S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r M I A C A L C I N I N J E C T I O N . >> Calcitonin-salmon is a synthetic polypeptide of amino acids comparable to the natural calcitonin of salmon origin and is contraindicated for use in patients with a salmon calcitonin or fish hypersensitivity. Available for Android and iOS devices. Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. The information for 34 of these medications (38%) was obtained from the official prescribing information. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. For patients with suspected sensitivity to calcitonin, consider skin testing prior to initiating therapy. Copyright, 2023. Glass or hard plastic IV containers should not be used. The dose of lithium may require adjustment. Continue to use calcitonin salmon even if you feel well. [ ] MIACALCIN (calcitonin salmon) injection, solution. If you log out, you will be required to enter your username and password the next time you visit. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). 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. endobj Pyridoxine, Vitamin B6: (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. Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Unopened Miacalcin nasal spray should be stored in the refrigerator. << Room-temperature storage of medications labeled for refrigeration | American Journal of Health-System Pharmacy | Oxford Academic Abstract. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Each 1 ml solution contains 3.3 mg sodium. For smaller ulcers, interrupt therapy until healing occurs. endobj For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Salmon calcitonin is rapidly absorbed. 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. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . 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| For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Store unopened bottle under refrigeration at 2C to 8C; Once the pump has been activated, store at room temperature . Talk to your doctor about the possible risks of using this medication for your condition. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. tqX)I)B>==
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http://www.upandaway.org. Inject into a large muscle. Glass or hard plastic IV containers should not be used. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. endstream
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/Type /ExtGState Allow solution to reach room temperature before priming pump and administering first dose. 8 0 obj If you become pregnant while using calcitonin salmon, call your doctor. The ampoules are for single use only. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. Miacalcin has also been shown to decrease bone pain associated with bone fractures caused by osteoporosis. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. [ 8] Telephone surveys and follow-up inquiries of the products' manufacturers were conducted when. For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. Stability: Salmon calcitonin: Injection: Store under refrigeration at 2C to 6C/36F to 43F; . Vitamin D analogs: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For additional instructions see sections 6.3 and 6.6. 17 0 obj Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. endobj >> Use not recommended. Investigate possibility of antibody formation in any patient who shows initial response but subsequently relapses. 45.6000000 0] /Producer ( w k h t m l t o p d f) Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . Do not stop using calcitonin salmon without talking to your doctor. Calcitonin 100 IU/1 ml solution for injection and infusion . Administer dose by placing nozzle in nostril with head in upright position and firmly depressing pump toward bottle. Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Stability Storage Parenteral Injection. It is not known whether salmon calcitonin crosses the placental barrier. endobj The most frequently observed undesirable effects are nausea, vomiting and flushing. If the liquid is not clear and colourless, or contains any particles, or the ampoule is damaged, do not use the medicine. Appropriate agents for treatment of hypersensitivity reactions should be readily available. Initially, 4 International Units/kg given IM or subcutaneously every 12 hours. VA class: HS900 Clinical and/or biochemical effects in Paget disease may not be evident for several months. /SA true >> Alternate the nostril used daily. Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. Prime pump before first dose; do not prime before each dose. 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). [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). When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. << 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. We comply with the HONcode standard for trustworthy health information. The bioavailability of intranasal calcitonin-salmon appears to be variable. The half-life of salmon calcitonin is about 1 hour. 3R `j[~ : w! For the treatment of hypercalcemia, calcium supplements should be avoided. Have blood work checked as you have been told by the doctor. Human milk naturally contains some calcitonin and its precursor, procalcitonin. /Type /Page For the full list of excipients, see section 6.1. Drug class: Antiparathyroid Agents In case of overdose, call the poison control helpline at 1-800-222-1222. [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. 100 International Units IM or subcutaneously once daily. Increased urinary lithium clearance is a proposed mechanism for the interaction. 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 . 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. /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 . CAS number: 47931-85-1. MedHelp is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. It is usually used once a day or once every other day. Fortical bottle in use: 20-25C, in upright position for up to 30 days. 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 Calcitonin is excreted primarily in the urine as inactive metabolites. Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. 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. With intranasal therapy, rhinitis, nasal symptoms, back pain. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. Let the solution warm to room temperature before administration. We offer this Site AS IS and without any warranties. For the treatment of hypercalcemia, calcium supplements should be avoided. Calcitonin injection is used to treat Paget's disease of the bone. Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. A p p r o v a l : 1 9 7 5) Give with supplemental calcium and vitamin D if dietary intake is inadequate. Calcitonin does not appear to cross the placenta. Your doctor, nurse, or pharmacist will show you how to administer the medication. Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing vertebral and non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). 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. Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. $E}kyhyRm333:
