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Calcitonin salmon
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- Active ingredient
- Calcitonin Salmon 400 [USP'U]/2 mL
- Other brand names
- Calcitonin Salmon (by Amneal Pharmaceuticals Llc)
- Calcitonin Salmon (by Apotex Corp.)
- Calcitonin Salmon (by Cipla Usa Inc.)
- Calcitonin Salmon (by Dr. Reddy's Laboratories, Inc.)
- Calcitonin Salmon (by Endo Usa, Inc.)
- Calcitonin Salmon (by Fresenius Kabi Usa, Llc)
- Calcitonin Salmon (by Hikma Pharmaceuticals Usa Inc.)
- Calcitonin Salmon (by Par Health Usa, Llc)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- View full label-group details →
- Drug class
- Calcitonin
- Dosage form
- Injection, Solution
- Routes
- Intramuscular
- Subcutaneous
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- September 9, 2025
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Calcitonin Salmon 400 [USP'U]/2 mL
- Other brand names
- Calcitonin Salmon (by Amneal Pharmaceuticals Llc)
- Calcitonin Salmon (by Apotex Corp.)
- Calcitonin Salmon (by Cipla Usa Inc.)
- Calcitonin Salmon (by Dr. Reddy's Laboratories, Inc.)
- Calcitonin Salmon (by Endo Usa, Inc.)
- Calcitonin Salmon (by Fresenius Kabi Usa, Llc)
- Calcitonin Salmon (by Hikma Pharmaceuticals Usa Inc.)
- Calcitonin Salmon (by Par Health Usa, Llc)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- Miacalcin (by Mylan Institutional Llc)
- View full label-group details →
- Drug class
- Calcitonin
- Dosage form
- Injection, Solution
- Routes
- Intramuscular
- Subcutaneous
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- September 9, 2025
- Manufacturer
- Sagent Pharmaceuticals
- Registration number
- ANDA219196
- NDC root
- 25021-473
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Calcitonin Salmon Injection is a synthetic form of a hormone called calcitonin, which is naturally produced by the thyroid gland in mammals and by certain glands in birds and fish. This medication is made up of 32 amino acids and is administered through a sterile solution via subcutaneous (under the skin) or intramuscular (into the muscle) injection. It is primarily used to treat conditions such as Paget's disease of bone, hypercalcemia (high calcium levels in the blood), and postmenopausal osteoporosis when other treatments are not suitable.
Calcitonin salmon works by acting on specific receptors in the body, particularly in bone cells, to help regulate calcium levels and bone metabolism. It has a greater potency and longer duration of action compared to natural calcitonin found in mammals. This makes it an effective option for managing certain bone-related conditions.
Uses
You may be prescribed this medication for several specific health conditions. It is used to treat symptomatic Paget's disease of bone, particularly when other treatments are not appropriate for you. Additionally, it can help manage hypercalcemia, a condition where there is too much calcium in the blood. If you are postmenopausal and have osteoporosis, this medication may also be an option when other treatments are unsuitable, although it’s important to note that it has not been shown to reduce the risk of fractures in these cases.
Dosage and Administration
If you are being treated for symptomatic Paget's disease of bone or postmenopausal osteoporosis, you will need to take 100 USP Units of the medication each day. It's important to make sure you are also getting enough calcium and vitamin D in your diet to support your treatment.
For hypercalcemia (high levels of calcium in the blood), your starting dose will be 4 USP Units for every kilogram of your body weight, taken every 12 hours. If you don’t see any improvement after 1 to 2 days, your doctor may increase the dose to 8 USP Units per kilogram, still every 12 hours. If there’s still no improvement after an additional 2 days, the dose may be further increased to 8 USP Units per kilogram every 6 hours. Always follow your healthcare provider's instructions closely for the best results.
What to Avoid
If you are allergic to calcitonin salmon or any of its ingredients, you should not use this medication. It's important to be aware that this drug is classified as a controlled substance, which means it has the potential for abuse or misuse. Additionally, using this medication can lead to dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider to ensure that this medication is safe for you, especially if you have any concerns about these issues.
Side Effects
You may experience some common side effects when using calcitonin salmon. About 10% of patients report nausea, which can occur with or without vomiting, especially when starting treatment. This side effect often lessens or goes away with continued use. Additionally, around 10% of patients may have inflammation at the injection site, and 2% to 5% may experience flushing of the face or hands. Other reactions can include skin rashes, itching of the ear lobes, and a salty taste.
