>> This product is available in the following dosage forms: 11 0 obj Musculoskeletal and connective tissue disorders. You will receive email when new content is published. Safety and efficacy have not been established; off-label use reported for selected conditions. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. 680.159999 0] The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement. Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. Store in a refrigerator (2C-8C). You've successfully added to your alerts. Do not use more or less of it or use it more often than prescribed by your doctor. No studies exist on the effects of Calcitonin on the ability to drive and use machines. For the treatment of hypercalcemia, calcium supplements should be avoided. 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. redness, swelling, or irritation at the site of injection, flushing (feeling of warmth) of the face or hands. S . hbbd``b`.@$8@\/ bm,@5@S %: H+q%U@BHHa $"F $ 2t N:GLAe`T& a Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. 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 Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts. Fracture reduction efficacy has not been demonstrated. Your doctor may do a skin test before you start calcitonin salmon to make sure you do not have an allergic reaction to it. With IM or sub-Q administration, 824 hours. stream 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. Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . This medicinal product contains 3.3 mg sodium per ml, equivalent to 0.16% of the WHO recommended maximum daily intake of 2 g sodium for an adult. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. endstream endobj startxref Calcium Gluconate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. [ 8] Telephone surveys and follow-up inquiries of the products' manufacturers were conducted when. (calcitonin-salmon) refrigeratorat36-46F. The release of calcium and phosphate from bone is reduced, and the extent of collagen breakdown is decreased. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Each bottle contains at least 30 doses. It is not known if the substance is excreted in human milk. Most events were mild in intensity. << endstream endobj 128 0 obj <>stream Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. [/Pattern /DeviceRGB] Discard the bottle after 30 doses. Following IM administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Talk with your doctor. However, you should not flush this medication down the toilet. 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. Let the solution warm to room temperature before administration. 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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. Human milk naturally contains some calcitonin and its precursor, procalcitonin. Calcitonin helps maintain calcium homeostasis. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. $O./ 'z8WG x 0YA@$/7z HeOOT _lN:K"N3"$F/JPrb[}Qd[Sl1x{#bG\NoX3I[ql2 $8xtr p/8pCfq.Knjm{r28?. Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). Inhibits lactation in animals. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Allow to reach room temperature before intramuscular or subcutaneous use. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. << Of the 189 medications listed in AHFS Drug Information 2006 for storage in a . Calcitonin ampoules 50 IU/ml should be inspected visually. Data are inadequate to support use of calcitonin in children. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Talk with the doctor. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. [0 /XYZ 69.5999999 x][o~_93EK! What special precautions should I follow? Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Initial dosage: 100 units (0.5 mL) daily. Destroyed in GI tract; administer parenterally or intranasally. For the treatment of hypercalcemia, calcium supplements should be avoided. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Alternate nostrils daily. 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. 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). 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 Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Tell all of your health care providers that you take Miacalcin ( calcitonin injection). What should I know about storage and disposal of this medication? Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Reduction in serum calcium concentration in patients with hypercalcemia persists for about 68 hours after single injection. Keep all supplies in a clean, dry place and out of reach of children. 16 0 obj /CreationDate (D:20210907165018-04'00') endobj 2-8C. Calcitonin has not been studied in pregnant women. This information is for use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. 1. Continue typing to refine. 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. AHFS Patient Medication Information. Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. /F7 7 0 R The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. xS*B.C 4T0 \.LcC4.TO+cCC#,.@ 30 /AIS false Advise patients to record number of doses used and to discard the bottle after 30 doses. 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. Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed in laboratory animals. 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 Increased urinary lithium clearance is a proposed mechanism for the interaction. Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. /MediaBox [0 0 612 792] Periodic nasal examinations with visualization of nasal mucosa, turbinates, septum, and mucosal blood vessel status are recommended for patients receiving calcitonin nasal spray. 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. 3 0 obj Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis. Each 1 ml solution contains 3.3 mg sodium. Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. 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. Call your doctor if you have any unusual problems while taking this medication. Because calcitonin is a peptide, the possibility of systemic allergic reactions exists and allergic-type reactions including isolated cases of anaphylactic shock have been reported in patients receiving calcitonin. For the treatment of hypercalcemia, calcium supplements should be avoided. Paricalcitol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The addition of 10 mM sodium phosphate buffer . Do not stop using calcitonin salmon without talking to your doctor. For the treatment of hypercalcemia, calcium supplements should be avoided. Initially, 4 units/kg every 12 hours; may increase dosage after 1 or 2 days (if response not adequate) to 8 units/kg every 12 hours; may further increase dosage after 2 days (if response not adequate) to 8 units/kg every 6 hours. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Hypocalcemia associated with tetany and seizure activity has been reported with calcitonin therapy. The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. Stability Storage Parenteral Injection. Please confirm that you would like to log out of Medscape. 112.799999 0] URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. 45.6000000 0] Since 6 manufacturers were unable to provide information for 10 medications, information was compiled and tabulated for 79 medications ( Table 1 ). Calcitonin does not appear to cross the placenta. 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. Compared to younger adults, the incidence of nasal adverse events (rhinitis, irritation, erythema, and excoriation) was higher in patients over 65 years of age, particularly those over the age of 75 years. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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.] Clinical and/or biochemical effects in Paget disease may not be evident for several months. Glass or hard plastic IV containers should not be used. 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. The metabolites lack the specific biological activity of calcitonin. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. /Font << /SMask /None>> H\@=OQEn$dy ! .|1=( |nr]zMtxXk!:?^rt:wn/6]rO6go'c?[\B_k}.t/i-P7qSEVH*}WecH^,T\er1],9 +"2"u6-N}}\ /#ay. If severe ulceration of the nasal mucosa occurs, calcitonin nasal spray should be discontinued. AHFS DI Essentials. For the treatment of hypercalcemia, calcium supplements should be avoided. [52559] Per treatment guidelines for Paget's disease, the use of injectable calcitonin-salmon leads to partial radiographic healing of lytic lesions, but most patients do not achieve normalization of bone turnover, and thus calcitonin has limited use versus newer, more effective agents (i.e., bisphosphonates). For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 9 0 obj Calcitonin salmon has same pharmacologic activity as calcitonin human, but calcitonin salmon is more potent and has longer duration of action. Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). However, the clinical relevance of this finding is not known (see section 5.2). Calcium; Vitamin D: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. 4 0 obj Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. MedHelp is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. Miacalcin and Fortical new unassembled bottles: 28C; protect from freezing. 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). The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration. /Creator () /Resources 19 0 R Calcitonin (salmon, synthetic) . For short-term use only. Calcitonin may cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patient's reaction. Dosage is to be adjusted to the individual patient's needs. k_b 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 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. Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline. Give with supplemental calcium and vitamin D if dietary intake is inadequate. Do not freeze. The development of these antibodies is not usually related to loss of clinical efficacy, although their presence in a small percentage of patients following long-term therapy with calcitonin may result in a reduced response to the product. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Hypersensitivity to calcitonin salmon or any of the excipients. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent.
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