Has been used in the treatment of glucocorticoid-induced osteoporosis [off-label]; however, other therapies (e.g., oral bisphosphonates) are preferred. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. Intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes. /XObject << Use multiple sites of injection when volume >2 mL. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Your doctor, nurse, or pharmacist will show you how to administer the medication. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Keep all appointments with your doctor and laboratory. 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. The admixtures with added buffer were studied under refrigerated storage as well. - Treatment of hypercalcemia of malignancy. Calcitonin is a human hormone that is also found in salmon. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Analyses of randomised controlled trials conducted in patients with osteoarthritis and osteoporosis have shown that calcitonin is associated with a statistically significant increase in the risk of cancer compared to patients treated with placebo. Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required. The duration of effect is 824 hours after subcutaneous administration. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 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. Calcitonin helps maintain calcium homeostasis. For additional instructions see sections 6.3 and 6.6. The metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. There is no information on the presence of calcitonin in human milk, the effects on the breast-fed infant, or the effects on milk production. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Development of neutralising antibodies to calcitonin.1. Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. Commenting is limited to medical professionals. 0
Remove the unopened bottle from the refrigerator and allow the spray to reach room temperature.Remove the protective cap.To prime the pump bottle, the bottle should be held upright and the 2 side arms of the pump depressed toward the bottle until a full spray is produced. 19 0 obj Individualize choice of therapy based on potential benefits (with respect to fracture risk reduction) and adverse effects of therapy, patient preferences, comorbidities, and risk factors. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). There are no data regarding a potential influence of calcitonin on human fertility. 1 Development of neutralising antibodies to calcitonin. The pump is primed once the first full spray is emitted.The nasal spray pump only requires priming before the first dose.To administer, carefully place the nozzle into the nostril with the patient's head in the upright position. Calcitonin directly inhibits osteoclasts, binding to plasma membrane receptors and increasing intracellular cyclic adenosine monophosphate (cAMP), as well as interfering with the membrane transport mechanisms of phosphate and calcium. Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of 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. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease; or a recommendation for a specific test, doctor, care provider, procedure, treatment plan, product, or course of action. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer. /F6 6 0 R Acts predominantly on bone to lower serum calcium concentration; also has direct effects on kidneys and GI tract. endstream
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The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. Initial dosage: 100 units (0.5 mL) daily. Chromium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Destroyed in GI tract; administer parenterally or intranasally. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. IM injection preferred when injection volume >2 mL. Calcitonin has not been studied in pregnant women. Calcitonin lowers serum calcium concentrations by inhibiting bone resorption with subsequent decreases in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline levels. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Musculoskeletal pain including arthralgia. Most events were mild in intensity. /CreationDate (D:20210907165018-04'00') Medically reviewed by Drugs.com on Mar 16, 2022. It is best to change which nostril you use each day. If you log out, you will be required to enter your username and password the next time you visit. Irrigant Sterile (Monarch Pharmaceuticals), Peg-interferon alfa-2a vial prefilled syringe, Penicillin G benzathine injection suspension, Penicillin G benzathine and penicillin G procaine injection suspension, Pneumococcal 7-valent conjugate vaccine (diphtheria CRM, Proparacaine hydrochloride ophthalmic solution, Rabies immune globulin (human) solvent/detergent treated, Tetanus immune globulin human solvent/detergent treated. Nausea/vomiting are less frequent when the injection is done in the evening and after meals. With IM or sub-Q administration, 824 hours. No studies exist on the effects of Calcitonin on the ability to drive and use machines. Solutions for infusion should be prepared immediately before use in soft plastic PVC infusion bags. /ExtGState << Calcitonin salmon helps treat osteoporosis and Paget's disease of bone but does not cure them. If the liquid is not clear and colourless, or contains any particles, or the ampoule is damaged, do not use the medicine. Malignancy: In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). /Pattern << Allow solution to reach room temperature before priming pump and administering first dose. Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing vertebral and non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). This product is available in the following dosage forms: The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. >> Discard the bottle after 30 doses. Serum calcium levels may be transiently decreased to below normal levels following administration of calcitonin, notably upon initiation of therapy in patients with abnormally high rates of bone turnover. If you become pregnant while using calcitonin salmon, call your doctor. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. If your usual dose is three times a week, give the missed dose on the next day and continue every other day thereafter. No embryo/fetal toxicities related to calcitonin-salmon were reported from maternal subcutaneous daily calcitonin-salmon doses in rats up to 80 International Units/kg/day from gestation day 6 to 15. /Contents 17 0 R Calcitonin-salmon is a synthetic polypeptide of amino acids comparable to the natural calcitonin of salmon origin and is contraindicated for use in patients with a salmon calcitonin or fish hypersensitivity. Carefully consider the benefits for the individual patient against the possible risks. Musculoskeletal and connective tissue disorders. For the treatment of hypercalcemia, calcium supplements should be avoided. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 100 International Units given IM or subcutaneously once daily is the recommended dose. For the treatment of hypercalcemia, calcium supplements should be avoided. Increased urinary lithium clearance is a proposed mechanism for the interaction. The duration of effect is 824 hours after intramuscular administration. [27980][52559] [57624], Calcitonin-salmon should be used during pregnancy only if the potential benefit justifies the use versus potential risks to the patient or fetus. Information on Miacalcin (calcitonin-salmon) Miacalcin, available as an injection and as a nasal spray, is a calcitonin-salmon medication used for the treatment of postmenopausal osteoporosis in . An increased incidence of pituitary adenomas has been reported in rats given synthetic salmon calcitonin for 1 year. \Mu}I'wP{|vq
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V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. Monitor by periodic determinations of serum alkaline phosphatase and urinary hydroxyproline excretion as well as evaluation of symptoms. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin salmon may cause other side effects. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Short-term administration results in a marked transient decrease in the volume and acidity of gastric secretions and the volume and the trypsin and amylase content of pancreatic secretions. Clinical and/or biochemical effects in Paget disease may not be evident for several months. Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . /SMask /None>> 3 0 obj This suggests an increased risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. 12 0 obj For the treatment of hypercalcemia, calcium supplements should be avoided. Store calcitonin salmon injection in its original container in the refrigerator. /SA true Please see our, 2010comirnaty-covid-19-vaccine-mRNA-pfizer-4000140, 2010covid-19-bivalent-vaccine-mrna-moderna-4000319. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. 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. 112.799999 0] Calcitonin is also contraindicated in patients with hypocalcaemia. - For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment. 8 0 obj Commercially available as calcitonin salmon. Vitamin D analogs: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The development of these antibodies is not usually related to loss of clinical efficacy, although their presence in a small percentage of patients following long-term therapy with calcitonin may result in a reduced response to the product. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. Then, continue a regular dosing schedule of every other day from that point. 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. 354.719999 0] endstream
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/ColorSpace << [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. Treatment of Paget disease of bone. However, care should be exercised in patients receiving concurrent treatment with cardiac glycosides or calcium channel blocking agents. Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Consider treatment with calcitonin or a bisphosphonate (e.g., alendronate, etidronate, pamidronate, risedronate) in patients with biochemical markers suggestive of an increase in bone remodeling, those who are symptomatic, and those at risk for future complications from their disease (e.g., those with pagetic lesions in weight-bearing regions or adjacent to joints). Administer dose by placing nozzle in nostril with head in upright position and firmly depressing pump toward bottle. /CSp /DeviceRGB S . Each 1 ml solution contains 3.3 mg sodium. 134 0 obj
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The information for 34 of these medications (38%) was obtained from the official prescribing information. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. hbbd``b`.@$8@\/ bm,@5@S %: H+q%U@BHHa $"F $
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For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. For smaller ulcers, interrupt therapy until healing occurs. In case of overdose, call the poison control helpline at 1-800-222-1222. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. Actions and Spectrum Calcitonin injection is used to treat Paget's disease of the bone. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. 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. These trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo which varied between 0.7% and 2.4% with long term therapy. 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