Calcitonin Salmon Spray
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Questions & Answers
Side Effects & Adverse Reactions
Because calcitonin is a polypeptide, the possibility of a systemic allergic reaction exists. A few cases of serious allergic-type reactions have been reported in patients receiving Calcitonin-Salmon Nasal Spray, including cases of anaphylaxis and anaphylactic shock. With injectable calcitonin-salmon there have been a few reports of serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis. The usual provisions should be made for the emergency treatment of such a reaction should it occur. Allergic reactions should be differentiated from generalized flushing and hypotension.
For patients with suspected sensitivity to calcitonin, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of calcitonin-salmon injection. Physicians may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from the Drug Safety Department of Par Pharmaceutical Companies Inc. at 1-800-828-9393.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Calcitonin-Salmon Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Calcitonin-Salmon Nasal Spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Calcitonin-Salmon Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 I.U. per day) intake to retard the progressive loss of bone mass. The evidence of efficacy is based on increases in spinal bone mineral density observed in clinical trials.
Two randomized, placebo controlled trials were conducted in 325 postmenopausal females [227 Calcitonin-Salmon Nasal Spray treated and 98 placebo treated] with spinal, forearm or femoral bone mineral density (BMD) at least one standard deviation below normal for healthy premenopausal females. These studies conducted over two years demonstrated that 200 I.U. daily of Calcitonin-Salmon Nasal Spray increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic females who were greater than 5 years postmenopause. Calcitonin-Salmon Nasal Spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as 6 months after initiation of therapy with persistence of this level for up to 2 years of observation.
No effects of Calcitonin-Salmon Nasal Spray on cortical bone of the forearm or hip were demonstrated. However, in one study, BMD of the hip showed a statistically significant increase compared with placebo in a region composed of predominantly trabecular bone after 1 year of treatment changing to a trend at 2 years that was no longer statistically significant.
History
There is currently no drug history available for this drug.
Other Information
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
Calcitonin-Salmon Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:
It is provided in 3.7 mL fill glass bottles as a solution for nasal administration. This is sufficient medication for at least 30 doses.
Active Ingredient:calcitonin-salmon, 2200 I.U. per mL (corresponding to 200 I.U. per 0.09 mL actuation).
Inactive Ingredients:sodium chloride, chlorobutanol, hydrochloric acid (added as necessary to adjust pH), purified water and nitrogen.
The activity of Calcitonin-Salmon Nasal Spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute of Biologic Standards and Control, Holly Hill, London.
Sources
Calcitonin Salmon Spray Manufacturers
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Physicians Total Care, Inc.
![Calcitonin Salmon Spray, Metered [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Calcitonin Salmon Spray | Physicians Total Care, Inc.
The recommended dose of Calcitonin-Salmon Nasal Spray in postmenopausal osteoporotic females is one spray (200 I.U.) per day administered intranasally, alternating nostrils daily.
Drug effect may be monitored by periodic measurements of lumbar vertebral bone mass to document stabilization of bone loss or increases in bone density. Effects of Calcitonin-Salmon Nasal Spray on biochemical markers of bone turnover have not been consistently demonstrated in studies in postmenopausal osteoporosis. Therefore, these parameters should not be solely utilized to determine clinical response to Calcitonin-Salmon Nasal Spray therapy in these patients.
Priming (Activation) of PumpBefore the first dose and administration, Calcitonin-Salmon Nasal Spray should be at room temperature. To prime the pump, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle until a full spray is produced. The pump is primed once the first full spray is emitted. To administer, the nozzle should be carefully placed into the nostril with the head in the upright position, and the pump firmly depressed toward the bottle. The pump should not be primed before each daily dose.
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Par Pharmaceutical Inc. (Mgc)
Calcitonin Salmon Spray | Par Pharmaceutical Inc. (mgc)
The recommended dose of Calcitonin Salmon Nasal Solution in postmenopausal osteoporotic females is one spray (200 International Unit) per day administered intranasally, alternating nostrils daily.
Drug effect may be monitored by periodic measurements of lumbar vertebral bone mass to document stabilization of bone loss or increases in bone density. Effects of Calcitonin Salmon Nasal Solution on biochemical markers of bone turnover have not been consistently demonstrated in studies in postmenopausal osteoporosis. Therefore, these parameters should not be solely utilized to determine clinical response to Calcitonin Salmon Nasal Solution therapy in these patients.
Priming (Activation) of PumpBefore the first dose and administration, Calcitonin Salmon Nasal Solution should be at room temperature. To prime the pump, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle until a full spray is produced. The pump is primed once the first full spray is emitted. To administer, the nozzle should be carefully placed into the nostril with the head in the upright position, and the pump firmly depressed toward the bottle. The pump should not be primed before each daily dose.
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Sandoz Inc
Calcitonin Salmon Spray | Sandoz Inc
2.1 Basic Dosing InformationThe recommended dose of calcitonin-salmon nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily.
2.2 Priming (Activation) of PumpUnopened calcitonin-salmon nasal spray should be stored in the refrigerator. Before using the first dose of calcitonin-salmon nasal spray, the patient should wait until it has reached room temperature. To prime the pump before it is used for the first time, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle, repeat until a full spray is released. The pump is primed once the first full spray is emitted. To administer, the nozzle should first be carefully placed into the nostril while the patient’s head is in the upright position, then the pump should be firmly depressed toward the bottle. The pump should not be primed before each daily dose.
2.3 Recommendations for Calcium and Vitamin D SupplementationPatients who use calcitonin-salmon nasal spray should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
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Apotex Corp.
Calcitonin Salmon Spray | Apotex Corp.
2.1 Basic Dosing InformationThe recommended dose of calcitonin salmon nasal spray is 1 spray (200 USP Calcitonin Salmon Units) per day administered intranasally, alternating nostrils daily.
2.2 Priming (Activation) of PumpUnopened calcitonin salmon nasal spray should be stored in the refrigerator. Before using the first dose of calcitonin salmon nasal spray, the patient should wait until it has reached room temperature. To prime the pump before it is used for the first time, the bottle should be held upright and the two white side arms of the pump depressed toward the bottle, repeat until a full spray is released. The pump is primed once the first full spray is emitted. To administer, the nozzle should first be carefully placed into the nostril while the patient’s head is in the upright position, then the pump should be firmly depressed toward the bottle. The pump should not be primed before each daily dose.
2.3 Recommendations for Calcium and Vitamin D SupplementationPatients who use calcitonin salmon nasal spray should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
![Calcitonin Salmon Spray, Metered [Par Pharmaceutical Inc. (Mgc)]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a6eaedb3-5c96-4859-be43-a48c9c818bc7&name=35e3dd68-677f-45e9-b4bf-f30fa2a34367-06.jpg)
![Calcitonin Salmon Spray, Metered [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0614bf53-9644-47d2-b46e-8efbcd63afe6&name=calcitonin-salmon-0B.jpg)
![Calcitonin Salmon Spray, Metered [Apotex Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c82eb602-12e1-692b-d660-f8d5b5736b54&name=200iu-carton.jpg)
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