Schedule H: High-dose formulations (60,000 IU oral; injectable preparations) Unscheduled: Low-dose oral forms (≤2000 IU daily formulations)

Oral, Intramuscular

• Tablets: 400 IU, 1000 IU, 2000 IU

• Chewable tablets: 1000 IU, 2000 IU

• Granules/Sachets: 60,000 IU

• Soft gelatin capsules: 60,000 IU

• Oral drops/solution: 400 IU/mL, 800 IU/mL (paediatric formulations)

• Injection (IM): 300,000 IU/mL (1 mL ampoule), 600,000 IU/1.5 mL ampoule

• Fixed-dose combinations: With calcium carbonate (various strengths — e.g., Calcium 500 mg + Vitamin D3 250 IU/500 IU)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Vitamin D Deficiency (Nutritional or Malabsorption-related)

Serum 25(OH)D <20 ng/mL = Deficiency; 20–30 ng/mL = Insufficiency

Parameter Recommendation

Starting dose (Loading) 60,000 IU orally once weekly for 6–8 weeks

Titration Based on 25(OH)D levels after 8 weeks; continue weekly if still deficient

Usual maintenance dose 1,000–2,000 IU daily OR 60,000 IU once monthly

Maximum dose 60,000 IU weekly during loading; daily dose equivalent should not exceed 4,000 IU/day long-term without specialist supervision

Clinical Notes:

• Recheck 25(OH)D level 6–8 weeks after completing loading dose

• Target 25(OH)D level: 30–60 ng/mL

• Maintenance regimen tailored to response; monthly dosing preferred for adherence

1. Osteomalacia (Adults) / Rickets (Children)

Parameter Adults Children (see Paediatric section)

Starting dose 60,000 IU orally once weekly for 8–12 weeks Weight/age-based (see below)

Titration Continue based on clinical and biochemical response As per specialist

Usual maintenance dose 1,000–2,000 IU daily (with calcium supplementation) 400–1,000 IU daily

Maximum dose 60,000 IU weekly during treatment phase Age-dependent

Clinical Notes:

• Co-administer calcium (1,000–1,500 mg/day elemental calcium in divided doses)

• Monitor serum calcium, phosphate, alkaline phosphatase

• Radiological improvement expected in 2–4 weeks in rickets

1. Osteoporosis (Supportive Therapy)

Parameter Recommendation

Starting dose 800–2,000 IU daily with calcium

Titration Not applicable

Usual maintenance dose 800–2,000 IU daily

Maximum dose 4,000 IU daily without specialist supervision

Clinical Notes:

• Always combine with adequate calcium intake (dietary or supplemental)

• Part of comprehensive osteoporosis management (with bisphosphonates, etc.)

• 60,000 IU monthly acceptable alternative for poor adherence

1. Hypoparathyroidism (Adjunctive Therapy)

Parameter Recommendation

Starting dose 1,000–2,000 IU daily

Titration Increase based on serum calcium response; may require 2,000–4,000 IU/day

Usual maintenance dose 1,000–4,000 IU daily

Maximum dose 4,000 IU daily (higher doses under specialist supervision with active vitamin D analogues)

Clinical Notes:

• Usually combined with calcium supplementation and/or calcitriol

• Close monitoring of serum calcium essential

• Active vitamin D (calcitriol) often preferred for calcium control

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Chronic Kidney Disease (non-dialysis, stages G1–G3b with 25(OH)D <30 ng/mL) — OFF-LABEL 1,000–2,000 IU daily OR 60,000 IU monthly Long-term with monitoring Specialist (Nephrology) supervision. Based on KDIGO and Indian nephrology practice. Monitor PTH, calcium, phosphate.

Chronic Liver Disease with Vitamin D Insufficiency — OFF-LABEL 2,000 IU daily OR 60,000 IU monthly Long-term Hepatology specialist. Impaired 25-hydroxylation may limit response. Monitor 25(OH)D and calcium. Based on Indian hepatology protocols.

