For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. 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. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. [0 /XYZ 69.5999999 We offer this Site AS IS and without any warranties. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. Do not freeze this medicine or shake the vials. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. The analgesic effect appears to be evident for acute vertebral fractures due to osteoporosis; there is no sufficient evidence that the drug has effectiveness for pain due to prior fracture. Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Development of neutralising antibodies to calcitonin.1. 0 Do not use calcitonin salmon injection if it has been out of the refrigerator for more than 24 hours. General disorders and administration site conditions. 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. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. /AIS false Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Store bottle in use at room temperature between 15C-30C (59F-86F) in an upright VA class: HS900 Intranasal Nasal Solution. For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. Alternate nostrils daily. 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). [0 /XYZ 43.6799999 The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use. 10 0 obj What side effects can this medication cause? However, care should be exercised in patients receiving concurrent treatment with cardiac glycosides or calcium channel blocking agents. MIACALCIN (calcitonin salmon) injection, solution. If the liquid is not clear and colourless, or contains any particles, or the ampoule is damaged, do not use the medicine. 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 . Calcitonin 400 IU/2 ml solution for i njection and infusion . Under exceptional circumstances, e.g. Carefully consider the benefits for the individual patient against the possible risks. Fracture reduction efficacy has not been demonstrated. Each bottle contains at least 30 doses. >> Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection. We disclaim all responsibility for the professional qualifications and licensing of, and services provided by, any physician or other health providers posting on or otherwise referred to on this Site and/or any Third Party Site. 8 0 obj 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. hb```e````f``cd@ Ar4 9i80lu&0md{ew3VH^2cg7{3kKRCFCK#a3V1(z 04004iPk]t #X2H31@ +X6& [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. 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. >> Give with supplemental calcium and vitamin D if dietary intake is inadequate. 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. ` [q`o` nJ| p >=0aE/ic*{5;_/X. 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%. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. /Title ( T h e s e h i g h l i g h t s d o n o t i n c l u d e a l l t h e i n f o r m a t i o n n e e d e d t o u s e M I A C A L C I N I N J E C T I O N s a f e l y a n d e f f e c t i v e l y . If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). /Annots 20 0 R Let the solution warm to room temperature before administration. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. It allows continued monitoring of the benefit/risk balance of the medicinal product. If you are using calcitonin salmon for osteoporosis, it is important that you get enough calcium and vitamin D. Your doctor may prescribe supplements if your dietary intake is not enough. [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). This has the potential to reduce the total dose delivered to the patient. Calcitonin has an antinociceptive activity that is independent of its action on bone resorption; the mechanism is not explicitly known. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room t << Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. If the volume of the injection exceeds 2 mL, the IM route is preferred and multiple injection sites should be used.Rotate sites of injection.Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use. When studied in rabbits, salmon calcitonin-salmon decreased fetal birth weights when given by subcutaneous injection in doses 4 to 18 times the recommended human parenteral dose and 70 to 278 times the recommended human intranasal dose (based on body surface area). endstream endobj startxref Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. Calcitonin helps maintain calcium homeostasis. Neoplasms benign, malignant and unspecified (incl cysts and polyps). Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. [0 /XYZ 69.5999999 Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. 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. Ensure adequate intake of calcium (at least 1,000 mg elemental calcium per day) and vitamin D (at least 10 mcg or 400 International Units per day) during calcitonin therapy. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. 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. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. They are dose dependent and more frequent after intravenous than after intramuscular or subcutaneous administration. Activity of calcitonin salmon expressed in terms of International Units (units). Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. 467.039999 0] [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). DRUG INTERACTIONS: Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. 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. related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. 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. 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). AHFS DI Essentials. Hypersensitivity to calcitonin salmon or any of the excipients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. If severe ulceration of the nasal mucosa occurs, calcitonin nasal spray should be discontinued. 285.599999 0] Please use this form to submit your questions or comments on how to make this article more useful to clinicians. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. 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