Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. With IM or sub-Q administration, 824 hours. 172.319999 0] Allergic-type reactions also reported in patients receiving calcitonin nasal spray. 1 Development of neutralising antibodies to calcitonin. 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. All Rights Reserved. 100 International Units given IM or subcutaneously once daily is the recommended dose. The presence of antibodies appears to bear no relationship to allergic reactions, which are rare. 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 is excreted primarily in the urine as inactive metabolites. 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. For additional instructions see sections 6.3 and 6.6. 5 0 obj Give supplemental calcium and vitamin D if dietary intake is inadequate. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. /Pattern << 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. 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. 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. redness, swelling, or irritation at the site of injection, flushing (feeling of warmth) of the face or hands. Continue to use calcitonin salmon even if you feel well. 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. Destroyed in GI tract; administer parenterally or intranasally. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Keep all appointments with your doctor and laboratory. [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. The dosing of Calcitonin should be individualized to the patient's specific requirements. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Individualize choice of therapy based on potential benefits (with respect to fracture risk reduction) and adverse effects of therapy, patient preferences, comorbidities, and risk factors. endobj ` [q`o` nJ| p >=0aE/ic*{5;_/X. Discard the bottle after 30 doses. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. /Filter /FlateDecode Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. Drug class: Antiparathyroid Agents Safety and efficacy have not been established; off-label use reported for selected conditions. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. In the kidney, calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. For the treatment of hypercalcemia, calcium supplements should be avoided. Activity of calcitonin salmon expressed in terms of International Units (units). In lactating animals given calcitonin, suppression of milk production has been observed. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. This is considered a species-specific effect and of no clinical relevance. Aspirate prior to injection to avoid injection into a blood vessel. Calcitonin-salmon has been shown to inhibit lactation in rats. 4 0 obj Solution for injection/infusion (injection/infusion). Vitamin D analogs: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. Do not stop using calcitonin salmon without talking to your doctor. >> 0 Calcitonin salmon may cause other side effects. Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. Instruct patients to seek medical care if symptoms of hypocalcemia develop. Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. However, the clinical relevance of this finding is not known. 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. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. /Creator () May 20, 2021, 19:48 ET. Talk to your doctor about the possible risks of using this medication for your condition. Duplication for commercial use must be authorized by ASHP. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. hwTTwz0z.0. 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. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. %PDF-1.4 % For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. << Following parenteral administration of 100 IU calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml. Use not recommended. Each 1 ml solution contains 3.3 mg sodium. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment. /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 . 680.159999 0] Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. 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. 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. Max: 8 International Units/kg IM or subcutaneously every 6 hours. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. Higher blood levels may be associated with increased incidence of nausea and vomiting. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. The metabolic fate of calcitonin has not been clearly established, but it is believed to be rapidly degraded by the kidneys, blood, and peripheral tissues into smaller inactive fragments. This branded product is no longer on the market. [ 8] Telephone surveys and follow-up inquiries of the products' manufacturers were conducted when. [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. endobj Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. 610.079999 0] By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. In case of overdose, call the poison control helpline at 1-800-222-1222. Follow all directions carefully. 1. The benefits for the individual patient should be carefully considered against possible risks. Peak effects are observed within 4 hours after parenteral administration. Glass or hard plastic IV containers should not be used. 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). Let the solution warm to room temperature before administration. In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with high risk of fractures (generally those who have experienced a previous hip or vertebral fracture or who have low BMD); pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients. 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 the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. The admixtures with added buffer were studied under refrigerated storage as well. $@D` J Vn)$ @bP1# H #O Calcitonin 400 IU/2 ml solution for i njection and infusion . [0 /XYZ 69.5999999 Dosage is to be adjusted to the individual patient's needs. The most frequently observed undesirable effects are nausea, vomiting and flushing. << 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). 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. 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. << >> Decreases in serum calcium are usually noted within 2 hours of a single dose; however, the hypocalcemic response to calcitonin therapy usually only lasts 4 to 7 days despite continued therapy. Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts. The half-life of salmon calcitonin is about 1 hour. - For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 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