[27980] [52559] [57624]. %%EOF This information is for use by healthcare professionals, Unit 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. k_b Descriptions Calcitonin injection is used to treat Paget's disease of the bone. 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). 610.079999 0] Your doctor may do a skin test before you start calcitonin salmon to make sure you do not have an allergic reaction to it. - For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment. 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 . Inhibits lactation in animals. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. It is not known whether salmon calcitonin crosses the placental barrier. 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. @ }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 All Rights Reserved. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment. 13 0 obj Store in a refrigerator (2C-8C). For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. With IM or sub-Q administration, 824 hours. Alternate nostrils daily. 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. Calcitonin 50 IU/1 ml solution for injection and infusion . Peak effects are observed within 4 hours after parenteral administration. For the treatment of hypercalcemia, calcium supplements should be avoided. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . 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. Safety and efficacy not established; off-label use reported. 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. Hypocalcemia associated with tetany and seizure activity has been reported with calcitonin therapy. Dihydrotachysterol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. Increased urinary lithium clearance is a proposed mechanism for the interaction. IM injection preferred when injection volume >2 mL. Sub-Q injection preferred for patient self-administration. 100 International Units IM or subcutaneously once daily. Higher blood levels may be associated with increased incidence of nausea and vomiting. Dispose of all empty syringes and vials as directed by your healthcare provider. Calcitonin lowers serum calcium concentrations by inhibiting bone resorption with subsequent decreases in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline levels. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline. This medicine is available only with your doctor's prescription. $E}kyhyRm333: }=#ve Calcitonin-salmon Nasal Spray:Before the first dose, the nasal spray should be at room temperature. V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. Calcitonin-salmon appears to have actions essentially identical to endogenous calcitonin of mammalian origin, but its potency per mg is greater than endogenous calcitonin, and it has a longer duration of action. With intranasal therapy, rhinitis, nasal symptoms, back pain. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. 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. [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. 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. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. 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. Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon, synthetic). When studied in rabbits, salmon calcitonin-salmon decreased fetal birth weights when given by subcutaneous injection in doses 4 to 18 times the recommended human parenteral dose and 70 to 278 times the recommended human intranasal dose (based on body surface area). For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Commenting is limited to medical professionals. Malignancy: In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). Please confirm that you would like to log out of Medscape. Allow to reach room temperature before intramuscular or subcutaneous use. 3 0 obj It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. MIACALCIN is a registered trademark of Novartis AG, licensed to the Viatris Companies. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals. Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. $@D` J Vn)$ @bP1# H #O 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. 2022 Viatris Inc. All Rights Reserved. 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. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. >> [0 /XYZ 69.5999999 Product Safety Department. Glass or hard plastic IV containers should not be used. 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). 112.799999 0] The stability of calcitonin salmon in calcitonin salmon nasal spray at elevated temperatures was studied. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Initial dosage: 100 units (0.5 mL) daily. Continue to use calcitonin salmon even if you feel well. This medicine is available only with your doctor's prescription. Calcium Acetate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. 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%. What side effects can this medication cause? Continue typing to refine. Pharmacokinetic/pharmacodynamic relationship. 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. 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. This effect is diminished as osteoclastic activity is reduced. Not known whether calcitonin is distributed into human milk. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. Before preparing a dose, look at the vial. It is not known if the substance is excreted in human milk. >> Duplication for commercial use must be authorized by ASHP. Administer once daily (as a single spray in 1 nostril) using metered-dose spray pump supplied by manufacturer. /SMask /None>> /CSpg /DeviceGray Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Human milk naturally contains some calcitonin and its precursor, procalcitonin. Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Monitor by periodic determinations of serum alkaline phosphatase and urinary hydroxyproline excretion as well as evaluation of symptoms. x+ | For short-term use only. Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon nasal spray (e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock). Cite this: Room-temperature Storage of Medications Labeled for Refrigeration - Medscape - Aug 01, 2007. . Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician. Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. Fracture reduction efficacy has not been demonstrated. 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. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Reporting suspected adverse reactions after authorisation of the medicinal product is important. endstream endobj startxref This suggests an increased risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. 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. 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