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. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Once the vial has been opened it can be kept at room temperature (not above 25C) for up to one month. For the treatment of hypercalcemia, calcium supplements should be avoided. 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. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. tqX)I)B>== 9. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 1 0 obj It is best to change which nostril you use each day. Human milk naturally contains some calcitonin and its precursor, procalcitonin. Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. 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. Inhibits lactation in animals. Let the solution warm to room temperature before administration. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. (See Cautions.). /Type /ExtGState 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. Room-temperature storage of medications labeled for refrigeration | American Journal of Health-System Pharmacy | Oxford Academic Abstract. Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed. 680.159999 0] 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 - Bone Resorption Inhibitors In the kidney, calcitonin increases the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. 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. For nasal dosage form (spray): For postmenopausal osteoporosis: Adults200 International Units (IU) or 1 spray into one nostril per day. It may also be used to prevent bone loss in women with postmenopausal osteoporosis and to treat hypercalcemia (too much calcium in the blood). Clcr not altered and proteinuria not reported; urine sediment returned to normal within 4 days following drug discontinuance. %%EOF 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. Safety and efficacy not established; off-label use reported. Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. The admixtures with added buffer were studied under refrigerated storage as well. [27980]Ensure adequate intake of calcium and vitamin D during osteoporosis treatment and prevention. 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). Appropriate agents for treatment of hypersensitivity reactions should be readily available. Calcitonin salmon injection is used to treat osteoporosis in postmenopausal women. This effect is diminished as osteoclastic activity is reduced. Give with supplemental calcium and vitamin D if dietary intake is inadequate. Dosage >100 units daily usually does not produce an improved response in patients who relapse while receiving calcitonin. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. 19 0 obj Product Safety Department. The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. 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. 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. This medicinal product contains 3.3 mg sodium per ml, equivalent to 0.16% of the WHO recommended maximum daily intake of 2 g sodium for an adult. In most patients with Paget disease, causes a decrease in the rate of bone turnover with a resultant decrease in elevated serum alkaline phosphatase concentrations and urinary hydroxyproline excretion. \Mu}I'wP{|vq wW7_=0Z&F0P13Mhx.='rU 8OIm0Kl{xA#{(/GOh\k j)/^z0r[q kSY+LOuC0 | in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months. Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. endobj Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations. Miacalcin: To prime pump, hold bottle upright and depress the 2 white side arms of pump toward the bottle until full spray is produced. endstream endobj 127 0 obj <>stream Inject into a large muscle. The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect. 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. (calcitonin-salmon) refrigeratorat36-46F. Appears to be rapidly metabolized to smaller inactive fragments in kidney, blood, and peripheral tissues. 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. Therefore, a nasal examination should be performed prior to the start of treatment with nasal calcitonin and at anytime nasal complaints occur. 16 0 obj 4 0 obj Onset of action of calcitonin is immediate following IV administration. 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. Guidelines recommend against calcitonin-salmon for the treatment of osteoporosis; the efficacy of calcitonin in preventing vertebral and non-vertebral fractures is not established, and the increase in bone mineral density observed is less than that reported for other agents (e.g., bisphosphonates). Otherwise, skip the missed dose and continue the regular dosing schedule the next day. \9_3chn|An hbbd``b` For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Calcitonin 50 IU/ml solution for injection and infusion. [0 /XYZ 69.5999999 Activity of calcitonin salmon expressed in terms of International Units (units). 2007;64(16):1711-1715. In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see section 5.3). Miacalcinbottle in use: 1530C, in upright position for up to 35 days. Frequent monitoring of the clinical and laboratory response including the measurement of serum calcium is recommended especially in the early phases of treatment. Ensure adequate intake of calcium (at least 1,000 mg elemental calcium per day) and vitamin D (at least 10 mcg or 400 International Units per day) during calcitonin therapy. Miacalcin Injection should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Cool, open the tube, dry in a 0.4, 0.6, and 0.9, respectively; and the retention time vacuum desiccator, remove the contents, and allow to for calcitonin salmon is about 9 min.] /Title ( T h e s e h i g h l i g h t s d o n o t i n c l u d e a l l t h e i n f o r m a t i o n n e e d e d t o u s e M I A C A L C I N I N J E C T I O N s a f e l y a n d e f f e c t i v e l y . 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). /Annots 20 0 R Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. There are no data regarding a potential influence of calcitonin on human fertility. Calcitonin is a human hormone that is also found in salmon. For the treatment of hypercalcemia, calcium supplements should be avoided. [/Pattern /DeviceRGB] Your doctor may order certain lab tests to check your body's response to calcitonin salmon. S . For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. Click the topic below to receive emails when new articles are available. Lithium: (Moderate) Reduced serum lithium concentrations have been observed in previously stabilized patients who initiated daily calcitonin salmon subcutaneous injections for osteoporosis. 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. Am J Health Syst Pharm. 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. Instruct patients to seek medical care if symptoms of hypocalcemia develop. /GSa 3 0 R $E}kyhyRm333: }=#ve 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. Before preparing a dose, look at the vial. endobj Known hypersensitivity to calcitonin salmon. - 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. Give supplemental calcium and vitamin D if dietary intake is inadequate. 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. Therefore, breast-feeding is not recommended during treatment. [27980] [52559] [57624]. Type I, clear glass ampoule containing 1 ml of solution. decreased appetite stomach pain swelling of the feet salty taste Some side effects can be serious. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat [see . Fortical bottle in use: 20-25C, in upright position for up to 30 days. Neoplasms benign, malignant and unspecified (incl cysts and polyps). Calcitonin is excreted primarily in the urine as inactive metabolites. 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.