Calcitonin

Calcitonin, also known as Calcitonin-Salmon, is a generic medicine of the brands Fortical and Miacalcin and is taken intranasally in the treatment of osteoporosis in postmenopausal women.

Overview

Calcitonin is a nasal spray medicine used for treating women with postmenopausal osteoporosis. These are women whose bones became weak and brittle, especially following menopause. The medicine is the man-made version of the protein hormone called “calcitonin,” released by the thyroid gland of mammals, including human, birds, and fish.

Osteoporosis is a condition in which the bones become weak and brittle due to the loss of bone mineral density (BMD) and bone mass. This reduces the quality and strength of bones. It is commonly seen in women who are past the stage of menopause, typically over 50 years of age.

Common effects of osteoporosis are curved spine, loss of height, and rounded shoulders. More significantly, it increases the risk for fractures of the spine, hip, and wrist. Calcitonin treatment is significant as it effectively increases bone mass and reduces the risk of spinal fractures.

Patients must be postmenopausal for at least 5 years prior to treatment and unable to be treated other than with Calcitonin. The medication is most effective when used with sufficient calcium and vitamin D. Its use is not recommended for preventing osteoporosis-related fractures in early postmenopausal women.

Condition treated:

  • Postmenopausal Osteoporosis

Type of Medicine:

  • Hormone

Before using Calcitonin

As with all medicinal treatments, patients should weigh the benefits against the risks of using Calcitonin. A discussion with your doctor may help you decide if this medicine is safe for you. Your doctor may consider your age, symptoms, and any medical condition (such as pregnancy), and family history before deciding to treat you.

Disclose all prescription and over-the-counter (OTC’s) medicines you may be taking or plan to take. These include herbal products, vitamin supplements, and nutritional supplements. This is important as Calcitonin is known to interact with the drug, lithium, and other medical problems. It may also interact with other agents such as those found in foods, alcohol, and tobacco.

Allergies:

Tell your doctor if you are allergic to this medicine. A pre-treatment test should be done to rule out an allergic reaction once you start taking the medicine.

Pregnant and breastfeeding women:

This medicine should be used cautiously in pregnant and breastfeeding women. No adequate studies were done to determine the safety and efficacy of use.

Pediatrics:

Similarly, the safety and efficacy of use in children is not established. Therefore, it is not recommended for use in pediatrics.

Geriatrics:

Although it may be safe to use in the treatment of elderly patients, unwanted side effects, e.g., irritation or redness of the nose, are more likely to occur when using the nasal spray.

The medicine is intended to be used along with a daily recommended dose of at least 1000 mg of calcium and 400 I.U. of vitamin D. Your doctor may prescribe these supplements if you are not getting enough of them in your daily diet.

Side effects:

A number of side effects are possible when using this medicine. Patients over 65 more commonly experience an increase in nasal symptoms that are mild but do not usually require medical attention. Side effects range from being more common to rare. The effects may not occur all at once, and the occurrence of one or more of them may require medical attention.

Effects requiring medical attention:

Some side effects are more common and will require medical attention. Call your doctor right away if you experience any of the following symptoms:

More common:

  • stuffy nose
  • bleeding of the nose
  • headaches that are persistent or severe
  • sneezing
  • runny nose
  • crusting or patching inside the nose
  • sores inside the nose or nasal bleeding
  • irritation of the nose (e.g., itching swelling, redness, soreness or dryness)

Less common

  • dizziness
  • head congestion
  • cough
  • sore throat
  • chills
  • swollen glands
  • fever
  • frequent urination
  • loss of sense of smell
  • wheezing that is severe
  • cloudy or bloody urine
  • difficulty breathing
  • difficulty urinating
  • pain or burning sensation while urinating

Rare

  • increased feeling of thirst
  • trembling hands and feet
  • skin rash, itching, or hives
  • change in taste
  • shaking in the legs, feet, arms, or hands

Incidence unknown:

Other side effects may occur, but the frequency and level of severity with which they do are unknown. If they occur, call your doctor right away. They include fainting, seizure, irregular heartbeat, confusion and blurry vision, in addition to the following:

