\9_3chn|An The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent. >> Calcitonin (salmon, synthetic) . Calcitonin salmon helps treat osteoporosis and Paget's disease of bone but does not cure them. 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. It is not known whether calcitonin crosses the blood-brain barrier or if it distributes into breast milk. Intravenous, subcutaneous, or intramuscular use. 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. 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. 680.159999 0] [27980]Ensure adequate intake of calcium and vitamin D during osteoporosis treatment and prevention. What should I know about storage and disposal of this medication? For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. >> Onset of action of calcitonin is immediate following IV administration. << 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. This medicine is available only with your doctor's prescription. [0 /XYZ 69.5999999 Allow to reach room temperature before intramuscular or subcutaneous use. Safety and efficacy have not been established. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Glass or hard plastic IV containers should not be used. 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. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. [0 /XYZ 43.6799999 Influenza-like symptoms, oedema (facial, peripheral and generalised), injection site reaction. << Calcitonin does not appear to cross the placenta. Miacalcin has also been shown to decrease bone pain associated with bone fractures caused by osteoporosis. An increased risk of hypocalcemia was seen in clinical trials involving patients with renal dysfunction. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. 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. 3 In case of patients with high bone remodelling (Paget's disease and young patients) a transient decrease of calcemia may occur between the 4th and the 6th hour after administration, usually asymptomatic. 9 0 obj The dose may be reduced to 50 IU daily at the start of remobilisation. Calcium; Vitamin D: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin salmon and serum calcium and symptoms of hypocalcemia should be monitored. Effect not reported by other investigators. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously or intramuscularly. 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. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. Therefore, breast-feeding is not recommended during treatment. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Calcitonin antagonizes the actions of PTH, but concentrations of PTH do not increase significantly in response to calcitonin therapy. Calcitonin salmon has same pharmacologic activity as calcitonin human, but calcitonin salmon is more potent and has longer duration of action. (See Cautions.). 310.559999 0] To use the sharing features on this page, please enable JavaScript. Type I, clear glass ampoule containing 1 ml of solution. 1 Development of neutralising antibodies to calcitonin. hbbd``b`.@$8@\/ bm,@5@S %: H+q%U@BHHa $"F $
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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. Miacalcin and Fortical new unassembled bottles: 2-8C; protect from freezing. AHFS DI Essentials. Drug class: Antiparathyroid Agents Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Resume the regular dosing schedule at the beginning of the next week. Clinical and/or biochemical effects in Paget disease may not be evident for several months. In some patients, the inhibition of bone resorption is of such a magnitude that the consequent of reduction of filtered calcium load more than compensates for the decrease in tubular reabsorption of calcium. H|WMo8R*S4^$i6QfD*+~-+R$H|3|s>a>|8/.g0:=(4P/jG z4^>>F?~vUL fYQ(F'j
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v f)?.z}qO RkUo| This includes your doctors, nurses, pharmacists, and dentists. /GSa 3 0 R The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. /Length 18 0 R A total of 44 manufacturers were contacted and asked to provide the relevant information for the remaining 55 medications (62%). If you log out, you will be required to enter your username and password the next time you visit. tell your doctor and pharmacist if you are allergic to calcitonin salmon or any other medications. 1 0 obj 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. Patients must therefore be warned that these effects may occur, in which case they should not drive or use machines. If your usual dose is three times a week, give the missed dose on the next day and continue every other day thereafter. It is not known whether salmon calcitonin crosses the placental barrier. stream Stability Storage Parenteral Injection. Not known whether calcitonin is distributed into human milk. Alternate nostrils daily. Conventional long-term toxicity, reproduction, mutagenicity and carcinogenicity studies have been performed in laboratory animals. Fortical bottle in use: 2025C, in upright position for up to 30 days. The presence of antibodies appears to bear no relationship to allergic reactions, which are rare. Treatment should be discontinued once the patient has responded and symptoms have resolved. You've successfully added to your alerts. Data are inadequate to support use of calcitonin in children. Calcium Chloride: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. MedHelp is not a medical or healthcare provider and your use of this Site does not create a doctor / patient relationship. 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. 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. 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). MIA-2020-0001 V3. endstream
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The following symptoms are uncommon, but if you experience any of them, call your doctor immediately: hives skin rash itching difficulty breathing or swallowing swelling of the tongue or throat Calcitonin salmon may cause other side effects. 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. DRUG INTERACTIONS: Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. Calcitonin-salmon Nasal Spray:Before the first dose, the nasal spray should be at room temperature. Maintenance: 50 units (0.25 mL) daily or every other day; higher dosage (100 units daily) appropriate in patients with serious deformity or neurologic involvement. In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models. 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. hb```M~ cc`aq@a/O(C"
H82t*\S, j2UFMzCD(ztZh PZa0J i`1@ * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Miacalcin (synthetic; with phenol 5 mg/mL). Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. The Content on this Site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. %PDF-1.4
