Protein binding | Very low (10-18%), primarily to serum proteins (albumin). |
| Volume of Distribution | 0.2-0.3 L/kg (minimal systemic distribution, consistent with poor absorption from oral topical use). |
| Bioavailability | Topical oral (mouthwash): <1% (minimal systemic absorption). |
| Onset of Action | Topical oral (mouthwash): 30 minutes to 1 hour for reduction of oral bacterial load. |
| Duration of Action | Topical oral: 12 hours (sustained antimicrobial effect with twice-daily use). |
15 mL chlorhexidine gluconate 0.12% oral rinse twice daily for 30 seconds and expectorate.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required; negligible systemic absorption. |
| Liver impairment | No dose adjustment required; negligible hepatic metabolism. |
| Pediatric use | Not recommended for children under 18 years due to safety and efficacy data lacking. |
| Geriatric use | No specific dose adjustment; use with caution if dysphagia or aspiration risk present. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PERIOGARD (PERIOGARD).
| Breastfeeding | No data on excretion in human milk. Because chlorhexidine is poorly absorbed after oral administration, levels in breast milk are expected to be negligible. M/P ratio unknown. Use with caution in nursing mothers, but considered compatible with breastfeeding due to minimal systemic absorption. |
| Teratogenic Risk | Periogard (chlorhexidine gluconate oral rinse) has not been studied in pregnant women. Animal reproduction studies have not been conducted. Based on limited systemic absorption, risk to fetus is considered low. However, due to insufficient data, use in pregnancy is generally avoided, especially during first trimester, unless clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to chlorhexidine gluconate or any component of the formulation
| Precautions | Avoid contact with eyes, ears, and mucous membranes; may cause staining of teeth, tongue, and dental restorations; hypoesthesia of tongue may occur; anaphylaxis and serious allergic reactions reported; use with caution in patients with known hypersensitivity; not for use in children under 6 years. |
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| Fetal Monitoring | No specific maternal or fetal monitoring required due to minimal systemic exposure. Routine prenatal care is sufficient. |
| Fertility Effects | No known effects on fertility based on available data. Chlorhexidine has not been studied for reproductive impact in humans. |