  • cramps in the stomach or abdomen
  • diarrhea
  • increased sweating
  • feeling bloated
  • unusual weight loss or weight gain
  • rapid weight gain
  • cramps in the arms, legs, hands, or face
  • difficulty swallowing
  • feeling unusually tired or weak
  • swelling of the face, lips, or tongue
  • puffiness or swelling of the eyelids or around the eyes
  • swelling of the lower legs, feet, arms, hands, or face
  • pain or tightness in the chest
  • tingling sensation or numbness of the feet or fingertips or around the mouth

Some side effects which may occur and usually do not require medical attention are as follows:

More common

  • joint pain
  • back pain

Less common or rare

  • nausea
  • body aches
  • constipation
  • upset stomach
  • itchy, dry, or burning eyes
  • tearing of the eyes
  • flushing
  • pain in the stomach or abdomen
  • muscle pain
  • mental depression

Incidence unknown

The following is a list of other side effects that may occur but the frequency and level of severity with which they do are unknown:

  • loss of hearing
  • difficulty seeing
  • difficulty hearing
  • persistent ringing, buzzing or mysterious noise in the ear

Side effects that may not need medical attention usually go away on their own as the body adjusts to the medicine. If they persist or become bothersome, talk with your doctor. You can ask for information on ways to reduce or prevent side effects from occurring.

Other side effects not listed may occur. Call your doctor if you notice unusual symptoms or changes in your health after taking Calcitonin, or side effects do not go away or become worse. Side effects can also be reported to the FDA at 1-800-FDA-1088.

Assembling/priming the nasal spray for use:

Carefully read all directions given by the doctor, pharmacist, and the patient information leaflet that may come with the medicine. The leaflet comes with step-by-step instructions and diagrams for prepping and activation of the spray. You may ask your pharmacist to demonstrate the use of the nasal spray or to assemble and prime it for you.

Assembling the spray bottle

  • Bring the medicine to room temperature (between 59°F-86°F).
  • Lift the plastic tab and pull the metal safety seal off the bottle.
  • Remove the rubber stopper out of the bottle.
  • Remove the protective plastic cap from the bottom of the spray unit.
  • Place the spray pump unit into the bottle and tighten to securely fasten by turning it clockwise.

Priming for use

If the nasal spray unit was not already primed by your pharmacist, prime it before use as follows:

  • Hold the bottle upright and away from you.
  • Press the pump several times until you see a faint spray. You may need to press the pump a few times before a spray is produced.
  • Your nasal spray is now prime and does not need priming again before each daily use.

Dosage:

Each bottle of Calcitonin nasal spray usually contains 30 doses of the medicine. One glass bottle and a screw-on pump are provided. These must be assembled and primed before the first dose. Each spray delivers a dosage strength of 200 I.U. (0.09 mL).

The information below represents the average dosage for adults. Your doctor will determine your specific dose and the duration of treatment. Follow all directions given, including those stated on the prescription label.

Adults - 1 spray into one nostril per day (200 I.U./0.09 mL). To avoid nasal irritation and other symptoms of side effects, you may spray into the other nostril each time you take your dose. For example, if you took your dose in the right side of the nose today, take your dose in the left side nostril tomorrow. Continue to alternate.

Children - Because its safety and efficacy are not established for use in pediatrics, this medicine is not recommended for children unless determined by a doctor.

After the nasal spray is assembled and primed for use, administer your dosage using the following directions, or as directed by a doctor or pharmacist.

  • First, gently blow your nose to clear the nostrils.
  • With your head upright, carefully place the nozzle into one nostril.
  • Press the pump once. This should be enough to deliver your dose. Do not spray more than once.
  • Do not breathe in while spraying.
  • Clean the nosepiece after each use by wiping it and replacing the cap.

Missed dose:

If you miss a dose of your medicine, take it as soon as possible. If the time is too close to your next dose, skip the missed dose and take the next scheduled dose on time.

Overdose:

Serious side effects or the risk of overdose are not known to occur when the nasal spray is taken in high doses. Single doses of the nasal spray, each with a maximum strength of 1600 I.U., were tested and considered safe, producing no serious adverse effect. However, take only the dose prescribed for you.

