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calcitonin salmon
Overview
What is Fortical?
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.
The active ingredient in FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray is a polypeptide of 32 amino acids manufactured by recombinant DNA technology and is identical to calcitonin-salmon produced by chemical synthesis.
This is shown by the following graphic formula:
It is provided in a 3.7 mL fill glass bottle as a solution for intranasal administration with sufficient medication for at least 30 doses. Each spray delivers 200 International Units calcitonin-salmon in a volume of 0.09 mL.
Active Ingredient
Inactive Ingredients
What does Fortical look like?
What are the available doses of Fortical?
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What should I talk to my health care provider before I take Fortical?
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How should I use Fortical?
The recommended dose of FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray in postmenopausal osteoporotic patients is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily. Each bottle, filled with 3.7 mL of solution, contains enough medication for 30 doses. 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.
What interacts with Fortical?
Clinical allergy to calcitonin-salmon.
What are the warnings of Fortical?
Allergic 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 emergency treatment if such a reaction should 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 a calcitonin-salmon injectable product. Physicians may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from Upsher-Smith Laboratories, Inc. by calling toll-free at 1-800-654-2299.
What are the precautions of Fortical?
1. Drug Interactions
Formal studies designed to evaluate drug interactions with calcitonin-salmon have not been done.
Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may need to be adjusted.
The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Paget's disease prior diphosphonate use appears to reduce the anti-resorptive response to calcitonin-salmon nasal spray.
2. Periodic Nasal Examinations
Periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessel status are recommended.
The development of mucosal alterations or transient nasal conditions have been reported in up to 9% of patients who received a calcitonin-salmon nasal spray and in up to 12% of patients who received placebo nasal spray in studies in postmenopausal women. The majority of patients (approximately 90%) in whom nasal abnormalities were noted also reported nasally related complaints/symptoms as adverse events. Therefore, a nasal examination should be performed prior to start of treatment with nasal calcitonin and at any time nasal complaints occur.
In all postmenopausal patients treated with a calcitonin-salmon nasal spray, the most commonly reported nasal adverse events included rhinitis (12%), epistaxis (3.5%), and sinusitis (2.3%). Smoking was shown not to have any contributory effect on the occurrence of nasal adverse events. One patient (0.3%) treated with a calcitonin-salmon nasal spray who was receiving 400 International Units daily developed a small nasal wound. In clinical trials in another disorder (Paget's disease), 2.8% of patients developed nasal ulcerations.
If severe ulceration of the nasal mucosa occurs, as indicated by ulcers greater than 1.5 mm in diameter or penetrating below the mucosa, or those associated with heavy bleeding, calcitonin-salmon nasal spray should be discontinued. Although smaller ulcers often heal without withdrawal of calcitonin-salmon nasal spray, medication should be discontinued temporarily until healing occurs.
3. Information for Patients
- trouble breathing
- swelling of your face, throat or tongue
- rapid heartbeat
- chest pain
- feel faint or dizzy
- Store new, unassembled bottles in the refrigerator between 36-46°F (2-8°C).
- Protect the product from freezing.
- Keep the bottle of Fortical Nasal Spray away from light.
- Before priming the pump and using a new bottle, allow it to reach room temperature.
- After opening a new bottle of Fortical Nasal Spray, store bottle in use with pump attached at room temperature, 68°F to 77°F (20°C to 25°C), in an upright position. Each bottle contains enough medicine for 30 doses.
- Throw away the empty bottle of Fortical Nasal Spray after you have used 30 doses.
- See for complete instructions on priming the pump and administering FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray.
Careful instructions on pump assembly, priming of the pump and nasal introduction of FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray should be given to the patient. Although instructions for patients are supplied with the individual bottle, procedures for use should be demonstrated to each patient. Patients should notify their physician if they develop significant nasal irritation.
Get emergency medical help right away if you have any of the following symptoms of a serious allergic reaction:
Patients should be advised of the following:
4. Carcinogenicity, Mutagenicity, Impairment of Fertility
An increased incidence of non-functioning pituitary adenomas has been observed in 1-year toxicity studies in Sprague-Dawley and Fischer 344 Rats administered (subcutaneously) calcitonin-salmon at dosages of 80 International Units per kilogram per day (16-19 times the recommended human parenteral dose and about 130-160 times the human intranasal dose based on body surface area).
