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The majority of patients in whom nasal abnormalities were noted also reported nasal complaints/symptoms as adverse events. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Talk to your doctor about the possible risks of using this medication for your condition. If the solution is discolored or contains particles, do not use it, and call your pharmacist. low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes. << For the treatment of hypercalcemia, calcium supplements should be avoided. CAS number: 47931-85-1. In lactating animals given calcitonin, suppression of milk production has been observed. 14 0 obj Hypocalcemia associated with tetany and seizure activity has been reported with calcitonin therapy. (See Cautions.). American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. This is considered a species-specific effect and of no clinical relevance. S e e f u l l p r e s c r i b i n g i n f o r m a t i o n f o r M I A C A L C I N I N J E C T I O N . Your doctor, nurse, or pharmacist will show you how to administer the medication. endobj elicited after each injection of calcitonin during chronic therapy has not been investigated. Actions and Spectrum In case of overdose, call the poison control helpline at 1-800-222-1222. Following parenteral administration of 100 IU calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml. For the treatment of hypercalcemia, vitamin D preparations should be avoided. 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. /Type /ExtGState Calcitonin 50 IU/ml solution for injection and infusion. Dispose of all empty syringes and vials as directed by your healthcare provider. 4c'I\o%:CfPtly8DVagJ 0\O1T5,T57*AZk.nzmJQS^uXh3B@TJ?C03I)^x
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Under exceptional circumstances, e.g. Calcium; Vitamin D: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Calcitonin 50 IU/1 ml solution for injection and infusion . 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). Calcium Acetate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Nausea/vomiting are less frequent when the injection is done in the evening and after meals. 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. 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. Peak effects are observed within 4 hours after parenteral administration. Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. Please enter a Recipient Address and/or check the Send me a copy checkbox. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Early treatment of hypercalcemic emergencies (with other appropriate agents) when a rapid decrease in serum calcium concentration is required. Aspirate prior to injection to avoid injection into a blood vessel. This website also contains material copyrighted by 3rd parties. 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 Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin. 3 0 obj URL of this page: https://medlineplus.gov/druginfo/meds/a682788.html. Musculoskeletal and connective tissue disorders. Copyright, 2023. However, the clinical relevance of this finding is not known (see section 5.2). Keep all appointments with your doctor and laboratory. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. [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. Adverse drug reactions from multiple sources including clinical trials and post-marketing experience are listed by MedDRA system organ class. 11 0 obj Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. This branded product is no longer on the market. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Onset of action of calcitonin is immediate following IV administration. &f;7m?T*'gc`SGss,QU! 2'8cq(=@ y@
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Before priming the pump and using a new bottle, allow it to reach room temperature. Healthcare providers may wish to refer patients who require skin testing to an allergist.Prepare testing solution in a tuberculin syringe by diluting 10 International Units (0.05 mL) of the calcitonin salmon injection to 1 mL with 0.9% Sodium Chloride injection. 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. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. [52559] Per treatment guidelines for Paget's disease, the use of injectable calcitonin-salmon leads to partial radiographic healing of lytic lesions, but most patients do not achieve normalization of bone turnover, and thus calcitonin has limited use versus newer, more effective agents (i.e., bisphosphonates). V5U?f1&&A(EgRM:BI>[:c]Y~Gtf]. Am J Health Syst Pharm. ;JrhxKXl]qXUp&t\eEj(Qf`9tG&*3?b6Ed!.DSO1^y6lh{\65 {5;x=FSNu'J+T;!B a0LC/%(1 Calcitonin-salmon has been shown to inhibit lactation in rats. 45.6000000 0] 1. Safety and efficacy have not been established; off-label use reported for selected conditions. Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. - Bone Resorption Inhibitors Talk with the doctor. [0 /XYZ 69.5999999 The dose may be reduced to 50 IU daily at the start of remobilisation. Drug class: Antiparathyroid Agents Activity of calcitonin salmon expressed in terms of International Units (units). Continue typing to refine. qn If you become pregnant while using calcitonin salmon, call your doctor. 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. Miacalcin bottle in use: 15-30C, in upright position for up to 35 days. Calcitonin has a short absorption half-life of 10-15 minutes. endobj Catecholamines, glucagon, gastrin, or cholecystokinin may stimulate calcitonin secretion. The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. Store calcitonin salmon injection in its original container in the refrigerator. To prime the pump before it is used for the first time, the bottle should be held upright and the two white Higher blood levels may be associated with increased incidence of nausea and vomiting. Uses for Miacalcin. %PDF-1.4
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In severe or emergency cases, intravenous infusion with up to 10 IU/kg body weight in 500 ml 0.9% w/v sodium chloride solution may be administered over a period of at least 6 hours. Secretion of calcitonin is regulated by serum calcium; high serum calcium increases the release of calcitonin. Unopened Miacalcin nasal spray should be stored in the refrigerator. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. It works by preventing bone breakdown and increasing bone density (thickness). Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. Osteoporosis is a disease that causes bones to weaken and break more easily. Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Peak effects are observed within 4 hours after parenteral administration. /SM 0.02 Calcitonin is excreted primarily in the urine as inactive metabolites. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. In normal volunteers, bioavailability of the intranasal formulation compared to the parenteral product is 3%, with a range of 0.330.6%. 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. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Qf Ml@DEHb!(`HPb0dFJ|yygs{. For the treatment of hypercalcemia, calcium supplements should be avoided. [57624]Miacalcin Nasal Spray Storage (or generic equivalent): After opening, store bottle in use at room temperature between 20 and 25 degrees C (68 and 77 degrees F) in an upright position, for up to 35 days. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. /Parent 2 0 R For patients using calcitonin nasal spray, provide careful instruction on storage, pump assembly, priming of pump, and administration. Data regarding the recommended maximum duration that refrigerated medications available in hospital pharmacies may be stored safely at room t [0 /XYZ 43.6799999 /Type /Page The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment. 310.559999 0] Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Hypocalcemia: Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. An antiemetic may be administered, if required. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Follow all directions carefully. 39 0 obj
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After subcutaneous administration, peak plasma levels are reached in about 23 minutes. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 150 0 obj
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There are no adequate studies of calcitonin-salmon injection during pregnancy to inform a drug associated risk for birth defects or miscarriage. What side effects can this medication cause? Store bottle in use at room temperature between 15C-30C (59F-86F) in an upright Calcitonin directly inhibits osteoclasts, binding to plasma membrane receptors and increasing intracellular cyclic adenosine monophosphate (cAMP), as well as interfering with the membrane transport mechanisms of phosphate and calcium. VA class: HS900 As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day. hb```M~ cc`aq@a/O(C"
H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ The metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. This product is available in the following dosage forms: 9 0 obj Analyses of randomised controlled trials conducted in patients with osteoarthritis and osteoporosis have shown that calcitonin is associated with a statistically significant increase in the risk of cancer compared to patients treated with placebo. Consider treatment with calcitonin or a bisphosphonate (e.g., alendronate, etidronate, pamidronate, risedronate) in patients with biochemical markers suggestive of an increase in bone remodeling, those who are symptomatic, and those at risk for future complications from their disease (e.g., those with pagetic lesions in weight-bearing regions or adjacent to joints). Type I, clear glass ampoule containing 1 ml of solution. , and call your pharmacist c ] Y~Gtf ] with injectable calcitonin-salmon have also been reported calcitonin... 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