It's important to be aware of more serious reactions as well. There have been reports of severe allergic reactions, including fatal anaphylaxis (a life-threatening allergic response), so skin testing may be recommended if you have a history of allergies to calcitonin salmon. There is also a noted increased risk of certain cancers in patients treated with this medication compared to those who are not. Other potential side effects include nocturia (frequent urination at night), feverish sensations, eye pain, poor appetite, abdominal pain, swelling in the feet, and low calcium levels, so ensure you are getting enough calcium and vitamin D.
Warnings and Precautions
You should be aware of some important warnings and precautions when using this medication. Serious allergic reactions, including life-threatening anaphylaxis, have been reported. If you have a history of allergies to calcitonin salmon, your doctor may recommend skin testing before starting treatment. Additionally, low calcium levels (hypocalcemia) can occur, so it's essential to ensure you are getting enough calcium and vitamin D in your diet.
There is also a potential increased risk of cancer (malignancy) associated with this medication, as suggested by a review of multiple clinical trials. Furthermore, your body may develop antibodies against calcitonin salmon, which could reduce the effectiveness of the treatment over time.
If you experience any severe allergic reactions, such as difficulty breathing or swelling of the face and throat, seek emergency help immediately. You should also stop using the medication and contact your doctor if you notice any unusual symptoms or if you have concerns about your calcium levels.
Overdose
If you take too much of this medication, you might experience a condition called hypocalcemic tetany, which involves muscle spasms due to low calcium levels. It's important to have access to calcium treatment if this happens. Additionally, a dose of 1,000 USP Units of calcitonin salmon given under the skin can lead to nausea and vomiting.
While taking doses of 32 USP Units per kilogram per day for 1 to 2 days has not shown other harmful effects, we still don’t have enough information about the risks of using high doses for a longer time. If you suspect an overdose, look out for symptoms like severe muscle spasms or persistent nausea. In such cases, seek immediate medical help to ensure your safety.
Pregnancy Use
There are currently no studies involving pregnant women that can determine the risk of birth defects or miscarriage associated with calcitonin salmon. However, animal studies have shown that when pregnant rabbits were given this medication at doses significantly higher than what is recommended for humans, there was a decrease in fetal birth weights. In contrast, no harmful effects on development were observed in rats given much higher doses during pregnancy.
It's important to note that in the general U.S. population, the estimated risk of major birth defects in recognized pregnancies is between 2% and 4%, while the risk of miscarriage ranges from 15% to 20%. If you are pregnant or planning to become pregnant, it's essential to discuss any medications with your healthcare provider to understand the potential risks and benefits.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to know that there is currently no information available about whether calcitonin salmon is present in human milk or how it might affect your child or your milk production. Studies in rats have shown that calcitonin can inhibit lactation, which means it may reduce milk supply.
When considering the use of calcitonin salmon, weigh the developmental and health benefits of breastfeeding against your need for this medication and any potential risks it may pose to your baby. Always consult with your healthcare provider to make the best decision for you and your child.
Pediatric Use
When considering this medication for your child, it's important to know that its safety and effectiveness in children have not been established. This means that there hasn't been enough research to confirm that it works well or is safe for pediatric patients (children and adolescents). Always consult with your child's healthcare provider to discuss any concerns and to explore the best treatment options for their specific needs.
Geriatric Use
When considering treatment with calcitonin salmon, it's important to note that clinical studies have not included enough participants aged 65 and older to fully understand how older adults may respond compared to younger individuals. However, based on other clinical experiences, no significant differences in responses have been reported between older and younger patients.
For older adults, it is generally recommended to start with a lower dose of the medication. This cautious approach is due to the higher likelihood of having reduced liver, kidney, or heart function, as well as the possibility of other health conditions or medications that could affect treatment. Always consult with a healthcare provider to determine the most appropriate dosage for your specific situation.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to talk to your healthcare provider about all the medications you are taking, especially if you are using calcitonin salmon alongside lithium. When these two are used together, calcitonin salmon can increase the amount of lithium that your body clears through urine, which may lower the levels of lithium in your blood. This could mean that your doctor might need to adjust your lithium dose to ensure it remains effective.
Since there are no reported interactions with laboratory tests, you can feel confident that your routine tests should not be affected by these medications. Always keep your healthcare provider informed about any changes in your medication regimen to ensure your safety and the effectiveness of your treatment.
