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). Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. Calcitonin-salmon is a synthetic polypeptide of amino acids comparable to the natural calcitonin of salmon origin and is contraindicated for use in patients with a salmon calcitonin or fish hypersensitivity. - Treatment of hypercalcemia of malignancy. AHFS DI Essentials. 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. endstream endobj startxref The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. Before priming the pump and using a new bottle, allow it to reach room temperature. Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. 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. The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. 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. Miacalcin: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle until full spray is produced. Serious allergic reactions (bronchospasm, swelling of tongue or throat, anaphylactic shock, at least 1 death due to anaphylaxis) reported in patients receiving calcitonin injection. Acts predominantly on bone to lower serum calcium concentration; also has direct effects on kidneys and GI tract. The dose of lithium may require adjustment. 100 International Units IM or subcutaneously once daily. What special dietary instructions should I follow? Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. %PDF-1.6 % The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. 12 0 obj Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Following IM administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin injection: Miacalcin (Novartis) 14 days: Manufacturer: Calcitonin nasal spray: For the treatment of hypercalcemia, calcium supplements should be avoided. . Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses. %%EOF For the full list of excipients, see section 6.1. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Miacalcinbottle in use: 1530C, in upright position for up to 35 days. Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. 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 calcitonin salmon injection in its original container in the refrigerator. Calcitonin is a human hormone that is also found in salmon. IM injection preferred when injection volume >2 mL. 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 tqX)I)B>== 9. Calcitonin ampoules 50 IU/ml should be inspected visually. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. endobj [0 /XYZ 69.5999999 General disorders and administration site conditions. Fracture reduction efficacy has not been demonstrated. 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. Calcitonin has not been studied in pregnant women. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . For the treatment of hypercalcemia, vitamin D preparations should be avoided. stream Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4). Allergic-type reactions also reported in patients receiving calcitonin nasal spray. endstream endobj 128 0 obj <>stream Calcitonin may cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patient's reaction. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. CONTRAINDICATIONS: Hypersensitivity to calcitonin salmon or any of the excipients. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Advise patients to record number of doses used and to discard the bottle after 30 doses. Mylan Institutional LLC. In lactating animals given calcitonin, suppression of milk production has been observed. Stability Storage Parenteral Injection. /ExtGState << Ampicillin 12 g in 1 L normal saline intravenous bags, without buffer addition, was stable for at least 24 hours when stored at room temperature. Type I, clear glass ampoule containing 1 ml of solution. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Calcitonin-salmon appears to have actions essentially identical to endogenous calcitonin of mammalian origin, but its potency per mg is greater than endogenous calcitonin, and it has a longer duration of action. 0 The result is a decrease in urinary calcium. [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). Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. Miacalcin and Fortical new unassembled bottles: 2-8C; protect from freezing. 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 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. 8 0 obj 2-8C. It is not known whether salmon calcitonin crosses the placental barrier. Calcium; Vitamin D: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin 400 IU/2 ml solution for i njection and infusion . It works by preventing bone breakdown and increasing bone density (thickness). 100 International Units given IM or subcutaneously once daily is the recommended dose. For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. If the volume of the injection exceeds 2 mL, the IM route is preferred and multiple injection sites should be used.Rotate sites of injection.Dispose of the used syringe and needle in an FDA-cleared sharps disposal container after use. [0 /XYZ 69.5999999 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. Inhibits lactation in animals. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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 Use multiple sites of injection when volume >2 mL. The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. 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. Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. We comply with the HONcode standard for trustworthy health information. Osteoporosis is a disease that causes bones to weaken and break more easily. 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. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months. Drug class: Antiparathyroid Agents Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. 5 0 obj [27980] 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). /Creator () Discard the bottle after 30 doses. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). Resume the regular dosing schedule at the beginning of the next week. Calcitonin has a short absorption half-life of 10-15 minutes. There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin (salmon, synthetic) . Treatment of Paget disease of bone. What side effects can this medication cause? If you are using calcitonin salmon for osteoporosis, it is important that you get enough calcium and vitamin D. Your doctor may prescribe supplements if your dietary intake is not enough. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Under exceptional circumstances, e.g. With parenteral therapy, nausea, vomiting, injection site reaction, flushing of the face, ears, hands, and feet. For the treatment of hypercalcemia, calcium supplements should be avoided. Click the topic below to receive emails when new articles are available. The admixtures with added buffer were studied under refrigerated storage as well. 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. For the treatment of hypercalcemia, calcium supplements should be avoided. Tell all of your health care providers that you take Miacalcin ( calcitonin injection). 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. The bioavailability of intranasal calcitonin-salmon appears to be variable. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. If your usual dose is one dose per day, use the missed dose if you remember it during the same day. 2007;64(16):1711-1715. Inject into a large muscle. )L^6 g,qm"[Z[Z~Q7%" 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. Effect not reported by other investigators. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 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. [27980]Ensure adequate intake of calcium and vitamin D during osteoporosis treatment and prevention. 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. Prime pump before first dose; do not prime before each dose. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. 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. Of the 189 medications listed in AHFS Drug Information 2006 for storage in a refrigerator,[9] 89 were present in our pharmacy department's refrigerator and were included in this review. Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. Miacalcin and Fortical new unassembled bottles: 28C; protect from freezing. 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