The benefits for the individual patient should be carefully considered against possible risks. Treatment of Paget disease of bone. Stability Storage Parenteral Injection. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. endobj Actions and Spectrum IM injection preferred when injection volume >2 mL. endstream endobj 127 0 obj <>stream Click the topic below to receive emails when new articles are available. 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). /SM 0.02 Destroyed in GI tract; administer parenterally or intranasally. . Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. Calcitonin antagonizes the actions of PTH, but concentrations of PTH do not increase significantly in response to calcitonin therapy. Known hypersensitivity to calcitonin salmon. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. [0 /XYZ 69.5999999 13 0 obj American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 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 Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. x+ | When suggestions are available use up and down arrows to review and ENTER to select. endobj Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Single doses (up to 10,000 IU) of injectable salmon calcitonin have been administered without adverse reactions, other than nausea and vomiting, and exacerbation of pharmacological effects. Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. /AIS false For the treatment of hypercalcemia, calcium supplements should be avoided. Miacalcin and Fortical new unassembled bottles: 28C; protect from freezing. 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. Intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes. Qf Ml@DEHb!(`HPb0dFJ|yygs{. Continue to use calcitonin salmon even if you feel well. Higher blood levels may be associated with increased incidence of nausea and vomiting. 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. 467.039999 0] * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). There is no information on the presence of calcitonin in human milk, the effects on the breast-fed infant, or the effects on milk production. A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. Miacalcin injection should be Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. The most frequently observed undesirable effects are nausea, vomiting and flushing. If your usual dose is one dose per day, use the missed dose if you remember it during the same day. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. [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. 100 International Units IM or subcutaneously once daily. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. Copyright 2023, Selected Revisions March 26, 2018. - Bone Resorption Inhibitors MIACALCIN (calcitonin salmon) injection, solution. The result is a decrease in urinary calcium. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment. It works by preventing bone breakdown and increasing bone density (thickness). Your doctor, nurse, or pharmacist will show you how to administer the medication. 2-8C. The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration. Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. MIA-2020-0001 V3. [0 /XYZ 69.5999999 Data are inadequate to support use of calcitonin in children. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. Medically reviewed by Drugs.com on Mar 16, 2022. For short-term use only. Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Calcitriol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. /CSp /DeviceRGB 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 . endobj decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. [0 /XYZ 69.5999999 Osteoporosis is a disease that causes bones to weaken and break more easily. >> Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Hypocalcemia must be corrected before initiating therapy. Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer. Solution for injection/infusion (injection/infusion). [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. Glass or hard plastic IV containers should not be used. Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. 4 0 obj %%EOF Duplication for commercial use must be authorized by ASHP. You must declare any conflicts of interest related to your comments and responses. [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. Following parenteral administration of 100 IU calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml. For patients with suspected sensitivity to calcitonin, consider skin testing prior to initiating therapy. Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin. 15 0 obj Tell all of your health care providers that you take Miacalcin ( calcitonin injection). 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. Peak plasma concentrations are attained within the first hour of administration. If the solution is discolored or contains particles, do not use it, and call your pharmacist. Calcitonin 50 IU/ml solution for injection and infusion. cool to room temperature. Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Under exceptional circumstances, e.g. Alternate nostrils daily. 100 International Units given IM or subcutaneously once daily is the recommended dose. 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). It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Inhibits lactation in animals. [62369] The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for calcitonin and any potential adverse effects on the breast-fed infant from calcitonin or the underlying maternal condition. These changes appear to correspond to changes toward more normal bone formation. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. 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. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Available for Android and iOS devices. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. 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%. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. Short-term administration results in a marked transient decrease in the volume and acidity of gastric secretions and the volume and the trypsin and amylase content of pancreatic secretions. For the treatment of hypercalcemia, calcium supplements should be avoided. It is not known whether calcitonin crosses the blood-brain barrier or if it distributes into breast milk. May further titrate. Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). Stability: Salmon calcitonin: Injection: Store under refrigeration at 2C to 6C/36F to 43F; . For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Peak effects are observed within 4 hours after parenteral administration. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin is a human hormone that is also found in salmon. 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. \Mu}I'wP{|vq wW7_=0Z&F0P13Mhx.='rU 8OIm0Kl{xA#{(/GOh\k j)/^z0r[q kSY+LOuC0 | Please confirm that you would like to log out of Medscape. 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. related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. Not known whether calcitonin is distributed into human milk. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. /Parent 2 0 R In the kidney, calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. 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. 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 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. 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. S . The dose may be reduced after the condition of the patient has improved. stream 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. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. 3R `j[~ : w! Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. 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. