Calcitonin-Salmon
Pronouncation: (kal-sih-TOE-nin–salmon)Class: Endocrine-Metabolic agent
Trade Names:
Miacalcin
- Injection 200 units/mL
- Nasal Spray 200 units/activation (0.09 mL/dose)
Miacalcin NS (Canada)
Pharmacology
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Feedback for Calcitonin-Salmon
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Decreases rate of bone turnover, presumably by regulating bone metabolism (blocking bone resorption). In conjunction with parathyroid hormone, endogenous calcitonin regulates serum calcium.
Pharmacokinetics
Absorption
InjectionT max is 16 to 25 min.
NasalRapidly absorbed. T max is 31 to 39ߙmin. Bioavailability is approximately 3%.
Distribution
Calcitonin does not cross the placenta.
Metabolism
Rapidly metabolized to inactive fragments, primarily by the kidneys but also in the blood and peripheral tissues.
Elimination
A small amount is excreted in the urine. The t ½ is 43 min.
Duration
5 to 8 days (hypocalcemic effect after chronic dosing).
Indications and Usage
Injection and nasal sprayTreatment of postmenopausal osteoporosis in women more than 5 yr of age postmenopause who cannot tolerate estrogens.
Injection onlyTreatment of moderate to severe Paget disease of bone; early treatment of hypercalcemic emergencies.
Contraindications
Standard considerations.
Dosage and Administration
Postmenopausal OsteoporosisAdults
Subcutaneous/IM 100 units every other day with supplemental calcium and adequate vitamin D. Nasal 200 units/day (1 spray) with supplemental calcium and vitamin D, alternating nostrils.
Paget DiseaseAdults Initial dose
Subcutaneous/IM 100ߙunits/day.
Maintenance doseSubcutaneous/IM 50ߙunits/day or every other day is usually sufficient.
HypercalcemiaAdults Starting dose
Subcutaneous/IM 4 units/kg every 12 h. Titrate gradually on basis of response to max dose of 8 units/kg every 6 h.
General Advice
- For skin testing, dilute injection to 10 units/mL by withdrawing 0.05 mL of the 200 units/mL injection solution into a tuberculin syringe and fill to 1 mL with sodium chloride injection; mix well, then discard 0.9 mL of diluted solution; inject 0.1 mL on inner aspect of forearm and observe for 15 min; appearance of more than mild erythema or wheal constitutes positive response.
- Injection
- For subcutaneous or IM administration only. Not for intradermal, IV, or intra-arterial administration.
- Do not administer if particulate matter, cloudiness, or discoloration noted.
- If volume of injection exceeds 2 mL, use multiple sites with IM injection.
- Nasal
- Delivery system contains enough medication for at least 30 doses. Discard any unused solution after 30 doses because spray may not deliver correct dose.
- Before priming pump and using new bottle, allow assembled bottle to come to room temperature.
- Prime pump before first use by holding upright. Depress pump until full spray is produced. Do not prime pump before each daily dose.
- To administer dose, carefully place nozzle in nostril, with head in upright position, and firmly depress pump.
Storage/Stability
Refrigerate injection (36° to 46°F). Refrigerate new, unassembled bottles of nasal spray. Protect from freezing. Store bottle in use at controlled room temperature (59° to 86°F) in upright position, for up to 35 days.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Nasal sprayAngina pectoris, hypertension (1% to 3%).
CNS
Nasal spray: Fatigue, depression, dizziness, paresthesia (1% to 3%). Injectable: Poor appetite; abdominal pain.
Dermatologic
Nasal sprayErythematous rash (1% to 3%).
InjectablePruritus of ear lobes; skin rash.
EENT
Nasal sprayRhinitis (12%); abnormal lacrimation, conjunctivitis (1% to 3%).
InjectableEye pain.
GI
Nasal sprayAbdominal pain, constipation, diarrhea, dyspepsia, nausea (1% to 3%).
InjectableNausea with or without vomiting (10%); salty taste.
Genitourinary
Nasal sprayCystitis (1% to 3%).
InjectableNocturia.
Hematologic-Lymphatic
Nasal sprayInfection, lymphadenopathy (1% to 3%).
Local
InjectableInflammation at subcutaneous or IM site (10%).
Musculoskeletal
Nasal sprayBack pain (5%); arthralgia (4%); arthrosis, myalgia (1% to 3%).
Respiratory
Nasal sprayEpistaxis (4%); bronchospasm, sinusitis, upper respiratory tract infection (1% to 3%).
Miscellaneous
Nasal sprayInfluenza-like symptoms (1% to 3%).
InjectableDeath caused by anaphylaxis (1 case), feet edema, feverish sensation.
Precautions
MonitorMonitor serum electrolytes and calcium. InjectionMonitor drug effect in Paget disease with periodic measurement of serum alkaline phosphatase and 24-h urinary hydroxyproline, and evaluation of symptoms. Evaluate urine sediment periodically in patients on chronic therapy. NasalPeriodically measure lumbar vertebral bone density to document stabilization of bone loss or increase in bone density. Monitor for nasal ulcerations. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Allergy
Systemic allergic reactions, including anaphylaxis, may occur. Consider skin testing for patients with suspected sensitivity to calcitonin.
Antibody formation
Circulating antibodies to calcitonin-salmon may occur after 2 to 18ߙmo of treatment. Treatment of Paget disease may or may not remain effective.
Hypocalcemic tetany
May occur with calcitonin. Although no cases have been reported, have parenteral calcium available during first several injections of calcitonin.
Osteogenic sarcoma
Incidence increased in Paget disease.
Overdosage
Symptoms
Nausea, vomiting.
Patient Information
- Advise patient or caregiver to review patient information leaflet before starting therapy and with each refill.
- Advise patient with osteoporosis of the following interventions, which help treat osteoporosis: 1,500 mg/day of calcium (diet and supplements); vitamin D supplementation; weight-bearing exercises; reduction of cigarette smoking and excessive alcohol consumption.
- Advise patient that follow-up visits and laboratory tests may be required to monitor therapy and to keep appointments.
- Nasal Spray
- Ensure patient understands how to prepare nasal spray, prime the pump, and administer the spray. If possible, have patient demonstrate technique to confirm understanding. Remind patient that pump is only primed before first dose and not before each dose.
- Instruct patient to keep track of total number of doses of nasal spray used and to discard the bottle after 30 doses have been used, even if some medicine remains in the bottle. Inform patient that even though some medicine may remain in the bottle, the pump may no longer be able to deliver the correct dose.
- Advise patient to notify health care provider if nasal irritation, redness, sores, or bleeding develops.
- Injection
- Ensure patient who will be self-administering calcitonin understands how to store, prepare and administer the dose, and dispose of used equipment and supplies. The first injection should be performed under the supervision of a qualified health care professional.
- Remind patient to rotate injection sites and never to inject into tissue that is inflamed, irritated, or bruised.
- Advise patient to notify health care provider if any of the following occur: persistent or recurrent nausea with or without vomiting, injection site reactions, or any unexplained symptoms or feelings.
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Osteoporosis, Paget's Disease, Hypercalcemia, Osteogenesis Imperfecta








