Overview
11 DESCRIPTION Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin salmon injection, USP, synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 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. 12.2 Pharmacodynamics Bone Single injections of calcitonin salmon caused a marked transient inhibition of the ongoing bone resorptive process.
Indications
- 1 INDICATIONS AND USAGE Calcitonin salmon injection, synthetic is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable ( 1.1 ) Treatment of hypercalcemia ( 1.2 ) Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) 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 ) 1.
Common Doses
- 0.5 mL
- 2 mL
- 1000 mg
Dosage
2 DOSAGE AND ADMINISTRATION Symptomatic Paget's disease of bone: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.1 , 2.5 ) Hypercalcemia: start with 4 USP Units/kg body weight every 12 hours. Increase to 8 USP Units/kg every 12 hours if no improvement in 1-2 days. Increase further to 8 USP Units/kg every 6 hours if no improvement after 2 more days ( 2.2 ) Postmenopausal osteoporosis: 100 USP Units daily. Ensure adequate calcium and vitamin D intake ( 2.3 , 2.5 ) 2.
Contraindications
- 4 CONTRAINDICATIONS Hypersensitivity to calcitonin salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions ( 5.1 )]. Hypersensitivity to calcitonin salmon or any of the excipients ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings and Precautions ( 5.2 )] Malignancy [see Warnings and Precautions ( 5.3 )] Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
Interactions
- 7 DRUG INTERACTIONS No formal drug interaction studies have been performed with calcitonin salmon injection. Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment. Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment ( 7 )