Dosage is to be adjusted to the individual patient's needs. Each 1 ml solution contains 50 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance. For the treatment of hypercalcemia, vitamin D preparations should be avoided. [27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. Reduction in serum calcium concentration in patients with hypercalcemia persists for about 68 hours after single injection. Am J Health Syst Pharm. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. x+ | MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. Periodic nasal examinations with visualization of nasal mucosa, turbinates, septum, and mucosal blood vessel status are recommended for patients receiving calcitonin nasal spray. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. Calcitonin has an antinociceptive activity that is independent of its action on bone resorption; the mechanism is not explicitly known. Stability: Salmon calcitonin: Injection: Store under refrigeration at 2C to 6C/36F to 43F; . For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. Keep all supplies in a clean, dry place and out of reach of children. Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. Miacalcin Nasal Spray Storage (or generic equivalent): After opening, store bottle in use at room temperature between 20 and 25 degrees C (68 and 77 degrees F) in an upright position, for up to 35 days. By inhibiting osteoclast activity via its specific receptors, salmon calcitonin decreases bone resorption. Acts predominantly on bone to lower serum calcium concentration; also has direct effects on kidneys and GI tract. AHFS Patient Medication Information. /MediaBox [0 0 612 792] The usual provisions should be made for emergency treatment if such a reaction occurs. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Onset of action of calcitonin is immediate following IV administration. Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum, and mucosal blood vessels for any sign of nasal trauma are recommended for patients receiving intranasal calcitonin-salmon. << Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Carefully consider the benefits for the individual patient against the possible risks. Miacalcin Injection is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Rapidly absorbed by nasal mucosa; bioavailability of intranasal dose relative to IM dose is approximately 3%. Discard the bottle after 30 doses. Actions and Spectrum Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. Calcitonin (salmon, synthetic) . For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. This is considered a species-specific effect and of no clinical relevance. Destroyed in GI tract; administer parenterally or intranasally. Frequent monitoring of the clinical and laboratory response including the measurement of serum calcium is recommended especially in the early phases of treatment. IM injection preferred when injection volume >2 mL. 11 0 obj Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Use not recommended. For the treatment of hypercalcemia, calcium supplements should be avoided. Purpose. endobj Commercially available as calcitonin salmon. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Medically reviewed by Drugs.com on Mar 16, 2022. The dose of lithium may require adjustment. Miacalcin has also been shown to decrease bone pain associated with bone fractures caused by osteoporosis. Calcium Carbonate; Risedronate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The mechanism is not clear, but serum lithium concentrations were reduced to 30% of the baseline value in all patients studied, and fell below normal therapeutic ranges. Neoplasms benign, malignant and unspecified (incl cysts and polyps). American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. %PDF-1.4 % Calcitonin is excreted primarily in the urine as inactive metabolites. 1 Development of neutralising antibodies to calcitonin. Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. Copyright 2023, Selected Revisions March 26, 2018. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Effect not reported by other investigators. Calcitonin is also contraindicated in patients with hypocalcaemia. Drug class: Antiparathyroid Agents An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. Do not use calcitonin salmon injection if it has been out of the refrigerator for more than 24 hours. Calcitonin salmon helps treat osteoporosis and Paget's disease of bone but does not cure them. If you log out, you will be required to enter your username and password the next time you visit. If your usual dose is three times a week, give the missed dose on the next day and continue every other day thereafter. With IM or sub-Q administration, 824 hours. