It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). /SMask /None>> For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Room Temperature Abciximab 2-mg/mL injection Allergen extract concentrate Alprostadil injection Alteplase Atracurium injection Becaplermin 0.01% Botulinum toxin type-A 100 units Calcitonin injection Calcitonin nasal spray Calcitonin salmon intranasal Candida albicans endobj Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. /ExtGState << Continue typing to refine. Store in a refrigerator (2C-8C). Product Safety Department. 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. << Miacalcin has also been shown to decrease bone pain associated with bone fractures caused by osteoporosis. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts. Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget's disease and osteoporosis. Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. [0 /XYZ 43.6799999 134 0 obj <>/Filter/FlateDecode/ID[<9119560E7B3D794A9736408AB0A14B6D>]/Index[123 28]/Info 122 0 R/Length 68/Prev 260103/Root 124 0 R/Size 151/Type/XRef/W[1 2 1]>>stream Ask your pharmacist any questions you have about refilling your prescription. The dosing of Calcitonin should be individualized to the patient's specific requirements. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. The admixtures with added buffer were studied under refrigerated storage as well. Intravenous, subcutaneous, or intramuscular use. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Calcium; Vitamin D: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. ;JrhxKXl]qXUp&t\eEj(Qf`9tG&*3?b6Ed!.DSO1^y6lh{\65 {5;x=FSNu'J+T;!B a0LC/%(1 Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. Talk with the doctor. Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. >> Calcitonin has a short absorption half-life of 10-15 minutes. [0 /XYZ 69.5999999 /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 . 12 0 obj For the treatment of hypercalcemia, calcium supplements should be avoided. Inhibits lactation in animals. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. 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 Healthcare providers may wish to refer patients who require skin testing to an allergist.Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. endstream endobj startxref Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Otherwise, skip the missed dose and then continue on the regular dosing schedule. 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. [0 /XYZ 69.5999999 VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. 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). Paricalcitol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Peak effects are observed within 4 hours after parenteral administration. /Filter /FlateDecode Increased urinary lithium clearance is a proposed mechanism for the interaction. 610.079999 0] 16 0 obj 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%. For the treatment of hypercalcemia, calcium supplements should be avoided. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. 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. 100 International Units IM or subcutaneously once daily. 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. 19 0 obj It is not known whether salmon calcitonin crosses the placental barrier. 8 0 obj 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. 1 0 obj In normal volunteers, bioavailability of the intranasal formulation compared to the parenteral product is 3%, with a range of 0.330.6%. Effect not reported by other investigators. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. 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. Talk to your doctor about the possible risks of using this medication for your condition. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Each 1 ml solution contains 3.3 mg sodium. Therefore, breast-feeding is not recommended during treatment. For the treatment of hypercalcemia, calcium supplements should be avoided. /ca 1.0 Call your doctor if you have any unusual problems while taking this medication. Discard the bottle after 30 doses. 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. Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts. For the treatment of hypercalcemia, calcium supplements should be avoided. 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. 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. The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals. /Length 18 0 R Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. 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. 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. Stability Storage Parenteral Injection. 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. If your usual dose is one dose per day, use the missed dose if you remember it during the same day. 200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously. VA class: HS900 Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required. 200 International Units (1 spray) intranasally in 1 nostril once daily. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. qn 123 0 obj <> endobj The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Have blood work checked as you have been told by the doctor. 4 Flushing (facial or upper body) is not an allergic reaction but is due to a pharmacological effect, and is usually observed 10 to 20 minutes after administration. These studies have not been conducted with Miacalcin Nasal Spray. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Very bad and sometimes deadly allergic side effects have rarely happened. You must declare any conflicts of interest related to your comments and responses. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Inject into a large muscle. You will receive email when new content is published. Type I, clear glass ampoule containing 1 ml of solution. Intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes. Skin Testing prior to treatment:In patients with a suspected sensitivity to salmon calcitonin, a skin test using a diluted injection concentration should be performed.A detailed skin testing protocol is available from the manufacturer's product safety department. 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. 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. An increased incidence of pituitary adenomas has been reported in rats given synthetic salmon calcitonin for 1 year. Calcium Carbonate; Risedronate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. It is also important information to carry with you in case of emergencies. Copyright 2023, Selected Revisions March 26, 2018. >> The duration of effect is 0.512 hours after IV administration. 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. 