Storage and Handling
To ensure the best performance and safety of your product, store it in a refrigerator at a temperature between 2° to 8°C (36° to 46°F). It's important to keep it protected from freezing, as extreme cold can damage the product.
The product is sterile (free from germs) and nonpyrogenic (does not cause fever), which is essential for safe use. Additionally, the container closure does not contain natural rubber latex, making it suitable for individuals with latex allergies. Always handle the product with care to maintain its integrity and effectiveness.
Additional Information
You may want to consider periodic examinations of urine sediment (the solid material that settles at the bottom of urine) as part of your health monitoring while using this medication. This can help ensure that any potential issues are identified early.
Currently, there is no additional information available regarding the potential for abuse, administration methods, or patient counseling.
FAQ
What is Calcitonin Salmon Injection?
Calcitonin Salmon Injection is a synthetic polypeptide hormone derived from salmon, used for subcutaneous or intramuscular injection.
What are the indications for using Calcitonin Salmon Injection?
It is indicated for the treatment of symptomatic Paget's disease of bone, hypercalcemia, and postmenopausal osteoporosis when alternative treatments are not suitable.
What are the common side effects of Calcitonin Salmon Injection?
Common side effects include nausea (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%).
Are there any contraindications for Calcitonin Salmon Injection?
Yes, it is contraindicated in individuals with hypersensitivity to calcitonin salmon or any of its excipients.
What should I do if I experience severe allergic reactions?
Serious hypersensitivity reactions, including anaphylaxis, have been reported. Consider skin testing prior to treatment if you have a suspected allergy.
Is Calcitonin Salmon Injection safe during pregnancy?
There are no studies in pregnant women, but animal studies have shown decreased fetal birth weights. Consult your doctor for advice.
Can Calcitonin Salmon Injection affect breastfeeding?
There is no information on its presence in human milk or its effects on breastfeeding. It has been shown to inhibit lactation in rats.
What are the dosing recommendations for symptomatic Paget's disease?
The recommended dose is 100 USP Units daily, with adequate calcium and vitamin D intake.
How should Calcitonin Salmon Injection be stored?
Store it in a refrigerator between 2° to 8°C (36° to 46°F) and protect it from freezing.
What should I be aware of regarding malignancy risks?
A meta-analysis suggests an increased risk of overall malignancies in patients treated with calcitonin salmon compared to those on placebo.
Packaging Info
The table below lists all NDC Code configurations of Calcitonin Salmon, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection, Solution | 400 [USP'U]/2 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Calcitonin Salmon, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
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 Injection, USP Synthetic is a synthetic polypeptide consisting of 32 amino acids arranged in the same linear sequence as calcitonin derived from salmon. This product is available as a sterile solution intended for subcutaneous or intramuscular injection. Each milliliter contains 200 USP Units of calcitonin salmon. Inactive ingredients per milliliter include acetic acid (2.25 mg), phenol (5 mg), sodium acetate trihydrate (2 mg), sodium chloride (7.5 mg), and water for injection.
Uses and Indications
This drug is indicated for the treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable. It is also indicated for the treatment of hypercalcemia. Additionally, this drug is indicated for the treatment of postmenopausal osteoporosis in cases where alternative treatments are not suitable; however, the efficacy for fracture reduction has not been demonstrated.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
For the treatment of symptomatic Paget's disease of bone, the recommended dosage is 100 USP Units administered daily. It is essential to ensure that patients receive adequate calcium and vitamin D intake during the course of treatment.
In cases of hypercalcemia, the initial dosage should be 4 USP Units per kilogram of body weight, administered every 12 hours. If there is no improvement observed within 1 to 2 days, the dosage may be increased to 8 USP Units per kilogram every 12 hours. Should there still be no improvement after an additional 2 days, the dosage can be further escalated to 8 USP Units per kilogram every 6 hours.
For the management of postmenopausal osteoporosis, the recommended dosage is also 100 USP Units daily, with a strong emphasis on ensuring adequate calcium and vitamin D intake.
Contraindications
Use of this product is contraindicated in patients with hypersensitivity to calcitonin salmon or any of the excipients. This contraindication is based on the potential for severe allergic reactions in susceptible individuals.
Warnings and Precautions
Serious hypersensitivity reactions, including instances of fatal anaphylaxis, have been documented in patients receiving calcitonin salmon. It is advisable to consider conducting skin testing prior to initiating treatment in individuals with a suspected hypersensitivity to this agent.
