Aredia

Generic Name: pamidronate (Intravenous route)

pam-i-DROE-nate

Commonly used brand name(s):

In the U.S.

• Aredia

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For Aredia

Pamidronate is used to treat hypercalcemia (too much calcium in the blood) that may occur with some types of cancer. It is also used to treat Paget's disease of bone and to treat bone metastases (spread of cancer).

This medicine is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, pamidronate is used in certain patients with the following medical conditions:

• Osteogenesis imperfecta

Before Using Aredia

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pamidronate in children with use in other age groups.

Geriatric

When pamidronate is given along with a large amount of fluids, older people tend to retain (keep) the excess fluid.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

• Anemia or
• Leukopenia or
• Thrombocytopenia—Your healthcare professional will watch your progress closely for two weeks after treatment.

• Heart problems—The increased amount of fluid may make this condition worse.

• Kidney problems—Pamidronate may build up in the bloodstream, which may increase the chance of unwanted effects.

Proper Use of Aredia

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 injection dosage form:
  • For treating hypercalcemia (too much calcium in the blood):
    • Adults—60 to 90 milligrams (mg) in a solution to be injected over 2 to 24 hours into a vein.
    • Children—Use and dose must be determined by your doctor.
  • For treating Paget's disease of bone:
    • Adults—Dose and frequency must be determined by your doctor. The usual dose range is 30 mg in a solution injected into a vein. Your doctor may repeat this dose each day for a total of 3 days of treatment.
    • Children—Use and dose must be determined by your doctor.
  • For treating bone metastases:
    • Adults—90 mg in a solution to be injected over 2 to 4 hours into a vein. Your dose may be given every three to four weeks or once a month.
    • Children—Use and dose must be determined by your doctor.

Precautions While Using Aredia

It is important that your doctor check your progress at regular visits after you have received pamidronate. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and a second treatment is needed.

For patients using this medicine for hypercalcemia (too much calcium in the blood):

• Your doctor may want you to follow a low-calcium diet. If you have any questions about this, check with your doctor.

Tell your doctor right away if you have severe bone, joint, or muscle pain while using this medicine .

Aredia 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 as soon as possible if any of the following side effects occur:

• Abdominal cramps
• black, tarry stools
• bleeding gums
• bloody in urine or stools
• blurred vision
• chest pain
• chills
• confusion
• convulsions (seizures)
• decrease in amount of urine
• dizziness
• drowsiness
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• headache
• increased thirst
• loss of appetite
• mood or mental changes
• muscle pain or cramps
• muscle spasms
• muscle twitching
• nausea
• nervousness
• noisy, rattling breathing
• numbness or tingling in hands, feet, or lips
• pinpoint red spots on skin
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• spread of cancer
• sore throat
• swelling of fingers, hands, feet, or lower legs
• trembling
• troubled breathing at rest
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• vomiting of blood or material that looks like coffee grounds
• weight gain

• Cough
• dilated neck veins
• extreme fatigue
• irregular breathing
• lower back or side pain
• painful or difficult urination
• pale skin
• swelling
• ulcers, sores, or white spots in mouth
• wheezing

• Decreased vision
• difficulty swallowing
• eye pain or tenderness
• eye redness
• hives
• itching
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• sensitivity of eye to light
• skin rash
• sweating
• tearing of eye
• tightness in chest

• Bone, joint, and/or muscle pain, severe and occasionally incapacitating
• faintness, or light-headedness when getting up from a lying or sitting position suddenly
• hives
• itching of the skin
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• skin rash
• tightness in chest

Note: Abdominal cramps, confusion, and muscle spasms are less common when pamidronate is given in doses of 60 mg or less.

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:

• Abdominal pain
• acid or sour stomach
• belching
• bladder pain
• bloody or cloudy urine
• body aches or pain
• bone pain
• cracks in skin at the corners of mouth
• constipation
• degenerative disease of the joint
• diarrhea
• difficult, burning, or painful urination
• difficult or labored breathing
• difficulty in moving
• ear congestion
• fear
• frequent urge to urinate
• general feeling of body discomfort or illness
• heartburn
• indigestion
• joint pain
• lack or loss of strength
• loss of voice
• lower back or side pain
• muscle aching or cramping
• muscle pains or stiffness
• nasal congestion
• nervousness
• pain and swelling at place of injection
• pain or tenderness around eyes and cheekbones
• runny nose
• sensitivity to heat
• shivering
• skin rash
• sleeplessness
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• sneezing
• soreness or redness around fingernails and toenails
• stomach discomfort, upset or pain
• stuffy nose
• sweating
• swollen joints
• trouble sleeping
• ulcers, sores, or white spots in mouth
• unable to sleep
• weight loss

• Ammonia-like breath odor
• feeling, seeing, or hearing things that are not there
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling unusually cold
• swelling or inflammation of the mouth
• unusual behavior

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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