Calcitonin Salmon Nasal Spray

What is Calcitonin Salmon Nasal Spray?

• Calcitonin Salmon Nasal Spray (Fortical; Miacalcin Nasal Spray) is a calcitonin, used to treat osteoporosis in women who are at least 5 years past menopause and cannot or do not want to take estrogen products.
• 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 (synthetic origin) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin.

Calcitonin

Calcitoninpeptide

What are the uses of this medicine?

• Calcitonin Salmon Nasal Spray (Fortical; Miacalcin Nasal Spray) is used is a prescription medicine used to treat osteoporosis in women more than 5 years after menopause.
• Calcitonin Salmon (synthetic origin) Nasal Spray should be used for women who cannot use other treatments or who choose not to use other treatments for osteoporosis.

Limitations of Use:

• It is not known if Calcitonin Salmon (synthetic origin) Nasal Spray lowers the chance of having bone fractures.
• Calcitonin Salmon (synthetic origin) Nasal Spray has not been shown to be effective in women less than 5 years after menopause.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with: Hypersensitivity to calcitonin salmon or any of the excipients.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• lithium

• 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.

Is this medicine FDA approved?

• Initial U.S. Approval: 1975

How should this medicine be used?

Recommended dosage:

• The recommended dose of calcitonin salmon nasal spray is 1 spray (200 USP Calcitonin Salmon Units) per day administered intranasally, alternating nostrils daily.
• Patients 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).

Administration:

• Calcitonin salmon comes as a spray to be used in the nose.
• It is usually used once a day, alternating nostrils every day.
• To help you remember to use calcitonin salmon, use it around the same time every day.
• Calcitonin salmon helps treat osteoporosis but does not cure it. Continue to use calcitonin salmon even if you feel well.
• Do not stop using calcitonin salmon without talking to your doctor.
• Unopened 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Nasal Spray: 2200 USP Calcitonin Salmon Units per mL of calcitonin salmon in a 2 mL or 3.7 mL fill glass bottle with attached pump.

This medicine is available in fallowing brand namesː

• Fortical; Miacalcin Nasal Spray

What side effects can this medication cause?

The most common side effects of this medicine include:

• back pain
• muscle aches
• headache
• runny nose

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 can cause serious side effects which may include:

• allergic reactions
• hypocalcemia
• nose irritation
• risk of cancer
• increase of certain cells (sediment) in your urine

What special precautions should I follow?

• Serious hypersensitivity reactions have been reported in patients receiving calcitonin salmon nasal spray, e.g., bronchospasm, swelling of the tongue or throat, anaphylaxis and anaphylactic shock. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin salmon.
• Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D.
• Nasal adverse reactions, including severe ulceration can occur. Periodic nasal examinations are recommended.
• A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin salmon-treated patients. The benefits for the individual patient should be carefully considered against possible risks.
• Circulating antibodies to calcitonin salmon have been reported with calcitonin salmon nasal spray.
• Instruct patients on pump assembly, priming of the pump, and nasal introduction of Calcitonin Salmon Nasal Spray. Although instructions for patients are supplied with the individual bottle, procedures for use should be demonstrated to each patient. Patients should notify their healthcare provider if they develop significant nasal irritation
• 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.
• 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 . Advise patients that the bottle should be discarded after 14 doses (2 mL fill) or 30 doses (3.7 mL fill), because after 14 or 30 doses, each spray may not deliver the correct amount of medication even if the bottle is not completely empty.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• The pharmacologic actions of calcitonin salmon nasal spray suggest that hypocalcemic tetany could occur in overdose.
• Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose.

Can this medicine be used in pregnancy?

• Calcitonin salmon nasal spray is not indicated for use in females of reproductive potential.
• There are no data with the use of calcitonin salmon nasal spray in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: calcitonin salmon
• Inactive Ingredients: benzalkonium chloride, hydrochloric acid, purified water and sodium chloride.

Who manufactures and distributes this medicine?

Manufactured by:

• Apotex Inc.
• Toronto, Ontario
• Canada

Manufactured for:

• Apotex Corp.
• Weston, FL

What should I know about storage and disposal of this medication?

• Store open bottles of Calcitonin Salmon (synthetic origin) Nasal Spray at room temperature between 20°C to 25°C (68°F to 77°F) for 30 days (2 mL fill) or 35 days (3.7 mL fill).
• Store unopened bottles of Calcitonin Salmon (synthetic origin) Nasal Spray in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze.
• Store Calcitonin Salmon (synthetic origin) Nasal Spray bottles in an upright position.
• Safely throw away Calcitonin Salmon (synthetic origin) Nasal Spray in the trash after you have used 14 doses (2 mL fill) or 30 doses (3.7 mL fill) (sprays).

• Dailymed label info on Calcitonin Salmon Nasal Spray
• FDA Calcitonin Salmon Nasal Spray

Calcitonin Salmon Nasal Spray Resources
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