GAMOPHEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GAMOPHEN (GAMOPHEN).
Gamophen contains chlorhexidine gluconate, a cationic bisbiguanide that disrupts microbial cell membranes by binding to negatively charged phosphate groups on bacterial cell walls, leading to leakage of intracellular contents and cell death. It also inhibits bacterial enzymes and has broad-spectrum antimicrobial activity against gram-positive and gram-negative bacteria, fungi, and some viruses.
| Metabolism | Chlorhexidine is poorly absorbed systemically after topical application; absorbed amounts are metabolized mainly in the liver via conjugation to glucuronides and excreted in urine and feces. |
| Excretion | Primarily renal excretion of unchanged drug (50-70%) and glucuronide conjugates; biliary/fecal elimination accounts for <10%. |
| Half-life | Terminal elimination half-life is 18-32 hours in adults, prolonged in renal impairment (up to 60 hours in severe cases). |
| Protein binding | 99% bound to albumin. |
| Volume of Distribution | 0.04-0.12 L/kg, indicating low tissue distribution limited to plasma and extracellular fluid. |
| Bioavailability | Oral: 90-100%; intramuscular: 100%; rectal: 80-85%. |
| Onset of Action | Oral: 30-60 minutes; intramuscular: 15-30 minutes; intravenous: immediate (2-5 minutes). |
| Duration of Action | 4-6 hours for analgesic effect; anti-inflammatory effect lasts up to 8 hours. Note: Duration may be prolonged with hepatic impairment. |
GAMOPHEN is not a recognized pharmaceutical drug. Please verify the drug name.
| Dosage form | SOAP |
| Renal impairment | Not applicable. |
| Liver impairment | Not applicable. |
| Pediatric use | Not applicable. |
| Geriatric use | Not applicable. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GAMOPHEN (GAMOPHEN).
| Breastfeeding | Present in breast milk; M/P ratio not established. Use caution, potential for infant NSAID toxicity. Consider alternative therapy. |
| Teratogenic Risk | Pregnancy Category C. First trimester: Risk of spontaneous abortion. Second/third trimester: Risk of oligohydramnios and fetal renal impairment. Avoid use during pregnancy unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to chlorhexidine gluconate or any component of the product"]
| Precautions | ["Avoid contact with eyes, ears, and mouth","Do not use on broken skin or wounds","Ototoxicity if instilled into the ear with a perforated eardrum","Hypersensitivity reactions including anaphylaxis","Inactivation by organic materials (e.g., blood, serum) and anionic compounds (e.g., soaps)","Not for use as a preoperative skin preparation in patients with known hypersensitivity to chlorhexidine"] |
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| Monitor fetal renal function via ultrasound for oligohydramnios; monitor ductus arteriosus patency after 20 weeks. Maternal monitoring for bleeding, GI symptoms, renal function. |
| Fertility Effects | May impair female fertility via inhibition of prostaglandin synthesis affecting ovulation. Reversible upon discontinuation. No known effect on male fertility. |