Clodronic acid (Oral, Injection)

Clodronate is a medicine that helps treat high levels of calcium in the blood due to changes in the body from cancer. Clodronate also helps with weak bones when cancer has spread to the bones from another area of the body.

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

It is very important that you drink enough fluids before and while taking clodronate.

If you will be taking this medicine for a long time, it is very important that your doctor sees you regularly to check the calcium in your blood and to see how well the clodronate is working.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare 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

Studies on this medicine have only been conducted in adult patients, and there is no specific information comparing the use of clodronate in children to its use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way in older adults as they do in younger adults or if they cause different side effects or problems in older individuals. There is no specific information comparing the use of clodronate in the elderly with its use in other age groups.

Breast Feeding

Studies in women who are breastfeeding have shown harmful effects on infants. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Stomach cramping or pain, nausea, stomach burning—Taking clodronate, especially by mouth, may worsen your stomach problems.

• Kidney problems—Taking clodronate may worsen your kidney issues. Your doctor may prescribe a smaller dose of clodronate for you.

Along with its needed effects, clodronic acid may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Breathing problems
• convulsions (seizures)
• mood or mental changes
• muscle cramps in hands, arms, feet, legs, or face
• muscle shaking
• problems with urination
• sores in throat
• stomach cramps or pain
• swelling of face, ankles or hands
• unusual heartbeats
• unusual tiredness or weakness

Symptoms of Overdose

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

• Convulsions (seizures)
• mood or mental changes
• muscle cramps
• problems with urination
• stomach pain or cramps
• trouble breathing
• unusual heartbeat

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 clodronic acid. Your health care professional may also 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

• Diarrhea
• increased bowel movements
• nausea and vomiting

Less common

• Cloudy urine
• mouth irritation

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.

Chemical Class: Bisphosphonate

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: For treating hypercalcemia (too much calcium in the blood): Adults—1600 milligrams (mg) to 2400 mg given in one or two divided amounts per day. Your doctor may give you capsules after you have had clodronate through your vein. You should not take more than 3200 mg in a day. You should take clodronate at least two hours before or after food. Children—Use and dosage must be determined by your doctor. For injection dosage form: For treating hypercalcemia (too much calcium in the blood): Adults—300 mg in a solution to be injected over at least two hours into a vein once a day for two to five days. The treatment will not be longer than seven days. The amount of medicine may be less if you have kidney problems. Children—Use and dosage must be determined by your doctor.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.