Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose. 10 0 obj Descriptions Calcitonin injection is used to treat Paget's disease of the bone. Your doctor may order certain lab tests to check your body's response to calcitonin salmon. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. These changes appear to correspond to changes toward more normal bone formation. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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). CONTRAINDICATIONS: Hypersensitivity to calcitonin salmon or any of the excipients. Monitor serum calcium and symptoms of hypocalcemia in patients with a history of hypocalcemia or a mineral metabolism disorder. 1 0 obj For the treatment of hypercalcemia, vitamin D preparations should be avoided. /XObject << For additional instructions see sections 6.3 and 6.6. hb```e````f``cd@ Ar4 9i80lu&0md{ew3VH^2cg7{3kKRCFCK#a3V1(z 04004iPk]t #X2H31@ +X6& Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin helps maintain calcium homeostasis. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. 310.559999 0] Fortical bottle in use: 20-25C, in upright position for up to 30 days. This medicine is available only with your doctor's prescription. 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. Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts. Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts. Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. 2021. Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic potential. @ }PM#!.;wfpEk#=&rsn|f#{wqU~o:{c]n_oO?g=w O_w-n2XS1m7~_\_/v1EcNd~sy~K7Gc8U9b8Y93\Xx[vWkkU ] c { pY 6 *| p t)8 v{ pRp0 87 7e 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. You've successfully added to your alerts. [0 /XYZ 69.5999999 For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. 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. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. endobj 15 0 obj However, you should not flush this medication down the toilet. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. Periodic nasal examinations with visualization of nasal mucosa, turbinates, septum, and mucosal blood vessel status are recommended for patients receiving calcitonin nasal spray. << Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Morgantown, W.V. [0 /XYZ 69.5999999 Calcitonin-salmon Nasal Spray:Before the first dose, the nasal spray should be at room temperature. Continue to use calcitonin salmon even if you feel well. /GSa 3 0 R For the treatment of hypercalcemia, vitamin D preparations should be avoided. If your usual dose is one dose per day, use the missed dose if you remember it during the same day. An increased incidence of pituitary adenomas has been reported in rats given synthetic salmon calcitonin for 1 year. /MediaBox [0 0 612 792] You will receive email when new content is published. For nasal dosage form (spray): For postmenopausal osteoporosis: Adults200 International Units (IU) or 1 spray into one nostril per day. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. [ ] Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. For the treatment of hypercalcemia, calcium supplements should be avoided. Your doctor may do a skin test before you start calcitonin salmon to make sure you do not have an allergic reaction to it. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. << It is not known whether calcitonin crosses the blood-brain barrier or if it distributes into breast milk. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. It is not known if the substance is excreted in human milk. Since 6 manufacturers were unable to provide information for 10 medications, information was compiled and tabulated for 79 medications ( Table 1 ). Each bottle contains at least 30 doses. 2007;64(16):1711-1715. As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day. Click the topic below to receive emails when new articles are available. >> It is also important information to carry with you in case of emergencies. k_b Common Miacalcin side effects may include: bleeding from your nose; runny or stuffy nose; dryness, itching, tenderness, or general discomfort of your nose; or. Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Keep all supplies in a clean, dry place and out of reach of children. Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. endstream endobj 40 0 obj <>>> endobj 41 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/TrimBox[0.0 0.0 585.0 783.0]/Type/Page>> endobj 42 0 obj <>stream Resume the regular dosing schedule at the beginning of the next week. Opened-room temperature68-77F storingatroomtemperature,whichevercomesfirst MucomystSolution,Mucosil [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. Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. endobj Calcitonin also has activity outside the bone. In case of overdose, call the poison control helpline at 1-800-222-1222. &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@ For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. For additional instructions see sections 6.3 and 6.6. Purpose. 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. Inject into a large muscle. Calcitonin is given parenterally (preferably by subcutaneous or intramuscular injection) or intranasally since calcitonin is destroyed in the GI tract. endobj qn Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. 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 Calcitonin 100 IU/1 ml solution for injection and infusion . Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. The stability of calcitonin salmon in calcitonin salmon nasal spray at elevated temperatures was studied. For the treatment of hypercalcemia, calcium supplements should be avoided. >> Development of neutralising antibodies to calcitonin.1. However, the clinical relevance of this finding is not known. 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. For additional instructions see sections 6.3 and 6.6. Catecholamines, glucagon, gastrin, or cholecystokinin may stimulate calcitonin secretion. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. In normal volunteers, bioavailability of the intranasal formulation compared to the parenteral product is 3%, with a range of 0.330.6%. ADVERSE REACTIONS: The most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%). The duration of effect is 0.512 hours after IV administration. Do not stop using calcitonin salmon without talking to your doctor. 150 0 obj <>stream Calcitonin may be considered for women who can not or will not take more effective agents; do not prescribe in early menopause as benefit/efficacy has not been observed within the first 5 years of menopause onset. Initial dosage: 100 units (0.5 mL) daily. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Store in a refrigerator (2C-8C). /PCSp 4 0 R Under exceptional circumstances, e.g. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. /CA 1.0 Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. CARLSBAD, Calif., May 20, 2021 /PRNewswire/ -- Leucadia Pharmaceuticals, a U.S. leader in generic injectables and the commercial arm of Custopharm, Inc., today announced . Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. For short-term use only. 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. Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. What special precautions should I follow? 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. [27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. Commenting is limited to medical professionals. A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. Hypersensitivity to calcitonin salmon or any of the excipients. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. Adverse drug reactions from multiple sources including clinical trials and post-marketing experience are listed by MedDRA system organ class. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. tqX)I)B>== 9. 1 Development of neutralising antibodies to calcitonin. Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. 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). Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. ` [q`o` nJ| p >=0aE/ic*{5;_/X. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If the response is not satisfactory after 1 to 2 days, increase the dose to 8 International Units/kg IM or subcutaneously every 12 hours. Glass or hard plastic IV containers should not be used. Do not administer a double dose to make up for a missed one. Calcitonin is a human hormone that is also found in salmon. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 9 0 obj With IM or sub-Q administration, 15 minutes. 45.6000000 0] Calcitonin salmon helps treat osteoporosis and Paget's disease of bone but does not cure them. Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. 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. 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. Prime pump before first dose; do not prime before each dose. 680.159999 0] The duration of effect is 824 hours after intramuscular administration. Am J Health Syst Pharm. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. 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 [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). The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. No studies exist on the effects of Calcitonin on the ability to drive and use machines. /AIS false Call your doctor if you have any unusual problems while taking this medication. endstream endobj 129 0 obj <>stream If the volume of the injection exceeds 2 mL, intramuscular injection is preferable and multiple injection sites should be used.Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.With chronic use, ensure adequate intake of calcium and vitamin D to reduce the risk of treatment-related hypocalcemia. S prescription, you should bring this list with you each time you visit a doctor or you. Normal volunteers, bioavailability of the bone you visit a doctor or if you admitted. Even if you feel well stability of calcitonin { 5 ; _/X was seen clinical. 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