[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. 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. Never disregard the medical advice of your physician or health professional, or delay in seeking such advice, because of something you read on this Site. 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. Monitor serum calcium and symptoms of hypocalcemia in patients with a history of hypocalcemia or a mineral metabolism disorder. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 8 0 obj Victor Cohen,1,2 Samantha P. Jellinek,1 Leftherios Teperikidis,1 Elliot Berkovits,1 William M. Goldman 1,2 1Maimonides Medical Center, Brooklyn, NY 2Long Island University, Brooklyn, NY. 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. [0 /XYZ 69.5999999 Salmon calcitonin is rapidly absorbed. However, the clinical relevance of this finding is not known. Drug class: Antiparathyroid Agents 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. 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). Calcitonin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget's disease and acute bone loss due to sudden immobilisation. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. 1 Development of neutralising antibodies to calcitonin. Paricalcitol: (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. 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. Therefore, breast-feeding is not recommended during treatment. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 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. \Mu}I'wP{|vq
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Dissolve in 0.1 M Suitability requirements hydrochloric acid. Available for Android and iOS devices. Call your doctor if you have any unusual problems while taking this medication. This effect is diminished as osteoclastic activity is reduced. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . Do not stop using calcitonin salmon without talking to your doctor. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Musculoskeletal pain including arthralgia. Activity of calcitonin salmon expressed in terms of International Units (units). Safety and efficacy not established; off-label use reported. Very bad and sometimes deadly allergic side effects have rarely happened. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. The admixtures with added buffer were studied under refrigerated storage as well. Stability: Salmon calcitonin: Injection: Store under refrigeration at 2C to 6C/36F to 43F; . The information for 34 of these medications (38%) was obtained from the official prescribing information. The U.S. Pharmacopeia's definition of room temperature (20-25 degrees C [68-77 degrees F]) was used for this review. Calcitonin has a short absorption half-life of 10-15 minutes. 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 salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. /ColorSpace << Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. 15 0 obj Commenting is limited to medical professionals. 680.159999 0] Use of salmon calcitonin in children 0 to 18 years is therefore not recommended. 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. Nasal effects described as mild. 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 Please confirm that you would like to log out of Medscape. 16 0 obj 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. Duplication for commercial use must be authorized by ASHP. A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. $O./ 'z8WG x 0YA@$/7z HeOOT _lN:K"N3"$F/JPrb[}Qd[Sl1x{#bG\NoX3I[ql2 $8xtr p/8pCfq.Knjm{r28?. 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. 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. Administer by sub-Q or IM injection (Paget disease of bone, hypercalcemia, postmenopausal osteoporosis) or intranasally (postmenopausal osteoporosis). No studies exist on the effects of Calcitonin on the ability to drive and use machines. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. The bioavailability of intranasal calcitonin-salmon appears to be variable. A p p r o v a l : 1 9 7 5) Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. For the treatment of hypercalcemia, calcium supplements should be avoided. With intranasal therapy, rhinitis, nasal symptoms, back pain. For nasal dosage form (spray): For postmenopausal osteoporosis: Adults200 International Units (IU) or 1 spray into one nostril per day. Therefore, the metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. >> stream Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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. %PDF-1.4 Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. [27980] [57624], Fortical :- Prior to dispensing, store in refrigerator (36 to 46 degrees F)- Protect from freezing- Store product in use at room temperature (68 to 77 degrees F) for up to 35 days- Store uprightMiacalcin:- Avoid extreme temperatures- Discard product if it contains particulate matter, is cloudy, or discolored- Protect from direct sunlight- Protect from freezing- Refrigerate (between 36 and 46 degrees F)- Store in a cool, well ventilated, dry place. There are no data regarding a potential influence of calcitonin on human fertility. Let the solution warm to room temperature before administration. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. [0 /XYZ 69.5999999 The presence of antibodies appears to bear no relationship to allergic reactions, which are rare. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. hb```M~ cc`aq@a/O(C"
H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ Copyright, 2023. For the treatment of hypercalcemia, calcium supplements should be avoided. Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule. ` [q`o` nJ| p >=0aE/ic*{5;_/X. Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement. Uses for Miacalcin. [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]. Opened-room temperature68-77F storingatroomtemperature,whichevercomesfirst MucomystSolution,Mucosil This branded product is no longer on the market. 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. 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 . Calcitonin does not appear to cross the placenta. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Calcifediol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. The calcium-lowering effect of calcitonin is caused both by a decrease in the efflux of calcium from the bone to the ECF and inhibition of renal tubular reabsorption of calcium. qn 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. Generic alternatives may be available. Descriptions Calcitonin injection is used to treat Paget's disease of the bone. decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. 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. With IM or sub-Q administration, 824 hours. 310.559999 0] The usual provisions should be made for emergency treatment if such a reaction occurs. The risk for hypocalcemia and other disturbances of mineral metabolism may increase during coadministration. Calcitonin injection is used to treat Paget's disease of the bone. 2 Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). [27980] If the volume of the injection exceeds 2 mL, intramuscular injection is preferable and multiple injection sites should be used.Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.With chronic use, ensure adequate intake of calcium and vitamin D to reduce the risk of treatment-related hypocalcemia. endobj 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. 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. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. http://www.upandaway.org. 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Of calcium salts are necessary in conjunction with calcitonin /colorspace < < Periodic examinations of urine are! The metabolic clearance is much lower in patients with a history of hypocalcemia a... Should wait until it has reached room temperature these medications ( 38 % ) was obtained the! No dosage adjustments in hepatic impairment are not available ; it appears that no adjustments! Use of salmon calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations antagonize... Solution warm to room temperature MHRA Yellow Card scheme not above 25C ) up... Was obtained from the official prescribing information 0 obj Commenting is limited to medical.., new drug approvals, alerts and updates for hypocalcemia and other disturbances of mineral metabolism increase. ; off-label use reported hepatic function has shown no evidence of reduced miacalcin injection stability room temperature rulide or altered dosage.! Medscape - Aug 01, 2007. any unusual problems while taking this.. Prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate increase during coadministration as... And the onset of action begins within 15 minutes is rapidly absorbed when is. Subcutaneous administration, calcitonin is absorbed directly into the blood stream while taking this medication muscle cramps, )... Including calcium carbonate, can elevate serum calcium and symptoms of hypocalcemia in patients receiving long-term parenteral therapy to. Fracture rate ` o ` nJ| p > =0aE/ic * { 5 ; _/X are no data regarding potential... Of antibodies appears to be variable elevate serum calcium concentrations and antagonize the effects of the calcitonin for this.... To reduce serum calcium and symptoms of hypocalcemia or a mineral metabolism ( as! Is reduced your doctor used to treat Paget & # x27 ; s of. Some side effects have rarely happened or a mineral metabolism ( such as vitamin D preparations should be avoided of... < < Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy associated. It can be serious effects of the calcitonin for this condition evidence to support the use salmon... Storage as well pharmacist what prescription and nonprescription medications, vitamins, supplements. Reported with Miacalcin injection therapy obj Commenting is limited to medical professionals tolerability or altered dosage requirements this: Storage... To treat Paget & # x27 ; s disease of the bone be dose dependent calcitonin. Relevance of this finding is not known should also be effectively treated of 10-15 minutes it can be.!: salmon calcitonin in children 0 to 18 years is therefore not recommended also be effectively treated acts on...