DECLOMYCIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DECLOMYCIN (DECLOMYCIN).
Binds to the 30S ribosomal subunit, inhibiting aminoacyl-tRNA binding to the mRNA-ribosome complex, thereby blocking protein synthesis.
| Metabolism | Primarily hepatic metabolism (minimal); excreted unchanged in urine and feces via bile. |
| Excretion | Renal: ~50% unchanged; biliary/fecal: ~40% as inactive metabolites; enterohepatic recycling occurs |
| Half-life | Terminal elimination half-life 10-17 hours; prolonged to 18-48 hours in renal impairment |
| Protein binding | 40-80% bound primarily to albumin |
| Volume of Distribution | 1.5-2.0 L/kg; indicates extensive tissue distribution with accumulation in bone and teeth |
| Bioavailability | Oral: 90-100% (administered only orally) |
| Onset of Action | Oral: 1-2 hours for therapeutic serum concentrations |
| Duration of Action | 12-24 hours after single oral dose; sustained due to enterohepatic circulation |
150 mg orally every 6 hours or 300 mg orally every 12 hours.
| Dosage form | SYRUP |
| Renal impairment | For GFR 50-80 mL/min: administer every 8-12 hours. For GFR 10-50 mL/min: administer every 12-24 hours. For GFR <10 mL/min: administer every 24-48 hours. |
| Liver impairment | No specific adjustment recommended for Child-Pugh A or B; use with caution in severe hepatic impairment (Child-Pugh C) as metabolism may be reduced. |
| Pediatric use | 8-12 mg/kg/day divided every 6-12 hours, not to exceed 600 mg/day. |
| Geriatric use | Use lowest effective dose due to increased risk of renal impairment and photosensitivity; monitor renal function closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DECLOMYCIN (DECLOMYCIN).
| Breastfeeding | Contraindicated during breastfeeding; excreted in breast milk (M/P ratio ~0.4–0.6); risks include teeth discoloration, bone growth inhibition, and photosensitivity in the infant. |
| Teratogenic Risk | First trimester: Avoid due to risk of fetal skeletal abnormalities and teeth discoloration. Second and third trimesters: Contraindicated; causes permanent yellow-gray-brown teeth discoloration and enamel hypoplasia; may inhibit fetal bone growth. |
| Fetal Monitoring |
■ FDA Black Box Warning
WARNING: Use during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of teeth (yellow-gray-brown) and enamel hypoplasia. This reaction is more common during long-term use but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
| Serious Effects |
["Hypersensitivity to demeclocycline or any tetracycline","Children under 8 years of age (due to permanent tooth discoloration)","Pregnancy and lactation (risk of fetal harm and tooth discoloration)","Renal impairment (accumulation and hepatotoxicity risk)"]
| Precautions | ["Photosensitivity: exaggerated sunburn reaction may occur; avoid prolonged sun exposure.","Superinfection: overgrowth of nonsusceptible organisms, including fungi, may occur.","Hepatotoxicity: rare but severe cases reported; monitor liver function.","Renal impairment: accumulation may occur; use caution and reduce dose.","Central nervous system: dizziness, headache, tinnitus have been reported."] |
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| Monitor maternal renal and hepatic function, complete blood count, and signs of superinfection. Fetal monitoring with serial ultrasounds for skeletal growth and teeth development if inadvertent exposure. |
| Fertility Effects | May impair fertility in both sexes; in males, reduces sperm motility and count; in females, may disrupt menstrual cycle and ovulation. |