Autoimmune Conditions (adjunctive — e.g., multiple sclerosis, rheumatoid arthritis) — OFF-LABEL 1,000–2,000 IU daily Long-term Specialist only. Evidence variable. Ensure sufficiency without toxicity. Based on emerging RCT data.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Prophylaxis of Vitamin D Deficiency (Exclusively Breastfed Infants)

Birth to 12 months 400 IU Once daily Until weaning to vitamin D-fortified diet

1–18 years (if at risk) 400–1,000 IU Once daily Ongoing if dietary intake inadequate

Dosing Structure:

Parameter Recommendation

Starting dose 400 IU daily from birth

Titration Not applicable for prophylaxis

Usual maintenance dose 400 IU daily

Maximum dose 1,000 IU daily for prophylaxis

1. Nutritional Rickets / Vitamin D Deficiency (Treatment)

Age-based Dosing:

Neonates (<1 month) 1,000–2,000 IU daily 6–8 weeks 400 IU daily

Infants (1–12 months) 2,000 IU daily OR 60,000 IU weekly for 6 weeks 6–8 weeks 400–1,000 IU daily

Children (1–12 years) 60,000 IU weekly 6–8 weeks 400–1,000 IU daily

Adolescents (>12 years) 60,000 IU weekly 6–8 weeks 1,000–2,000 IU daily

Dosing Structure (Children 1–12 years):

Parameter Recommendation

Starting dose 60,000 IU orally once weekly

Titration Continue weekly if 25(OH)D remains <30 ng/mL after 6 weeks

Usual maintenance dose 400–1,000 IU daily

Maximum dose 60,000 IU weekly during loading; avoid exceeding 2,000 IU daily equivalent for maintenance

Alternative Loading Regimen:

• 3,000–6,000 IU daily for 12 weeks (age-adjusted)

IM Injection (Specialist Only):

• Reserved for severe malabsorption, poor oral adherence, or severe symptomatic rickets

• 300,000 IU IM single dose — repeat after 3 months if needed

• Close calcium monitoring essential post-injection

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Duration Notes

Chronic Kidney Disease (Stages 2–3)— OFF-LABEL >1 year 1,000–2,000 IU daily (adjusted to 25(OH)D level) Long-term Paediatric nephrology only. Monitor calcium, phosphate, PTH. Based on KDIGO paediatric recommendations adapted for Indian practice.

Chronic Liver Disease — OFF-LABEL >1 year 2,000–4,000 IU daily or equivalent Long-term Paediatric gastroenterology/hepatology only. May require active vitamin D analogues. Limited efficacy due to impaired hepatic hydroxylation.

Malabsorption Syndromes (Coeliac, IBD) — OFF-LABEL >1 year Higher doses (2,000–4,000 IU daily) based on 25(OH)D levels Long-term Specialist only. May require parenteral supplementation.

Age Restrictions:

• Oral low-dose vitamin D (400 IU daily) is safe from birth

• High-dose therapy (≥60,000 IU single dose) generally avoided in infants <12 months except under specialist supervision

• IM injections: Not recommended below 1 year except in exceptional circumstances

Safety Monitoring in Children:

• Serum calcium: 3–4 weeks after starting high-dose therapy

• 25(OH)D level: 6–8 weeks after loading course

• Monitor for symptoms of hypercalcaemia (vomiting, constipation, irritability, lethargy)

• Growth monitoring with long-term supplementation

G1–G2 >60 No dose adjustment. Standard dosing for deficiency.

G3a–G3b 30–59 No dose adjustment. Monitor 25(OH)D, calcium, phosphate, PTH every 3–6 months.

G4 15–29 Use with caution. Specialist supervision. Monitor closely. Consider calcitriol/alfacalcidol if PTH elevated.

G5 / Dialysis <15 Specialist only. Cholecalciferol may be used to correct 25(OH)D deficiency, but active vitamin D analogues (calcitriol, alfacalcidol) usually required for calcium-PTH management.

Note: In advanced CKD, renal 1α-hydroxylase activity is reduced, limiting conversion of 25(OH)D to active 1,25(OH)₂D. Active vitamin D analogues are often needed.

