You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Activity of calcitonin salmon expressed in terms of International Units (units). 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 For the treatment of hypercalcemia, vitamin D preparations should be avoided. Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. hbbd``b` Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see section 4.8). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. For the treatment of hypercalcemia, vitamin D preparations should be avoided. This branded product is no longer on the market. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. ` [q`o` nJ| p >=0aE/ic*{5;_/X. A detailed skin testing protocol is available from the manufacturers; consult the specific prescribing information for contact information for the skin testing protocol. The metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. 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. Copyright, 2023. Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. [0 /XYZ 69.5999999 Product Safety Department. @ }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 Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. Please enter a Recipient Address and/or check the Send me a copy checkbox. 123 0 obj <> endobj endstream endobj 129 0 obj <>stream >> Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 14 0 obj 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 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. By using this Site you agree to the following, By using this Site you agree to the following, Miacalcin injection prescribing information. Carefully consider the benefits for the individual patient against the possible risks. Destroyed in GI tract; administer parenterally or intranasally. >> Known hypersensitivity to calcitonin salmon. Give supplemental calcium and vitamin D if dietary intake is inadequate. http://www.upandaway.org. The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. redness, swelling, or irritation at the site of injection, flushing (feeling of warmth) of the face or hands. Polypeptide hormone secreted by parafollicular cells (C cells) of thyroid gland; acts predominantly on bone to lower serum calcium concentration and inhibit bone resorption. Calcitonin 50 IU/ml solution for injection and infusion. 100 International Units given IM or subcutaneously once daily is the recommended dose. Calcitonin 100 IU/1 ml solution for injection and infusion . related compound B (calcitonin salmon-glycine) are 110-115 in an air oven. Following parenteral administration of 100 IU calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml. For the treatment of hypercalcemia, calcium supplements should be avoided. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Alternate nostrils daily. %PDF-1.4 % 200 International Units (1 spray) intranasally in 1 nostril once daily. Treatment should be discontinued once the patient has responded and symptoms have resolved. Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. 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). Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat. Dosage is to be adjusted to the individual patient's needs. 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). 1. Click the topic below to receive emails when new articles are available. These changes appear to correspond to changes toward more normal bone formation. You must declare any conflicts of interest related to your comments and responses. /Resources 19 0 R << Calcitonin injection is used to treat Paget's disease of the bone. Pharmacokinetic/pharmacodynamic relationship. Has been used in the treatment of glucocorticoid-induced osteoporosis [off-label]; however, other therapies (e.g., oral bisphosphonates) are preferred. 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. 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. Advise patients using calcitonin nasal spray to notify their clinician if nasal irritation develops. endstream endobj startxref 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. Hypersensitivity reactions should be differentiated from generalized flushing and hypotension. Uses for Miacalcin. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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. [0 /XYZ 69.5999999 Prescribing Information. 1 0 obj Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. << Miacalcin has also been shown to decrease bone pain associated with bone fractures caused by osteoporosis. Talk to your doctor about the possible risks of using this medication for your condition. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration. H\@=OQEn$dy ! .|1=( |nr]zMtxXk!:?^rt:wn/6]rO6go'c?[\B_k}.t/i-P7qSEVH*}WecH^,T\er1],9 +"2"u6-N}}\ /#ay. Monitor serum calcium concentrations closely in patients with severe renal impairment (CrCl less than 30 mL/minute) or renal failure (and/or on dialysis) receiving calcimimetics. Qf Ml@DEHb!(`HPb0dFJ|yygs{. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Adverse drug reactions from multiple sources including clinical trials and post-marketing experience are listed by MedDRA system organ class. 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. 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). Before preparing a dose, look at the vial. Intranasal spray pumps deliver 0.09 mL of solution per actuation; each 0.09-mL spray delivers 200-unit dose. Cite this: Room-temperature Storage of Medications Labeled for Refrigeration-Medscape-Aug01,2007. A controlled study, which was prematurely discontinued, failed to demonstrate any benefit of calcitonin-salmon on fracture rate. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. For the treatment of hypercalcemia, calcium supplements should be avoided. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medically reviewed by Drugs.com on Mar 16, 2022. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. $O./ 'z8WG x 0YA@$/7z HeOOT _lN:K"N3"$F/JPrb[}Qd[Sl1x{#bG\NoX3I[ql2 $8xtr p/8pCfq.Knjm{r28?. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Inject into a large muscle. MIA-2020-0001 V3. The duration of effect is 824 hours after intramuscular administration. A detailed skin testing protocol is available from the Mylan Pharmaceuticals Inc. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. /SMask /None>> x][o~_93EK! * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). Allow to reach room temperature before intramuscular or subcutaneous use. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. 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). This product is available in the following dosage forms: Safety and efficacy have not been established; off-label use reported for selected conditions. The dose may be reduced to 50 IU daily at the start of remobilisation. Calcitonin has a short absorption half-life of 10-15 minutes. 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). 12 0 obj Lithium: (Moderate) Reduced serum lithium concentrations have been observed in previously stabilized patients who initiated daily calcitonin salmon subcutaneous injections for osteoporosis. \9_3chn|An tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. endobj 8 0 obj When suggestions are available use up and down arrows to review and ENTER to select. Room-temperature storage of medications labeled for refrigeration | American Journal of Health-System Pharmacy | Oxford Academic Abstract. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . 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. The metabolites lack the specific biological activity of calcitonin. What side effects can this medication cause? Most events were mild in intensity. >> Fracture reduction efficacy has not been demonstrated. After subcutaneous administration, peak plasma levels are reached in about 23 minutes. 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