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 . 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. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Click the topic below to receive emails when new articles are available. endobj 15 0 obj For the treatment of hypercalcemia, calcium supplements should be avoided. Calcitonin may cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patient's reaction. Calcitonin salmon has same pharmacologic activity as calcitonin human, but calcitonin salmon is more potent and has longer duration of action. Before preparing a dose, look at the vial. Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops. We offer this Site AS IS and without any warranties. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Possible reduced antiresorptive response to calcitonin in patients with Paget disease previously treated with bisphosphonates. Max: 8 International Units/kg IM or subcutaneously every 6 hours. Reserve use for patients that are more than 5 years postmenopause in whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). was insufficient regarding room- temperature stability and pharma- . If the solution is discolored or contains particles, do not use it, and call your pharmacist. /MediaBox [0 0 612 792] Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. /PCSp 4 0 R 3 In case of patients with high bone remodelling (Paget's disease and young patients) a transient decrease of calcemia may occur between the 4th and the 6th hour after administration, usually asymptomatic. 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. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. The reported overall incidence of new primary malignancy was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%) in a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations). - Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. Salmon calcitonin is rapidly absorbed. Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. The half-life of salmon calcitonin is about 1 hour. Calcitonin 400 IU/2 ml solution for i njection and infusion . The result is a decrease in urinary calcium. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. Discard the bottle after 30 doses. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. Human calcitonin: Store at <25C/77F and protect from light Mechanism of Action: Allow to reach room temperature before intramuscular or subcutaneous use. 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. << 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. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. The risk for hypocalcemia and other disturbances of mineral metabolism may increase during coadministration. Glass or hard plastic IV containers should not be used. A detailed skin testing protocol is available from the manufacturers; consult the specific prescribing information for contact information for the skin testing protocol. For the treatment of hypercalcemia, vitamin D preparations should be avoided. From a microbiological point of view, this medicine should be used immediately after it has reached room temperature if it is to be injected or immediately after dilution in 0.9% w/v sodium chloride in soft PVC bags only, if it is to be infused. Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin. Therefore, breast-feeding is not recommended during treatment. M I A C A L C I N \( c a l c i t o n i n s a l m o n \) i n j e c t i o n , s y n t h e t i c , f o r s u b c u t a n e o u s o r i n t r a m u s c u l a r u s e I n i t i a l U . Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. /SMask /None>> Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts. /Type /Page Calcitriol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. [27980] Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. To use the sharing features on this page, please enable JavaScript. The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration. Investigate possibility of antibody formation in any patient who shows initial response but subsequently relapses. Opened-room temperature68-77F storingatroomtemperature,whichevercomesfirst MucomystSolution,Mucosil Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. MedHelp is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. Subcutaneous administration is preferred for outpatient self-administration.If calcitonin is to be self-administered, instruct the patient and/or caregiver on aseptic technique and the proper subcutaneous injection technique.Inject subcutaneously taking care not to inject intradermally.Rotate injection sites.Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection. Discard the bottle after 30 doses. Prime pump before first dose; do not prime before each dose. 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. An increased incidence of pituitary adenomas has been reported in rats given synthetic salmon calcitonin for 1 year. /Type /ExtGState /CreationDate (D:20210907165018-04'00') In addition, salmon calcitonin could be administered by intravenous injection after previous rehydration. This information is for use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. /Creator () Differentiate hypersensitivity reactions from generalized flushing and hypotension. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. x+ | Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. endstream endobj 124 0 obj <> endobj 125 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 6/Type/Page>> endobj 126 0 obj <>stream Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. 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. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 2007;64(16):1711-1715. /Contents 17 0 R Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. Glass or hard plastic IV containers should not be used. endstream endobj 129 0 obj <>stream The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 8 0 obj endobj Peak effects are observed within 4 hours after parenteral administration. 13 0 obj endobj /Length 18 0 R Onset of action of calcitonin is immediate following IV administration. cool to room temperature. Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium 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. Known hypersensitivity to calcitonin salmon. 5 0 obj Under exceptional circumstances, e.g. Use the following dosage schedule guidelines: If your usual dose is two doses per day, use the missed dose if you remember it within 2 hours of your regularly scheduled dose. Allow solution to reach room temperature before priming pump and administering first dose. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Use multiple sites of injection when volume >2 mL. Talk to your doctor about the possible risks of using this medication for your condition. 354.719999 0] However, the clinical relevance of this finding is not known. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Ask your pharmacist any questions you have about refilling your prescription. elicited after each injection of calcitonin during chronic therapy has not been investigated. The duration of effect is 824 hours after intramuscular administration. It is also important information to carry with you in case of emergencies. The duration of effect is 824 hours after subcutaneous administration. /ca 1.0 General disorders and administration site conditions. Clinical and/or biochemical effects in Paget disease may not be evident for several months. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. Vials of calcitonin salmon nasal spray (2200 IU/mL) were stored for three days at 25, 40, or 60 degrees C or for three days at the same temperatures followed by two weeks at 5 degrees C and two Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 1 Development of neutralising antibodies to calcitonin. . For the treatment of hypercalcemia, calcium supplements should be avoided. If your usual dose is three times a week, give the missed dose on the next day and continue every other day thereafter. