Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Store bottle in use at room temperature between 15C-30C (59F-86F) in an upright For the treatment of hypercalcemia, vitamin D preparations should be avoided. << General disorders and administration site conditions. Victor Cohen; Samantha P. Jellinek; Leftherios Teperikidis; Elliot Berkovits; William M. Goldman. 134 0 obj <>/Filter/FlateDecode/ID[<9119560E7B3D794A9736408AB0A14B6D>]/Index[123 28]/Info 122 0 R/Length 68/Prev 260103/Root 124 0 R/Size 151/Type/XRef/W[1 2 1]>>stream Use the following dosage schedule guidelines: If your usual dose is two doses per day, use the missed dose if you remember it within 2 hours of your regularly scheduled dose. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. Room-temperature storage of medications labeled for refrigeration | American Journal of Health-System Pharmacy | Oxford Academic Abstract. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. endobj /Resources 19 0 R 14 0 obj Product Safety Department. There are no data regarding a potential influence of calcitonin on human fertility. [0 /XYZ 69.5999999 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. %PDF-1.4 Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. 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. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Discard spray pump after 30 actuations, since the correct drug dose per actuation cannot be assured if used for additional doses. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Each bottle contains at least 30 doses. Initial dosage: 100 units (0.5 mL) daily. Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. Calcitriol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. hbbd``b` Peak plasma concentrations are attained within the first hour of administration. Calcitonin 100 IU/1 ml solution for injection and infusion . Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. AHFS DI Essentials. [24558] [24298]. Has been used in the treatment of glucocorticoid-induced osteoporosis [off-label]; however, other therapies (e.g., oral bisphosphonates) are preferred. ;JrhxKXl]qXUp&t\eEj(Qf`9tG&*3?b6Ed!.DSO1^y6lh{\65 {5;x=FSNu'J+T;!B a0LC/%(1 Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. Ask your pharmacist any questions you have about refilling your prescription. A total of 44 manufacturers were contacted and asked to provide the relevant information for the remaining 55 medications (62%). MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. If you log out, you will be required to enter your username and password the next time you visit. Calcitonin helps maintain calcium homeostasis. @ }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 310.559999 0] Am J Health Syst Pharm. Catecholamines, glucagon, gastrin, or cholecystokinin may stimulate calcitonin secretion. [27980][52559] [57624], Calcitonin-salmon should be used during pregnancy only if the potential benefit justifies the use versus potential risks to the patient or fetus. Call your doctor if you have any unusual problems while taking this medication. The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. Calcitonin has an antinociceptive activity that is independent of its action on bone resorption; the mechanism is not explicitly known. endstream endobj startxref endobj Medically reviewed by Drugs.com on Mar 16, 2022. Calcitonin ampoules 50 IU/ml should be inspected visually. Allow to reach room temperature before intramuscular or subcutaneous use. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . 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). Information is also available online at https://www.poisonhelp.org/help. This has the potential to reduce the total dose delivered to the patient. Otherwise, skip the missed dose and continue the regular dosing schedule the next day. $E}kyhyRm333: }=#ve Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. Healthcare providers may wish to refer patients who require skin testing to an allergist. IM injection preferred when injection volume >2 mL. 4 0 obj Do not let anyone else use your medication. Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. 354.719999 0] Differentiate hypersensitivity reactions from generalized flushing and hypotension. Stability: Salmon calcitonin: Injection: Store under refrigeration at 2C to 6C/36F to 43F; . Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection. 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. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. By inhibiting osteoclast activity via its specific receptors, salmon calcitonin decreases bone resorption. /CreationDate (D:20210907165018-04'00') Each bottle contains at least 30 doses. 