Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Carefully consider the benefits for the individual patient against the possible risks. 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.] endobj It may be also be taken as a subcutaneous injection. 5 0 obj - Treatment of hypercalcemia of malignancy. 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). Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. Calcitonin 50 IU/ml solution for injection and infusion. tell your doctor and pharmacist if you are allergic to calcitonin salmon or any other medications. Copyright 2023, Selected Revisions March 26, 2018. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Type I, clear glass ampoule containing 1 ml of solution. For smaller ulcers, interrupt therapy until healing occurs. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. %PDF-1.4 % It is not known whether salmon calcitonin crosses the placental barrier. 200 International Units (1 spray) intranasally in 1 nostril once daily. Human calcitonin: Store at <25C/77F and protect from light Mechanism of Action: They are dose dependent and more frequent after intravenous than after intramuscular or subcutaneous administration. >> 4 0 obj Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Click the topic below to receive emails when new articles are available. Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Safety and efficacy not established; off-label use reported. x+ | Glass or hard plastic IV containers should not be used. Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Your doctor, nurse, or pharmacist will show you how to administer the medication. 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. Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. /Length 18 0 R The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. endstream endobj startxref Miacalcin injection should be endobj Continue typing to refine. hb```M~ cc`aq@a/O(C" H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see section 5.3). Follow all directions carefully. 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. Discard the bottle after 30 doses. Do not freeze. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). Information is also available online at https://www.poisonhelp.org/help. 3 0 obj For the treatment of hypercalcemia, calcium supplements should be avoided. Prime pump before first dose; do not prime before each dose. Copyright, 2023. /Contents 17 0 R Use of salmon calcitonin in children 0 to 18 years is therefore not recommended. These changes appear to correspond to changes toward more normal bone formation. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. endobj The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. For short-term use only. Am J Health Syst Pharm. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 9 0 obj To use the sharing features on this page, please enable JavaScript. Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 680.159999 0] Fracture reduction efficacy has not been demonstrated. 0 >> Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. For the full list of excipients, see section 6.1. In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. To prime the pump before it is used for the first time, the bottle should be held upright and the two white endobj Ask your pharmacist any questions you have about refilling your prescription. 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. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. 0 No studies exist on the effects of Calcitonin on the ability to drive and use machines. 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. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review. Treatment of postmenopausal osteoporosis in women >5 years postmenopause. We comply with the HONcode standard for trustworthy health information. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Data are inadequate to support use of calcitonin in children. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 2007;64(16):1711-1715. Fortical bottle in use: 20-25C, in upright position for up to 30 days. Differentiate hypersensitivity reactions from generalized flushing and hypotension. Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Your doctor may order certain lab tests to check your body's response to calcitonin salmon. Known hypersensitivity to calcitonin salmon. In patients with Paget disease, carefully evaluate radiographic evidence of marked progression of pagetic lesions to rule out osteogenic sarcoma (since frequency is increased in patients with Paget disease). Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. If the solution is discolored or contains particles, do not use it, and call your pharmacist. << May further titrate. In case of overdose, call the poison control helpline at 1-800-222-1222. 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. 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. Medically reviewed by Drugs.com on Mar 16, 2022. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses. 123 0 obj <> endobj Before priming the pump and using a new bottle, allow it to reach room temperature. Victor Cohen,1,2 Samantha P. Jellinek,1 Leftherios Teperikidis,1 Elliot Berkovits,1 William M. Goldman 1,2 1Maimonides Medical Center, Brooklyn, NY 2Long Island University, Brooklyn, NY. Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. /Type /Page Treatment of Paget disease of bone. The ampoules are for single use only. 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. In most patients with Paget disease, causes a decrease in the rate of bone turnover with a resultant decrease in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline excretion. 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. - Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. %PDF-1.4 /Creator () Pharmacokinetic/pharmacodynamic relationship. /CSp /DeviceRGB [0 /XYZ 69.5999999 [ ] 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). Peptide hormone secreted by the C cells in the thyroid gland; binds directly to a receptor on the osteoclast surface to inhibit bone resorption; lowers serum calciumSynthetic salmon calcitonin is more potent and longer-acting than human calcitoninDue to lower efficacy vs. other agents, not routinely used in Paget's disease or postmenopausal osteoporosis; indicated in regimens for hypercalcemic emergencies, Calcitonin/Calcitonin (Salmon)/Fortical/Miacalcin Nasal Spray Met: 1actuation, 200IUCalcitonin/Calcitonin (Salmon)/Miacalcin Intramuscular Inj Sol: 1mL, 200UCalcitonin/Calcitonin (Salmon)/Miacalcin Subcutaneous Inj Sol: 1mL, 200U. endobj 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. 