172.319999 0] Safety and efficacy not established; off-label use reported. 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. >> endobj Peak effects are observed within 4 hours after parenteral administration. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Possibility of hypocalcemic tetany following parenteral administration; have calcium injection readily available, particularly during first several doses of parenteral calcitonin. In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see section 5.3). 14 0 obj << For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. For the full list of excipients, see section 6.1.
/Parent 2 0 R Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses. 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 the solution is discolored or contains particles, do not use it, and call your pharmacist. If your usual dose is three times a week, give the missed dose on the next day and continue every other day thereafter. This information is for use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. hb```M~ cc`aq@a/O(C"
H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ The result is a decrease in urinary calcium. For the treatment of hypercalcemia, calcium supplements should be avoided. endobj Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin. The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. /CreationDate (D:20210907165018-04'00') [27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. An antiemetic may be administered, if required. Do not administer a double dose to make up for a missed one. %PDF-1.6
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Calcitonin is secreted into the milk. Calcitonin-salmon injection is administered intramuscularly or subcutaneously. Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. Store unopened bottle under refrigeration at 2C to 8C; Once the pump has been activated, store at room temperature . Results: Of the 189 medications listed in AHFS Drug Information 2006 for storage in a. Intranasal Nasal Solution. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Of the 189 medications listed in AHFS Drug Information 2006 for storage in a . Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room t Dissolve in 0.1 M Suitability requirements hydrochloric acid. MIACALCIN (calcitonin salmon) injection, solution. 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. [27980] /ColorSpace << [27980] [52559] [57624]Calcitonin is a hypocalcemic hormone whose effects are generally opposite those of parathyroid hormone (PTH). Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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%. 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. endobj Under exceptional circumstances, e.g. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For short-term use only. Serious allergic reactions (bronchospasm, swelling of tongue or throat, anaphylactic shock, at least 1 death due to anaphylaxis) reported in patients receiving calcitonin injection. The addition of 10 mM sodium phosphate buffer . Do not use more or less of it or use it more often than prescribed by your doctor. VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. Sub-Q injection preferred for patient self-administration. [27980] [52559] [57624]. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. 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. Give with supplemental calcium and vitamin D if dietary intake is inadequate. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Calcium Acetate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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. Activity of calcitonin salmon expressed in terms of International Units (units). %PDF-1.4
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It allows continued monitoring of the benefit/risk balance of the medicinal product. endobj What side effects can this medication cause? http://www.upandaway.org. Calcitonin does not appear to cross the placenta. [27980]Ensure adequate intake of calcium and vitamin D during osteoporosis treatment and prevention. Therefore, breast-feeding is not recommended during treatment. The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. Opened-room temperature68-77F storingatroomtemperature,whichevercomesfirst MucomystSolution,Mucosil Pharmacokinetic/pharmacodynamic relationship. 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. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. 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. Calcitonin lowers serum calcium concentrations by inhibiting bone resorption with subsequent decreases in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline levels. Fracture reduction efficacy has not been demonstrated. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 4 0 obj Fortical bottle in use: 2025C, 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 Call your doctor if you have any unusual problems while taking this medication. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. This has the potential to reduce the total dose delivered to the patient. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 1 Development of neutralising antibodies to calcitonin. Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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). Follow all directions carefully. This effect is diminished as osteoclastic activity is reduced. 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. /SMask /None>> 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. Calcitonin is also contraindicated in patients with hypocalcaemia. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. 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. >> << Brand names: Fortical, Miacalcin 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. 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. decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. Carefully consider the benefits for the individual patient against the possible risks. All Rights Reserved. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. 5 0 obj Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. Most events were mild in intensity. With IM or sub-Q administration, 824 hours. What special dietary instructions should I follow? Each 1 ml solution contains 50 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance. 20 0 obj Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed in laboratory animals. Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. 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. 17 0 obj This is considered a species-specific effect and of no clinical relevance. For the treatment of hypercalcemia, calcium supplements should be avoided. Nasal effects described as mild. AHFS DI Essentials.