The findings suggest that calcitonin-salmon reduced the latency period for development of the pituitary adenomas that do not produce hormones, probably through the perturbation of physiologic processes involved in the evolution of this commonly occurring endocrine lesion in the rat. Although administration of calcitonin-salmon reduces the latency period of the development of nonfunctional proliferative lesions in rats, it did not induce the hyperplastic/neoplastic process.
Calcitonin-salmon was tested for mutagenicity using four strains of and two strains of , with and without rat liver metabolic activation, and found to be non-mutagenic. The drug was also not mutagenic in a chromosome aberration test in Chinese Hamster ovary cells .
5. Laboratory Tests
Urine sediment abnormalities have not been reported in ambulatory volunteers treated with calcitonin-salmon nasal spray. Coarse granular casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no evidence of renal abnormality and the urine sediment became normal after calcitonin was stopped. Periodic examinations of urine sediment should be considered.
6. Pregnancy
7. Nursing Mothers
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on this drug since many drugs are excreted in human milk. Calcitonin has been shown to inhibit lactation in animals.
8. Pediatric Use
There are no data to support the use of FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray in children. Disorders of bone in children referred to as idiopathic juvenile osteoporosis have been reported rarely. The relationship of these disorders to postmenopausal osteoporosis has not been established and experience with the use of calcitonin in these disorders is limited.
9. Geriatric Use
In a large multi-centered, double-blind, randomized clinical study of calcitonin-salmon nasal spray, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 and over. Compared to subjects less than 65 years old, the incidence of nasal adverse events (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly those over the age of 75. Most events were mild in intensity. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
What are the side effects of Fortical?
The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to calcitonin-salmon nasal spray (N=341) and to placebo nasal spray (N=131), and reported in greater than 3% of calcitonin-salmon nasal spray treated patients are presented in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).
In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with calcitonin-salmon nasal spray. Adverse events reported in 1%-3% of patients are identified with an asterisk(*). The remainder occurred in less than 1% of patients. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to calcitonin-salmon nasal spray has not been established.
Body as a whole – General Disorders:
Integumentary:
Musculoskeletal/Collagen:
Respiratory/Special Senses:
Cardiovascular:
Gastrointestinal:
Liver/Metabolic:
Endocrine:
Urinary System:
Central and Peripheral Nervous System:
Hearing/Vestibular:
Vision:
Vascular:
Hematologic/Resistance Mechanisms:
Psychiatric:
Immune System Disorders
Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with calcitonin-salmon nasal spray than in those patients treated with injectable calcitonin. Nausea, with or without vomiting, which occurred in 1.8% of patients treated with the nasal spray (and 1.5% of those receiving placebo nasal spray) occurs in about 10% of patients who take injectable calcitonin-salmon. Flushing, which occurred in less than 1% of patients treated with the nasal spray, occurs in 2-5% of patients treated with injectable calcitonin-salmon. Although the administered dosages of injectable and nasal spray calcitonin-salmon are comparable (50-100 units daily of injectable versus 200 units daily of nasal spray), the nasal dosage form has a mean bioavailability of about 3% (range 0.3%-30.6%) and therefore provides less drug to the systemic circulation, possibly accounting for the decrease in frequency of adverse reactions.
The collective foreign marketing experience with calcitonin-salmon nasal spray does not show evidence of any notable difference in the incidence profile of reported adverse reactions when compared with that seen in the clinical trials.
| Adverse Reaction | Calcitonin-Salmon Nasal SprayN=341% of Patients | PlaceboN=131% of Patients |
|---|---|---|
| Rhinitis | 12.0 | 6.9 |
| Symptom of Nose | 10.6 | 16.0 |
| Back Pain | 5.0 | 2.3 |
| Arthralgia | 3.8 | 5.3 |
| Epistaxis | 3.5 | 4.6 |
| Headache | 3.2 | 4.6 |
What should I look out for while using Fortical?
Clinical allergy to calcitonin-salmon.
What might happen if I take too much Fortical?
No instances of overdose with calcitonin-salmon nasal spray have been reported and no serious adverse reactions have been associated with high doses. There is no known potential for drug abuse for calcitonin-salmon.
Single doses of calcitonin-salmon nasal spray up to 1600 International Units, doses up to 800 International Units per day for 3 days and chronic administration of doses up to 600 International Units per day have been studied without serious adverse effects. A 1000 International Units dose of calcitonin-salmon injectable product given subcutaneously may produce nausea and vomiting. A 32 International Units per kg per day dose of calcitonin-salmon injectable product for 1or 2 days demonstrated no additional adverse effects.
There have been no reports of hypocalcemic tetany. However, the pharmacologic actions of FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray suggest that this could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose.
How should I store and handle Fortical?
FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL). A screw-on pump is provided. Following priming, the pump will deliver solution containing 200 International Units of calcitonin-salmon per activation. FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray contains 2200 International Units/mL calcitonin-salmon and is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump ().FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL). A screw-on pump is provided. Following priming, the pump will deliver solution containing 200 International Units of calcitonin-salmon per activation. FORTICAL calcitonin-salmon (rDNA origin) Nasal Spray contains 2200 International Units/mL calcitonin-salmon and is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump ().
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Osteoporosis is a disease characterized by low bone mass and architectural deterioration of bone tissue leading to enhanced bone fragility and a consequent increase in fracture risk as patients approach or fall below a bone mineral density associated with increased frequency of fracture. The most common type of osteoporosis occurs in postmenopausal women. Osteoporosis is a result of a disproportionate rate of bone resorption compared to bone formation, which disrupts the structural integrity of bone, rendering it more susceptible to fracture. The most common sites of these fractures are the vertebrae, hip, and distal forearm (Colles' fracture). Vertebral fractures occur with the highest frequency and are associated with back pain, spinal deformity and a loss of height.
Calcitonin, given by the intranasal route, has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis but not in early postmenopausal women.
Non-Clinical Toxicology
Clinical allergy to calcitonin-salmon.Formal studies designed to evaluate drug interactions with calcitonin-salmon have not been done.
Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may need to be adjusted.
The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Paget's disease prior diphosphonate use appears to reduce the anti-resorptive response to calcitonin-salmon nasal spray.
Formal studies designed to evaluate drug interactions with calcitonin-salmon have not been done.
Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may need to be adjusted.
The effects of prior use of diphosphonates in postmenopausal osteoporosis patients have not been assessed; however, in patients with Paget's disease prior diphosphonate use appears to reduce the anti-resorptive response to calcitonin-salmon nasal spray.
The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to calcitonin-salmon nasal spray (N=341) and to placebo nasal spray (N=131), and reported in greater than 3% of calcitonin-salmon nasal spray treated patients are presented in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).
In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with calcitonin-salmon nasal spray. Adverse events reported in 1%-3% of patients are identified with an asterisk(*). The remainder occurred in less than 1% of patients. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to calcitonin-salmon nasal spray has not been established.
Body as a whole – General Disorders:
Integumentary:
Musculoskeletal/Collagen:
Respiratory/Special Senses:
Cardiovascular:
Gastrointestinal:
Liver/Metabolic:
Endocrine:
Urinary System:
Central and Peripheral Nervous System:
Hearing/Vestibular:
Vision:
Vascular:
Hematologic/Resistance Mechanisms:
Psychiatric:
Immune System Disorders
Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with calcitonin-salmon nasal spray than in those patients treated with injectable calcitonin. Nausea, with or without vomiting, which occurred in 1.8% of patients treated with the nasal spray (and 1.5% of those receiving placebo nasal spray) occurs in about 10% of patients who take injectable calcitonin-salmon. Flushing, which occurred in less than 1% of patients treated with the nasal spray, occurs in 2-5% of patients treated with injectable calcitonin-salmon. Although the administered dosages of injectable and nasal spray calcitonin-salmon are comparable (50-100 units daily of injectable versus 200 units daily of nasal spray), the nasal dosage form has a mean bioavailability of about 3% (range 0.3%-30.6%) and therefore provides less drug to the systemic circulation, possibly accounting for the decrease in frequency of adverse reactions.
The collective foreign marketing experience with calcitonin-salmon nasal spray does not show evidence of any notable difference in the incidence profile of reported adverse reactions when compared with that seen in the clinical trials.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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