Schedule H

Oral, Intravenous

• Oral capsules: 0.25 mcg, 0.5 mcg

• Oral solution/drops: 0.25 mcg/mL

• Injection: 1 mcg/mL (ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypocalcaemia in Chronic Kidney Disease (CKD-MBD)

Route: Oral

Parameter Recommendation

Starting dose 0.25 mcg orally once daily

Titration Increase by 0.25 mcg/day every 2–4 weeks based on serum calcium, phosphorus, and PTH

Usual maintenance dose 0.25–1 mcg/day

Maximum dose 2 mcg/day (under specialist supervision)

Clinical Notes:

• Ensure serum phosphorus is controlled before initiation (use phosphate binders if required)

• Target corrected calcium: 8.4–9.5 mg/dL

• Monitor for hypercalcaemia and hyperphosphataemia

1. Hypoparathyroidism

Route: Oral

Parameter Recommendation

Starting dose 0.25 mcg orally once daily

Titration Increase by 0.25 mcg/day every 2–4 weeks based on serum calcium

Usual maintenance dose 0.5–2 mcg/day in 1–2 divided doses

Maximum dose 2 mcg/day

Clinical Notes:

• Concurrent calcium supplementation usually required (1–3 g/day elemental calcium)

• Aim for serum calcium at lower end of normal range to avoid hypercalciuria

• Monitor urinary calcium excretion periodically

1. Vitamin D-Dependent Rickets / Osteomalacia (Type I or II)

Route: Oral

Parameter Recommendation

Starting dose 0.25 mcg orally once daily

Titration Adjust every 2–4 weeks based on clinical, radiological, and biochemical response

Usual maintenance dose 0.25–1 mcg/day

Maximum dose 2 mcg/day

Clinical Notes:

• Ensure adequate dietary calcium intake (500–1000 mg/day)

• Type II (receptor defect) may require higher doses

• Monitor alkaline phosphatase for response

1. Secondary Hyperparathyroidism in Dialysis Patients (CKD Stage 5D)

Route: Intravenous (post-dialysis)

Parameter Recommendation

Starting dose 0.5–1 mcg IV three times weekly post-dialysis

Titration Adjust every 2–4 weeks based on PTH, calcium, and phosphorus

Usual maintenance dose 0.5–3 mcg IV three times weekly

Maximum dose 4 mcg per week (total)

Clinical Notes:

• IV route preferred in dialysis patients for reliable absorption

• Withhold dose if corrected calcium >10.5 mg/dL or phosphorus >6.5 mg/dL

• Target PTH as per KDIGO guidelines (2–9 times upper limit of normal)

Secondary Indications — Adults (Off-label)

Indication Dose Duration Setting Evidence Basis

Postmenopausal osteoporosis — OFF-LABEL 0.25 mcg orally twice daily Long-term with calcium supplementation Specialist only Meta-analyses showing modest BMD improvement; Indian endocrinology practice

Psoriasis (severe, resistant) — OFF-LABEL 0.25–0.5 mcg/day orally Variable; under dermatology supervision Specialist only Limited evidence; dermatology specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Vitamin D-Dependent Rickets / Hypoparathyroidism

Route: Oral — Under Paediatric Endocrinologist/Nephrologist supervision

<1 year 0.04–0.08 mcg/day Adjust per calcium/PTH every 2–4 weeks 0.05–0.2 mcg/day 0.25 mcg/day

1–5 years 0.25 mcg/day 0.25 mcg increments every 2–4 weeks 0.25–0.5 mcg/day 0.75 mcg/day

6–12 years 0.25 mcg/day 0.25 mcg increments every 2–4 weeks 0.25–0.75 mcg/day 1 mcg/day

12 years / Adolescents 0.25–0.5 mcg/day Adjust based on labs 0.5–1 mcg/day 2 mcg/day

Clinical Notes:

• Ensure adequate calcium intake: 500–1000 mg/day (age-appropriate)

• Oral drops preferred for infants and young children

Safety Monitoring:

• Serum calcium, phosphorus: weekly for first 4 weeks, then biweekly

• Urinary calcium:creatinine ratio periodically (to detect hypercalciuria)

• PTH levels every 4–8 weeks during titration

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Setting Evidence Basis

Secondary hyperparathyroidism in paediatric CKD — OFF-LABEL 10–20 ng/kg/day orally; adjust every 2–4 weeks Long-term Paediatric Nephrology only Indian Society of Nephrology protocols; IAP guidelines

Age Restriction: Not recommended below 1 month of age except under specialist paediatric endocrinology/nephrology supervision.

CKD Stage 1–4 No dose reduction; dose guided by calcium, phosphorus, and PTH targets

CKD Stage 5 (non-dialysis) Use with caution; careful monitoring for hypercalcaemia

CKD Stage 5D (dialysis) IV route preferred; dose guided by PTH suppression goals

Peritoneal dialysis Oral route may be used; monitor closely

Key Monitoring: Serum calcium, phosphorus, calcium-phosphorus product, PTH; watch for vascular calcification risk

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

• Hypervitaminosis D

• Known hypersensitivity to calcitriol or any vitamin D analog

• Severe hyperphosphataemia (>6.5 mg/dL) without adequate phosphate control

• Metastatic calcification or evidence of vitamin D toxicity

• Risk of hypercalcaemia — requires regular calcium monitoring

• Patients on digitalis glycosides (hypercalcaemia increases digoxin toxicity risk)

• Concurrent thiazide diuretics (additive hypercalcaemia risk)

• Granulomatous diseases (sarcoidosis, tuberculosis) — increased sensitivity to vitamin D

