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risedronate

Pronunciation

Generic Name: risedronate (rih SED ro nayt)
Brand Name: Actonel, Atelvia

What is risedronate?

Risedronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Risedronate is used to treat or prevent osteoporosis in men and women. Risedronate is also used to treat Paget's disease of bone.

Risedronate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about risedronate?

You should not take this medication if you are allergic to risedronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

What should I discuss with my healthcare provider before taking risedronate?

You should not take this medication if you are allergic to risedronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

To make sure risedronate is safe for you, tell your doctor if you have:

  • low blood calcium (hypocalcemia);

  • a vitamin D deficiency;

  • kidney disease; or

  • an ulcer in your stomach or esophagus.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use risedronate, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether risedronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take risedronate?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Risedronate tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day. Some tablets are taken once each week, or only 1 or 2 times each month.

Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

After taking a risedronate tablet, carefully follow these instructions:

  • Do not lie down or recline for at least 30 minutes after taking risedronate.

  • Do not eat or drink anything other than plain water.

  • Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking risedronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

Do not take two different strengths of risedronate tablet at the same time.

If you take risedronate only once a week, take it on the same day and time each week.

Do not crush, chew, or suck the risedronate tablet. Swallow it whole. The pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take risedronate for longer than 3 to 5 years if you take it for osteoporosis.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take risedronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take risedronate tablets once a week, or once or twice per month: If you forget to take risedronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking risedronate?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Some medicines can make it harder for your body to absorb risedronate.

Risedronate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using risedronate and call your doctor at once if you have:

  • chest pain, new or worsening heartburn;

  • difficulty or pain when swallowing;

  • pain or burning under the ribs or in the back;

  • severe or ongoing indigestion;

  • severe joint, bone, or muscle pain;

  • new or unusual pain in your thigh or hip; or

  • jaw pain, numbness, or swelling.

Common side effects may include:

  • mild stomach pain or upset stomach;

  • flu symptoms, muscle pain;

  • diarrhea, constipation;

  • mild joint or back pain; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

See also: Side effects (in more detail)

Risedronate dosing information

Usual Adult Dose for Paget's Disease:

30 mg orally once a day. Therapy should be continued for 2 months. A drug free interval of at least 2 months should be allowed to assess response. Retreatment may be considered after a 2 month period for patients who have relapsed or did not respond based on a failure to normalize serum alkaline phosphatase levels. Data are not available regarding more than one course of treatment.

Usual Adult Dose for Osteoporosis:

For prevention or treatment of postmenopausal osteoporosis: 5 mg orally once daily or 35 mg orally once a week. Also, risedronate 75 mg may be given orally once a day on two consecutive days, for a total of two tablets monthly. Additionally, risedronate 150 mg may be given orally once a month.

For treatment of osteoporosis in men: 35 mg orally once a week.

For prevention or treatment of glucocorticoid induced osteoporosis: 5 mg orally once daily.

Patients should receive adequate supplements of calcium and vitamin D.

Patients should be instructed that if they miss a dose of risedronate 35 mg once a week, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once a week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.

If one or both tablets of risedronate 75 mg on two consecutive days/month are missed, and the next month's scheduled doses are more than 7 days away, the patient should be instructed as follows: If both tablets are missed, take one risedronate 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning; if only one risedronate 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate 75 mg on two consecutive days/month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days. If one or both tablets of risedronate 75 mg on two consecutive days/month are missed, and the next month's scheduled doses are within 7 days, patients should wait until their next month's scheduled doses and then continue taking risedronate 75 mg on two consecutive days/month as originally scheduled.

If the dose of risedronate 150 mg once a month is missed, and the next month's scheduled dose is more than 7 days away, the patient should be instructed to take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate 150 mg once a month as originally scheduled. Patients should not take more than one 150 mg tablet within 7 days. If the dose of risedronate 150 mg once a month is missed, and the next month's scheduled dose is within 7 days, patients should wait until their next month's scheduled dose and then continue taking risedronate 150 mg once a month as originally scheduled.

Usual Adult Dose for Prevention of Osteoporosis:

For prevention or treatment of postmenopausal osteoporosis: 5 mg orally once daily or 35 mg orally once a week. Also, risedronate 75 mg may be given orally once a day on two consecutive days, for a total of two tablets monthly. Additionally, risedronate 150 mg may be given orally once a month.

For treatment of osteoporosis in men: 35 mg orally once a week.

For prevention or treatment of glucocorticoid induced osteoporosis: 5 mg orally once daily.

Patients should receive adequate supplements of calcium and vitamin D.

Patients should be instructed that if they miss a dose of risedronate 35 mg once a week, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once a week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.

If one or both tablets of risedronate 75 mg on two consecutive days/month are missed, and the next month's scheduled doses are more than 7 days away, the patient should be instructed as follows: If both tablets are missed, take one risedronate 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning; if only one risedronate 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate 75 mg on two consecutive days/month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days. If one or both tablets of risedronate 75 mg on two consecutive days/month are missed, and the next month's scheduled doses are within 7 days, patients should wait until their next month's scheduled doses and then continue taking risedronate 75 mg on two consecutive days/month as originally scheduled.

If the dose of risedronate 150 mg once a month is missed, and the next month's scheduled dose is more than 7 days away, the patient should be instructed to take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate 150 mg once a month as originally scheduled. Patients should not take more than one 150 mg tablet within 7 days. If the dose of risedronate 150 mg once a month is missed, and the next month's scheduled dose is within 7 days, patients should wait until their next month's scheduled dose and then continue taking risedronate 150 mg once a month as originally scheduled.

What other drugs will affect risedronate?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with risedronate, especially:

  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with risedronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about risedronate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 11.03. Revision Date: 2013-05-30, 3:00:20 PM.

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