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Actonel DR

Common Name:

risedronate delayed-release


How does Actonel DR work? What will it do for me?

Risedronate delayed-release belongs to the group of medications called bisphosphonates. It is used for the treatment and prevention of osteoporosis for postmenopausal women. Risedronate delayed-release helps to slow bone loss by slowing down the cells that break down bone called osteoclasts. This allows the cells that build bone (called osteoblasts) to work more efficiently and increase the bone mineral density. By making bones stronger, risedronate delayed-release can help to reduce the risk of osteoporosis-related broken bones.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does Actonel DR come in?

Each delayed-release, oval-shaped, yellow tablet with "EC 35" engraved on one side contains risedronate 35 mg. Nonmedicinal ingredients: edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer dispersion, silicified microcrystalline cellulose, polysorbate 80, simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.

How should I use Actonel DR?

The usual dose of risedronate delayed-release is 35 mg taken once a week in the morning with breakfast. Do not take this medication before breakfast or on an empty stomach.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are
taking the medication without consulting your doctor.

Swallow the tablet whole (do not chew, crush, or cut it) with at least 120 mL (4 ounces) of plain water. Do not lie down for at least 30 minutes after taking the tablet.

Calcium supplements and antacids can interfere with how well this medication works and should be taken at a different time of day.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take the missed dose the following day and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take Actonel DR?

Do not take this medication if you:

  • are allergic to risedronate or any ingredients of this medication
  • have hypocalcemia (low blood calcium levels)

What side effects are possible with Actonel DR?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • diarrhea
  • headache
  • heartburn or acid reflux
  • joint, bone, or muscle pain
  • nausea
  • sore throat, or nose
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • delayed healing and infection of mouth and jaw (usually after tooth extraction)
  • difficulty swallowing
  • eye pain, redness, or swelling
  • mouth sores painful teeth, mouth or jaw
  • new or unusual pain in the hip, groin, or thigh
  • sensitivity of eyes to light
  • severe pain in bones, muscles, or joints
  • signs of damage to the esophagus (e.g., pain in the esophagus [throat area] or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
  • signs of low levels of calcium in the blood (e.g., numbness, tingling, or muscle spasms)
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)
  • symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)
  • symptoms of thigh bone fracture (e.g., severe and sharp leg pain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Actonel DR?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Effects on the esophagus and stomach: Risedronate delayed-release may irritate the lining of the esophagus (the tube that connects the mouth and the stomach) and the stomach.

Esophagitis (inflammation of the esophagus lining), ulcers, and erosions have been reported by people who take risedronate delayed-release. To ease the passage of the medication to the stomach, and thus reduce the risk of irritation of the esophagus, swallow risedronate delayed-release with at least 120 mL (4 ounces) of plain water with breakfast. Do not lie down for at least 30 minutes after taking the tablet.

If you experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn, stop taking this medication and contact your doctor.

Jaw problems: Some people taking this type of medication have developed a type of jaw problem called osteonecrosis of the jaw. This is more likely to occur if you have dental surgery, have cancer, are receiving chemotherapy or corticosteroids (e.g., prednisone), or already have dental health problems. It is important to practice good mouth care during treatment with this medication. Talk to your doctor to find out whether you might be at risk. Your doctor may ask you to see your dentist before you start this medication. Dental work should be done before you start treatment with this medication and if possible dental procedures should be avoided during treatment.

If you experience any mouth sores, pain, swelling, or infection of the mouth or jaw, especially after having a tooth removed, contact your doctor immediately.

Kidney function: Risedronate may not be removed from the body at the expected rate if the kidneys are not working properly. This increases the risk of side effects for the person taking this medication. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have severely reduced kidney function, you should not take risedronate delayed-release.

Low calcium levels or vitamin D deficiency: Risedronate delayed-release may lower the calcium levels in your blood. If you have low blood calcium before you start taking this medication, it may get worse during treatment. Your low blood calcium must be treated before you take this medication. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms.

Call your doctor right away if you have symptoms of low blood calcium such as spasms, twitches, or cramps in your muscles; or numbness or tingling in your fingers, toes, or around your mouth.

Your doctor may prescribe or suggest that you take calcium and vitamin D to help prevent low calcium levels in your blood, while you take risedronate delayed-release.

Musculoskeletal pain: Severe bone, muscle, and joint pain have been reported by some people taking this medication. If you experience any severe symptoms, talk to your doctor about whether you should continue taking this medication.

Other risedronate products: Do not take this medication if you are already taking a medication than contains risedronate.

Thigh bone fractures: Some people have developed fractures with little or no trauma in their thigh bone while taking this or similar medications. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh. Call your doctor immediately if you have these symptoms.

Vision issues: Some people have developed inflammation of the eye after taking this or similar medication. If you develop any issues with your eye or vision, call your doctor immediately.

Pregnancy: Risedronate delayed-release is not intended to be taken by pregnant women and has not been studied for use by pregnant women.

Breast-feeding: Risedronate delayed-release is not intended to be taken by breast-feeding women. It is not known if risedronate passes into breast milk.

Children: The safety and effectiveness of this medication have not been established for children.

What other drugs could interact with Actonel DR?

There may be an interaction between risedronate delayed-release and any of the following:

  • aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • calcium supplements
  • deferasirox
  • H2 antagonists (e.g., famotidine, ranitidine)
  • iron-containing products
  • magnesium-containing supplements or laxatives
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen, ketoprofen)
  • proton pump inhibitors (PPIs; e.g., esomeprazole, omeprazole, pantoprazole)
  • systemic angiogenesis inhibitors (e.g., axitinib, bevacizumab, lenalidomide, pazopanib, regorafenib, vandetanib)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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