Finished product reference
Calcitonin, Salmon
Spray · Nasal · 100 IU/1 dose · 16 puff
- List code
- 1415
- Pharmacologic class
- Calcitonin
What it is and how it works
Mechanism of Action Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.
Indications
Calcitonin-salmon synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable • Treatment of hypercalcemia • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated Limitations of Use: • Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) Treatment of Paget's Disease of Bone Calcitonin-salmon injec t ion is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients.
Dosage and administration (summary)
• Symptomatic Paget’s disease of bone: 100 International Units daily. Ensure adequate calcium and vitamin D intake ( 2.1 , 2.5 ) • Hypercalcemia: start with 4 International Units/kg body weight every 12 hours. Increase to 8 International Units/kg every 12 hours if no improvement in 1-2 days. Increase further to 8 International Units/kg every 6 hours if no improvement after 2 more days • Postmenopausal osteoporosis: 100 International Units daily.
Contraindications
Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat . Hypersensitivity to calcitonin-salmon or any of the excipients
Warnings and precautions
• Serious hypersensitivity reactions, including reports of fatal anaphylaxis have been reported. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin-salmon • Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D • Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin-salmon treated patients ( 5.3 , 6.1 ) • Circulating antibodies to calcitonin-salmon may develop, and may cause loss of response to treatment Hypersensitivity Reactions Serious hypersensitivity reac…
Pregnancy
Pregnancy Risk Summary There are no studies with calcitonin-salmon injection in pregnant women to inform a drug associated risk for birth defects or miscarriage. In an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 4 to18 times the recommended parenteral human dose caused a de…
Storage and supply
How Supplied Calcitonin-salmon Injection, USP Synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 International Units per mL. NDC 43598-051-11 carton containing 1 x 2 mL multi-dose vial Storage and Handling Store in refrigerator between 2°C to 8°C (36°F to 46°F).
Source: Calcitonin Salmon (Calcitonin Salmon) — US FDA prescribing information, 2025-09-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.