• Hypercalcaemia (serum calcium >10.5 mg/dL or ionised calcium elevated)

• Hypervitaminosis D (25(OH)D >100 ng/mL with symptoms)

• Known hypersensitivity to cholecalciferol or any formulation component (e.g., peanut oil in some preparations)

• Severe hyperphosphataemia (without specialist management)

• Metastatic calcification

• Granulomatous diseases (sarcoidosis, tuberculosis, histoplasmosis) — extra-renal 1α-hydroxylase activity may cause hypercalcaemia

• Nephrolithiasis history — particularly calcium-containing stones

• Concurrent use of high-dose calcium supplements

• Concurrent thiazide diuretic use — increased hypercalcaemia risk

• Fat malabsorption syndromes — may require higher doses or parenteral route

• Advanced CKD (G4–G5) — reduced conversion to active form

• Concurrent use of medications affecting vitamin D metabolism (anticonvulsants, rifampicin)

• Elderly with reduced renal reserve

• Infants and children — accurate dosing essential to avoid toxicity

Parameter Information

Overall safety Safe at recommended doses; deficiency is common in pregnancy in India

Recommended intake 400–2,000 IU daily; up to 4,000 IU/day considered safe

High-dose regimens 60,000 IU weekly may be used for deficiency correction under supervision

Risk assessment No evidence of teratogenicity at therapeutic doses; hypervitaminosis D may cause fetal hypercalcaemia

Preferred alternatives Cholecalciferol is preferred over ergocalciferol

When to use Routine supplementation recommended for all pregnant women in India (as per MoHFW guidelines)

Monitoring Serum calcium if on high-dose therapy; standard antenatal care otherwise

Parameter Information

Compatibility Compatible with breastfeeding

Recommended dose Maintenance doses (1,000–2,000 IU daily) are safe

Milk levels Low at routine doses; increases with maternal supplementation but remains within safe limits

High-dose therapy Single doses of 60,000 IU monthly are acceptable; avoid repeated megadoses (e.g., >300,000 IU)

Preferred alternatives None required; cholecalciferol is the preferred form

Infant monitoring Routine; observe for signs of hypercalcaemia if mother on very high doses (irritability, poor feeding, constipation)

Note: Maternal high-dose supplementation (e.g., 4,000–6,400 IU/day) can increase breast milk vitamin D content sufficiently to meet infant requirements — an alternative strategy to direct infant supplementation (research-based, not yet standard practice in India).

Parameter Recommendation

Starting dose 800–1,000 IU daily for maintenance; 60,000 IU weekly for deficiency

Titration Based on 25(OH)D response

Usual maintenance dose 800–2,000 IU daily

Special considerations Higher prevalence of deficiency; reduced skin synthesis and dietary intake

Benefits Adequate vitamin D associated with reduced fall risk and improved muscle function

Risks Hypercalcaemia (especially with concurrent thiazide use); reduced renal reserve may impair calcium handling

Monitoring 25(OH)D and serum calcium every 6–12 months; renal function baseline and periodically

Drug/Class Interaction Mechanism Management

Thiazide diuretics Increased risk of hypercalcaemia Thiazides reduce renal calcium excretion Monitor serum calcium, especially in elderly. Use lower vitamin D doses if needed.

Digitalis glycosides(digoxin) Hypercalcaemia potentiates digitalis toxicity (arrhythmias) Calcium enhances digitalis cardiac effects Avoid hypercalcaemia; monitor calcium and for signs of digitalis toxicity

Phenytoin, Phenobarbital, Carbamazepine Reduced vitamin D efficacy Hepatic enzyme induction accelerates vitamin D metabolism Higher vitamin D doses may be required (2,000–4,000 IU/day). Monitor 25(OH)D levels.

Rifampicin Reduced vitamin D efficacy CYP450 induction Higher doses may be needed during TB treatment. Monitor 25(OH)D.

Drug/Class Interaction Management

Glucocorticoids(prednisolone, dexamethasone) May reduce intestinal calcium absorption and impair vitamin D action Higher vitamin D doses (1,000–2,000 IU/day) recommended during chronic steroid therapy

Cholestyramine, Colestipol Reduced vitamin D absorption Administer vitamin D ≥2 hours before or 4–6 hours after bile acid sequestrants

Orlistat Reduced fat-soluble vitamin absorption Take vitamin D at bedtime (separate from orlistat); consider higher doses

Aluminium-containing antacids May reduce vitamin D absorption Separate administration; avoid prolonged concurrent use

High-dose calcium supplements Combined hypercalcaemia risk Monitor serum calcium periodically; limit total elemental calcium to ≤1,500 mg/day from all sources

Calcitriol/Alfacalcidol Additive hypercalcaemia risk Use combination under specialist supervision with close calcium monitoring

At standard doses (≤2,000 IU/day):

• Generally well tolerated

• Rare: mild GI upset

At high doses (≥60,000 IU/week, especially prolonged):

• Nausea

• Constipation

• Abdominal discomfort

• Headache

• Metallic taste

• Fatigue

Effect Notes

Hypercalcaemia Most important toxicity. Symptoms: polyuria, polydipsia, anorexia, nausea, vomiting, constipation, weakness, confusion, cardiac arrhythmias. Discontinue vitamin D and calcium immediately. Rehydrate. Seek specialist input.

