Uses for Miacalcin. For the treatment of hypercalcemia, calcium supplements should be avoided. [0 /XYZ 69.5999999 VA class: HS900 [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]. Serious allergic-type reactions such as bronchospasm, swelling of the tongue and throat, anaphylactic shock. Intranasal spray pumps deliver 0.09 mL of solution per actuation; each 0.09-mL spray delivers 200-unit dose. Healthcare providers may wish to refer patients who require skin testing to an allergist. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 467.039999 0] 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. The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose. - Bone Resorption Inhibitors Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. 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 . Calcitonin salmon helps treat osteoporosis and Paget's disease of bone but does not cure them. Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. Otherwise, skip the missed dose and then continue on the regular dosing schedule. Tell all of your health care providers that you take Miacalcin ( calcitonin injection). Before using the first dose of Miacalcin nasal spray, the patient should wait until it has reached room temperature. 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. 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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Safety and efficacy have not been established. Use not recommended. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. 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. [0 /XYZ 69.5999999 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. In case of overdose, call the poison control helpline at 1-800-222-1222. The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals. Calcitonin is excreted primarily in the urine as inactive metabolites. Calcitonin injection: Miacalcin (Novartis) 14 days: Manufacturer: Calcitonin nasal spray: endobj /F6 6 0 R For patients with a suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment. /SM 0.02 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. endobj This effect is diminished as osteoclastic activity is reduced. 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. 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 osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. 123 0 obj <> endobj 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. If patient or caregiver is to administer parenteral calcitonin, provide careful instructions on proper administration methods, including aseptic technique. The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement. was insufficient regarding room- temperature stability and pharma- . /Creator () Treatment should be discontinued once the patient has responded and symptoms have resolved. The most frequently observed undesirable effects are nausea, vomiting and flushing. x+ | Sub-Q injection preferred for patient self-administration. Use calcitonin salmon injection exactly as directed. The dose of lithium may require adjustment. The ampoules are for single use only. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . /Filter /FlateDecode Type I, clear glass ampoule containing 1 ml of solution. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. Calcitonin (salmon, synthetic) . The metabolites lack the specific biological activity of calcitonin. General disorders and administration site conditions. Discard the bottle after 30 doses. Remaining contents should be discarded. The data suggest an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. Following IM administration, calcitonin is absorbed directly into the systemic circulation and the onset of action begins within 15 minutes. /ca 1.0 Product Safety Department. 3 0 obj 15 0 obj H|WMo8R*S4^$i6QfD*+~-+R$H|3|s>a>|8/.g0:=(4P/jG z4^>>F?~vUL fYQ(F'j f)u}b-)i4IAp=u8txYfgsB^ =>siV@x[nh2;f1.(fL34sJ\As S/I]MURf Q/MMb}2u'9#[G &sx@z; 5*=dD&]uKJ5O v f)?.z}qO RkUo| << Each bottle contains at least 30 doses. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). Information is also available online at https://www.poisonhelp.org/help. It is usually used once a day or once every other day. [27980] [52559] [57624], Use calcitonin with caution during breast-feeding. >> Calcitonin also has activity outside the bone. Onset of action of calcitonin is immediate following IV administration. [0 /XYZ 69.5999999 Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. For patients with suspected sensitivity to calcitonin, consider skin testing prior to initiating therapy. /CreationDate (D:20210907165018-04'00') x][o~_93EK! 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. Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations. 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. Continue typing to refine. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 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. Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations. Keep all supplies in a clean, dry place and out of reach of children. Use multiple sites of injection when volume >2 mL. In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see section 5.3). Very bad and sometimes deadly allergic side effects have rarely happened. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Nasal effects described as mild. Stability Storage Parenteral Injection. \Mu}I'wP{|vq wW7_=0Z&F0P13Mhx.='rU 8OIm0Kl{xA#{(/GOh\k j)/^z0r[q kSY+LOuC0 | >> 150 0 obj <>stream 4 0 obj Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. << Treatment of Paget disease of bone. endstream endobj 124 0 obj <> endobj 125 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 6/Type/Page>> endobj 126 0 obj <>stream Aspirate prior to injection to avoid injection into a blood vessel. This website also contains material copyrighted by 3rd parties. This suggests an increased risk of malignancies in calcitonin salmon-treated patients compared to placebo-treated patients. xS*B.C 4T0 \.LcC4.TO+cCC#,.@ 30 Please use this form to submit your questions or comments on how to make this article more useful to clinicians. The risk for hypocalcemia and other disturbances of mineral metabolism may increase during coadministration. If you are using calcitonin salmon for osteoporosis, it is important that you get enough calcium and vitamin D. Your doctor may prescribe supplements if your dietary intake is not enough. The addition of 10 mM sodium phosphate buffer . /GSa 3 0 R 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. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Have blood work checked as you have been told by the doctor. If severe ulceration of the nasal mucosa occurs, calcitonin nasal spray should be discontinued. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Although smaller ulcers often heal without withdrawal of calcitonin nasal spray, the medication should be discontinued temporarily until healing occurs. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. The benefits for the individual patient should be carefully considered against possible risks. /Resources 19 0 R Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. 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. On Medscape are moderated and should be discontinued of bone but does not cure them and tends decrease. Mineralisation defect with calcitonin 1 mL of solution per actuation ; each 0.09-mL spray delivers 200-unit dose calcitonin-salmon-treated patients to! 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