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%. Store in a refrigerator (2C-8C). This medicine is available only with your doctor's prescription. /Type /Page The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. Neoplasms benign, malignant and unspecified (incl cysts and polyps). Type I, clear glass ampoule containing 1 ml of solution. hb```M~ cc`aq@a/O(C" H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. Experience with calcitonin in children with idiopathic juvenile osteoporosis is very limited; the relationship between this disorder and postmenopausal osteoporosis is not established. Otherwise, skip the missed dose and continue the regular dosing schedule the next day. However, you should not flush this medication down the toilet. << 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. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. \Mu}I'wP{|vq wW7_=0Z&F0P13Mhx.='rU 8OIm0Kl{xA#{(/GOh\k j)/^z0r[q kSY+LOuC0 | &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@ 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. AHFS DI Essentials. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease; or a recommendation for a specific test, doctor, care provider, procedure, treatment plan, product, or course of action. Do not freeze. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. %PDF-1.4 % Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. 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 . Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. ` [q`o` nJ| p >=0aE/ic*{5;_/X. Should symptoms of overdose appear, treatment should be symptomatic. endstream endobj 127 0 obj <>stream Calcitonin 100 IU/1 ml solution for injection and infusion . Resume the regular dosing schedule at the beginning of the next week. Vitamin D analogs: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Follow all directions carefully. 14 0 obj 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 /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 . endobj Each 1 ml solution contains 3.3 mg sodium. 285.599999 0] The admixtures with added buffer were studied under refrigerated storage as well. Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. /Annots 20 0 R /Contents 17 0 R There is no information on the presence of calcitonin in human milk, the effects on the breast-fed infant, or the effects on milk production. In case of overdose, call the poison control helpline at 1-800-222-1222. 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. 100 International Units given IM or subcutaneously once daily is the recommended dose. endobj Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). Calcitonin salmon injection is also used to treat Paget's disease of bone and to quickly reduce calcium levels in the blood when needed. ADVERSE REACTIONS: The most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%). Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. << Purpose. Individualize choice of therapy based on potential benefits (with respect to fracture risk reduction) and adverse effects of therapy, patient preferences, comorbidities, and risk factors. Each bottle contains at least 30 doses. This product is available in the following dosage forms: 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. V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. Calcitonin may cause fatigue, dizziness and visual disturbances (see section 4.8) which may impair the patient's reaction. When suggestions are available use up and down arrows to review and ENTER to select. x+ | Common Miacalcin side effects may include: bleeding from your nose; runny or stuffy nose; dryness, itching, tenderness, or general discomfort of your nose; or. It works by preventing bone breakdown and increasing bone density (thickness). Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection. 0 After subcutaneous administration, peak plasma levels are reached in about 23 minutes. endstream endobj startxref << Initially, 4 units/kg every 12 hours; may increase dosage after 1 or 2 days (if response not adequate) to 8 units/kg every 12 hours; may further increase dosage after 2 days (if response not adequate) to 8 units/kg every 6 hours. Since 6 manufacturers were unable to provide information for 10 medications, information was compiled and tabulated for 79 medications ( Table 1 ). Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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. 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). Store unopened bottle under refrigeration at 2C to 8C; Once the pump has been activated, store at room temperature . We comply with the HONcode standard for trustworthy health information. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. 150 0 obj <>stream Ampicillin 12 g in 1 L normal saline intravenous bags, without buffer addition, was stable for at least 24 hours when stored at room temperature. Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. 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. 11 0 obj Call your doctor if you have any unusual problems while taking this medication. elicited after each injection of calcitonin during chronic therapy has not been investigated. By inhibiting osteoclast activity via its specific receptors, salmon calcitonin decreases bone resorption. 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, vitamin D preparations should be avoided. If you become pregnant while using calcitonin salmon, call your doctor. endobj The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. /Producer ( w k h t m l t o p d f) Calcitonin salmon has same pharmacologic activity as calcitonin human, but calcitonin salmon is more potent and has longer duration of action. Administer by sub-Q or IM injection (Paget disease of bone, hypercalcemia, postmenopausal osteoporosis) or intranasally (postmenopausal osteoporosis). The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. For the treatment of hypercalcemia, calcium supplements should be avoided. [0 /XYZ 69.5999999 This is considered a species-specific effect and of no clinical relevance. 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. Before preparing a dose, look at the vial. ;JrhxKXl]qXUp&t\eEj(Qf`9tG&*3?b6Ed!.DSO1^y6lh{\65 {5;x=FSNu'J+T;!B a0LC/%(1 \9_3chn|An Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy. Information is also available online at https://www.poisonhelp.org/help. Your doctor may do a skin test before you start calcitonin salmon to make sure you do not have an allergic reaction to it. 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. Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. [0 /XYZ 69.5999999 Do not stop using calcitonin salmon without talking to your doctor. 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. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. Continue to use calcitonin salmon even if you feel well. Give supplemental calcium and vitamin D if dietary intake is inadequate. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 4c'I\o%:CfPtly8DVagJ 0\O1T5,T57*AZk.nzmJQS^uXh3B@TJ?C03I)^x \1:8b3b-ap\^Ooy55SV4>mZ1>8-i%;AHJ1ANK~._$lMa|j{'Zfkhc b}/L-Dmr!neJIbe?F',Z1$~o@2Qm_D5=xc[% 5w[7vqzX?sXlzvu.u+ZDBZ-Q g8SmT}n [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]. 8 0 obj 2007;64(16):1711-1715. Intranasal RouteAbsorption through the nasal mucosa is rapid, with peak plasma concentrations achieved in 3139 minutes. Safety and efficacy have not been established. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. /CSpg /DeviceGray Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Healthcare providers may wish to refer patients who require skin testing to an allergist. Clinical and/or biochemical effects in Paget disease may not be evident for several months. The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals. 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. 5 0 obj /AIS false 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. %PDF-1.4 It is usually used once a day or once every other day. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. was insufficient regarding room- temperature stability and pharma- . There is a relationship between the subcutaneous dose of calcitonin and peak plasma concentrations. 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