TERRA-CORTRIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TERRA-CORTRIL (TERRA-CORTRIL).
TERRA-CORTRIL is a combination product containing oxytetracycline (a tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit) and hydrocortisone (a corticosteroid that suppresses inflammation by inducing phospholipase A2 inhibitory proteins and inhibiting leukocyte migration).
| Metabolism | Oxytetracycline: not extensively metabolized; hydrocortisone: hepatic metabolism via CYP3A4. |
| Excretion | Renal: 70-85% (predominantly as unchanged drug); Fecal: 15-30% (via biliary elimination) |
| Half-life | 3-5 hours (terminal elimination half-life in adults; prolonged in hepatic impairment or neonates) |
| Protein binding | 77-85% (primarily to albumin and corticosteroid-binding globulin (CBG)) |
| Volume of Distribution | 0.4-0.6 L/kg (well distributed into tissues; crosses placental barrier) |
| Bioavailability | Topical: 10-30% (depending on skin integrity and occlusion); Intramuscular: 80-95%; Oral (not a standard route for Terra-Cortril): 60-70% (first-pass metabolism) |
| Onset of Action | Topical: 2-3 hours for anti-inflammatory effect; Intramuscular: 1-2 hours for adrenal suppression |
| Duration of Action | Topical: 12-24 hours (dependent on formulation and severity); Intramuscular: 24-48 hours (single dose); Systemic effects persist for 24-36 hours after discontinuation |
| Molecular Weight | 416.5 |
TERRA-CORTRIL is a combination product containing oxytetracycline 250 mg and hydrocortisone 100 mg. Usual adult dose: 1 tablet orally every 6 hours.
| Dosage form | SUSPENSION |
| Renal impairment | No specific adjustment for oxytetracycline; use caution in severe renal impairment (CrCl <30 mL/min) as tetracyclines may accumulate. Hydrocortisone does not require renal adjustment. |
| Liver impairment | No specific adjustment for oxytetracycline. Hydrocortisone: no dose adjustment needed; however, in severe hepatic impairment (Child-Pugh C), monitor for enhanced glucocorticoid effects. |
| Pediatric use | Not recommended for children under 12 years due to tetracycline effects on bone and teeth. For older children: 25 mg/kg/day oxytetracycline divided every 6 hours, but use only if benefit outweighs risk. Hydrocortisone dose: 0.5-1 mg/kg/day. |
| Geriatric use | Use with caution due to increased risk of tetracycline-induced renal impairment and corticosteroid side effects. Monitor renal function and consider lower doses of oxytetracycline. Hydrocortisone: start at lowest effective dose. |
| 1st trimester | Risk cannot be ruled out. Avoid use unless clearly needed. |
| 2nd trimester | Risk cannot be ruled out. Avoid use unless clearly needed. |
| 3rd trimester | Risk cannot be ruled out. Avoid use unless clearly needed. Prolonged use may suppress fetal adrenal function. |
Clinical note
Comprehensive clinical and safety monograph for TERRA-CORTRIL (TERRA-CORTRIL).
| Placental transfer | Corticosteroids cross the placenta. Risk of adrenal suppression in fetus with high doses or prolonged use. |
| Breastfeeding | Trace amounts in milk unlikely to cause adverse effects in infant. Use caution, especially with prolonged therapy or high doses. |
| Lactation Rating |
■ FDA Black Box Warning
Not applicable (no FDA boxed warning identified for this product).
| Serious Effects |
Hypersensitivity to any componentSystemic fungal infectionsLive or live-attenuated vaccines (concurrent use)
| Precautions | Prolonged use may lead to overgrowth of nonsusceptible organisms including fungi, Systemic absorption of hydrocortisone may cause adrenal suppression, Not for use in viral or fungal infections alone, Avoid use in eyes with corneal abrasion or ulcer |
| Food/Dietary | No specific food interactions with topical TERRA-CORTRIL. However, if used orally (oxytetracycline component), avoid dairy products, antacids, iron supplements, and calcium-rich foods within 2 hours of oral dose as they reduce absorption. No dietary restrictions for topical use. |
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| L2: Safer |
| Teratogenic Risk | In first trimester, increased risk of cleft palate (odds ratio 1.2-1.7) and possibly congenital heart defects. Second/third trimester use associated with intrauterine growth restriction, adrenal suppression in fetus, and oligohydramnios. Chronic use may cause preterm birth. Risk is dose- and duration-dependent. |
| Fetal Monitoring | Monitor maternal blood pressure, glucose levels (glucocorticoid-induced hyperglycemia), and signs of infection. Fetal ultrasound for growth restriction if prolonged use in 2nd/3rd trimester. Assess fetal adrenal suppression (e.g., ultrasound for adrenal size) near term if high-dose use. Evaluate neonatal adrenal insufficiency post-delivery if maternal use in late pregnancy. |
| Fertility Effects | No direct adverse effect on fertility. May improve fertility in women with inflammatory conditions (e.g., autoimmune diseases) by reducing inflammation that impairs ovulation. No known negative impact on spermatogenesis in men at typical doses. |
| Clinical Pearls | TERRA-CORTRIL is a fixed-dose combination of oxytetracycline (a tetracycline antibiotic) and hydrocortisone (a corticosteroid). Used topically for inflammatory skin conditions with secondary bacterial infection. Avoid prolonged use due to risk of skin atrophy, secondary fungal infection, and antibiotic resistance. Do not use for viral infections (e.g., herpes simplex). |
| Patient Advice | Apply a thin layer to affected area 2-4 times daily as directed. · Do not use on large areas of skin or for longer than prescribed. · Avoid contact with eyes, mouth, or open wounds. · Wash hands before and after application, unless treating hands. · Notify your doctor if no improvement after 1 week or if condition worsens. · Do not cover treated areas with bandages unless instructed. · This medication is for external use only. |