Pronunciation:

tye-loo-DROE-nate

Brand Names:

• Skelid

Classifications:

Chemical—

Bisphosphonate

Uses of This Medicine:

Tiludronate is used to treat Paget's disease of the bone. This medicine is a bisphosphonate that helps make the bones stronger.

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—

Appropriate studies have not been performed on the relationship of age to the effects of tiludronate in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tiludronate in the elderly.

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Anemia or
• Blood clotting problems or
• Cancer or use of cancer medicines or
• Dental or tooth problems or
• Infection or
• Poor oral hygiene—Use with caution. May increase risk for a serious side effect with the jaw.

• Barrett's esophagus or
• Bone or joint pain or
• Esophagus problems (e.g., difficulty with swallowing or inflammation) or
• Muscle pain, severe or
• Stomach or bowel problems (e.g., gastritis, heartburn or ulcers)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

Swallow the tablet whole with a large glass (8 ounces) of plain water. Do not drink mineral water, milk, coffee, juice, or any other liquid when you take the tablet. It is best to take this medicine on an empty stomach, either 2 hours before or 2 hours after eating.

Do not lie down for at least 30 minutes after taking this medicine.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D while you are taking this medicine. Your doctor can help you choose the best diet for your condition.

If you use calcium supplements, mineral supplements, indomethacin, or aspirin, take them either 2 hours before or 2 hours after you take tiludronate. If you use antacids, wait at least 2 hours after your dose before you take the antacid. If you take these medicines together with tiludronate, it may keep the medicine from working properly.

Tiludronate takes up to 3 months to work. If you feel that the medicine is not working, talk to your doctor. Do not stop taking the medicine without checking with your doctor.

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 oral dosage form (tablets):
  • For treating Paget's disease:
    • Adults—400 milligrams (mg) once a day for at least 3 months.
    • Children—Use and dose must be determined by your doctor.

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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. .

This medicine can irritate your esophagus. Stop taking this medicine and call your doctor right away if you have severe heartburn (new or worse than usual), pain with swallowing, chest pain, trouble with swallowing, or feel like food is getting stuck in your esophagus.

It is important that you tell all of your doctors or dentist that you are taking tiludronate. Make sure you tell your doctor about any new medical problems, especially with your teeth or jaw. If you have dental procedures while using this medicine, you may have an increased chance for serious jaw problems. Tell your doctor right away if you have any jaw tightness, swelling, numbness, or pain while using this medicine.

This medicine can cause muscle or joint pain that in some cases is very severe. Tell your doctor right away if you have bone, joint, or muscle pain while using this medicine.

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 immediately if any of the following side effects occur:

More common

Cough

fever

head congestion

hoarseness or other voice changes

nasal congestion

runny nose

sneezing

sore throat

Less common

Blindness

blurred or decreased vision

burning, dry, or itching eyes

chest pain

discharge or excessive tearing

eye pain

headache

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swelling of the face, feet, or lower legs

unusual weight gain

Rare

Bladder pain

blistering, peeling, or loosening of the skin

bloody or cloudy urine

difficult, burning, or painful urination

dizziness or lightheadedness

fainting

feeling of constant movement of self or surroundings

frequent urge to urinate

headache

itching red skin lesions, often with a purple center

lower back or side pain

nervousness

pain or swelling in the arms or legs without any injury

pounding in the ears

sensation of spinning

slow or fast heartbeat

sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach cramps

confusion

convulsions

difficulty with breathing

irregular heartbeats

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

shortness of breath

tremor

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

body pain (general)

diarrhea

nausea

upset stomach

Less common

Bone fractures

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

confusion

difficulty having a bowel movement (stool)

dizziness

dry skin

hair loss

increased thirst

increased urination

joint pain

loss of appetite

muscle cramps or spasms

muscle pain

red or irritated eyes

skin rash

stomach gas

throat pain

tooth disorder

trouble thinking

vomiting

Rare

Dry mouth

fear or nervousness

feeling of warmth

lack or loss of strength

redness of the face, neck, arms and occasionally, upper chest

sleepiness or unusual drowsiness

stomach pain

sleeplessness

trouble sleeping

unable to sleep

unusual tiredness or weakness

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.