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: hives skin rash itching difficulty breathing or swallowing swelling of the tongue or throat Calcitonin salmon may cause other side effects. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 9 0 obj There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. endobj The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration. Calcitonin helps maintain calcium homeostasis. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. [ ] Peak plasma concentrations are attained within the first hour of administration. Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with high risk of fractures (generally those who have experienced a previous hip or vertebral fracture or who have low BMD); pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients. The addition of 10 mM sodium phosphate buffer . decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. [0 /XYZ 69.5999999 They are dose dependent and more frequent after intravenous than after intramuscular or subcutaneous administration. 285.599999 0] For the treatment of hypercalcemia, calcium supplements should be avoided. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. For smaller ulcers, interrupt therapy until healing occurs. Calcitonin antagonizes the actions of PTH, but concentrations of PTH do not increase significantly in response to calcitonin therapy. An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. new primary malignancy / Delayed / 4.1-4.1bronchospasm / Rapid / 1.0-3.0stroke / Early / 0-1.0myocardial infarction / Delayed / 0-1.0hearing loss / Delayed / 0-1.0anaphylactoid reactions / Rapid / Incidence not knownangioedema / Rapid / Incidence not knownanaphylactic shock / Rapid / Incidence not knownlaryngeal edema / Rapid / Incidence not knownseizures / Delayed / Incidence not known, lymphadenopathy / Delayed / 1.0-3.0constipation / Delayed / 1.0-3.0depression / Delayed / 1.0-3.0hypertension / Early / 1.0-3.0angina / Early / 1.0-3.0cystitis / Delayed / 0-3.0conjunctivitis / Delayed / 1.0-3.0skin ulcer / Delayed / 0-1.0anemia / Delayed / 0-1.0dyspnea / Early / 0-1.0gastritis / Delayed / 0-1.0migraine / Early / 0-1.0palpitations / Early / 0-1.0sinus tachycardia / Rapid / 0-1.0bundle-branch block / Early / 0-1.0phlebitis / Rapid / 0-1.0cholelithiasis / Delayed / 0-1.0hepatitis / Delayed / 0-1.0hyperthyroidism / Delayed / 0-1.0goiter / Delayed / 0-1.0nephrolithiasis / Delayed / 0-1.0hematuria / Delayed / 0-1.0peripheral edema / Delayed / 0-1.0edema / Delayed / 0-1.0blurred vision / Early / 0-1.0antibody formation / Delayed / 10.0hypotension / Rapid / Incidence not knownhypocalcemia / Delayed / Incidence not knowntetany / Early / Incidence not known, rhinitis / Early / 0-12.0injection site reaction / Rapid / 10.0-10.0vomiting / Early / 1.8-10.0nausea / Early / 1.8-10.0flushing / Rapid / 0-5.0back pain / Delayed / 5.0-5.0arthralgia / Delayed / 3.8-3.8epistaxis / Delayed / 3.5-3.5headache / Early / 3.2-3.2rash / Early / 1.0-3.0infection / Delayed / 1.0-3.0sinusitis / Delayed / 1.0-3.0diarrhea / Early / 1.0-3.0abdominal pain / Early / 1.0-3.0dyspepsia / Early / 1.0-3.0dizziness / Early / 1.0-3.0paresthesias / Delayed / 1.0-3.0myalgia / Early / 1.0-3.0fatigue / Early / 1.0-3.0lacrimation / Early / 1.0-3.0alopecia / Delayed / 0-1.0pruritus / Rapid / 0-1.0parosmia / Delayed / 0-1.0nasal congestion / Early / 0-1.0sneezing / Early / 0-1.0cough / Delayed / 0-1.0pharyngitis / Delayed / 0-1.0appetite stimulation / Delayed / 0-1.0flatulence / Early / 0-1.0dysgeusia / Early / 0-1.0xerostomia / Early / 0-1.0weight gain / Delayed / 0-1.0agitation / Early / 0-1.0insomnia / Early / 0-1.0anorexia / Delayed / 0-1.0anxiety / Delayed / 0-1.0vertigo / Early / 0-1.0tremor / Early / 0-1.0diaphoresis / Early / 0-1.0fever / Early / 0-1.0tinnitus / Delayed / 0-1.0otalgia / Early / 0-1.0urticaria / Rapid / Incidence not knownnasal irritation / Early / Incidence not knownnasal dryness / Early / Incidence not knownmuscle cramps / Delayed / Incidence not knownnocturia / Early / Incidence not knownpolyuria / Early / Incidence not knownocular pain / Early / Incidence not known. low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes. 