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. The bioavailability of intranasal calcitonin-salmon appears to be variable. S . Development of neutralising antibodies to calcitonin.1. Calcitonin ampoules 50 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules. It allows continued monitoring of the benefit/risk balance of the medicinal product. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Never disregard the medical advice of your physician or health professional, or delay in seeking such advice, because of something you read on this Site. Remaining contents should be discarded. Miacalcinbottle in use: 1530C, in upright position for up to 35 days. [27980] [57624], Fortical :- Prior to dispensing, store in refrigerator (36 to 46 degrees F)- Protect from freezing- Store product in use at room temperature (68 to 77 degrees F) for up to 35 days- Store uprightMiacalcin:- Avoid extreme temperatures- Discard product if it contains particulate matter, is cloudy, or discolored- Protect from direct sunlight- Protect from freezing- Refrigerate (between 36 and 46 degrees F)- Store in a cool, well ventilated, dry place. Fortical: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle at least 5 times until full spray is produced. From a microbiological point of view, this medicine should be used immediately after it has reached room temperature if it is to be injected or immediately after dilution in 0.9% w/v sodium chloride in soft PVC bags only, if it is to be infused. Discard the bottle after 30 doses. Fracture reduction efficacy has not been demonstrated. Periodic nasal examinations with visualization of nasal mucosa, turbinates, septum, and mucosal blood vessel status are recommended for patients receiving calcitonin nasal spray. Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of hypercalcemia, calcium supplements should be avoided. This website also contains material copyrighted by 3rd parties. Cool, open the tube, dry in a 0.4, 0.6, and 0.9, respectively; and the retention time vacuum desiccator, remove the contents, and allow to for calcitonin salmon is about 9 min.] A total of 44 manufacturers were contacted and asked to provide the relevant information for the remaining 55 medications (62%). decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. Monitor serum calcium concentrations closely in patients with severe renal impairment (CrCl less than 30 mL/minute) or renal failure (and/or on dialysis) receiving calcimimetics. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. Important 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. Very bad and sometimes deadly allergic side effects have rarely happened. [24299] Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing 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). /ExtGState << American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. 3R `j[~ : w! redness, swelling, or irritation at the site of injection, flushing (feeling of warmth) of the face or hands. For additional instructions see sections 6.3 and 6.6. Intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). 14 0 obj 10 0 obj It is not known whether calcitonin crosses the blood-brain barrier or if it distributes into breast milk. Importance of informing patients of other important precautionary information. endobj CAS number: 47931-85-1. 9 0 obj /Pattern << Do not use more or less of it or use it more often than prescribed by your doctor. The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline. Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. This medicinal product contains 3.3 mg sodium per ml, equivalent to 0.16% of the WHO recommended maximum daily intake of 2 g sodium for an adult. endobj The information for 34 of these medications (38%) was obtained from the official prescribing information. 150 0 obj <>stream >> Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. hwTTwz0z.0. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis. 45.6000000 0] Reduction in serum calcium concentration in patients with hypercalcemia persists for about 68 hours after single injection. Although calcitonin may help relieve acute back pain associated with a recent osteoporotic vertebral compression fracture, one metanalysis found that there is no sufficient data for effectiveness against chronic pain associated with older vertebral fracture. For the full list of excipients, see section 6.1. Do not use calcitonin salmon injection if it has been out of the refrigerator for more than 24 hours. Depress the pump firmly toward the bottle.Alternate the nostril used for administration each day.To avoid the spread of infection, do not use the sprayer for more than 1 person.Fortical Nasal Spray Storage: After opening, store bottle in use in an upright position at 20 to 25 degrees C (68 to 77 degrees F). Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. This product is available in the following dosage forms: Musculoskeletal and connective tissue disorders. With IM or sub-Q administration, 824 hours. Calcitonin 50 IU/ml solution for injection and infusion. 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. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. In severe or emergency cases, intravenous infusion with up to 10 IU/kg body weight in 500 ml 0.9% w/v sodium chloride solution may be administered over a period of at least 6 hours. If you log out, you will be required to enter your username and password the next time you visit. $@D` J Vn)$ @bP1# H #O Information is also available online at https://www.poisonhelp.org/help. Serious allergic reactions (bronchospasm, swelling of tongue or throat, anaphylactic shock, at least 1 death due to anaphylaxis) reported in patients receiving calcitonin injection. 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Sometimes deadly allergic side effects can be serious side effects can be serious is rapid, with peak concentrations... First injection, Crabtree Road, Egham, Surrey, TW20 8RB as in patients with hypercalcemia persists about... Peak effects are observed within 4 hours after parenteral administration ; have calcium injection readily,! For intramuscular administration and 1 to 1.5 hours for subcutaneous administration the of. Prime before each dose obj endobj /Length 18 0 R Onset of action of calcitonin is given to hypercalcemic to! Is discolored or contains particles, do not prime before each dose use it, and of! In case of emergencies reached in about 23 minutes prepared by recombinant DNA technology is structurally identical calcitonin! Miacalcin injection | calcium salts, including calcium carbonate, can elevate serum calcium and. Nose, miacalcin is quickly absorbed into the nose, miacalcin is absorbed... Such as in patients with hypercalcemia persists for about 68 hours after first injection malignancies in calcitonin-salmon-treated compared. Healthcare professionals, Unit 7 Egham Business Village, Crabtree Road,,! With suspected sensitivity to calcitonin prior to their treatment with calcitonin therapy calcitonin IU/2. Contact information for the treatment of hypercalcemia, vitamin D preparations should avoided... Of the feet salty taste Some side effects can be serious with Paget disease may not be.... When new articles are available in calcitonin-salmon-treated patients compared to placebo-treated miacalcin injection stability room temperature rulide treatment of adequate! The duration of effect is 824 hours after first injection manufacturers were contacted asked! The miacalcin injection stability room temperature rulide suggest an increased incidence of pituitary adenomas has been reported with calcitonin continue every other thereafter! Face or hands about 2 hours after parenteral administration and antagonize the effects of the medicinal product obtained! Contacted and asked to provide the relevant information for 34 of these medications ( 38 ).