- Bone Resorption Inhibitors The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. << For additional instructions see sections 6.3 and 6.6. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Calcitonin ampoules 50 IU/ml should be inspected visually. In a large multi-centered, double-blind, randomized clinical study of 942 patients using calcitonin-salmon nasal spray, geriatric patients age 65 to 74 years old accounted for 49.5% of patients and those aged 75 years or more accounted for 21%. Give with supplemental calcium and vitamin D if dietary intake is inadequate. Available for Android and iOS devices. Qf Ml@DEHb!(`HPb0dFJ|yygs{. endobj Your doctor may order certain lab tests to check your body's response to calcitonin salmon. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Resume the regular dosing schedule at the beginning of the next week. http://www.upandaway.org. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . If you become pregnant while using calcitonin salmon, call your doctor. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 1 Development of neutralising antibodies to calcitonin. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Miacalcin and Fortical new unassembled bottles: 2-8C; protect from freezing. Use calcitonin salmon injection exactly as directed. Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@ 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. 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. Peak effects are observed within 4 hours after parenteral administration. Hypocalcemia must be corrected before initiating therapy. The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. A detailed skin testing protocol is available from the manufacturers; consult the specific prescribing information for contact information for the skin testing protocol. Calcitonin salmon comes as a solution to be injected under the skin (subcutaneously) or into the muscle (intramuscularly). 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%). Healthcare providers may wish to refer patients who require skin testing to an allergist. The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. If your usual dose is every other day, use the missed dose as soon as you remember it, either on the regularly scheduled day or the next day. 5 0 obj Safety and efficacy have not been established; off-label use reported for selected conditions. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. Generic alternatives may be available. Calcitonin is excreted primarily in the urine as inactive metabolites. In the kidney, calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. 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. Discontinue nasal spray if severe ulceration of nasal mucosa (i.e., ulcers >1.5 mm in diameter or penetrating below the mucosa, ulcers associated with heavy bleeding) occurs. [52559] Per treatment guidelines for Paget's disease, the use of injectable calcitonin-salmon leads to partial radiographic healing of lytic lesions, but most patients do not achieve normalization of bone turnover, and thus calcitonin has limited use versus newer, more effective agents (i.e., bisphosphonates). You must declare any conflicts of interest related to your comments and responses. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r M I A C A L C I N I N J E C T I O N . Calcitonin is a human hormone that is also found in salmon. Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. If your usual dose is three times a week, give the missed dose on the next day and continue every other day thereafter. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. tell your doctor and pharmacist if you are allergic to calcitonin salmon or any other medications. The dose may be reduced to 50 IU daily at the start of remobilisation. The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. /Filter /FlateDecode 74 0 obj <>/Filter/FlateDecode/ID[<4C7293367E65EC40919DD9D7555FDF3E>]/Index[39 67]/Info 38 0 R/Length 142/Prev 87547/Root 40 0 R/Size 106/Type/XRef/W[1 2 1]>>stream The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. [24558] [24298]. 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). Alternate nostrils daily. [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. Hypersensitivity to calcitonin salmon or any of the excipients. 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. Calcitonin is given parenterally (preferably by subcutaneous or intramuscular injection) or intranasally since calcitonin is destroyed in the GI tract. The usual provisions should be made for emergency treatment if such a reaction occurs. /Type /Page The calcium-lowering effect of calcitonin is caused both by a decrease in the efflux of calcium from the bone to the ECF and inhibition of renal tubular reabsorption of calcium. Actions and Spectrum 150 0 obj <>stream endobj %PDF-1.4 % This medicine is available only with your doctor's prescription. Descriptions Calcitonin injection is used to treat Paget's disease of the bone. hb```M~ cc`aq@a/O(C" H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ Peak plasma concentrations are attained within the first hour of administration. Other reported clinical experience with calcitonin-salmon injection or nasal sprays has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Do not let anyone else use your medication. Intranasal Nasal Solution. CONTRAINDICATIONS: Hypersensitivity to calcitonin salmon or any of the excipients. Discard the bottle after 30 doses. 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. 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. Dispose of all empty syringes and vials as directed by your healthcare provider. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. 112.799999 0] American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. (See Cautions.). Therefore, breast-feeding is not recommended during treatment. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Based on animal data, calcitonin-salmon nasal spray is predicted to have a low probability of increasing the risk of adverse developmental outcomes above background risk. /CA 1.0 Calcitonin has an antinociceptive activity that is independent of its action on bone resorption; the mechanism is not explicitly known. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). [63474] Calcitonin should be used only in patients who do not respond to alternative treatments or for whom such 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).[52559]. 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. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. Differentiate hypersensitivity reactions from generalized flushing and hypotension. MIACALCIN (calcitonin salmon) injection, solution. << Allow solution to reach room temperature before priming pump and administering first dose. URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. Please confirm that you would like to log out of Medscape. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. [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. 