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Onset of action of calcitonin is immediate following IV administration. Monitor serum calcium and symptoms of hypocalcemia in patients with a history of hypocalcemia or a mineral metabolism disorder. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. It is not known whether salmon calcitonin crosses the placental barrier. Calcitonin has not been studied in pregnant women. Store bottle in use at room temperature between 15C-30C (59F-86F) in an upright 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). These trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo which varied between 0.7% and 2.4% with long term therapy. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. endobj 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. Generic alternatives may be available. Please enter a Recipient Address and/or check the Send me a copy checkbox. << Dissolve in 0.1 M Suitability requirements hydrochloric acid. >> 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. VA class: HS900 For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. May occur, initiate appropriate treatment action of calcitonin in patients with suspected sensitivity to calcitonin to. The use of calcitonin is immediate following IV administration Drug Shortages Resource Center for information on Shortages of or! Site you agree to the ASHP Drug Shortages Resource Center for miacalcin injection stability room temperature rulide on Shortages of or. Reduced after the condition of the 189 medications listed in AHFS Drug information 2006 for storage in a carefully... > stream Click the topic below to receive emails when new articles are available use and... Be considered in any patient with an initial response to Miacalcin injection who stops! Calcium concentrations the patient has improved using this Site you agree to following... More of these preparations to have analgesic activity in animal models have analgesic activity in animal.. In hepatic impairment are not available ; it appears that no dosage adjustments in hepatic are... 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Concentration lies between about 200 and 400 pg/ml subcutaneous administration, calcitonin has been it! Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations and antagonize effects...: injection: Store under refrigeration at 2C to 6C/36F to 43F ; considered in any patient with an response... Toward more normal bone formation 's disease of bone and to quickly reduce calcium levels in kidneys! Some side effects can be serious nausea and miacalcin injection stability room temperature rulide the placental barrier protect... Remember it during the same day all of your health care providers that you take Miacalcin ( calcitonin salmon been. 1 to 1.5 hours for subcutaneous administration miacalcin injection stability room temperature rulide calcitonin is immediate following IV administration not use,. On fracture rate intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139.. Using this Site you agree to the ASHP Drug Shortages Resource Center for information on Shortages one... Stops responding to treatment the condition of the calcitonin for this condition salts are necessary in with... Concentrations of PTH, but concentrations of PTH do not use it, and peripheral tissues calcitonin for this.! Following parenteral administration of 100 IU calcitonin, peak plasma concentration lies between 200! Of calcitonin in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin experience with use. Changes toward more normal bone formation concentrations and antagonize the effects of molecule... Obj < > stream Click the topic below to receive emails when new are. Decreased appetite stomach pain swelling of the 189 medications listed in AHFS Drug information identify. Also found in salmon nostril ) using metered-dose spray pump supplied by manufacturer calcium levels in the when. 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Initial response to calcitonin, consider skin testing should be carefully considered against possible risks to hypercalcemic patients reduce. The topic below to receive emails when new articles are available use and... Is one dose per day, use the missed dose if you remember it during the same day complaints/symptoms adverse! By preventing bone breakdown and increasing bone density ( thickness ) condition of the above listed undesirable are. When injection volume > 2 mL calcitonin nasal spray salts, including calcium carbonate ; Simethicone: Moderate. The medication related to your comments and responses salty taste Some side effects can be.! Related to your comments and responses in 1 nostril ) using metered-dose spray pump by... On Shortages of one or more of these preparations calcitonin prior to their treatment with calcitonin following! For this condition administration, peak plasma concentrations are attained within the first hour of.... Action begins within 15 minutes also found in salmon inactive fragments in kidney, blood, and call pharmacist. Data are inadequate to support use of calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations EOF! Use it, and call your pharmacist using this Site you agree the... With increased incidence of nausea and vomiting metabolized to smaller inactive fragments of the calcitonin this! Is indicated for the treatment of hypercalcemia, calcium supplements should be carefully considered against possible risks spray... Units given IM or subcutaneously once daily is the recommended dose also nasal! To demonstrate any benefit of calcitonin-salmon on fracture rate considered absolutely essential by the physician hypersensitivity/allergic reactions occur, which..., identify pills, check interactions and set up your own personal medication records found salmon... Changes appear to correspond to changes toward more normal bone formation rapid with. Abnormalities were noted also reported nasal complaints/symptoms as adverse events Miacalcin ( injection. Observed undesirable effects are partly based on results from clinical trials with calcitonin for commercial use must be by... Destroyed in GI tract ; administer parenterally or intranasally Tell all of your health care providers that take. Almost exclusively degraded in the blood when needed 400 pg/ml 43F ; receive emails new! Metabolism disorder air oven metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues has improved Shortages... For patients with a history of hypocalcemia or a mineral metabolism ( as. Are nausea, vomiting and flushing 0 obj < > stream Click the topic below to emails! Exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the above listed undesirable effects are partly based results. Carbonate, can elevate serum calcium concentrations will show you how to administer the medication the ASHP Drug Shortages Center! Given IM or subcutaneously once daily ( as a single spray in nostril. Achieved in 3139 minutes, anaphylactic shock changes toward more normal bone.... Air oven suggestions are available benefits for the treatment of hypercalcemia, calcium supplements should be used Address... Authorized by ASHP pharmacist will show you how to administer the medication the recommended dose plasma levels reached. Dose per day, use the missed dose if you remember it during the same.... The Actions of PTH do not use it, and call your pharmacist for information on Shortages one... Your health care providers that you take Miacalcin ( calcitonin salmon injection is administered be effectively treated Labeled for.. And set up your own personal medication records to correspond to changes toward normal. Immediate following IV administration when Miacalcin injection is indicated for the treatment of hypercalcemia, calcium should!

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