Hypercalciuria Precedes hypercalcaemia; monitor urinary calcium if prolonged high-dose therapy

Nephrocalcinosis / Nephrolithiasis With chronic excessive dosing. May lead to CKD.

Acute Kidney Injury Secondary to severe hypercalcaemia and nephrocalcinosis

Metastatic calcification Rare; soft tissue calcium deposits with prolonged toxicity

Seizures (infants) Due to severe hypercalcaemia from dosing errors. Emergency management required.

After loading dose (6–8 weeks) Serum 25(OH)D to assess response; serum calcium if high-dose therapy used

High-dose therapy Serum calcium every 4–6 weeks during loading phase

Long-term maintenance 25(OH)D every 6–12 months to ensure adequacy; serum calcium annually or if symptoms suggest hypercalcaemia

Special populations (CKD, granulomatous disease) Calcium, phosphate, PTH every 3 months; more frequent initially

Paediatric high-dose therapy Serum calcium 3–4 weeks after initiation

Target Levels:

• 25(OH)D: 30–60 ng/mL (75–150 nmol/L)

• Avoid sustained levels >100 ng/mL (toxicity risk)

Single Ingredient:

• D-Rise (USV)

• Uprise-D3 (Alkem)

• Tayo 60K (Eris)

• Arachitol (Abbott) — also available as injection

• Calcirol (Cadila)

• D3 Must (Mankind)

• Depura (Sanofi)

• Calcitas D3 (Intas)

Paediatric Formulations (Drops/Syrup):

• D-Drops (various)

• Zydrop D3 (Zydus)

• Uprise D3 drops

Injectable:

• Arachitol 300,000 IU/mL, 600,000 IU/1.5 mL (Abbott)

Fixed-Dose Combinations (with Calcium):

• Shelcal 500/HD (Torrent)

• Calcimax (Meyer)

• CCM (Abbott)

• Gemcal (Ipca)

• Macalvit (Macleods)

• Calvit D3 (Alkem)

Note: Cholecalciferol is included in NLEM 2022 (oral formulations). Available in government supply and Jan Aushadhi outlets at lower cost.

1. Standard Indian regimen: 60,000 IU weekly × 6–8 weeks followed by monthly maintenance is effective, safe, and improves adherence compared to daily low-dose regimens.

1. Always co-prescribe calcium: During repletion of severe deficiency/rickets/osteomalacia, ensure adequate calcium intake (dietary or supplemental, 1,000–1,500 mg/day elemental calcium) to prevent "hungry bone" syndrome.

1. Daily dose equivalent ceiling: Long-term intake should not exceed 4,000 IU/day equivalent without specialist supervision and monitoring — higher doses increase hypercalcaemia risk.

1. IM injection caveats: Reserve for genuine malabsorption or documented non-adherence. Single large doses may cause transient hypercalcaemia — monitor calcium 2–4 weeks post-injection.

1. CKD considerations: Cholecalciferol corrects 25(OH)D deficiency but does not address secondary hyperparathyroidism in advanced CKD — calcitriol or alfacalcidol often needed additionally.

1. Drug-induced deficiency: Patients on anticonvulsants (phenytoin, carbamazepine) or rifampicin require higher vitamin D doses prophylactically — accelerated hepatic metabolism.

vitamin D3; cholecalciferol; rickets; osteomalacia; osteoporosis; calcium metabolism; pregnancy-safe; paediatric supplementation; NLEM India; renal-bone disease; elderly falls

RxIndia v1.0 — 05 Jan 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia / National Formulary of India

• NLEM 2022

• API Textbook of Medicine

• ICMR-NIN RDA Guidelines for Indians (2020)

• Indian Academy of Pediatrics (IAP) Guidelines on Vitamin D Supplementation

• AIIMS Clinical Protocols — Endocrinology & Paediatrics

• MoHFW guidelines on maternal and child nutrition

• KDIGO CKD-MBD Guidelines (adapted for Indian nephrology practice)

• CMC Vellore, AIIMS inpatient protocols for vitamin D therapy