Description
Calcitonin nasal spray is used together with calcium and vitamin D to treat bone loss in women with postmenopausal osteoporosis who have been postmenopause for at least 5 years.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of calcitonin nasal spray in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of calcitonin nasal spray in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, irritation or redness of the nose, stuffy or runny nose), which may require caution in patients receiving calcitonin nasal spray.
Breastfeeding
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.
Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Lithium
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Paget's disease—Use with caution. Some medicines used for this condition (eg, alendronate, etidronate, or risedronate) may keep calcitonin nasal spray from working properly.
- Hypocalcemia (low calcium levels) or
- Vitamin D deficiency—Must be treated first before using this medicine.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.
Each spray bottle contains 30 doses of the medicine. Keep track of the doses you use and throw away any unused medicine after 30 doses, even if the bottle is not completely empty.
This medicine usually comes with patient instructions. Read the instructions carefully before using this medicine. If you have any questions about using the pump spray, ask your doctor.
To assemble the pump:
- If your medicine and its pump were not already assembled by the pharmacist, carefully follow the instructions provided with the container.
- Remove the bottle of solution from the refrigerator and let it slowly warm up to room temperature (less than 77 degrees 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 a new bottle, 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 to clear the nostrils.
- 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 (spray):
- For postmenopausal osteoporosis:
- Adults—200 International Units (IU) or 1 spray into one nostril per day. It is best to change which nostril you use each day. As an example, you should spray into the left side on the first day, then into the right side on the second day, and back to the left side on the third day.
- Children—Use and dose must be determined by your doctor.
- For postmenopausal osteoporosis:
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 out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the unopened bottle in the refrigerator. Do not freeze. You may store the opened bottle in an upright position at room temperature, away from heat and direct light. An opened bottle of Miacalcin® can be stored for up to 35 days, and an opened bottle of Fortical® can be stored for up to 30 days. Throw away any unused medicine after 30 or 35 days based on the brand you are using.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. Your doctor may also want to check your nose before and during treatment with this medicine.
Your doctor might give you an allergy skin test to see if you are allergic to calcitonin before using this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine. If these side effects occur, get emergency help at once.
This medicine can lower your calcium levels in the blood (hypocalcemia). Check with your doctor right away if you have abdominal or stomach cramps, confusion, convulsions, difficulty breathing, mood or mental changes, muscle cramps in hands, arms, feet, legs, or face, or numbness and tingling around the mouth, fingertips, or feet.
This medicine may cause irritation in the nose that can be painful and serious. Check with your doctor right away if you have more than one of the following symptoms: sneezing, runny or stuffy nose, shortness of breath, troubled breathing, or heavy nosebleeds.
This medicine may increase your risk of having cancer. Talk to your doctor if you have concerns about this risk.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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 immediately 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
- sneezing
- stuffy nose
Less common
- Bloody or cloudy urine
- chills
- cough
- difficult, burning, or painful urination
- difficulty with breathing or wheezing (severe)
- dizziness
- fever
- frequent urge to urinate
- head congestion
- loss of sense of smell
- sore throat
- swollen glands
Rare
- Hair loss
- hives, itching, or skin rash
- increased thirst
- shakiness in the legs, arms, hands, or feet
- taste disturbances
- trembling or shaking of the hands or feet
Incidence not known
- Abdominal or stomach cramps
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- confusion
- diarrhea
- difficulty with swallowing
- fainting
- increased sweating
- irregular heartbeats
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- pain or tightness in the chest
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- seizures
- unusual tiredness or weakness
- unusual weight gain or loss
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 or stomach pain
- body aches
- burning, dry, or itching eyes
- constipation
- flushing
- mental depression
- muscle pain
- nausea
- unusual tearing of the eyes
- upset stomach
Incidence not known
- Continuing ringing or buzzing or other unexplained noise in the ears
- hearing loss
- trouble hearing
- trouble seeing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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