4 Flushing (facial or upper body) is not an allergic reaction but is due to a pharmacological effect, and is usually observed 10 to 20 minutes after administration. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. 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. endstream endobj startxref A detailed skin testing protocol is available from the manufacturers; consult the specific prescribing information for contact information for the skin testing protocol. In lactating animals given calcitonin, suppression of milk production has been observed. /Pattern << Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. endstream endobj startxref Safety and efficacy not established; off-label use reported. Common Miacalcin side effects may include: bleeding from your nose; runny or stuffy nose; dryness, itching, tenderness, or general discomfort of your nose; or. Rapidly absorbed by nasal mucosa; bioavailability of intranasal dose relative to IM dose is approximately 3%. Peak effects are observed within 4 hours after parenteral administration. Ensure adequate intake of calcium (at least 1,000 mg elemental calcium per day) and vitamin D (at least 10 mcg or 400 International Units per day) during calcitonin therapy. For the treatment of hypercalcemia, calcium supplements should be avoided. However, the clinical relevance of this finding is not known (see section 5.2). Known hypersensitivity to calcitonin salmon. 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. endobj hbbd``b`.@$8@\/ bm,@5@S %: H+q%U@BHHa $"F $ 2t N:GLAe`T& a 112.799999 0] Instead, the best way to dispose of your medication is through a medicine take-back program. Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. [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. For additional instructions see sections 6.3 and 6.6. A p p r o v a l : 1 9 7 5) Your doctor may order certain lab tests to check your body's response to calcitonin salmon. If there is anything . endobj 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 . Discard the bottle after 30 doses. Discontinue nasal spray if severe ulceration of nasal mucosa (i.e., ulcers >1.5 mm in diameter or penetrating below the mucosa, ulcers associated with heavy bleeding) occurs. 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. Denosumab: (Moderate) Monitor serum calcium, phosphorus, and magnesium concentrations within 14 days of denosumab injection during concurrent treatment with calcimimetics such as calcitonin. Hypersensitivity to calcitonin salmon or any of the excipients. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Higher blood levels may be associated with increased incidence of nausea and vomiting. Each bottle contains at least 30 doses. 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. Do not administer a double dose to make up for a missed one. Duplication for commercial use must be authorized by ASHP. 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. Because it is a large peptide, any systemic absorption by the infant is unlikely because it is probably destroyed in the infant's gastrointestinal tract. /Type /Page 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. 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. The result is a decrease in urinary calcium. Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts. Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. Data are inadequate to support use of calcitonin in children. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Advise patients to record number of doses used and to discard the bottle after 30 doses. 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. The half-life of salmon calcitonin is about 1 hour. Alternate nostrils daily. 16 0 obj This website also contains material copyrighted by 3rd parties. Calcitonin (salmon, synthetic) . Actions and Spectrum The information for 34 of these medications (38%) was obtained from the official prescribing information. endstream endobj 128 0 obj <>stream This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. It is also important information to carry with you in case of emergencies. Calcitonin is excreted primarily in the urine as inactive metabolites. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. 200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously. Do not freeze this medicine or shake the vials. /Producer ( w k h t m l t o p d f) Have blood work checked as you have been told by the doctor. 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. Calcitonin antagonizes the actions of PTH, but concentrations of PTH do not increase significantly in response to calcitonin therapy. 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. Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. 1. Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed in laboratory animals. Treatment should be discontinued once the patient has responded and symptoms have resolved. Product Safety Department. 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). Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose. AHFS DI Essentials. The dose of lithium may need to be adjusted. Calcium Carbonate; Risedronate: (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. Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy. hwTTwz0z.0. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. endobj Max: 8 International Units/kg IM or subcutaneously every 6 hours. Carefully consider the benefits for the individual patient against the possible risks. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. Initial dosage: 100 units (0.5 mL) daily. 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. 2007American Society of Health-System Pharmacists. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. Allergic-type reactions also reported in patients receiving calcitonin nasal spray. This product is available in the following dosage forms: @ }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 The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. In some patients, the inhibition of bone resorption is of such a magnitude that the consequent of reduction of filtered calcium load more than compensates for the decrease in tubular reabsorption of calcium. To prime the pump before it is used for the first time, the bottle should be held upright and the two white For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. k_b Development of neutralising antibodies to calcitonin.1. Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. , a nasal examination should be avoided reporting suspected adverse reactions after authorisation of the 189 medications listed AHFS! For this condition: ( Moderate ) calcitonin is about 1 hour injection is used to treat in. Risedronate: ( Moderate ) calcitonin is given to hypercalcemic patients to serum. Salmon have been performed in laboratory animals medications listed in AHFS Drug information 2006 for storage in a reduced response... In case of emergencies material copyrighted by 3rd parties the 189 medications in. 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