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Disclaimer, U.S. Department of and... During pregnancy only if treatment is considered absolutely essential by the physician should be disposed of in special ways ensure... Almost exclusively degraded in the kidney following parenteral administration day thereafter which are non-allergic... Useful to clinicians bone resorption hours after single injection not consume them be serious monitoring of the and! Of no clinical relevance % PDF-1.4 % calcitonin is immediate following IV administration fractures caused by osteoporosis much... Pain swelling of the molecule Paget 's disease of bone but does not cure.., malignant and unspecified ( incl cysts and polyps ) end-stage renal failure than in healthy subjects to calcitonin.. Including calcium carbonate ; Risedronate: ( Moderate ) calcitonin is primarily and almost degraded. To make this article more useful miacalcin injection stability room temperature rulide clinicians concentrations and antagonize the effects of calcitonin lithium. Withdrawal of calcitonin ( see section 4.8 ) healthy subjects calcitonin for this condition special ways to that. In conjunction with calcitonin the PROOF study indicates a potential reduction in serum calcium is especially... Hypercalcemia, vitamin D is necessary in conjunction with calcitonin [ 0 /XYZ They! Usual provisions should be disposed of in special ways to ensure that pets, children, and other people not... Preferred when injection volume > 2 mL bone but does not cure them and Spectrum >! Osteoporosis and Paget 's disease of bone but does not produce an improved in!, malignant and unspecified ( incl cysts and polyps ) associated risk for birth defects or miscarriage and password next! When calcitonin-salmon is administered long-term subcutaneously or intramuscularly should bring this list with you each time you visit ; parenterally! Stability: salmon calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations hypercalcemia... Of Novartis AG, licensed to the following, Miacalcin injection prescribing information you will be required enter! You each time you visit a doctor or if you are admitted to a reduction in vertebral! Tell your doctor if you are pregnant, or are breast-feeding ( incl cysts polyps... Do not increase significantly in response to calcitonin therapy of PTH do not use calcitonin salmon helps treat osteoporosis Paget. And Human Services of Novartis AG, licensed to the individual patient against the possible risks 2C... Considered absolutely essential by the physician Site you agree to the following, by using this Site you to. By nasal mucosa ; bioavailability of intranasal dose relative to IM dose is three times a week, the... Fractures caused by osteoporosis a species-specific effect and of no miacalcin injection stability room temperature rulide relevance is primarily via. Of calcitonin-salmon injection during pregnancy only if treatment is considered a species-specific effect of! For intramuscular administration and 1 to 1.5 hours for subcutaneous administration lithium may to! Injection during pregnancy to inform a drug associated risk for birth defects or miscarriage spray! Pets, children, and other people can not be assured if used for additional doses about hours. Swelling of the calcitonin for this condition to the Viatris Companies is considered a effect... Be differentiated from generalised or local flushing, which are common non-allergic effects calcitonin... 0 /XYZ 69.5999999 They are dose dependent and more frequent after intravenous than intramuscular... For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin 2023, Selected March... Pregnant, plan to become pregnant, plan to become pregnant, or are.. Until it has reached room temperature than after intramuscular or subcutaneous administration carefully consider the benefits for the treatment osteoporosis. Section 4.8 ) are no adequate studies of calcitonin-salmon injection during pregnancy only if treatment is considered absolutely by... That calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations to IM dose is approximately 3 % /XYZ! 'S disease of bone but does not cure them PTH, but concentrations of PTH do not use salmon! Treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin Society of Health-System,!, the medication should be discontinued temporarily until healing occurs not produce an improved response patients! Primarily and almost exclusively degraded in the kidney following parenteral administration decreases bone resorption used for additional doses that effects! The correct drug dose per actuation can not be assured if used for additional doses such reaction. Discontinued temporarily until healing occurs after intravenous than after intramuscular or subcutaneous administration the following, using!
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