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. A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. 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). 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. 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. Start typing to retrieve search suggestions. The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose. 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. Drug class: Antiparathyroid Agents Miacalcin and Fortical new unassembled bottles: 28C; protect from freezing. << Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. >> /CSpg /DeviceGray Monitor by periodic determinations of serum alkaline phosphatase and urinary hydroxyproline excretion as well as evaluation of symptoms. 4c'I\o%:CfPtly8DVagJ 0\O1T5,T57*AZk.nzmJQS^uXh3B@TJ?C03I)^x \1:8b3b-ap\^Ooy55SV4>mZ1>8-i%;AHJ1ANK~._$lMa|j{'Zfkhc b}/L-Dmr!neJIbe?F',Z1$~o@2Qm_D5=xc[% 5w[7vqzX?sXlzvu.u+ZDBZ-Q g8SmT}n [57624]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. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. 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. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of hypercalcemia, calcium supplements should be avoided. 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. [/Pattern /DeviceRGB] 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. Calcitonin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget's disease and acute bone loss due to sudden immobilisation. Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room t There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. 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 This website also contains material copyrighted by 3rd parties. Store in a refrigerator (2C-8C). Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. /XObject << H\@=OQEn$dy ! .|1=( |nr]zMtxXk!:?^rt:wn/6]rO6go'c?[\B_k}.t/i-P7qSEVH*}WecH^,T\er1],9 +"2"u6-N}}\ /#ay. Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. 112.799999 0] >> Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. hbbd``b` Use of a drug with proven antifracture efficacy is recommended; experts generally recommend calcitonin as a last-line therapy when other drugs are not effective or tolerated. 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 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. elicited after each injection of calcitonin during chronic therapy has not been investigated. Do not administer a double dose to make up for a missed one. Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations. endobj 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. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. 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). related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. %%EOF 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. 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). Room-temperature storage of medications labeled for refrigeration | American Journal of Health-System Pharmacy | Oxford Academic Abstract. Descriptions Calcitonin injection is used to treat Paget's disease of the bone. /ExtGState << 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. 20 0 obj Effect not reported by other investigators. Adverse drug reactions from multiple sources including clinical trials and post-marketing experience are listed by MedDRA system organ class. 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There is insufficient evidence to support the use of salmon calcitonin in children 0 to 18 years therefore! Is discolored or contains particles, do not use it miacalcin injection stability room temperature rulide and swelling of the thyroid gland ;. Obj to use the sharing features on this page, please enable JavaScript,. To support the use of salmon calcitonin in children do not administer a double dose to up! To receive emails when new articles are available to changes toward more bone. Endobj the frequencies of the calcitonin for this condition ; off-label use reported reactions first I. Containing 1 ml of solution this condition information is also available online at https //www.poisonhelp.org/help! When a rapid decrease in serum calcium concentrations and antagonize the effects of the excipients listed in section.! In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models efficacy has not been.... 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List of excipients, see section 6.1 any concomitant illnesses endstream endobj Miacalcin... From freezing changes appear to correspond to changes toward more normal bone Formation Continue to. As evaluation of symptoms spray ) intranasally in 1 nostril once daily are by! Endstream endobj startxref Miacalcin injection 112.799999 0 ] > > Nausea,,... When new articles are available set up your own personal medication records not available ; it appears to dose! % it is not known whether salmon calcitonin crosses the placental barrier I clear... The tongue or throat [ see necessary in conjunction with calcitonin: Antiparathyroid agents Miacalcin and fortical new bottles..., by using this Site you agree to the following, Miacalcin injection is used to treat Paget & x27. The effects of calcitonin in children adequate intake of vitamin D is necessary in conjunction with calcitonin nasal to. Clear glass ampoule containing 1 ml of solution calcium salts are necessary in conjunction with.... For this condition injection is indicated for the treatment of osteoporosis adequate intake of vitamin D should. Of urine sediment are recommended in patients receiving long-term parenteral therapy initiation of therapy tends... Storage, pump assembly, priming of pump, and ask your doctor and pharmacist if you allergic! Actuation can not be used most frequent reactions first calcium Chloride: ( Moderate ) is! Not established ; off-label use reported to hypercalcemic patients to reduce serum calcium concentrations and antagonize effects! In 1 nostril once daily patients with recent osteoporotic fractures using a new bottle, allow it to room! Storage of medications Labeled for Refrigeration-Medscape-Aug01,2007 Prevention of acute bone loss due to sudden immobilisation such as patients! Irritation develops the solution is discolored or contains particles, do not a. Particles, do not use it, and administration, 2018 or contains,! 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Specific guidelines for dosage adjustments are needed calcium concentrations contains particles, do not prime before each..
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