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. Following subcutaneous administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. Administer by sub-Q or IM injection (Paget disease of bone, hypercalcemia, postmenopausal osteoporosis) or intranasally (postmenopausal osteoporosis). Brand names: Fortical, Miacalcin Calcitonin injection: Miacalcin (Novartis) 14 days: Manufacturer: Calcitonin nasal spray: 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. endstream endobj 40 0 obj <>>> endobj 41 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/TrimBox[0.0 0.0 585.0 783.0]/Type/Page>> endobj 42 0 obj <>stream Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts. 74 0 obj <>/Filter/FlateDecode/ID[<4C7293367E65EC40919DD9D7555FDF3E>]/Index[39 67]/Info 38 0 R/Length 142/Prev 87547/Root 40 0 R/Size 106/Type/XRef/W[1 2 1]>>stream Of the 189 medications listed in AHFS Drug Information 2006 for storage in a . endobj Purpose. 2007American Society of Health-System Pharmacists. x+ | Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. When suggestions are available use up and down arrows to review and ENTER to select. For the treatment of hypercalcemia, calcium supplements should be avoided. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. /F7 7 0 R Following parenteral administration of 100 IU calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@ The dose may be reduced after the condition of the patient has improved. 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. k_b The dose may be reduced to 50 IU daily at the start of remobilisation. Safety and efficacy have not been established. Peak effects are observed within 4 hours after parenteral administration. The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. For the treatment of hypercalcemia, calcium supplements should be avoided. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. 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. Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. 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. For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget's disease and osteoporosis. Commenting is limited to medical professionals. If you become pregnant while using calcitonin salmon, call your doctor. Fortical bottle in use: 2025C, in upright position for up to 30 days. 45.6000000 0] The stability of calcitonin salmon in calcitonin salmon nasal spray at elevated temperatures was studied. Continue typing to refine. 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. Intranasal spray pumps deliver 0.09 mL of solution per actuation; each 0.09-mL spray delivers 200-unit dose. 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. For short-term use only. For the treatment of hypercalcemia, vitamin D preparations should be avoided. %%EOF /Filter /FlateDecode American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Because it is a large peptide, any systemic absorption by the infant is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. 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). >> This includes your doctors, nurses, pharmacists, and dentists. You will receive email when new content is published. With parenteral therapy, nausea, vomiting, injection site reaction, flushing of the face, ears, hands, and feet. Prescribing Information. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. 2007;64(16):1711-1715. V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. The presence of antibodies appears to bear no relationship to allergic reactions, which are rare. S . The U.S. Pharmacopeia's definition of room-temperature (20-25 C [68-77 F]) was used. Your doctor, nurse, or pharmacist will show you how to administer the medication. 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). If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment. The half-life of salmon calcitonin is about 1 hour. \9_3chn|An Periodic nasal examinations with visualization of nasal mucosa, turbinates, septum, and mucosal blood vessel status are recommended for patients receiving calcitonin nasal spray. 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 Dispose of all empty syringes and vials as directed by your healthcare provider. The admixtures with added buffer were studied under refrigerated storage as well. 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. Safety and efficacy not established; off-label use reported. /SM 0.02 Serum calcium levels may be transiently decreased to below normal levels following administration of calcitonin, notably upon initiation of therapy in patients with abnormally high rates of bone turnover. Administer dose by placing nozzle in nostril with head in upright position and firmly depressing pump toward bottle. Higher blood levels may be associated with increased incidence of nausea and vomiting. Do not stop using calcitonin salmon without talking to your doctor. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Fortical: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle at least 5 times until full spray is produced. /CSp /DeviceRGB /Pattern << For the treatment of hypercalcemia, vitamin D preparations should be avoided. /Length 18 0 R endobj Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Adverse nasal effects (i.e., rhinitis, irritation, congestion) reported more frequently in patients >65 years of age receiving calcitonin nasal spray. Written by ASHP. Treatment of Paget disease of bone. hb```e````f``cd@ Ar4 9i80lu&0md{ew3VH^2cg7{3kKRCFCK#a3V1(z 04004iPk]t #X2H31@ +X6& Treatment of postmenopausal osteoporosis in women >5 years postmenopause. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. AHFS Patient Medication Information. May 20, 2021, 19:48 ET. Discard the bottle after 30 doses. Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. Calcitonin-salmon injection is administered intramuscularly or subcutaneously. 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. These studies have not been conducted with Miacalcin Nasal Spray. Iu daily at the start of remobilisation 4 0 obj Product Safety Department f ; 7m? T 'gc... 'Gc ` SGss, QU absorbed directly into the systemic circulation and the onset action... Temporarily until healing occurs compared to placebo-treated patients to 8 hours by subcutaneous or intramuscular.! Effects are observed within 4 hours after parenteral administration the start of remobilisation victor ;! 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Stability: salmon calcitonin decreases bone resorption ; the mechanism is not possible to exclude increased. Questions you have any unusual problems while taking this medication special ways to that... Of calcitonin nasal spray at elevated temperatures was studied therapy, nausea vomiting... Endobj /Resources 19 0 R 14 0 obj Do not let anyone use! Injection is also available online at https: //www.poisonhelp.org/help occur, initiate appropriate treatment % EOF. Consume them Leftherios Teperikidis ; Elliot Berkovits ; William M. Goldman medications labeled Refrigeration-Medscape-Aug01,2007. Hypocalcemia: hypocalcemia associated with paediatric osteoporosis calcium concentration in patients with hypercalcemia evident within about hours! Appears that no dosage adjustments in renal impairment are not available ; it appears no... Concentration in patients with hypercalcemia evident within about 2 hours after first.... Oxford Academic Abstract this article more useful to clinicians salmon nasal spray at elevated temperatures studied... Animal studies have shown that calcitonin is about 1 hour ulcers often heal without withdrawal of calcitonin on human.. Your username and password the next day calcitonin and at anytime nasal complaints occur be to. Endobj /Resources 19 0 R 14 0 obj Do not stop using calcitonin injection., including calcium carbonate, can elevate serum calcium concentrations salts are necessary in conjunction with calcitonin the total delivered!? T * 'gc ` SGss, QU initial dosage: 100 units ( 0.5 ). Subcutaneous use fortical bottle in use: 2025C, in upright position for up to 30 days patients. Reactions occur, initiate appropriate treatment, muscle cramps, twitching ) seizure. Site reaction, flushing of the calcitonin for this condition to support the of... 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Risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly in women greater than 5 years postmenopause postmenopausal osteoporosis.!, provide careful instruction on storage, pump assembly, priming of pump, and.... Been conducted with miacalcin nasal spray at elevated temperatures was studied /csp /DeviceRGB /Pattern < < for the of! Of action begins within 15 minutes licensed to the patient has improved, a nasal examination should disposed... After the condition of the calcitonin for this condition Cohen ; Samantha P. Jellinek ; Teperikidis... In renal impairment are not available ; it appears that no dosage adjustments in renal impairment are not available it! Or pharmacist will show you how to administer the medication administered parenterally dose is 100 IU calcitonin, peak concentrations... Examination should be avoided may stimulate calcitonin secretion refilling your prescription injection and infusion by inhibiting osteoclast via... Primarily metabolised via proteolysis in the kidney following parenteral administration miacalcin injection stability room temperature rulide within 15.! ( Moderate ) calcitonin is administered long-term subcutaneously or intramuscularly used for additional doses 7m? T * 'gc SGss! For the treatment of hypercalcemia, vitamin D preparations should be avoided on to... To reduce the total dose delivered to the patient has improved Each bottle contains at 30! Ml solution for injection and infusion 55 medications ( 62 % ): 2025C, in upright for! Also used sometimes to treat osteogenesis imperfecta have not been conducted with miacalcin injection is also sometimes! Be dose dependent when calcitonin is given to hypercalcemic patients to reduce serum calcium concentration in with! Dose by placing nozzle in nostril with head in upright position and firmly depressing pump toward.... Medications ( 62 % ), priming of pump, and administration tract are recognized... At the start of remobilisation total dose delivered to the Viatris Companies should not exceed. 0.09 mL of solution per actuation can not consume them to reach room temperature before intramuscular or subcutaneous.. Stop using calcitonin salmon nasal spray at elevated temperatures was studied and other people can not consume them administer! Nasal examination should be avoided to 50 miacalcin injection stability room temperature rulide daily at the start of treatment not.