Description
Risedronate delayed-release tablets and tablets are used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. Risedronate tablets may also be used to increase bone mass in men who have osteoporosis, and in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). Risedronate tablets are also used to treat Paget's disease of the bone. .
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Tablet, Delayed Release
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
Use of risedronate is not indicated in children.
Appropriate studies have not been performed on the relationship of age to the effects of Actonel® with calcium 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 risedronate in the elderly.
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.
- Esomeprazole
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
- Dental or tooth problems or
- Dental procedures (eg, dental implants, tooth extraction) or
- Infection or
- Poor oral hygiene or
- Surgery (eg, dental surgery)—May increase risk for severe jaw problems.
- Esophagus (the tube that runs from your throat to your stomach) problems (eg, achalasia, stricture) or
- Hypocalcemia (low calcium in the blood) or
- Inability to stand or sit upright for at least 30 minutes or
- Kidney problems, severe or
- Trouble with swallowing—Should not be used in patients with these conditions.
- Stomach or bowel problems (eg, Barrett's esophagus, duodenitis, gastritis, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. May make these conditions worse.
Proper Use
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you are using the delayed-release tablets:
- Take it in the morning right after breakfast.
- Swallow the tablet whole with at least 4 ounces of plain water. Do not crush, chew, or cut it.
Take the regular tablets with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken as soon as you get out of bed in the morning at least 30 minutes before any food, beverage, or other medicines. Food and beverages (eg, mineral water, coffee, tea, or juice) will decrease the amount of risedronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids that contain calcium or calcium supplements also will decrease the absorption of risedronate.
Swallow the regular tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.
Do not lie down for 30 minutes after taking risedronate. This will help risedronate reach your stomach faster. It also will help prevent irritation to your esophagus.
It is important that you eat a well-balanced diet with adequate amounts of calcium and vitamin D (found in milk or other dairy products). However, do not take any food, beverages, or calcium supplements within 30 minutes or longer after taking risedronate. To do so may keep this medicine from working properly.
Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.
Tell your doctor if you do weight-bearing exercises, smoke or drink excessively. Your doctor will need to take these into consideration in deciding your dose.
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 (delayed-release tablets):
- For treatment of postmenopausal osteoporosis:
- Adults—35 milligrams (mg) once a week, taken right after breakfast.
- Children—Use is not recommended.
- For treatment of postmenopausal osteoporosis:
- For oral dosage form (tablets):
- For prevention and treatment of corticosteroid-induced osteoporosis:
- Adults—5 milligrams (mg) once a day at least 30 minutes before the first food or drink of the day other than water.
- Children—Use is not recommended.
- For prevention and treatment of postmenopausal osteoporosis:
- Adults—5 milligrams (mg) once a day or 35 mg once-a-week at least 30 minutes before the first food or drink of the day other than water. Alternatively, you may take one 75 mg tablet per day for two consecutive days each month or 150 mg tablet once a month.
- Children—Use is not recommended.
- For treatment of osteoporosis in men:
- Adults—35 milligrams (mg) once a week at least 30 minutes before the first food or drink of the day other than water.
- Children—Use is not recommended. .
- For treatment of Paget's disease of the bone:
- Adults—30 milligrams (mg) once a day at least 30 minutes before the first food or drink of the day other than water for two months. Your doctor may tell you to repeat this dose.
- Children—Use is not recommended.
- For prevention and treatment of corticosteroid-induced osteoporosis:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
For patients taking the delayed-release tablets: If you missed taking it once a week, take 1 tablet on the morning that you remember. Do not take two tablets on the same day. Return to your regular schedule the following week.
For patients taking the regular tablets each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.
If you are on a weekly schedule and miss a dose of the regular tablets, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.
For patients taking the regular tablets on two consecutive days each month, and the next month's scheduled doses are more than 7 days away: If both tablets are missed, take the first tablet on the morning after the day it is remembered. Take the second tablet on the next morning. If only one tablet is missed, take the missed tablet on the morning after the day it is remembered. Return to your regular schedule the following month. Do not take more than two tablets within 7 days.
For patients taking the regular tablets on two consecutive days each month, and the next month's scheduled doses are 1 to 7 days away: Wait until the next month and take the tablets on the scheduled days. Return to your regular schedule the following month. Do not take more than two tablets within 7 days.
For patients taking the regular tablets once a month and the next month's scheduled dose is more than 7 days away: Take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the following month. Do not take more than 1 tablet within 7 days.
For patients taking the regular tablets once a month and the next month's scheduled dose is 1 to 7 days away: Wait until the next month and take the tablet on the scheduled day of the month. Resume your usual schedule taking the medicine on your chosen day the following month. Do not take more than 1 tablet within 7 days.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.
You should not take Actonel® tablets if you are also using Atelvia®.delayed-release tablets. These medicines should not be taken together because both medicines contain risedronate. Ask your doctor if you have any questions.
This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking this medicine and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
It is important that you tell all of your health care providers that you are taking risedronate. If you are having dental procedures done while taking risedronate you may have an increased chance of getting a severe problem of your jaw.
Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
This medicine could lower the amount of calcium in your blood. Call your doctor right away if you develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.
This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
This medicine may interact with the dye used for bone scans.
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
- Abdominal or stomach pain
- skin rash
Less common
- Abdominal or stomach pain (severe)
- belching
- bone pain
- cramping of the stomach
- trouble swallowing
Rare
- Red, sore eyes
Incidence not known
- Bone, joint, or muscle pain, severe and occasionally incapacitating
- chest pain
- heartburn
- pain or burning in the throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Confusion
- convulsions
- difficulty with breathing
- irregular heartbeats
- 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
- cough or hoarseness
- diarrhea
- fever or chills
- headache
- joint pain
- lower back or side pain
- painful or difficult urination
Less common
- Acid or sour stomach
- bladder pain
- bloody or cloudy urine
- blurred vision or change in vision
- body aches or pains
- congestion
- constipation
- difficult, burning, or painful urination
- difficulty with moving
- dizziness
- dry eyes
- dryness or soreness of the throat
- frequent urge to urinate
- general feeling of discomfort or illness
- indigestion
- leg cramps
- muscle pain or stiffness
- nausea
- nervousness
- pain, swelling, or redness in the joints
- pounding in the ears
- ringing in the ears
- runny nose
- slow or fast heartbeat
- stomach discomfort or upset
- swelling of the feet or lower legs
- tender swollen glands in the neck
- voice changes
- weakness
Rare
- Fainting
- fear
- itching skin
- loss of appetite
- pale skin
- passing of gas
- redness, swelling, or soreness of the tongue
- sneezing
- stomach fullness
- tightness in the chest
- troubled breathing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- wheezing
Incidence not known
- Eye pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle pain
- redness of the eye
- sensitivity of the eye to light
- skin blisters
- tearing
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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