/CSpg /DeviceGray Miacalcin Nasal Spray Storage (or generic equivalent): After opening, store bottle in use at room temperature between 20 and 25 degrees C (68 and 77 degrees F) in an upright position, for up to 35 days. Keep all supplies in a clean, dry place and out of reach of children. 20 0 obj To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. Compared to younger adults, the incidence of nasal adverse events (rhinitis, irritation, erythema, and excoriation) was higher in patients over 65 years of age, particularly those over the age of 75 years. 310.559999 0] 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. To use the sharing features on this page, please enable JavaScript. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Most events were mild in intensity. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. Healthcare providers may wish to refer patients who require skin testing to an allergist. /Annots 20 0 R Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. tell your doctor and pharmacist if you are allergic to calcitonin salmon or any other medications. There is a relationship between the subcutaneous dose of calcitonin and peak plasma concentrations. Glass or hard plastic IV containers should not be used. Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Duplication for commercial use must be authorized by ASHP. [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. Discard the bottle after 30 doses. Hypersensitivity to calcitonin salmon or any of the excipients. Purpose. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Copyright, 2023. To prime the pump before it is used for the first time, the bottle should be held upright and the two white In most patients with Paget disease, causes a decrease in the rate of bone turnover with a resultant decrease in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline excretion. With IM or sub-Q administration, 824 hours. 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. H|WMo8R*S4^$i6QfD*+~-+R$H|3|s>a>|8/.g0:=(4P/jG z4^>>F?~vUL fYQ(F'j
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v f)?.z}qO RkUo| [24558] [24298]. 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. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. $E}kyhyRm333:
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Otherwise, skip the missed dose and continue the regular dosing schedule the next day. Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. Your doctor, nurse, or pharmacist will show you how to administer the medication. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Continue to use calcitonin salmon even if you feel well. 17 0 obj Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. The dose of lithium may need to be adjusted. 12 0 obj Nausea/vomiting are less frequent when the injection is done in the evening and after meals. Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin. For the treatment of hypercalcemia, calcium supplements should be avoided. related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. 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. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. For the treatment of hypercalcemia, calcium supplements should be avoided. >> Start typing to retrieve search suggestions. Your doctor may order certain lab tests to check your body's response to calcitonin salmon. For smaller ulcers, interrupt therapy until healing occurs. 105 0 obj
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Calcitonin does not appear to cross the placenta. Therefore, breast-feeding is not recommended during treatment. Miacalcinbottle in use: 1530C, in upright position for up to 35 days. Available for Android and iOS devices. endobj [/Pattern /DeviceRGB] Your doctor may do a skin test before you start calcitonin salmon to make sure you do not have an allergic reaction to it. Mix thoroughly.Discard 0.9 mL of the diluted test injection and administer the remaining 0.1 mL intracutaneously on the flexor surface of the forearm.Development of mild erythema or wheal within 15 minutes indicates a positive reaction and calcitonin-salmon should not be administered. What side effects can this medication cause? The metabolites lack the specific biological activity of calcitonin. Calcitonin lowers serum calcium concentrations by inhibiting bone resorption with subsequent decreases in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline levels. endobj The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. What should I know about storage and disposal of this medication? cool to room temperature. Store unopened bottle under refrigeration at 2C to 8C; Once the pump has been activated, store at room temperature . Am J Health Syst Pharm. /Type /Page Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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. @ }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 Otherwise, skip the missed dose and then continue on the regular dosing schedule. Calcitonin ampoules 50 IU/ml should be inspected visually. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Adverse drug reactions from multiple sources including clinical trials and post-marketing experience are listed by MedDRA system organ class. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. For the treatment of hypercalcemia, calcium supplements should be avoided. Catecholamines, glucagon, gastrin, or cholecystokinin may stimulate calcitonin secretion. Directly inhibits osteoclastic bone resorption, altering the function and/or number of osteoclasts. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 134 0 obj
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Do not administer a double dose to make up for a missed one. << Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. In case of overdose, call the poison control helpline at 1-800-222-1222. The reported overall incidence of new primary malignancy was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%) in a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations). Inhibits lactation in animals. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. 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. \9_3chn|An 100 International Units IM or subcutaneously once daily. - Bone Resorption Inhibitors Am J Health Syst Pharm. endstream
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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. For the treatment of hypercalcemia, calcium supplements should be avoided. In lactating animals given calcitonin, suppression of milk production has been observed. Please see our, 2010comirnaty-covid-19-vaccine-mRNA-pfizer-4000140, 2010covid-19-bivalent-vaccine-mrna-moderna-4000319. 100 International Units given IM or subcutaneously once daily is the recommended dose. << 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. 10 0 obj For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. Safety and efficacy have not been established. Solution for injection/infusion (injection/infusion). Medically reviewed by Drugs.com on Mar 16, 2022. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. It may be also be taken as a subcutaneous injection. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Allergic-type reactions also reported in patients receiving calcitonin nasal spray. For the treatment of hypercalcemia, calcium supplements should be avoided. 150 0 obj
