Calcium Acetate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. VA class: HS900 >> 100 International Units given IM or subcutaneously once daily is the recommended dose. Alternate the nostril used daily. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. 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. This branded product is no longer on the market. IM injection preferred when injection volume >2 mL. Frequent monitoring of the clinical and laboratory response including the measurement of serum calcium is recommended especially in the early phases of treatment. 19 0 obj Nasal effects described as mild. For the treatment of hypercalcemia, calcium supplements should be avoided. AHFS DI Essentials. (calcitonin-salmon) refrigeratorat36-46F. Dispose of all empty syringes and vials as directed by your healthcare provider. Talk with your doctor. 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. When suggestions are available use up and down arrows to review and ENTER to select. 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 is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts. The admixtures with added buffer were studied under refrigerated storage as well. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. $O./ 'z8WG x 0YA@$/7z HeOOT _lN:K"N3"$F/JPrb[}Qd[Sl1x{#bG\NoX3I[ql2 $8xtr p/8pCfq.Knjm{r28?. If you log out, you will be required to enter your username and password the next time you visit. Nausea/vomiting are less frequent when the injection is done in the evening and after meals. endobj An increase in serum calcium concentrations helps to reduce bone resorption and loss of bone mass, and offsets the effect of calcitonin in lowering serum calcium levels. redness, swelling, or irritation at the site of injection, flushing (feeling of warmth) of the face or hands. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. Generic alternatives may be available. Stability: Salmon calcitonin: Injection: Store under refrigeration at 2C to 6C/36F to 43F; . Calcitonin-salmon injection is administered intramuscularly or subcutaneously. 172.319999 0] http://www.upandaway.org. Data are inadequate to support use of calcitonin in children. MIACALCIN (calcitonin salmon) injection, solution. 2021. H|WMo8R*S4^$i6QfD*+~-+R$H|3|s>a>|8/.g0:=(4P/jG z4^>>F?~vUL fYQ(F'j f)u}b-)i4IAp=u8txYfgsB^ =>siV@x[nh2;f1.(fL34sJ\As S/I]MURf Q/MMb}2u'9#[G &sx@z; 5*=dD&]uKJ5O v f)?.z}qO RkUo| Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin also has activity outside the bone. 2 Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . Inhibits lactation in animals. 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 helps maintain calcium homeostasis. Pyridoxine, Vitamin B6: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Written by ASHP. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . [0 /XYZ 69.5999999 Calcitonin (salmon, synthetic) . 3 0 obj Initial dosage: 100 units (0.5 mL) daily. qn Start typing to retrieve search suggestions. Actions and Spectrum 17 0 obj /PCSp 4 0 R Dissolve in 0.1 M Suitability requirements hydrochloric acid. However, the clinical relevance of this finding is not known (see section 5.2). 150 0 obj <>stream 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. Malignancy: In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). In a large multi-centered, double-blind, randomized clinical study of 942 patients using calcitonin-salmon nasal spray, geriatric patients age 65 to 74 years old accounted for 49.5% of patients and those aged 75 years or more accounted for 21%. Increased urinary lithium clearance is a proposed mechanism for the interaction. Fortical bottle in use: 2025C, in upright position for up to 30 days. Sub-Q injection preferred for patient self-administration. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. This medicine is available only with your doctor's prescription. &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@ In case of overdose, call the poison control helpline at 1-800-222-1222. General disorders and administration site conditions. DRUG INTERACTIONS: Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. 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. These changes appear to correspond to changes toward more normal bone formation. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. 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 osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. $@D` J Vn)$ @bP1# H #O Otherwise, skip the missed dose and continue the regular dosing schedule the next day. These trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo which varied between 0.7% and 2.4% with long term therapy. This product is available in the following dosage forms: Hypocalcemia must be corrected before initiating therapy. Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. 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. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Tell all of your health care providers that you take Miacalcin ( calcitonin injection). << was insufficient regarding room- temperature stability and pharma- . The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. This suggests an increased risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. We disclaim all responsibility for the professional qualifications and licensing of, and services provided by, any physician or other health providers posting on or otherwise referred to on this Site and/or any Third Party Site. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Importance of informing patients of other important precautionary information. Use of a drug with proven antifracture efficacy is recommended; experts generally recommend calcitonin as a last-line therapy when other drugs are not effective or tolerated. The analgesic effect appears to be evident for acute vertebral fractures due to osteoporosis; there is no sufficient evidence that the drug has effectiveness for pain due to prior fracture. 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. Keep all appointments with your doctor and laboratory. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. 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. Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Do not freeze this medicine or shake the vials. 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. Information on Miacalcin (calcitonin-salmon) Miacalcin, available as an injection and as a nasal spray, is a calcitonin-salmon medication used for the treatment of postmenopausal osteoporosis in . 3 In case of patients with high bone remodelling (Paget's disease and young patients) a transient decrease of calcemia may occur between the 4th and the 6th hour after administration, usually asymptomatic. Dosage is to be adjusted to the individual patient's needs. Acts predominantly on bone to lower serum calcium concentration; also has direct effects on kidneys and GI tract. 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. (See Cautions.). If there is anything . Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Peak effects are observed within 4 hours after parenteral administration. The release of calcium and phosphate from bone is reduced, and the extent of collagen breakdown is decreased. %PDF-1.4 % For the treatment of hypercalcemia, calcium supplements should be avoided. Copyright, 2023. Lithium: (Moderate) Reduced serum lithium concentrations have been observed in previously stabilized patients who initiated daily calcitonin salmon subcutaneous injections for osteoporosis. For the treatment of hypercalcemia, calcium supplements should be avoided. endobj 10 0 obj It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. 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. /GSa 3 0 R Miacalcinbottle in use: 1530C, in upright position for up to 35 days. [0 /XYZ 69.5999999 Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. 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. Pharmacokinetic/pharmacodynamic relationship. It works by preventing bone breakdown and increasing bone density (thickness). However, the clinical relevance of this finding is not known. Hypersensitivity to calcitonin salmon or any of the excipients. H\@=OQEn$dy ! .|1=( |nr]zMtxXk!:?^rt:wn/6]rO6go'c?[\B_k}.t/i-P7qSEVH*}WecH^,T\er1],9 +"2"u6-N}}\ /#ay. 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. 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. 2007American Society of Health-System Pharmacists. Calcitonin has not been studied in pregnant women. 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). Treatment of Paget disease of bone. 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). 11 0 obj [0 /XYZ 69.5999999 Each bottle contains at least 30 doses. 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. This has the potential to reduce the total dose delivered to the patient. Miacalcin Injection is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. /Producer ( w k h t m l t o p d f) Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement. Room Temperature Abciximab 2-mg/mL injection Allergen extract concentrate Alprostadil injection Alteplase Atracurium injection Becaplermin 0.01% Botulinum toxin type-A 100 units Calcitonin injection Calcitonin nasal spray Calcitonin salmon intranasal Candida albicans 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). Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed in laboratory animals. 1. This is considered a species-specific effect and of no clinical relevance. Musculoskeletal pain including arthralgia. Prescribing Information. )L^6 g,qm"[Z[Z~Q7%" Effect not reported by other investigators. 5 0 obj To prime the pump before it is used for the first time, the bottle should be held upright and the two white 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. For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. Since 6 manufacturers were unable to provide information for 10 medications, information was compiled and tabulated for 79 medications ( Table 1 ). Elimination half-life of intranasal salmon calcitonin is approximately 43 minutes. Unopened Miacalcin nasal spray should be stored in the refrigerator. What should I know about storage and disposal of this medication? Human milk naturally contains some calcitonin and its precursor, procalcitonin. 2007;64(16):1711-1715. May further titrate. A detailed skin testing protocol is available from the manufacturers; consult the specific prescribing information for contact information for the skin testing protocol. 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 data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon nasal spray (e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock). Use of salmon calcitonin in children 0 to 18 years is therefore not recommended. 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