Pronunciation:

kal-si-TOE-nin (SA-man)

Brand Names:

• Fortical
• Miacalcin
• Miacalcin Ns

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Calcitonin

Uses of This Medicine:

Calcitonin is used to treat women with postmenopausal osteoporosis (bone loss). It is used together with calcium and vitamin D.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

There is no specific information comparing the use of calcitonin in children with use in older age groups.

Older adults—

Calcitonin nasal solution has been tested in elderly patients and has not been found to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

This medicine usually comes with patient directions. Read them carefully before using this medicine. If you have any questions about using the pump spray, ask your doctor, nurse, or pharmacist.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often or for a longer time than directed.

To assemble the pump:

• If your medicine and its pump were not already assembled by the pharmacist, carefully follow the instructions provided:
• Remove the bottle of solution from the refrigerator and let it sit until it warms to room temperature (less than 77 °F).
• Lift the plastic tab and pull the metal safety seal off the bottle.
• Hold the bottle upright and carefully pull the rubber stopper out of the bottle.
• Hold the spray pump unit and remove the plastic cap from the bottom of the unit.
• Hold the bottle upright and place the spray pump unit into the bottle.
• Turn the spray pump unit clockwise and tighten it until it is securely fastened.

To prepare this medicine:

• Before you use a new bottle of calcitonin spray, the spray pump will need to be primed (started). If your pharmacist assembled the unit for you, check to see if it has already been primed by pumping the unit once. If a full spray comes out, the unit has already been primed; if not, you must prime the pump.
• To prime, hold the bottle upright and away from you, then pump it several times until you see a faint spray.
• Do not prime the pump again before each daily use.

To use the nose spray:

• Before using the spray, blow your nose gently.
• Keeping your head in an upright position, carefully place the nozzle into one nostril.
• Press the pump toward the bottle one time. Do not spray more than once.
• Do not inhale while spraying.
• To keep the nosepiece clean, wipe it with a clean tissue and replace the dust cap after use.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (nose spray):
  • For treatment of women with osteoporosis after menopause:
    • Adults—One spray into one nostril once a day. It is best to spray into the nostril on one side one day and the other side the next day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep the bottle closed when you are not using it. Keep it in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After the bottle is opened, it may be kept at room temperature (no more than 77 °F) until the medicine is gone. Opened or unopened bottles left at room temperature for more than 30 days must be discarded.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Crusting, patches, or sores inside the nose

dryness, itching, redness, swelling, tenderness, or other signs of nasal irritation not present before use of this medicine

headaches (severe or continuing)

nosebleeds

runny nose

Less common

Bloody or cloudy urine

breathing difficulty or wheezing (severe)

difficult, burning, or painful urination

dizziness

frequent urge to urinate

loss of sense of smell

swollen glands

upper respiratory infection, with chest pain, chills, cough, ear congestion or pain, fever, head congestion, hoarseness or other voice changes, nasal congestion, runny nose, sneezing, or sore throat

Rare

Hair loss

hives, itching, or skin rash

increased thirst

taste disturbances

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

joint pain

Less common or rare

Abdominal pain

burning, dry, or itching eyes

constipation

diarrhea

flu-like symptoms (fever with or without chills, headache, body ache)

flushing

mental depression

muscle pain

nausea

unusual tearing of eyes

unusual tiredness or weakness

upset stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.