If an overdose does occur, call the poison control center right away at 1-800-222-1222 and seek urgent medical care. Stop using the medicine after the period of treatment is complete, as directed by your healthcare professional.

Interactions:

Some medicines may require the use of other medicines for it to work as it should. In such cases, any interaction that occurs is expected and required. Some unwanted interactions may also occur with these or other drugs being taken by the patient during treatment.

Drug interaction:

Care should be taken to tell your doctor about all medicines (prescription, non-prescription, vitamin or nutritional supplements, or herbal products) you are taking or plan to take during treatment. This can help your doctor take the necessary precautions when prescribing your dosage.

Interaction with the following drug may occur:

  • Lithium

Lithium may interact with Calcitonin and cause an increase in the risk of side effects. These two drugs should not be used together. If both drugs are prescribed during treatment, your doctor may change how often you can use one or both of them. He/she may also change your dose altogether. No other significant interaction is shown to occur with other drugs.

Interaction with other medical conditions:

The nasal spray should be used with caution in patients with Paget’s Disease. Certain medicines used to treat this condition, such as etidronate, risedronate or alendronate, may interact and prevent the nasal spray from working effectively.

Patients who have Hypocalcemia (low calcium levels) or a vitamin D deficiency must be treated first before beginning treatment with Calcitonin. It is important to let your doctor know if you have any of these medical conditions as they may interact with the nasal spray treatment.

Food interaction:

Also ask your doctor for information on the possible interaction of this drug with foods, tobacco, or alcohol.

Warnings:

  • Use Calcitonin nasal spray only when it is prescribed for your treatment.
  • Get approval and directions from your doctor before you start or stop using the medication or change the dose.
  • Spray the medicine directly into the nostril. Avoid spraying into the eyes or on the skin. If this happens, rinse the eyes or skin immediately with water.
  • Tell your doctor if you become pregnant during treatment. Your doctor may continue treatment if the benefits of taking the medicine are more than the risks.
  • If you miss a dose, do not take extra doses to make up the missed dose.
  • Throw away the medicine after completing the treatment even if medicine remains in the bottle.
  • Do not keep or use the medicine after it expires.
  • Do not share with anyone else even if they have similar symptoms to yours.
  • Keep all doctor’s appointments for periodical examinations of the nose. These follow-ups are important to ensure the medicine is not causing injury, such as nasal ulcers, rhinitis, or sinusitis to the nose or nasal cavity.
  • Keep Calcitonin out of reach of children.

Storage:

All unopened and unused medicine should be kept refrigerated between 2°C-8°C (36°F-46°F). Do not freeze. Any bottle of medicine in use should be kept at room temperature between 15°C-30°C (59°F-86°F), in an upright position, for up to 30-35 days.

Each bottle contains at least 30 doses. Throw away the spray bottles as soon as they are empty in the manner directed by your pharmacist, healthcare professional or local waste disposal company.

Summary

Due to the pain, risk of fractures, disability, and other effects of postmenopausal osteoporosis, an effective treatment was needed. Calcitonin therapy became a preferred and effective treatment for the condition. Its significance in bone health in postmenopausal women is acknowledged in medicine.
This hormone is particularly suitable for treatment in patients who have been postmenopausal for at least five years prior to treatment and for whom other treatments, such as with estrogen, is not possible. Its efficacy is based on signs of increase in spinal bone mineral density and improvement in bone strength.

One of the notable limitations of the drug is its inability to be used for bone care in the prevention of postmenopausal osteoporosis. The hormonal medicine is not recommended for preventative treatment in early postmenopausal women either, since there is no evidence that it increases bone mineral density in these women.
There is also no evidence that the medicine increases bone mass in the hip.

Like most medication, Calcitonin Nasal Spray has its side effects. Its safety and efficacy are well established, and most of the common side effects affect the nasal cavity and usually require medical attention. There appears to be no serious side effects even among the list of side effects with incidence unknown.

Adverse interaction is seen only with the drug lithium, and the medical conditions Paget’s Disease, Hypocalcemia (low calcium levels), and Vitamin D deficiency.

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Last Reviewed:
December 24, 2017
Last Updated:
December 22, 2017
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