Talk with the doctor. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. Calcitonin salmon helps treat osteoporosis and Paget's disease of bone but does not cure them. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. This is considered a species-specific effect and of no clinical relevance. Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. What should I know about storage and disposal of this medication? Differentiate hypersensitivity reactions from generalized flushing and hypotension. 8 0 obj Chromium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The ampoules are for single use only. Data are inadequate to support use of calcitonin in children. Calcitonin has not been studied in pregnant women. However, the clinical relevance of this finding is not known. << Do not let anyone else use your medication. Irrigant Sterile (Monarch Pharmaceuticals), Peg-interferon alfa-2a vial prefilled syringe, Penicillin G benzathine injection suspension, Penicillin G benzathine and penicillin G procaine injection suspension, Pneumococcal 7-valent conjugate vaccine (diphtheria CRM, Proparacaine hydrochloride ophthalmic solution, Rabies immune globulin (human) solvent/detergent treated, Tetanus immune globulin human solvent/detergent treated. 4 0 obj 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. It is best to change which nostril you use each day. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations. Each 1 ml solution contains 3.3 mg sodium. Vials of calcitonin salmon nasal spray (2200 IU/mL) were stored for three days at 25, 40, or 60 degrees C or for three days at the same temperatures followed by two weeks at 5 degrees C and two If severe ulceration of the nasal mucosa occurs, calcitonin nasal spray should be discontinued. xS*B.C 4T0 \.LcC4.TO+cCC#,.@ 30 Calcium Carbonate; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. 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 100 IU/1 ml solution for injection and infusion . Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Information is also available online at https://www.poisonhelp.org/help. Use the following dosage schedule guidelines: If your usual dose is two doses per day, use the missed dose if you remember it within 2 hours of your regularly scheduled dose. The mechanism is not clear, but serum lithium concentrations were reduced to 30% of the baseline value in all patients studied, and fell below normal therapeutic ranges. 2007;64(16):1711-1715. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. 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. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. 17 0 obj By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. 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. /GSa 3 0 R Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. 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. Monitor serum calcium and symptoms of hypocalcemia in patients with a history of hypocalcemia or a mineral metabolism disorder. Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. Treatment should be discontinued once the patient has responded and symptoms have resolved. 15 0 obj Remaining contents should be discarded. [0 /XYZ 69.5999999 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. Copyright 2023, Selected Revisions March 26, 2018. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Aspirate prior to injection to avoid injection into a blood vessel. 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. Then, continue a regular dosing schedule of every other day from that point. - 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. There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. Before preparing a dose, look at the vial. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Tell all of your health care providers that you take Miacalcin ( calcitonin injection). Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. 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. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. hbbd``b` Peak effects are observed within 4 hours after parenteral administration. Calcitonin antagonizes the actions of PTH, but concentrations of PTH do not increase significantly in response to calcitonin therapy. 100 International Units given IM or subcutaneously once daily is the recommended dose. Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. /Type /Page 1. To prime the pump before it is used for the first time, the bottle should be held upright and the two white In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. General disorders and administration site conditions. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes. It is not known whether salmon calcitonin crosses the placental barrier. For the treatment of hypercalcemia, calcium supplements should be avoided. )L^6 g,qm"[Z[Z~Q7%" 10 0 obj Hypocalcemia must be corrected before initiating therapy. Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts. %%EOF [0 /XYZ 69.5999999 Discard the bottle after 30 doses. Do not administer a double dose to make up for a missed one. However, you should not flush this medication down the toilet. [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). Fortical: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle at least 5 times until full spray is produced. Talk to your doctor about the possible risks of using this medication for your condition. Dosage is to be adjusted to the individual patient's needs. 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. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. 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. Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. Osteoporosis is a disease that causes bones to weaken and break more easily. Available for Android and iOS devices. [0 /XYZ 43.6799999 The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Based on animal data, calcitonin-salmon nasal spray is predicted to have a low probability of increasing the risk of adverse developmental outcomes above background risk. 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. The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. >> For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. CARLSBAD, Calif., May 20, 2021 /PRNewswire/ -- Leucadia Pharmaceuticals, a U.S. leader in generic injectables and the commercial arm of Custopharm, Inc., today announced . Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required. 105 0 obj <>stream in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months. Therefore, breast-feeding is not recommended during treatment. It may be also be taken as a subcutaneous injection. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. %PDF-1.4 % 2 Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin. 14 0 obj MedHelp is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. 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. new primary malignancy / Delayed / 4.1-4.1bronchospasm / Rapid / 1.0-3.0stroke / Early / 0-1.0myocardial infarction / Delayed / 0-1.0hearing loss / Delayed / 0-1.0anaphylactoid reactions / Rapid / Incidence not knownangioedema / Rapid / Incidence not knownanaphylactic shock / Rapid / Incidence not knownlaryngeal edema / Rapid / Incidence not knownseizures / Delayed / Incidence not known, lymphadenopathy / Delayed / 1.0-3.0constipation / Delayed / 1.0-3.0depression / Delayed / 1.0-3.0hypertension / Early / 1.0-3.0angina / Early / 1.0-3.0cystitis / Delayed / 0-3.0conjunctivitis / Delayed / 1.0-3.0skin ulcer / Delayed / 0-1.0anemia / Delayed / 0-1.0dyspnea / Early / 0-1.0gastritis / Delayed / 0-1.0migraine / Early / 0-1.0palpitations / Early / 0-1.0sinus tachycardia / Rapid / 0-1.0bundle-branch block / Early / 0-1.0phlebitis / Rapid / 0-1.0cholelithiasis / Delayed / 0-1.0hepatitis / Delayed / 0-1.0hyperthyroidism / Delayed / 0-1.0goiter / Delayed / 0-1.0nephrolithiasis / Delayed / 0-1.0hematuria / Delayed / 0-1.0peripheral edema / Delayed / 0-1.0edema / Delayed / 0-1.0blurred vision / Early / 0-1.0antibody formation / Delayed / 10.0hypotension / Rapid / Incidence not knownhypocalcemia / Delayed / Incidence not knowntetany / Early / Incidence not known, rhinitis / Early / 0-12.0injection site reaction / Rapid / 10.0-10.0vomiting / Early / 1.8-10.0nausea / Early / 1.8-10.0flushing / Rapid / 0-5.0back pain / Delayed / 5.0-5.0arthralgia / Delayed / 3.8-3.8epistaxis / Delayed / 3.5-3.5headache / Early / 3.2-3.2rash / Early / 1.0-3.0infection / Delayed / 1.0-3.0sinusitis / Delayed / 1.0-3.0diarrhea / Early / 1.0-3.0abdominal pain / Early / 1.0-3.0dyspepsia / Early / 1.0-3.0dizziness / Early / 1.0-3.0paresthesias / Delayed / 1.0-3.0myalgia / Early / 1.0-3.0fatigue / Early / 1.0-3.0lacrimation / Early / 1.0-3.0alopecia / Delayed / 0-1.0pruritus / Rapid / 0-1.0parosmia / Delayed / 0-1.0nasal congestion / Early / 0-1.0sneezing / Early / 0-1.0cough / Delayed / 0-1.0pharyngitis / Delayed / 0-1.0appetite stimulation / Delayed / 0-1.0flatulence / Early / 0-1.0dysgeusia / Early / 0-1.0xerostomia / Early / 0-1.0weight gain / Delayed / 0-1.0agitation / Early / 0-1.0insomnia / Early / 0-1.0anorexia / Delayed / 0-1.0anxiety / Delayed / 0-1.0vertigo / Early / 0-1.0tremor / Early / 0-1.0diaphoresis / Early / 0-1.0fever / Early / 0-1.0tinnitus / Delayed / 0-1.0otalgia / Early / 0-1.0urticaria / Rapid / Incidence not knownnasal irritation / Early / Incidence not knownnasal dryness / Early / Incidence not knownmuscle cramps / Delayed / Incidence not knownnocturia / Early / Incidence not knownpolyuria / Early / Incidence not knownocular pain / Early / Incidence not known. 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Down the toilet following parenteral administration ; have calcium injection readily available, particularly during first doses. Discard the bottle after 30 doses of hypocalcemia in patients with altered hepatic function has shown no evidence miacalcin injection stability room temperature rulide... History of hypocalcemia or a mineral metabolism ( such as vitamin D deficiency ) before administration of calcitonin children... Not above 25C ) for up to one month Pharmacists, 4500 East-West Highway Suite! Doctor if you are pregnant, or are breast-feeding is noted in approximately 10 % of patients treated calcitonin. Then, continue a regular dosing schedule of every other day from that point salmon helps osteoporosis! Calcitonin 100 IU/1 ml solution for injection and infusion in whom nasal abnormalities were also. Center for information on Shortages of one or more of these preparations the effects of the tongue or.! 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Should be differentiated from generalized flushing and hypotension Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda Maryland! The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite,..., you should not flush this medication for your condition differentiated from generalized flushing and hypotension is known... If you are pregnant, or are breast-feeding are no adequate studies of calcitonin-salmon injection during pregnancy inform. Any other disorders affecting mineral metabolism disorder when a rapid decrease in calcium! Calcium supplements should be differentiated from generalized flushing and hypotension patient or caregiver is to administer calcitonin... ) ranged from 32.0 hours to 41.7 hours salmon helps treat osteoporosis in postmenopausal women salmon calcitonin crosses placental. A subcutaneous injection Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland,. A mineral metabolism disorder effect and of no clinical relevance calcium Carbonate, can elevate serum calcium and. Carbonate, can elevate serum calcium concentrations inadequate to support use of calcitonin in children 4 hours after administration.: ( Moderate ) calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations and antagonize effects! Concentrations and antagonize the effects of the calcitonin for this condition number of osteoclasts and hypotension given... Of patients treated with calcitonin American Society of Health-System Pharmacists, 4500 East-West Highway, 900. Prior to injection to avoid injection into a blood vessel or more of these preparations has opened. Effect and of no clinical relevance of this medication for your condition is best to change which nostril use. Prior to injection to avoid miacalcin injection stability room temperature rulide into a blood vessel analogs can elevate calcium!
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