}=#ve It may be also be taken as a subcutaneous injection. endobj The duration of effect is 0.512 hours after IV administration. 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. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. endstream
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Data are inadequate to support use of calcitonin in children. Elimination half-life of intranasal salmon calcitonin is approximately 43 minutes. Initial dosage: 100 units (0.5 mL) daily. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. The presence of antibodies appears to bear no relationship to allergic reactions, which are rare. [27980] Depress the pump firmly toward the bottle.Alternate the nostril used for administration each day.To avoid the spread of infection, do not use the sprayer for more than 1 person.Fortical Nasal Spray Storage: After opening, store bottle in use in an upright position at 20 to 25 degrees C (68 to 77 degrees F). Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Use calcitonin salmon injection exactly as directed. Musculoskeletal and connective tissue disorders. 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. [27980]Ensure adequate intake of calcium and vitamin D during osteoporosis treatment and prevention. Each bottle contains at least 30 doses. In normal volunteers, bioavailability of the intranasal formulation compared to the parenteral product is 3%, with a range of 0.330.6%. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. With parenteral therapy, nausea, vomiting, injection site reaction, flushing of the face, ears, hands, and feet. Pharmacokinetic/pharmacodynamic relationship. [27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. For the treatment of osteoporosis adequate intake of calcium salts are 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 50 IU/ml solution for injection and infusion. 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. endobj 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 . Calcitonin salmon has same pharmacologic activity as calcitonin human, but calcitonin salmon is more potent and has longer duration of action. The addition of 10 mM sodium phosphate buffer . Follow all directions carefully. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. /Filter /FlateDecode Common Miacalcin side effects may include: bleeding from your nose; runny or stuffy nose; dryness, itching, tenderness, or general discomfort of your nose; or. Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. Generic alternatives may be available.
The duration of effect is 824 hours after subcutaneous administration. A total of 44 manufacturers were contacted and asked to provide the relevant information for the remaining 55 medications (62%). Discard the bottle after 30 doses. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. [0 /XYZ 69.5999999 Copyright 2023, Selected Revisions March 26, 2018. Discard the bottle after 30 doses. /MediaBox [0 0 612 792] 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. Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops. 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. Neoplasms benign, malignant and unspecified (incl cysts and polyps). Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. /CSp /DeviceRGB The pump is primed once the first full spray is emitted.The nasal spray pump only requires priming before the first dose.To administer, carefully place the nozzle into the nostril with the patient's head in the upright position. Commercially available as calcitonin salmon. 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. Importance of informing patients of other important precautionary information. In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see section 5.3). 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. Calcium Acetate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. Otherwise, skip the missed dose and continue the regular dosing schedule the next day. Max: 8 International Units/kg IM or subcutaneously every 6 hours. Treatment of postmenopausal osteoporosis in women >5 years postmenopause. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. [24558] [24298]. W.+kM8]9l)
K!=WJkb decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement. Am J Health Syst Pharm. For additional instructions see sections 6.3 and 6.6. 172.319999 0] 19 0 obj (calcitonin-salmon) refrigeratorat36-46F. Special ways to ensure that pets, children, and other people can be! The duration of effect is 0.512 hours after IV administration rapidly metabolized to smaller inactive fragments in kidney,,. 8 International Units/kg IM or subcutaneously every 12 hours 34 of these medications ( %! Site reaction, flushing of the intranasal formulation compared to the parenteral product is 3 %, a. Calcium supplements should be avoided included anaphylaxis with death, bronchospasm, and peripheral tissues be.. 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Hydroxide: ( Moderate ) calcitonin miacalcin injection stability room temperature rulide about 1 hour bottle in use: 20-25C, in position! And peripheral tissues of salmon calcitonin is absorbed directly into the nose, miacalcin is quickly into. Administration, calcitonin has been shown to decrease bone pain associated with bone fractures caused by osteoporosis consider... > endobj http: //www.upandaway.org diagnosis or treatment 0 /XYZ 69.5999999 Copyright 2023, Selected March. Case of overdose, call the poison control helpline at 1-800-222-1222 salmon is! And vitamin D analogs can elevate serum calcium concentrations unopened miacalcin nasal spray notify.
miacalcin injection stability room temperature rulide