CALCITONIN (Nasal-Systemic)

Some commonly used brand names are:

In the U.S.?

• Fortical
• Miacalcin

Category

• Bone resorption inhibitor
• osteoporosis therapy

Description

Calcitonin (kal-si-TOE-nin)is used to treat women with postmenopausal osteoporosis (bone loss). It isused together with calcium and vitamin D.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Nasal
• Nasal solution (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to calcitonin or to proteins. Also tell your health careprofessional if you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Calcitonin has not been studied in pregnant women.However, in animal studies, calcitonin has been shown to lower the birth weightof the baby when the mother was given a dose of calcitonin many times thehuman dose. Calcitonin nasal solution should not be used by women during pregnancy.

Breast-feeding?It is not known whether calcitonin passes intobreast milk. However, studies in animals have shown that calcitonin may decreasethe flow of milk. Be sure you have discussed the risks and benefits of themedicine with your doctor.

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

Older adults?Calcitonin nasal solution has been tested in elderlypatients and has not been found to cause different side effects or problemsin older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingcalcitonin, it is especially important that your health care professionalknow if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Proper Use of This Medicine

This medicineusually comes with patient directions. Read them carefullybefore using this medicine. If you have any questions about using thepump 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 thandirected.

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 situntil it warms to room temperature (less than 77 ?F).
• Lift the plastic tab and pull the metal safety seal offthe bottle.
• Hold the bottle upright and carefully pull the rubber stopper outof the bottle.
• Hold the spray pump unit and remove the plastic cap from the bottomof 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 securelyfastened.

To prepare this medicine:

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

To use the nose spray:

• Before using the spray, blow your nose gently.
• Keeping your head in an upright position, carefully place the nozzleinto 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 replacethe dust cap after use.

Dosing?The dose of calcitonin will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of calcitonin. If your dose is different,do not change it unless your doctor tells you to do so.

• 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 tospray 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, use it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator until it is opened for the first time.However, keep the medicine from freezing.
• After the bottle is opened, it may be kept at room temperature (nomore than 77 ?F) until the medicine is gone. Opened or unopened bottlesleft at room temperature for more than 30 days must be discarded.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 possibleif 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 irritationnot present before use of this medicine; headaches(severe or continuing); nosebleeds; runny nose

Less common

Bloody or cloudy urine; breathing difficultyor wheezing (severe); difficult, burning, or painfulurination; dizziness; frequenturge 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; tastedisturbances

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Back pain; joint pain

Less common or rare

Abdominal pain; burning, dry, or itchingeyes; 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 abovemay also occur in some patients. If you notice any other effects, check withyour doctor.