Patients should be monitored for hypocalcemia, which has been reported in some cases. To mitigate this risk, it is essential to ensure that patients have an adequate intake of calcium and vitamin D.
Additionally, a meta-analysis encompassing 21 clinical trials has indicated a potential increase in the risk of overall malignancies among patients treated with calcitonin salmon. Healthcare professionals should remain vigilant regarding this risk and consider appropriate patient counseling and monitoring.
Furthermore, the development of circulating antibodies to calcitonin salmon may occur, potentially leading to a diminished therapeutic response. Regular assessment of treatment efficacy is recommended to identify any loss of response that may necessitate a reevaluation of the treatment regimen.
Side Effects
Patients receiving calcitonin salmon have reported a range of adverse reactions, which can be categorized by frequency and seriousness.
Common adverse reactions include nausea with or without vomiting, which occurs in approximately 10% of patients. This symptom is most pronounced at the initiation of treatment but typically diminishes or resolves with continued use. Injection site inflammation is also reported in about 10% of patients, alongside flushing of the face or hands, which occurs in approximately 2% to 5% of patients. Additional dermatologic reactions include local inflammatory responses at the injection site, skin rashes, and pruritus of the ear lobes.
Other adverse reactions noted in clinical trials and postmarketing experiences include nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and a salty taste.
Serious adverse reactions have been documented, including hypersensitivity reactions, with some cases resulting in fatal anaphylaxis. It is advisable to consider skin testing for patients with a history of suspected hypersensitivity to calcitonin salmon prior to treatment. Hypocalcemia has also been reported, necessitating adequate intake of calcium and vitamin D. Furthermore, circulating antibodies to calcitonin salmon may develop in some patients, potentially leading to a loss of therapeutic response.
A meta-analysis of 21 randomized, controlled clinical trials indicates an increased risk of overall malignancies in patients treated with calcitonin salmon compared to those receiving placebo. This finding underscores the importance of monitoring for malignancy in patients undergoing treatment.
Drug Interactions
Concomitant use of calcitonin salmon and lithium may result in a reduction of plasma lithium concentrations. This interaction is attributed to the increased urinary clearance of lithium when both agents are administered together. Therefore, it may be necessary to adjust the dosage of lithium to maintain therapeutic levels.
No information regarding other drug or laboratory test interactions has been provided.
Packaging & NDC
The table below lists all NDC Code configurations of Calcitonin Salmon, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection, Solution | 400 [USP'U]/2 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Therefore, the use of this medication in children, infants, and adolescents should be approached with caution, as there is insufficient data to support its use in these populations.
Geriatric Use
Clinical studies of calcitonin salmon did not include a sufficient number of subjects aged 65 years and older to determine whether this population responds differently from younger subjects. However, other reported clinical experience has not identified significant differences in responses between elderly patients and younger patients.
In general, dose selection for geriatric patients should be approached with caution. It is advisable to start at the low end of the dosing range, taking into account the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies. Careful monitoring of these patients is recommended to ensure safety and efficacy.
Pregnancy
There are no studies with calcitonin salmon in pregnant women to inform a drug-associated risk for birth defects or miscarriage. In an animal reproduction study, subcutaneous administration of calcitonin salmon to pregnant rabbits during organogenesis at doses 4 to 18 times the recommended parenteral human dose resulted in a decrease in fetal birth weights. However, no adverse developmental outcomes were observed in rats receiving subcutaneous calcitonin salmon at doses up to 9 times the recommended human parenteral dose based on body surface area.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Given the available data, healthcare professionals should weigh the potential risks and benefits of calcitonin salmon use in pregnant patients, particularly considering the observed effects on fetal birth weights in animal studies. Caution is advised when prescribing this medication to women of childbearing potential.
Lactation
There is no information available regarding the presence of calcitonin salmon in human milk, nor are there data on its effects on breastfed infants or on milk production in lactating mothers. However, calcitonin has been shown to inhibit lactation in animal studies involving rats.
When considering the use of calcitonin salmon in lactating mothers, the developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for the medication. Additionally, potential adverse effects on the breastfed infant from calcitonin salmon or from the underlying maternal condition must be taken into account.
Renal Impairment
There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In cases of overdosage, healthcare professionals should be vigilant for the potential occurrence of hypocalcemic tetany. It is essential that provisions for the parenteral administration of calcium are readily available to manage this condition effectively.
Administration of calcitonin salmon at a dose of 1,000 USP Units subcutaneously may lead to gastrointestinal disturbances, specifically nausea and vomiting. Therefore, monitoring for these symptoms is advised following administration.
Clinical data indicate that doses of 32 USP Units per kg per day for a duration of 1 to 2 days do not result in any significant adverse effects. However, it is important to note that there is insufficient data regarding the toxicity associated with chronic high-dose administration. Consequently, caution should be exercised when considering prolonged use at elevated doses, and ongoing assessment of the patient's condition is recommended.
Nonclinical Toxicology
The incidence of pituitary adenomas was increased in rats following one and two years of subcutaneous exposure to synthetic calcitonin salmon. The relevance of this finding to humans remains uncertain, as pituitary adenomas are commonly observed in aging rats. Notably, these adenomas did not progress to metastatic tumors, and no other treatment-related neoplasms were identified. Furthermore, synthetic calcitonin salmon-related neoplasms were not detected in mice after two years of dosing.
In rat studies, the only significant neoplastic finding associated with subcutaneous administration of calcitonin salmon was an increased incidence of pituitary adenomas in male Fisher 344 rats and female Sprague Dawley rats after one year of treatment, as well as in male Sprague Dawley rats dosed for one and two years. In female Sprague Dawley rats, the incidence of pituitary adenomas after two years was notably high across all treatment groups (ranging from 80% to 92%, including control groups), making it difficult to differentiate a treatment-related effect from the natural background incidence. The lowest dose in male Sprague Dawley rats that exhibited an increased incidence of pituitary adenomas after two years of dosing was approximately 1.7 USP Units/kg/day, which is about one-sixth of the maximum recommended subcutaneous dose in humans (100 USP Units/day) when adjusted for body surface area. These findings suggest that calcitonin salmon may have reduced the latency period for the development of non-functioning pituitary adenomas.
In contrast, no evidence of carcinogenic potential was observed in male or female mice dosed subcutaneously for two years with synthetic calcitonin salmon at doses up to 800 USP Units/kg/day. This dose is approximately 39 times the maximum recommended subcutaneous dose in humans (100 USP Units/day) based on body surface area conversion.
Synthetic calcitonin salmon has been evaluated for mutagenicity and was found to be negative in tests using Salmonella typhimurium (five strains) and Escherichia coli (two strains), both with and without rat liver metabolic activation. Additionally, it was not clastogenic in a chromosome aberration test conducted in Chinese Hamster V79 cells, nor was there any evidence of clastogenicity in the in vivo mouse micronucleus test.
The effects of calcitonin salmon on fertility have not been assessed in animal studies.
Postmarketing Experience
Postmarketing experience has indicated a potential increase in the risk of malignancy associated with the use of the product. Healthcare professionals are advised to inform patients of this risk, as detailed in the Warnings and Precautions section (5.3).
Patient Counseling
Healthcare providers should instruct patients and caregivers on the proper sterile injection technique for Calcitonin Salmon Injection. It is essential to emphasize the importance of proper disposal of needles to ensure safety and prevent injury.
Patients should be informed about the potential increase in the risk of malignancy associated with the use of this medication. It is crucial for healthcare providers to discuss this risk openly, allowing patients to make informed decisions regarding their treatment.
For patients diagnosed with postmenopausal osteoporosis or Paget's disease of bone, healthcare providers should advise them to maintain an adequate intake of calcium and vitamin D. Specifically, patients should aim for at least 1000 mg of elemental calcium and 400 USP Units of vitamin D per day to support their bone health.
Additionally, healthcare providers must instruct patients to seek emergency medical assistance immediately if they experience any signs or symptoms of a serious allergic reaction. Prompt action is vital in such cases to ensure patient safety and well-being.
Storage and Handling
The product is supplied in a sterile, nonpyrogenic form and is packaged in containers that do not contain natural rubber latex. It is essential to store the product in a refrigerator at a temperature range of 2° to 8°C (36° to 46°F) to maintain its integrity and efficacy. Care should be taken to protect the product from freezing, as exposure to freezing temperatures may compromise its quality.
Additional Clinical Information
Periodic examinations of urine sediment should be considered for patients undergoing treatment. There is no additional information available regarding abuse potential, route, method, frequency of administration, patient counseling, or postmarketing experience.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Calcitonin Salmon as submitted by Sagent Pharmaceuticals. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.