Schedule H

Intramuscular, Subcutaneous, Intranasal

• Injection (Salmon calcitonin): 50 IU/mL, 100 IU/mL (ampoules/vials)

• Nasal Spray (Salmon calcitonin): 200 IU/actuation (metered-dose spray)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Hypercalcaemia (malignancy-associated or other causes)

Parameter Recommendation

Starting dose 4 IU/kg SC or IM every 12 hours

Titration If inadequate response after 24–48 hours, may increase to 8 IU/kg every 6–12 hours

Usual maintenance dose 4–8 IU/kg every 6–12 hours

Maximum dose 8 IU/kg per dose (maximum 32 IU/kg/day)

Clinical notes Rapid onset of action (2–4 hours); peak effect at 12–24 hours; tachyphylaxis develops within 48–72 hours limiting effectiveness beyond this period; use as bridge therapy while awaiting bisphosphonate effect or when bisphosphonates contraindicated

1. Paget's Disease of Bone (symptomatic cases)

Parameter Recommendation

Starting dose 100 IU SC or IM once daily

Titration Continue daily dosing for initial 2–4 weeks; then reduce frequency based on clinical and biochemical response

Usual maintenance dose 50–100 IU SC or IM every other day or 3 times weekly

Maximum dose 100 IU/day

Clinical notes Reserved for patients intolerant or unresponsive to bisphosphonates; efficacy decreases with prolonged use due to antibody formation; monitor serum alkaline phosphatase for response

1. Postmenopausal Osteoporosis (adjunctive therapy — nasal spray)

Parameter Recommendation

Starting dose 200 IU intranasally once daily

Titration Not applicable

Usual maintenance dose 200 IU intranasally once daily (alternate nostrils each day)

Maximum dose 200 IU/day

Clinical notes NOT first-line therapy for fracture prevention; primarily used for analgesic effect in acute vertebral compression fractures; supplement with calcium and vitamin D; long-term use associated with potential cancer risk — limit duration

Secondary Indications — Adults (Off-label)

Indication Dose Duration Specialist Status Evidence Basis

Acute vertebral fracture pain relief (OFF-LABEL) 100 IU SC/IM daily OR 200 IU intranasally once daily 2–4 weeks Specialist only (Rheumatology/Orthopaedics) Meta-analyses demonstrate analgesic effect superior to placebo; bone-protective effect is secondary; commonly used in Indian orthopaedic and rheumatology practice

Complex Regional Pain Syndrome (OFF-LABEL) 100 IU SC/IM daily 2–4 weeks Specialist only (Pain Medicine) Limited evidence from case series; used in refractory cases under pain specialist supervision

PAEDIATRIC DOSING (Specialist Only)

⚠️ Use in paediatric population is uncommon. Safety and efficacy data are limited. Use ONLY under specialist supervision (paediatric endocrinology/oncology).

Primary Indications

Hypercalcaemia (malignancy-associated or other causes)

≥1 year 2–4 IU/kg SC or IM every 12 hours May increase to 8 IU/kg every 6–12 hours based on serum calcium response 8 IU/kg per dose (32 IU/kg/day)

Safety Monitoring:

• Serum calcium every 6–12 hours during acute treatment

• Monitor for flushing, nausea, injection site reactions

• Ensure adequate hydration

• Discontinue once serum calcium normalised or alternative therapy established

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Osteogenesis Imperfecta (OFF-LABEL) 2–4 IU/kg SC or IM every other day Individualised; typically short-term Specialist only (Paediatric Endocrinology); limited evidence; bisphosphonates preferred; used for symptom control in select cases

Age Restriction: Not recommended below 1 year of age except under paediatric endocrinology/oncology supervision with documented justification.

No dose adjustment required.

Calcitonin is preferred over bisphosphonates in acute hypercalcaemia with concurrent renal impairment due to lack of nephrotoxicity. Safe to use across all eGFR ranges.

• Known hypersensitivity to salmon calcitonin or any formulation excipient

• History of anaphylaxis or serious allergic reaction to calcitonin

• Hypocalcaemia (pre-existing or uncorrected)

• Risk of hypocalcaemia — particularly in malnourished, osteoporotic, or vitamin D-deficient patients; correct vitamin D and calcium status before initiating long-term therapy

• Tachyphylaxis — effectiveness diminishes after 48–72 hours of continuous use in acute hypercalcaemia

• Antibody formation — may develop with prolonged use, reducing efficacy

• Nasal formulation — avoid or use with caution in patients with chronic rhinitis, nasal polyps, or nasal mucosal ulceration

• Long-term cancer risk — meta-analyses suggest increased relative risk of malignancy with prolonged nasal calcitonin use; limit duration of therapy

• Allergy testing — consider skin testing in patients with suspected salmon allergy before first dose

Parameter Recommendation

Risk category Limited human data; animal studies inconclusive; safety not established

Preferred alternatives IV hydration, loop diuretics, and corticosteroids for hypercalcaemia in pregnancy

When it may be used Only if potential benefit clearly outweighs risk — requires specialist obstetric and endocrinology input

What to monitor Maternal serum calcium; fetal growth and development via ultrasound

Parameter Recommendation

Compatibility Not recommended — insufficient human data

Expected drug levels in milk Unknown in humans; inhibits lactation in animal studies

