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. |
| Molecular Weight | 396.65 |
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 | DELTALIN (vitamin D2) is generally considered safe at recommended doses during the first trimester; however, excessive doses (>4000 IU/day) may be teratogenic and are contraindicated. |
| 2nd trimester | Use with caution; maintain doses within RDA (600 IU/day) as high doses can lead to hypercalcemia and potential fetal harm. |
| 3rd trimester | Similar to second trimester; avoid supraphysiologic doses to prevent neonatal hypercalcemia and other adverse effects. |
Clinical note
Comprehensive clinical and safety monograph for DELTALIN (DELTALIN).
| Placental transfer | Vitamin D2 crosses the placenta readily; fetal levels are approximately 60-80% of maternal levels. |
| Breastfeeding | DELTALIN is excreted into breast milk in low amounts. At normal doses, it is considered compatible with breastfeeding; however, high maternal doses may lead to elevated levels in milk and risk of hypercalcemia in the infant. |
■ FDA Black Box Warning
None.
| Serious Effects |
HypercalcemiaVitamin D toxicityMalabsorption syndromeSevere renal impairment
| 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. |
| Food/Dietary | No specific food interactions; however, dietary calcium intake should be consistent. High magnesium foods may affect absorption? No. Avoid excessive intake of calcium-rich foods if hypercalcemia risk. |
| Clinical Pearls |
Loading safety data…
| Lactation Rating | L1 (Safe) |
| 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 | 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. |
| Deltalin (ergocalciferol) is a vitamin D2 supplement used for deficiency and prophylaxis. Monitor serum calcium and phosphate levels during therapy. Use caution in patients with hypercalcemia, hypercalciuria, or renal impairment. Deltalin can increase digoxin toxicity risk via hypercalcemia. For rickets, radiographic healing confirms efficacy. |
| Patient Advice | Take exactly as prescribed; do not double dose if missed. · Report symptoms of hypercalcemia: nausea, vomiting, constipation, weakness, or confusion. · Avoid taking with other vitamin D supplements unless directed by healthcare provider. · Inform healthcare provider of all medications, especially digoxin, thiazide diuretics, and antacids. · Store at room temperature away from light and moisture. |