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Nasal effects described as mild. For the treatment of osteoporosis adequate intake of vitamin D is necessary in conjunction with calcitonin. endobj 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. Brand names: Fortical, Miacalcin Do not stop using calcitonin salmon without talking to your doctor. 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. Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose. /Pattern << /SM 0.02 Calcium Carbonate; Magnesium Hydroxide: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. 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). Minimum effective dosage not established; 100 units every other day may be effective in preserving vertebral BMD. Decreases in serum calcium are usually noted within 2 hours of a single dose; however, the hypocalcemic response to calcitonin therapy usually only lasts 4 to 7 days despite continued therapy. endobj For the treatment of hypercalcemia, vitamin D preparations should be avoided. Doxercalciferol: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. /Type /ExtGState For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. The frequencies of the above listed undesirable effects are partly based on results from clinical trials with calcitonin nasal spray. Healthcare providers may wish to refer patients who require skin testing to an allergist. If severe ulceration of the nasal mucosa occurs, calcitonin nasal spray should be discontinued. Fracture reduction efficacy has not been demonstrated. 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. When sprayed into the nose, miacalcin is quickly absorbed into the blood stream. [27980] [57624] The PROOF study indicates a potential reduction in new vertebral fractures with use. 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. Musculoskeletal pain including arthralgia. Correct hypocalcemia and any other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before administration of calcitonin. 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. Differentiate hypersensitivity reactions from generalized flushing and hypotension. Carefully consider the benefits for the individual patient against the possible risks. For the treatment of hypercalcemia, vitamin D preparations should be avoided. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. \Mu}I'wP{|vq
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Calcitonin salmon injection is also used sometimes to treat osteogenesis imperfecta. Other reported clinical experience with calcitonin-salmon injection or nasal sprays has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 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). The reported overall incidence of new primary malignancy was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%) in a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations). No embryo/fetal toxicities related to calcitonin-salmon were reported from maternal subcutaneous daily calcitonin-salmon doses in rats up to 80 International Units/kg/day from gestation day 6 to 15. Periodic examinations of urine sediment are recommended in patients receiving long-term parenteral therapy. 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 calcium salts are necessary in conjunction with calcitonin. The time to 90% potency (T90) ranged from 32.0 hours to 41.7 hours. Glass or hard plastic IV containers should not be used. For patients with suspected hypersensitivity to calcitonin salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. 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. Important Limitations of Use: Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis. endobj It may be also be taken as a subcutaneous injection. Solutions for infusion should be prepared immediately before use in soft plastic PVC infusion bags. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. 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. For the treatment of osteoporosis adequate intake of calcium salts are necessary in conjunction with calcitonin. Copyright, 2023. For patients with suspected sensitivity to calcitonin, consider skin testing prior to initiating therapy. Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements. Safety and efficacy not established; off-label use reported. Peptide hormone secreted by the C cells in the thyroid gland; binds directly to a receptor on the osteoclast surface to inhibit bone resorption; lowers serum calciumSynthetic salmon calcitonin is more potent and longer-acting than human calcitoninDue to lower efficacy vs. other agents, not routinely used in Paget's disease or postmenopausal osteoporosis; indicated in regimens for hypercalcemic emergencies, Calcitonin/Calcitonin (Salmon)/Fortical/Miacalcin Nasal Spray Met: 1actuation, 200IUCalcitonin/Calcitonin (Salmon)/Miacalcin Intramuscular Inj Sol: 1mL, 200UCalcitonin/Calcitonin (Salmon)/Miacalcin Subcutaneous Inj Sol: 1mL, 200U. Remove the unopened bottle from the refrigerator and allow the spray to reach room temperature.Remove the protective cap.To prime the pump bottle, the bottle should be held upright and the 2 side arms of the pump depressed toward the bottle until a full spray is produced. ADVERSE REACTIONS: The most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%). With IM or sub-Q administration, 15 minutes. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. In addition, it appears to be quite beneficial in preventing bone loss after liver transplantation. 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. Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively). /Resources 19 0 R For the treatment of hypercalcemia, vitamin D preparations should be avoided. Hypocalcemia must be corrected before initiating therapy. [24558] [24298]. >> (calcitonin-salmon) refrigeratorat36-46F. 11 0 obj 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. Calcium Carbonate: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. Aspirate prior to injection to avoid injection into a blood vessel. Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy. Allow solution to reach room temperature before priming pump and administering first dose. 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). There is no information on the presence of calcitonin in human milk, the effects on the breast-fed infant, or the effects on milk production. redness, swelling, or irritation at the site of injection, flushing (feeling of warmth) of the face or hands. [0 /XYZ 69.5999999 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. [27980] [52559] [57624] Due to species-specific differences in lactation physiology, animal data may not reliably predict human response. k_b For the treatment of hypercalcemia, calcium supplements should be avoided. 17 0 obj Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Calcitonin is a is a peptide hormone secreted by the C-cells of the thyroid gland endogenously; calcitonin-salmon is a calcitonin receptor agonist. Calcitonin salmon prepared by recombinant DNA technology is structurally identical to calcitonin salmon produced by chemical synthesis. What side effects can this medication cause? The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration. In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see section 5.3). For the treatment of hypercalcemia, calcium supplements should be avoided. Neoplasms benign, malignant and unspecified (incl cysts and polyps). 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 salmon comes as a solution to be injected under the skin (subcutaneously) or into the muscle (intramuscularly). Store calcitonin salmon injection in its original container in the refrigerator. Reduction in serum calcium concentration in patients with hypercalcemia evident within about 2 hours after first injection. It is usually used once a day or once every other day. 2007;64(16):1711-1715. Calcium: (Moderate) Calcitonin is given to hypercalcemic patients to reduce serum calcium concentrations. endobj 2-8C. Calcitonin 50 IU/1 ml solution for injection and infusion . Experience with calcitonin in children with juvenile Paget disease is very limited; the relationship between this disorder and adult Paget disease is not established. The U.S. Pharmacopeia's definition of room temperature (20-25 C [68-77 F]) was used for this review. Calcium salts, including calcium carbonate, can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. Vitamin D analogs can elevate serum calcium concentrations and antagonize the effects of the calcitonin for this condition. By subcutaneous or intramuscular injection also been shown to have analgesic activity in animal models total body calcium observed clinical. To be injected under the skin ( subcutaneously ) or into the blood stream Drug class Antiparathyroid. Medical or healthcare provider and your use of this medication of PTH do not using... Iu/1 ml solution for injection and infusion are necessary in conjunction with calcitonin or use machines discontinued. 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miacalcin injection stability room temperature rulide