• Immobilized patients (increased hypercalcaemia risk)

• Ensure adequate hydration, especially in elderly and paediatric patients

• Elevated calcium-phosphorus product increases vascular calcification risk

Aspect Recommendation

Overall safety Limited human data; animal studies show teratogenicity at high doses

When to use Only if benefit clearly outweighs risk; specialist supervision essential

Preferred alternative Cholecalciferol for routine vitamin D supplementation/deficiency

Maternal monitoring Serum calcium every 2–4 weeks; avoid hypercalcaemia

Fetal monitoring Fetal growth; neonatal calcium levels after birth

Aspect Recommendation

Compatibility Compatible with breastfeeding at standard therapeutic doses

Drug levels in milk Low; calcitriol has minimal transfer to breast milk

Preferred alternative Cholecalciferol for routine supplementation

Infant monitoring Signs of hypercalcaemia: poor feeding, vomiting, irritability, constipation

Maternal monitoring Maintain maternal calcium within normal range

Parameter Recommendation

Starting dose 0.25 mcg orally once daily (same as adults)

Titration Slower titration (every 4 weeks); elderly have increased sensitivity

Special risks Higher susceptibility to hypercalcaemia; symptoms include confusion, constipation, polyuria, delirium

Comorbidities Common mild CKD may alter response; monitor creatinine

Drug interactions Thiazides commonly used; increases hypercalcaemia risk — monitor closely

Monitoring More frequent calcium monitoring (weekly initially)

Drug/Class Interaction Management

Thiazide diuretics Additive hypercalcaemia due to reduced renal calcium excretion Avoid combination or monitor serum calcium very closely

Digoxin Hypercalcaemia increases risk of digoxin toxicity and arrhythmias Monitor serum calcium and digoxin levels; ECG monitoring

Magnesium-containing antacids Risk of hypermagnesaemia, especially in CKD Avoid in renal impairment

Calcium supplements (high dose) Additive hypercalcaemia Monitor total calcium intake; adjust doses accordingly

Drug/Class Interaction Management

Phenytoin, Phenobarbital, Carbamazepine Increase calcitriol metabolism via CYP enzyme induction May require higher calcitriol doses; monitor calcium

Glucocorticoids Antagonize vitamin D effects on calcium absorption Monitor bone health; may need higher calcitriol dose

Cholestyramine, Colestipol Reduce oral absorption of calcitriol Separate administration by at least 2–4 hours

Phosphate binders (calcium-based) Additive calcium load Monitor serum calcium; prefer non-calcium binders if hypercalcaemia risk

Rifampicin May increase calcitriol metabolism Monitor calcium response; dose adjustment may be needed

Oral iron, zinc supplements May reduce calcitriol absorption Space administration by ≥2 hours

• Hypercalcaemia (dose-dependent; most common)

• Headache

• Nausea, vomiting

• Constipation

• Metallic taste

• Fatigue, weakness

• Polydipsia, polyuria

Adverse Effect Clinical Notes

Hypercalcaemic crisis Severe nausea, confusion, cardiac arrhythmias, coma; discontinue immediately; requires emergency management

Nephrocalcinosis With chronic overdose; irreversible renal damage possible; annual renal ultrasound in long-term use

Soft tissue/vascular calcification Especially with elevated calcium-phosphorus product in CKD; increases cardiovascular risk

Hypersensitivity reactions Rare; discontinue if occurs

→ At first sign of hypercalcaemia: Stop calcitriol, hydrate patient, recheck calcium, resume at lower dose once normalized

After initiation/dose change Serum calcium and phosphorus: weekly for first 4 weeks, then biweekly until stable

Long-term (maintenance) Serum calcium and phosphorus: monthly; PTH every 3 months (in CKD); urinary calcium:creatinine ratio periodically

Paediatric long-term use Annual renal ultrasound to assess for nephrocalcinosis

• Rocaltrol® (Roche)

• Calcirol® (Cadila)

• One-Alpha® (Leo Pharma)

• Calcitas® (Intas)

• Aarcal® (Aristo)

• Calnit® (Lupin)

• D-Triol® (Franco-Indian)

• Multiple generic preparations available

NLEM Status: Included in NLEM 2022

Government Supply: Available under NPCDCS and public health programmes

• Not for routine vitamin D deficiency: Calcitriol is the active form; cholecalciferol (D3) or ergocalciferol (D2) is preferred for nutritional deficiency. Calcitriol is reserved for conditions where 1-alpha-hydroxylation is impaired (CKD, hypoparathyroidism)

• Phosphate control first: In CKD patients, ensure serum phosphorus is controlled before starting calcitriol to avoid elevated calcium-phosphorus product and vascular calcification

• Silent hypercalcaemia risk: Initiation without monitoring can lead to asymptomatic hypercalcaemia; always check calcium within first week of starting or dose change

• IV use in dialysis only: Injectable calcitriol is intended for dialysis units; not for routine outpatient IV administration

• Patient education: Advise patients to report symptoms of hypercalcaemia (nausea, vomiting, constipation, weakness, confusion)

• Thiazide caution: Very commonly co-prescribed in elderly hypertensives; combination significantly raises hypercalcaemia risk

calcitriol; active vitamin D; CKD-MBD; secondary hyperparathyroidism; hypocalcaemia; hypoparathyroidism; nephrology; paediatric rickets; hypercalcaemia-risk; NLEM India

RxIndia v1.1 — 04 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Drug Formulary

• Indian Society of Nephrology CKD-MBD Guidelines

• IAP Guidelines (Paediatric Vitamin D disorders)

• National List of Essential Medicines (NLEM) 2022

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics