![CALCITONIN SALMON 200 [iU]/.09mL Spray, Metered, 3.7 mL — NDC 49884-0161-11 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a6eaedb3-5c96-4859-be43-a48c9c818bc7&name=calcitonin-salmon-9.jpg)
CALCITONIN SALMON 200 [iU]/.09mL Spray, Metered, 3.7 mL
Past resolved recalls for this product (1)
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Calcitonin class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Calcitonin salmon nasal spray is generally considered a second-choice option for postmenopausal osteoporosis. It's typically recommended when other osteoporosis treatments — like b...
- Why is my doctor prescribing this instead of other osteoporosis medications?
- Before you use it for the very first time, take the bottle out of the refrigerator and let it reach room temperature. Then prime the pump by pressing the side arms down repeatedly...
- The most common issues are nasal — things like a runny nose, nosebleeds, dryness, or irritation inside the nose. Back pain, joint pain, and headache are also reported. Those are wo...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $11.834 | $43.79 / 3.7 ml |
| Medicaid paysCMS SDUD · 12 mo | $14.53 | $53.75 / 3.7 ml |
| Medicare drug plans payPart D · Q2 2026 | $16.99 | $62.87 / 3.7 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Calcitonin Salmon 200 [iU]/.09mLthis 49884-0161-11 | Par | 3.7 ml | $11.834 | AB | Availability likely | — |
| Calcitonin Salmon 200 [iU] 60505-0823-00 | Apotex | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 49884-0161-11 You're viewing this | 3.7 mL in 1 BOTTLE, GLASS (49884-161-11) | 2009-06-08 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Calcitonin Salmon Nasal Solution is a calcitonin, indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated. ( 1.1 ) 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.
( 1.2 , 5.4 ) Calcitonin Salmon Nasal Solution has not been shown to increase bone mineral density in early postmenopausal women ( 1.2 )
1.1Treatment of Postmenopausal Osteoporosis Calcitonin Salmon Nasal Solution is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Calcitonin Salmon Nasal Solution should be reserved for patients for 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).
1.2Important 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 [see Warnings and Precautions ( 5.4 ) ]. Calcitonin Salmon Nasal Solution has not been shown to increase spinal bone mineral density in early postmenopausal women.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intranasal use only: one spray (200 International Units) per day, alternating nostrils daily ( 2.1 ) Prior to first use, allow the bottle to reach room temperature and prime the pump (2.2 ) Ensure adequate calcium and vitamin D intake ( 2.3 )
2.1Basic Dosing Information The recommended dose of Calcitonin Salmon Nasal Solution is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily.
2.2Priming (Activation) of Pump Unopened Calcitonin Salmon Nasal Solution should be stored in the refrigerator. Before using the first dose of Calcitonin Salmon Nasal Solution, 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.
2.3Recommendations for Calcium and Vitamin D Supplementation Patients who use Calcitonin Salmon Nasal Solution should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Calcitonin Salmon Nasal Solution consists of one glass bottle and one screw-on pump. The bottle contains 3.7 mL of calcitonin-salmon clear solution at a concentration of 2200 International Units per mL. A primed pump delivers 0.09 mL (200 International Units) calcitonin-salmon per actuation.
Nasal Spray: 2200 International Units per mL of calcitonin-salmon in a 3.7 mL fill glass bottle with screw-on pump. Each actuation delivers 200 International Units of calcitonin-salmon (3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions ( 5.1 ) ]. Hypersensitivity to calcitonin-salmon or any of the excipients (4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions including anaphylactic shock have been reported. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin-salmon ( 5.1 ) Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D ( 5.2 ) Nasal adverse reactions, including severe ulceration can occur.
Periodic nasal examinations are recommended ( 5.3 ) Malignancy: A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin-salmon-treated patients ( 5.4 , 6.1 ) Circulating antibodies to calcitonin-salmon may develop, and may cause loss of response to treatment ( 5.5 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions have been reported in patients receiving Calcitonin Salmon Nasal Solution, e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock. Reports of serious hypersensitivity reactions with injectable calcitonin-salmon have also been reported, including reports of death attributed to anaphylaxis. The usual provisions should be made for emergency treatment if such a reaction occurs.
Hypersensitivity reactions should be differentiated from generalized flushing and hypotension [see Contraindications ( 4 ) ]. For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of a calcitonin-salmon injectable product. Healthcare providers may wish to refer patients who require skin testing to an allergist.
A detailed skin testing protocol is available from the Medical Services Department of Par Health at 1-800-828-9393.
5.2Hypocalcemia Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with calcitonin therapy. Hypocalcemia must be corrected before initiating therapy with Calcitonin Salmon Nasal Solution. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated.
In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with Calcitonin Salmon Nasal Solution. Use of Calcitonin Salmon Nasal Solution is recommended in conjunction with an adequate intake of calcium and vitamin D [see Dosage and Administration ( 2.3 ) ].
5.3Nasal Adverse Reactions Adverse reactions related to the nose including rhinitis and epistaxis have been reported. Development of mucosal alterations may occur. Therefore, periodic nasal examinations with visualization of the nasal mucosa, turbinates, septum and mucosal blood vessels are recommended prior to start of treatment with Calcitonin Salmon Nasal Solution, periodically during the course of therapy, and at any time nasal symptoms occur.
Calcitonin Salmon Nasal Solution should be discontinued 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. Although smaller ulcers often heal without withdrawal of Calcitonin Salmon Nasal Solution, medication should be discontinued temporarily until healing occurs [see Adverse Reactions (6.1 ) ].
5.4Malignancy In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal solution or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The benefits for the individual patient should be carefully considered against possible risks [see Adverse Reactions ( 6.1 ) ].
5.5Antibody Formation Circulating antibodies to calcitonin-salmon have been reported with Calcitonin Salmon Nasal Solution. The possibility of antibody formation should be considered in an…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions ( 5.1 ) ]. Hypocalcemia [see Warnings and Precautions ( 5.2 ) ]. Nasal Adverse Reactions [see Warnings and Precautions ( 5.3 ) ].
Malignancy [see Warnings and Precautions ( 5.4 ) ]. Most common adverse reactions (3% or greater) are rhinitis, epistaxis and other nasal symptoms, back pain, arthralgia, and headache ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Calcitonin Salmon Nasal Solution in the treatment of postmenopausal osteoporosis was assessed in 5 randomized, double-blind, placebo controlled trials that enrolled postmenopausal women, aged 45 to 75 years. The duration of the trials ranged from 1 to 2 years.
The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to Calcitonin Salmon Nasal Solution (N=341) and to placebo nasal solution (N=131), and reported in greater than 3% of Calcitonin Salmon Nasal Solution treated patients are presented in the following table. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to Calcitonin Salmon Nasal Solution has not been established.
Table 1: Adverse Reactions Occurring in at Least 3% of Postmenopausal Patients Treated with Calcitonin Salmon Nasal Solution † Symptom of nose includes: nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/blocked, small wound, bleeding wound, tenderness, uncomfortable feeling and sore across bridge of nose. Calcitonin Salmon Nasal Solution Placebo Nasal Solution Adverse Reaction N = 341 % of Patients N = 131 % of Patients Rhinitis 12 7 Symptom of Nose † 11 16 Back Pain 5 2 Arthralgia 4 5 Epistaxis 4 5 Headache 3 5 Nasal Adverse Reactions: In all postmenopausal patients treated with Calcitonin Salmon Nasal Solution, the most commonly reported nasal adverse reactions included rhinitis (12%), epistaxis (4%), and sinusitis (2%).
Smoking did not have a contributory effect on the occurrence of nasal adverse reactions. Adverse reactions reported in 1% to 3% of patients treated with Calcitonin Salmon Nasal Solution include: influenza-like symptoms, erythematous rash, arthrosis, myalgia, sinusitis, upper respiratory tract infection, bronchospasm, abdominal pain, nausea, dizziness, paresthesia, abnormal lacrimation, conjunctivitis, lymphadenopathy, infection, and depression. Malignancy A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal solution or investigational oral formulations) was conducted to assess the risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients.
The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with calcitonin-salmon and 4732 treated with placebo). The overall incidence of malignancies reported in these 21 trials was higher among calcitonin-salmon-treated patients (254/6151 or 4.1%) compared with placebo-treated patients (137/4732 or 2.9%). Findings were similar when analyses were restricted to the 18 nasal spray only trials [calcitonin-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)].
The meta-analysis results suggest an increased risk of overall malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients when all 21 trials are included…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug interaction studies have been performed with Calcitonin Salmon Nasal Solution. Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment.
Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS There are no data to support use in children (8.4) Nasal reactions are more common in elderly patients ( 8.5 )
8.1Pregnancy Risk Summary Calcitonin Salmon Nasal Solution is not indicated for use in females of reproductive potential. There are no data with the use of Calcitonin Salmon Nasal Solution in pregnant women. In an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 4 to 18 times the recommended parenteral human dose caused a decrease in fetal birth weights.
No adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see Data ). Data Animal Data Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of 54 International Units/m 2 ) and 70 to 278 times the intranasal dose recommended for human use based on body surface area. No embryo/fetal toxicities related to Calcitonin Salmon Nasal Solution were reported from maternal subcutaneous daily doses in rats up to 80 International Units/kg/day from gestation day 6 to 15.
8.2Lactation Risk Summary Calcitonin Salmon Nasal Solution is not indicated for use in females of reproductive potential. There is no information on the presence of calcitonin-salmon in human milk, the effects on the breastfed child, or the effects on milk production. Calcitonin has been shown to inhibit lactation in rats.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use In a multi-centered, double-blind, randomized clinical study of calcitonin-salmon nasal solution, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 years old and older. Compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly among those over the age of 75. 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.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Calcitonin Salmon Nasal Solution is not indicated for use in females of reproductive potential. There are no data with the use of Calcitonin Salmon Nasal Solution in pregnant women. In an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 4 to 18 times the recommended parenteral human dose caused a decrease in fetal birth weights.
No adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see Data ). Data Animal Data Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of 54 International Units/m 2 ) and 70 to 278 times the intranasal dose recommended for human use based on body surface area. No embryo/fetal toxicities related to Calcitonin Salmon Nasal Solution were reported from maternal subcutaneous daily doses in rats up to 80 International Units/kg/day from gestation day 6 to 15.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In a multi-centered, double-blind, randomized clinical study of calcitonin-salmon nasal solution, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 years old and older. Compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly among those over the age of 75. 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.
🆘 Overdosage ▾
10 OVERDOSAGE The pharmacologic actions of Calcitonin Salmon Nasal Solution suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose. Single doses of Calcitonin Salmon Nasal Solution 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action.
The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.
12.2Pharmacodynamics The information below, describing the clinical pharmacology of calcitonin, has been derived from studies with injectable calcitonin-salmon. The mean bioavailability of calcitonin-salmon nasal solution is approximately 3% of the injectable calcitonin-salmon in healthy subjects and, therefore, the conclusions concerning the clinical pharmacology of this preparation may be different. Bone Single injections of calcitonin-salmon caused a marked transient inhibition of the ongoing bone resorptive process.
With prolonged use, there is a persistent, smaller decrease in the rate of bone resorption. Histologically, this is associated with a decreased number of osteoclasts and an apparent decrease in their resorptive activity. In healthy adults, who have a relatively low rate of bone resorption, the administration of exogenous calcitonin‑salmon results in decreases in serum calcium within the limits of the normal range.
In healthy children and in patients whose bone resorption is more rapid, decreases in serum calcium are more pronounced in response to calcitonin-salmon. Kidney Studies with injectable calcitonin-salmon show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption. Comparable studies have not been conducted with Calcitonin Salmon Nasal Solution.
Gastrointestinal Tract Some evidence from studies with injectable preparations suggests that calcitonin-salmon may have effects on the gastrointestinal tract. Short-term administration of injectable calcitonin-salmon results in marked transient decreases in the volume and acidity of gastric juice and in the volume and the trypsin and amylase content of pancreatic juice. Whether these effects continue to be elicited after each injection of calcitonin-salmon during chronic therapy has not been investigated.
These studies have not been conducted with Calcitonin Salmon Nasal Solution. Calcium Homeostasis In two clinical studies designed to evaluate the pharmacodynamic response to calcitonin-salmon nasal solution, administration of calcitonin-salmon 100 to 1600 International Units to healthy volunteers resulted in rapid and sustained decreases within the normal range for both total serum calcium and serum ionized calcium. Single doses of calcitonin-salmon greater than 400 International Units did not produce any further biological response to the drug.
12.3Pharmacokinetics The bioavailability of Calcitonin Salmon Nasal Solution relative to intramuscular administration in healthy volunteers is between 3% and 5%. Calcitonin Salmon Nasal Solution is absorbed rapidly by the nasal mucosa with a mean T max of about 13 minutes. The terminal half-life of calcitonin-salmon has been calculated to be around 18 minutes and no evidence of accumulation was observed with multiple dosing.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action.
The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Available as a metered dose clear solution in a 3.7 mL fill clear glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL/spray). A screw-on pump is provided.
The pump, following priming, will deliver 0.09 mL of solution. Calcitonin Salmon Nasal Solution contains 2200 International Units/mL calcitonin-salmon and is provided in an individual box containing one glass bottle and one screw-on pump (NDC 49884-161-11). Storage and Handling Store unopened bottle in refrigerator between 2°C to 8°C (36°F to 46°F).
Freezing is to be avoided. Store bottle in use at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses.
Discard bottle after 30 doses.
📋 Description ▾
11 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 Nasal Solution 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 a 3.7 mL fill glass bottle as a solution for nasal administration.
This is sufficient medication for 30 doses. Active Ingredient: calcitonin-salmon, 2200 International Units per mL (corresponding to 200 International Units per 0.09 mL actuation). Inactive Ingredients: sodium chloride, chlorobutanol (possesses a characteristic odor), hydrochloric acid (added as necessary to adjust pH), purified water and nitrogen.
The activity of Calcitonin Salmon Nasal Solution 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 Biological Standards and Control, Holly Hill, London. formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use). Instruct patients on pump assembly, priming of the pump, and nasal introduction of Calcitonin Salmon Nasal Solution. Although instructions for patients are supplied with the individual bottle, procedures for use should be demonstrated to each patient [see Dosage and Administration ( 2.2 ) ].
Patients should notify their healthcare provider if they develop significant nasal irritation [see Warnings and Precautions ( 5.3 ) ] . Inform patients of the potential increase in risk of malignancy [see Warnings and Precautions ( 5.4 ) ]. Advise patients to maintain an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day) intake [see Dosage and Administration ( 2.3 ) ].
Instruct patients to seek emergency medical help or go to the nearest hospital emergency room right away if they develop any signs or symptoms of a serious allergic reaction. Advise patients how to correctly store unopened and opened product [see How Supplied/Storage and Handling ( 16 ) ]. Advise patients that the bottle should be discarded after 30 doses, because after 30 doses, each spray may not deliver the correct amount of medication even if the bottle is not completely empty.