The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review. Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. Minimum effective dosage not established; 100 units every other day may be effective in preserving vertebral BMD. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Product Safety Department. If you become pregnant while using calcitonin salmon, call your doctor. [0 /XYZ 69.5999999 /XObject << 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
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v f)?.z}qO RkUo| In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. Musculoskeletal pain including arthralgia. x+ |
Your doctor may order certain lab tests to check your body's response to calcitonin salmon. For smaller ulcers, interrupt therapy until healing occurs. Use multiple sites of injection when volume >2 mL. endobj If you log out, you will be required to enter your username and password the next time you visit. 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. CARLSBAD, Calif., May 20, 2021 /PRNewswire/ -- Leucadia Pharmaceuticals, a U.S. leader in generic injectables and the commercial arm of Custopharm, Inc., today announced . 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. Treatment of postmenopausal osteoporosis in women >5 years postmenopause. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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. It is not known whether salmon calcitonin crosses the placental barrier. Very bad and sometimes deadly allergic side effects have rarely happened. 2007;64(16):1711-1715. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. [0 /XYZ 69.5999999 tell your doctor and pharmacist if you are allergic to calcitonin salmon or any other medications. The duration of effect is 824 hours after intramuscular administration. Max: 8 International Units/kg IM or subcutaneously every 6 hours. endobj [0 /XYZ 69.5999999 However, you should not flush this medication down the toilet. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). In addition to adequate intake of calcium/vitamin D and other lifestyle modifications (e.g., exercise, avoidance of excessive alcohol and tobacco use), experts recommend that pharmacologic therapy for osteoporosis be considered in postmenopausal women with high risk of fractures (generally those who have experienced a previous hip or vertebral fracture or who have low BMD); pharmacologic therapy also may be considered in postmenopausal women with low bone mass, although there is less evidence supporting overall fracture risk reduction in such patients. For the treatment of hypercalcemia, calcium supplements should be avoided. Remove the unopened bottle from the refrigerator and allow the spray to reach room temperature.Remove the protective cap.To prime the pump bottle, the bottle should be held upright and the 2 side arms of the pump depressed toward the bottle until a full spray is produced. Effect not reported by other investigators. The dose of lithium may require adjustment. xS*B.C 4T0 \.LcC4.TO+cCC#,.@ 30
Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). For the treatment of hypercalcemia, calcium supplements should be avoided. << The bioavailability of intranasal calcitonin-salmon appears to be variable. The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. 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. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. endstream
endobj
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Instruct patients to seek medical care if symptoms of hypocalcemia develop. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. The release of calcium and phosphate from bone is reduced, and the extent of collagen breakdown is decreased. Calcitonin is excreted primarily in the urine as inactive metabolites. [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. ;JrhxKXl]qXUp&t\eEj(Qf`9tG&*3?b6Ed!.DSO1^y6lh{\65 {5;x=FSNu'J+T;!B a0LC/%(1 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. Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. Dispose of all empty syringes and vials as directed by your healthcare provider. Fracture reduction efficacy has not been demonstrated. Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis. [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]. Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. W.+kM8]9l)
K!=WJkb Start typing to retrieve search suggestions. It is best to change which nostril you use each day. 100 International Units IM or subcutaneously once daily. endstream
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Talk with your doctor. For additional instructions see sections 6.3 and 6.6. Safety and efficacy have not been established; off-label use reported for selected conditions. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Fortical bottle in use: 20-25C, in upright position for up to 30 days. 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). [24299] Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing 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). Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Short-term administration results in a marked transient decrease in the volume and acidity of gastric secretions and the volume and the trypsin and amylase content of pancreatic secretions. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months. Coarse granular casts and casts containing renal tubular epithelial cells reported in some young adult volunteers at bedrest who received parenteral calcitonin in a study of its effect on immobilization osteoporosis. endobj Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Development of neutralising antibodies to calcitonin.1. Solution for injection/infusion (injection/infusion). 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. /Filter /FlateDecode 200 International Units/day intranasally for osteoporosis; 100 International Units IM or subcutaneously for most indications; for acute hypercalcemia, up to 32 international units/kg/day IM or subcutaneously. 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. /CSp /DeviceRGB Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use. %%EOF
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. Each bottle contains at least 30 doses. 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. Adverse drug reactions from multiple sources including clinical trials and post-marketing experience are listed by MedDRA system organ class. Common Miacalcin side effects may include: bleeding from your nose; runny or stuffy nose; dryness, itching, tenderness, or general discomfort of your nose; or. 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. . 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-salmon) refrigeratorat36-46F. Click the topic below to receive emails when new articles are available. elicited after each injection of calcitonin during chronic therapy has not been investigated. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Should symptoms of overdose appear, treatment should be symptomatic.
miacalcin injection stability room temperature rulide