Preferred alternatives IV hydration, loop diuretics for hypercalcaemia; avoid calcitonin if possible during breastfeeding

What to monitor in infant If inadvertent exposure: feeding adequacy, growth, signs of hypocalcaemia

Parameter Recommendation

Starting dose Use lower end of dosing range (e.g., 4 IU/kg for hypercalcaemia; 50–100 IU for Paget's disease)

Titration Slower titration recommended; assess response before dose escalation

Key risks Increased susceptibility to GI adverse effects (nausea, vomiting); nasal irritation with spray formulation; higher risk of falls if volume-depleted; increased baseline hypocalcaemia risk

Monitoring Serum calcium closely; hydration status; nasal mucosa integrity with intranasal use

Interacting Drug Mechanism / Effect Action

Lithium Calcitonin may reduce serum lithium levels by antagonizing lithium-induced hypercalcaemia and promoting renal lithium excretion Monitor lithium levels closely; may require lithium dose adjustment

Interacting Drug Mechanism / Effect Action

Loop diuretics (furosemide, torsemide) Additive hypocalcaemic effect Monitor serum calcium closely when used concurrently

Aminoglycoside antibiotics Theoretical additive risk of hypocalcaemia Avoid concurrent use if possible; monitor calcium if co-administration unavoidable

Bisphosphonates (zoledronic acid, alendronate) No pharmacokinetic interaction but no synergistic benefit; typically not used together for same indication Sequential use is appropriate (calcitonin as bridge while awaiting bisphosphonate effect)

Cardiac glycosides (digoxin) Hypocalcaemia may alter cardiac sensitivity to digoxin Monitor for arrhythmias if calcium levels fluctuate significantly

• Nausea and vomiting (more common with injection than nasal spray)

• Facial flushing and warmth

• Injection site reactions (pain, redness, swelling)

• Nasal irritation, dryness, rhinorrhoea, epistaxis (with intranasal formulation)

• Headache

• Dizziness

• Mild transient hypocalcaemia

• Diarrhoea

• Abdominal discomfort

Adverse Effect Clinical Significance

Anaphylaxis / Severe allergic reactions Rare but potentially fatal; may occur even after previous uneventful exposure; discontinue immediately; requires emergency management

Severe hypocalcaemia May cause tetany, seizures, cardiac arrhythmias; requires calcium supplementation and drug discontinuation

Malignancy (with long-term use) Meta-analyses suggest increased relative risk of cancer with prolonged intranasal calcitonin use; limit duration of therapy; regulatory advisories issued

Nasal mucosal ulceration With prolonged intranasal use; requires periodic nasal examination and discontinuation if ulceration develops

During acute treatment (hypercalcaemia) Serum calcium every 6–12 hours until stable

After initiation / dose change Serum calcium within 24–48 hours; clinical response assessment

Long-term maintenance Serum calcium and phosphate monthly for first 3 months, then every 3–6 months; periodic nasal mucosa inspection (every 3–6 months with intranasal use); serum alkaline phosphatase (for Paget's disease); reassess need for continued therapy regularly given cancer risk concerns

Injection formulations:

• Miacalcic (Novartis) — 50 IU, 100 IU

• Calcimax (Dr. Reddy's)

• Calcinose (Intas)

• Ostocalcin (Zydus)

• Tonocalcin (Torrent)

Nasal spray formulations:

• Miacalcic Nasal Spray (Novartis) — 200 IU/dose

• Nasocalcin (Cipla)

• Calcitonin Nasal (Sun Pharma)

Note: Availability of specific brands may vary by region; verify current availability with local distributors.

NPPA Status: Not included in NLEM 2022; not under DPCO price control. Prices vary significantly between brands.

• Tachyphylaxis is the major limitation — effectiveness in hypercalcaemia diminishes after 48–72 hours; use as bridge therapy while awaiting bisphosphonate effect (which takes 2–4 days) or when bisphosphonates are contraindicated

• Preferred in renal impairment — unlike bisphosphonates, calcitonin is safe across all eGFR levels, making it the agent of choice for acute hypercalcaemia in CKD patients

• Analgesic benefit precedes bone effect — in acute vertebral fractures, pain relief occurs within days and is often the primary therapeutic goal; bone-protective effect is modest

• Long-term use is discouraged — regulatory agencies have issued advisories regarding increased cancer risk with prolonged nasal calcitonin use; limit duration and reassess need regularly

• Correct vitamin D and calcium deficiency first — before initiating long-term therapy for osteoporosis or Paget's disease to minimize hypocalcaemia risk

• Consider skin testing — in patients with suspected fish/salmon allergy before first dose, as salmon calcitonin may cause severe allergic reactions

Calcitonin; salmon calcitonin; hypercalcaemia; Paget's disease; osteoporosis; vertebral fracture pain; bone metabolism; hormonal agent; renal-safe; injectable; nasal spray; Schedule H

RxIndia v1.0 — 12 May 2025

• CDSCO — Approved product information

• Indian Pharmacopoeia / National Formulary of India

• API Textbook of Medicine

• AIIMS Drug Formulary

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics

• National Osteoporosis Guidelines — India

• ICMR recommendations for hypercalcaemia management

• BMJ 2012 meta-analysis on cancer risk with long-term calcitonin use (for off-label/safety information)

• Indian manufacturer package inserts (Miacalcic, Nasocalcin)