DELTALIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELTALIN (DELTALIN).
Vitamin D analog; binds to vitamin D receptors, increasing intestinal absorption of calcium and phosphate, promoting renal tubular reabsorption of calcium, and enhancing bone mineralization.
| Metabolism | Hepatic hydroxylation to active metabolites (e.g., calcifediol, calcitriol); undergoes enterohepatic recycling. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 60-70% of the administered dose; biliary/fecal elimination accounts for 30-40%, primarily as metabolites. |
| Half-life | Terminal elimination half-life ranges from 24 to 36 hours in adults with normal renal function; may be prolonged (up to 72 hours) in renal impairment. |
| Protein binding | ~95% bound primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Apparent volume of distribution (Vd) is 0.5-1.0 L/kg, indicating moderate tissue distribution. |
| Bioavailability | Oral: 80-90%; Intramuscular: 90-100% (assumes complete absorption); Intravenous: 100%. |
| Onset of Action | Oral: 2-4 hours; Intramuscular: 30-60 minutes; Intravenous: 5-15 minutes. |
| Duration of Action | Oral: 6-12 hours; Intramuscular: 8-12 hours; Intravenous: 6-8 hours. Duration is dose-dependent and may be extended in renal impairment. |
0.5 mg orally once daily, titrated to a maximum of 1 mg daily based on response and tolerability.
| Dosage form | CAPSULE |
| Renal impairment | No adjustment required for GFR ≥30 mL/min; use with caution and reduce dose by 50% for GFR <30 mL/min; contraindicated in dialysis. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: not recommended. |
| Pediatric use | 0.01 mg/kg orally once daily, not to exceed 0.5 mg daily; adjust based on response. |
| Geriatric use | Initiate at 0.25 mg orally once daily; titrate slowly due to increased sensitivity and risk of hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELTALIN (DELTALIN).
| Breastfeeding | Deltalin is excreted in human milk. The M/P ratio is unknown. Caution is advised; consider the risk of hypercalcemia in the breastfed infant. Monitoring of infant serum calcium is recommended if used. |
| Teratogenic Risk | FDA Pregnancy Category D. Vitamin D analogues can cause hypercalcemia, which may lead to fetal supravalvular aortic stenosis, elfin facies, and intellectual disability. Risk is highest in the first trimester. Avoid use during pregnancy unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypercalcemia, hypervitaminosis D, malabsorption syndrome, and known hypersensitivity to vitamin D or any component of the formulation.
| Precautions | May cause hypercalcemia; monitor serum calcium and phosphate levels regularly. Use with caution in patients with renal impairment, hyperphosphatemia, or sarcoidosis. Avoid use in patients with evidence of vitamin D toxicity. |
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| Monitor maternal serum calcium, phosphate, and 25-hydroxyvitamin D levels. Fetal ultrasound for cardiac anomalies if used in first trimester. Assess for signs of hypercalcemia in the neonate. |
| Fertility Effects | No known adverse effects on fertility in animal studies. In humans, limited data; hypercalcemia may impair reproductive function but not directly linked to fertility impairment. |