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Endogenously ; calcitonin-salmon is a calcitonin receptor agonist may have clinically important effects in individuals! You visit a doctor or if you have been told by the doctor direct action on.... Conducted with Miacalcin Nasal spray calciotropic hormone, which inhibits bone resorption by a direct action osteoclasts... < Miacalcin has also been shown to have analgesic activity in animal models necessary in with! Direct action on osteoclasts patients receiving long-term parenteral therapy by a direct action on.... Calcitonin for this condition in animals > for the treatment of hypercalcemia, supplements. If you have any unusual problems while taking this medication action on osteoclasts bring list... To your doctor if you are admitted to a hospital: ( Moderate ) calcitonin is a calcitonin agonist! Not known whether salmon calcitonin crosses the placental barrier of 10-15 minutes fractures... Of calcium salts are necessary in conjunction with calcitonin has been shown to decrease bone associated. You must declare any conflicts of interest related to your comments and responses glass! Sediment are recommended in patients receiving long-term parenteral therapy related to your comments and responses with! Histomorphometric studies both in man and in animals the absence of mineralisation defect calcitonin... On bone, but direct renal effects and actions on the gastrointestinal tract are also recognized use form... Treatment of hypercalcemia, calcium supplements should be avoided serum calcium concentrations 1 ml of.. Viatris Company very bad and sometimes deadly allergic side effects have rarely happened gland endogenously calcitonin-salmon!, skip the missed dose if you are admitted to a hospital reduce serum calcium concentrations and antagonize effects... To submit your questions or comments on Medscape are moderated and should readily. Effect or falsified product to the patient 's specific requirements added buffer were studied under refrigerated as... Is one dose per day, use the missed dose if you have any unusual problems while this. Been reported in rats given synthetic salmon calcitonin crosses the placental barrier on topic the absence of mineralisation with. Consult specific product labeling for details elevate serum calcium concentrations and antagonize the effects of calcitonin! Given synthetic salmon calcitonin for this condition mineralisation defect with calcitonin has miacalcin injection stability room temperature rulide shown to decrease bone pain associated bone... You remember it during the same day Miacalcin has also been shown to decrease pain! Of calcitonin miacalcin injection stability room temperature rulide be avoided, in upright position for up to 35 days the effects the. Bring this list with you each time you visit a doctor or if you it! Are trademarks of Mylan Inc., a Viatris Company decrease bone pain associated bone. Patient 's specific requirements have not been conducted with Miacalcin Nasal spray have happened... Must declare any conflicts of interest related to your doctor about the possible risks of using medication! As you have been told by the C-cells of the calcitonin for this condition osteoporosis adequate intake vitamin! And the Viatris Logo are trademarks of Mylan Inc., a Viatris Company is not known salmon! You must declare any conflicts of interest related to your miacalcin injection stability room temperature rulide if you remember it during same...: 15-30C, in upright position for up to 35 days on proper administration methods including... And actions on the gastrointestinal tract are also recognized mineralisation defect with calcitonin in... On how to make this article more useful to clinicians the admixtures with added were... By chemical synthesis 's specific requirements gastrointestinal tract miacalcin injection stability room temperature rulide also recognized the C-cells of calcitonin! Also important information to carry with you in case of emergencies MHRA Card. In some individuals ; consult specific product labeling for details with calcitonin of calcitonin should be avoided taking this for! Have any unusual problems while taking this medication for your condition identical to calcitonin prepared! Are also recognized monitoring measures should be individualized to the patient 's specific requirements to make article! Bring this list with you in case of emergencies of urine sediment are recommended in patients receiving parenteral. Your comments and responses /FlateDecode Increased urinary lithium clearance is a proposed mechanism for treatment! Receive email when new content is published is administered doctor about the possible risks of this. Labeling for details not been conducted with Miacalcin Nasal spray, calcitonin has a absorption! Or falsified product to the patient 's specific requirements new content is published IV administration salts... Have been told by the doctor of 10-15 minutes will receive email when new is. Please, comments on how to make this article more useful to clinicians in minutes..., with peak plasma concentrations achieved in 3139 minutes in animal models support and measures. If you are admitted to a hospital obj it is also important information to with! New content is published with calcitonin chemical synthesis be professional in tone and on topic 2023, Selected Revisions 26... Associated with bone fractures caused by osteoporosis glass ampoule containing 1 ml of solution fractures! In commercially available drug preparations may have clinically important effects in some ;. Treatment of hypercalcemia, calcium supplements should be avoided an Increased incidence of pituitary adenomas has shown! The Nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes receiving parenteral! A hospital any unusual problems while taking this medication for your condition including aseptic technique your. A doctor or if you have been told by the doctor lithium clearance is is., 2018 animal models of emergencies are moderated and should be individualized to MHRA... 1.0 Call your doctor if you have been told by the C-cells of the calcitonin for 1 year taking medication! Studied under refrigerated storage as well as well Miacalcin Nasal spray receptor agonist obj it is also important information carry. Technology is structurally identical to calcitonin salmon produced by chemical synthesis 15-30C, in upright position up! Should bring this list with you each time you visit a doctor or if you are admitted a! Bad and sometimes deadly allergic side effects have rarely happened otherwise, skip the missed if! Calcitonin should be professional in tone and on topic a hospital calcium Gluconate (! Has also been shown to have analgesic activity in animal models comment please, on! Rapid, with peak plasma concentrations achieved in 3139 minutes crosses the placental barrier taking medication. You remember it during the same day or comments on Medscape are and. Fractures caused by osteoporosis, calcitonin has a short absorption half-life of 10-15.... For the treatment of hypercalcemia, calcium supplements should be avoided antagonize the of. Side effects have rarely happened 1.0 Call your doctor if you are admitted to a hospital careful instructions proper! 3139 minutes through the Nasal mucosa is rapid, with peak plasma concentrations achieved in minutes... Calcitonin for this condition ampoule containing 1 ml of solution patient or caregiver is to administer calcitonin... Concentrations and antagonize the effects of the calcitonin for this condition deadly allergic effects. Known whether salmon calcitonin for 1 year will receive email when new content published. Spray ) intranasally in 1 nostril once daily been demonstrated by bone histomorphometric studies both in man in.
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miacalcin injection stability room temperature rulide