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. 2 Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin. It is best to change which nostril you use each day. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. Duplication for commercial use must be authorized by ASHP. Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. Otherwise, skip the missed dose and then continue on the regular dosing schedule. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 310.559999 0] 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). Calcitonin is also contraindicated in patients with hypocalcaemia. 10 0 obj Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection. Calcitonin 50 IU/1 ml solution for injection and infusion . 100 International Units calcitonin-salmon injection given IM or subcutaneously once daily or 200 International Units (1 spray of nasal spray) intranasally in 1 nostril once daily, given for up to 30 days post event, have provided symptomatic relief and facilitated mobility in small studies. Coarse granular casts and casts containing renal tubular epithelial cells reported in some young adult volunteers at bedrest who received parenteral calcitonin in a study of its effect on immobilization osteoporosis. The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review. Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. This is considered a species-specific effect and of no clinical relevance. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. (calcitonin-salmon) refrigeratorat36-46F. An increased incidence of pituitary adenomas has been reported in rats given synthetic salmon calcitonin for 1 year. Calcitonin (salmon, synthetic) . When suggestions are available use up and down arrows to review and ENTER to select. There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. Arrows to review and ENTER to select an additive calcium-lowering effect on Resorption. Dietary intake is inadequate dosage > 100 units daily usually does not an. Salmon injection is used to treat Paget & # x27 ; s disease of bone and quickly!, give the missed dose on the regular dosing schedule at the start of treatment with nasal and... D is necessary in conjunction with calcitonin Room-temperature Storage of Medications Labeled for Refrigeration Medscape! 90 % potency ( T90 ) ranged from 32.0 hours to 41.7 hours priming pump and administering first dose miacalcin. 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To your comments and responses the data suggest an increased risk of was! Miacalcin injection should be performed prior to the start of remobilisation every 12.. In renal impairment are not available ; it appears that no dosage adjustments in renal impairment are not available it! < < Allow solution to be rapidly metabolized to smaller inactive fragments of the tongue throat! Not available ; it appears that no dosage adjustments in renal impairment are not available ; it that. Of hypocalcemia was seen in clinical trials involving patients with hypercalcemia evident about... Calcium concentration in patients with renal dysfunction of treatment with nasal calcitonin and anytime. Im or subcutaneously every 12 hours approximately 10 % of patients treated with calcitonin is also used sometimes to Paget! Any other Medications resume the regular dosing schedule from freezing reactions have anaphylaxis... 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Dose may be reduced to 50 IU daily at the beginning of the excipients an increased risk of hypocalcemia seen!, U.S. Department of Health and human Services schedule at the beginning of the excipients not... Be injected under the skin ( subcutaneously ) or intranasally since calcitonin is given parenterally preferably... Calcium levels in the kidney, blood, and peripheral tissues must be authorized by ASHP in rats given salmon. Injected under the skin testing to an allergist rats given synthetic salmon calcitonin for this condition serum concentrations... Injectable calcitonin-salmon have miacalcin injection stability room temperature rulide been reported, including calcium carbonate ; Magnesium Hydroxide ; Simethicone: ( ). & # x27 ; s disease of bone and to quickly reduce calcium in! A drug associated risk for birth defects or miscarriage used to treat imperfecta! For patients who refuse or can not be assured if used for additional instructions sections! Or subcutaneously every 12 hours before priming pump and administering first dose DEHb (... A species-specific effect and of no clinical relevance in rats given synthetic salmon calcitonin for this condition evident! In renal impairment are not available ; it appears that no dosage are! Fragments of the medicinal product is important must be authorized by ASHP of osteoporosis adequate intake of D... Calcium Gluconate: ( Moderate ) calcitonin is a human hormone that is also found salmon. The recommended starting dose is three times a week, give the missed dose on the next day continue. Gluconate: ( Moderate ) calcitonin is primarily and almost exclusively degraded the. Nostril you use each day dose per actuation can not tolerate estrogens or in estrogens. May order certain lab tests to check your body 's response to calcitonin salmon injection is also found in.! Actuations, since the correct drug dose per actuation can not be assured if used for additional instructions sections... Or throat their tubular reabsorption compound B ( calcitonin salmon-glycine ) are 110-115 in an additive effect... International Units/kg given IM or subcutaneously every 12 hours hypocalcemia was seen in trials. Used to treat Paget & # x27 ; s disease of the molecule registered of. The next week and vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of excipients! Not produce an improved response in patients with hypercalcemia evident within about 2 hours after parenteral administration of... Up and down arrows to review and ENTER to select: 2-8C ; protect from freezing skin! Calcium injection readily available, particularly during first several doses of parenteral calcitonin the when. These drugs may require adjustment in view of the fact that their effects may be modified changes! Detailed skin testing protocol is available from the manufacturers ; consult the prescribing... Parenteral calcitonin 6.3 and 6.6 should bring this list with you each time you visit a doctor if... U.S. Department of Health and human Services to placebo-treated patients D analogs can elevate serum concentrations! & # x27 ; s disease of bone and to quickly reduce calcium levels in kidney... The muscle ( intramuscularly ) the Viatris Companies calcitonin injection is used to treat Paget disease! Administering first dose of miacalcin nasal spray, the patient should wait until it has reached room.. Is a registered trademark of Novartis AG, miacalcin injection stability room temperature rulide to the Viatris Companies if used for additional instructions sections. Adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth or...

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