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The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. What special dietary instructions should I follow? An antiemetic may be administered, if required. Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. 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. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Since 6 manufacturers were unable to provide information for 10 medications, information was compiled and tabulated for 79 medications ( Table 1 ). Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. 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). Reduction in serum calcium concentration in patients with hypercalcemia persists for about 68 hours after single injection. Use multiple sites of injection when volume >2 mL. 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. For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. [0 /XYZ 69.5999999 Calcitonin directly inhibits osteoclasts, binding to plasma membrane receptors and increasing intracellular cyclic adenosine monophosphate (cAMP), as well as interfering with the membrane transport mechanisms of phosphate and calcium. (calcitonin-salmon) refrigeratorat36-46F. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Not known whether calcitonin is distributed into human milk. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. endstream
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It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. However, the clinical relevance of this finding is not known (see section 5.2). 9 0 obj Healthcare providers may wish to refer patients who require skin testing to an allergist.Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. Calcitonin injection: Miacalcin (Novartis) 14 days: Manufacturer: Calcitonin nasal spray: 680.159999 0] 112.799999 0] If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. The most frequently observed undesirable effects are nausea, vomiting and flushing. $O./ 'z8WG x 0YA@$/7z HeOOT _lN:K"N3"$F/JPrb[}Qd[Sl1x{#bG\NoX3I[ql2 $8xtr p/8pCfq.Knjm{r28?. This is considered a species-specific effect and of no clinical relevance. << Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. 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. >> For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. tqX)I)B>==
9. The information for 34 of these medications (38%) was obtained from the official prescribing information. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. We comply with the HONcode standard for trustworthy health information. If you log out, you will be required to enter your username and password the next time you visit. MIA-2020-0001 V3. The dose may be reduced to 50 IU daily at the start of remobilisation. Allow to reach room temperature before intramuscular or subcutaneous use. 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. 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). Differentiate hypersensitivity reactions from generalized flushing and hypotension. 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. 200 International Units (1 spray) intranasally in 1 nostril once 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. Importance of informing patients of other important precautionary information. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. . Calcitonin salmon comes as a solution to be injected under the skin (subcutaneously) or into the muscle (intramuscularly). Calcitonin 400 IU/2 ml solution for i njection and infusion . %PDF-1.6
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However, you should not flush this medication down the toilet. When suggestions are available use up and down arrows to review and ENTER to select. 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). The dose may be reduced after the condition of the patient has improved. You must declare any conflicts of interest related to your comments and responses. [63474] Calcitonin should be used only in patients who do not respond to alternative treatments or for whom such 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).[52559]. 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. qn For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. 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. Before preparing a dose, look at the vial. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. 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. Alternate nostrils daily. Prescribing Information. [27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 2007American Society of Health-System Pharmacists. If the solution is discolored or contains particles, do not use it, and call your pharmacist. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. /CreationDate (D:20210907165018-04'00') If the response is not satisfactory after 1 to 2 days, increase the dose to 8 International Units/kg IM or subcutaneously every 12 hours. Unopened Miacalcin nasal spray should be stored in the refrigerator. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. Max: 8 International Units/kg IM or subcutaneously every 6 hours. http://www.upandaway.org. Calcitonin is given parenterally (preferably by subcutaneous or intramuscular injection) or intranasally since calcitonin is destroyed in the GI tract. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Onset of action of calcitonin is immediate following IV administration. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Store in a refrigerator (2C-8C). Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. endobj 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 Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum, and mucosal blood vessels for any sign of nasal trauma are recommended for patients receiving intranasal calcitonin-salmon. IM injection preferred when injection volume >2 mL. For the treatment of hypercalcemia, vitamin D preparations should be avoided. It is not known whether salmon calcitonin crosses the placental barrier. 19 0 obj Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Miacalcin injection is available as a clear, colorless, sterile solution of synthetic calcitonin salmon, USP in individual 2 mL multi-dose vials containing 200 USP Units per mL. Do not use calcitonin salmon injection if it has been out of the refrigerator for more than 24 hours. 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. If there is anything . American Journal of Health-System Pharmacy, Regranex topical gel (Ortho-McNeil-Janssen), Diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined, Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, Erythromycin ethylsuccinate oral suspension, Enbrel (Immunex Corporation [Amgen and Wyeth Pharmaceuticals]), Repeated periods of exposure for a combined maximal duration of 6 days, Filgrastim vials and Singleject prefilled syringes, Insulin glargine (rDNA origin) vial or cartridge, Lantus vial or cartridge (Sanofi-Aventis), 70% insulin aspart protamine suspension and 30% insulin as part injection (rDNA origin) pen fill cartridge, Novolog Mix 70/30 pen fill cartridge (Novo Nordisk), 70% insulin aspart protamine suspension and 30% insulin as part injection (rDNA origin) vial, Lente human insulin (rDNA origin) zinc suspension, NPH, human insulin isophane suspension (rDNA origin), Regular human insulin injection (rDNA origin), Humulin Ultralente human insulin (rDNA origin) extended zinc suspension, Neomycin sulfate-polymixin B sulfate solution for irrigation, Neosporin G.U. Prepared synthetically or using recombinant DNA technology; contains the 32 amino acids in the same linear sequence as occurs in natural calcitonin of salmon origin. 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). 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. 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%. Treatment of Paget disease of bone. Antibody Formation: Circulating antibodies to calcitonin salmon have been reported with Miacalcin injection. Higher blood levels may be associated with increased incidence of nausea and vomiting. AHFS Patient Medication Information. 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. S . Should symptoms of overdose appear, treatment should be symptomatic. Discard the bottle after 30 doses. Osteoporosis is a disease that causes bones to weaken and break more easily. Do not freeze this medicine or shake the vials. MIACALCIN (calcitonin salmon) injection, solution. However, care should be exercised in patients receiving concurrent treatment with cardiac glycosides or calcium channel blocking agents.
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