Actonel

Name: Actonel

Actonel Side Effects

Common Side Effects of Actonel

Tell your doctor if any of the following side effects become severe or don't go away:

  • Mild stomach pain or upset stomach
  • Diarrhea or constipation
  • Burping
  • Dry mouth
  • Mild joint or back pain
  • Headache
  • Dizziness
  • Muscle pain
  • Flu-like symptoms
  • Frequent or painful urination

Serious Side Effects of Actonel

Tell your doctor immediately if you experience any of the symptoms listed in the Actonel Warnings section above, or any of the following serious side effects:

  • Numbness, pain, or swelling of the jaw
  • Painful or swollen gums
  • Loosening of teeth
  • Difficult or painful swallowing
  • Severe indigestion
  • New or worsening heartburn
  • Chest pain
  • Pain or burning under the ribs or in the back
  • Severe joint, bone, or muscle pain
  • Unusual or severe pain in your thigh or hip
  • Itching, rash, hives, or blisters on the skin
  • Difficulty breathing
  • Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • Muscle spasms, twitching, or cramps
  • Swollen, red, or painful eyes
  • Sensitivity to light

What is risedronate, and how does it work (mechanism of action)?

  • Risedronate is in a class of drugs called bisphosphonates used for the treatment of Paget's disease of bone (in which the formation of bone is abnormal) and in persons with osteoporosis (in which the density and strength of bones are reduced). Other biphosphonates include the drugs alendronate (Fosamax), ibandronate (Boniva), pamidronate (Aredia), tiludronate (Skelid), and etidronate (Didronel). Bone is continually being formed and dissolved. New bone is laid down by cells called osteoblasts while old bone is removed by cells called osteoclasts. Bisphosphonates strengthen bone by inhibiting bone removal (resorption) by osteoclasts. By slowing down the rate at which bone is dissolved, risedronate increases the amount of bone. Risedronate is more potent in blocking the dissolution of bone than etidronate and alendronate.
  • The FDA approved risedronate for the treatment of Paget's disease in 1998 and for the prevention and treatment of osteoporosis in 1999.

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 use risedronate 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).

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

You should not use risedronate if you are allergic to it, 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.

It is not known whether risedronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Risedronate Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

5 mg

Actonel

Warner Chilcott

30 mg

Actonel

Warner Chilcott

35 mg

Actonel

Warner Chilcott

75 mg

Actonel

Warner Chilcott

150 mg

Actonel

Warner Chilcott

Risedronate Sodium Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

35 mg (4 tablets) with Calcium Carbonate 1.25 g (24 tablets)

Actonel with Calcium

Warner Chilcott

What do I need to tell my doctor BEFORE I take Actonel?

  • If you have an allergy to risedronate or any other part of Actonel (risedronate tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: A swallowing tube (esophagus) that is not normal, low calcium levels, kidney disease, or trouble swallowing.
  • If you are not able to stand or sit up for 30 minutes.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Actonel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Actonel Description

Actonel (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Actonel tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:

Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.

Inactive Ingredients

All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.

Dose strength-specific ingredients include: 5 mgferric oxide yellow, lactose monohydrate; 30 mglactose monohydrate; 35 mgferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mgferric oxide red; 150 mgFD&C blue #2 aluminum lake.

Side Effects of Actonel

Actonel may cause serious side effects. See “Drug Precautions”.

The most common side effects of Actonel are:

  • pain, including back and joint pain
  • stomach area (abdominal) pain
  • heartburn

Actonel can cause allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue, or throat.

Tell your doctor if you have any side effect that is severe, or does not go away.

This is not a complete list of Actonel side effects. Ask your doctor or pharmacist for more information.

Inform MD

Before you receive Actonel, tell you doctor about all the medical conditions you have including if you have:

  • swallowing problems
  • stomach or digestive problems
  • low blood calcium
  • plans to have dental surgery or teeth removed
  • kidney problems
  • trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. 

Other Requirements

  • Store Actonel at room temperature, 68° F to 77° F (20° C to 25° C).
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep Actonel and all medicines out of the reach of children.

Patient Handout

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Important information

You should not use Actonel 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 Actonel 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).

How should I take Actonel?

Take Actonel exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Actonel 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.

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

After taking a Actonel tablet, carefully follow these instructions:

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

  • 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 Actonel. 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 Actonel tablet at the same time.

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

Do not crush, chew, or suck the 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 Actonel. 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 Actonel for longer than 3 to 5 years if you take it for osteoporosis.

Actonel 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.

Actonel side effects

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

Stop using Actonel 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;

  • jaw pain, numbness, or swelling; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Actonel 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.

Actonel dosing information

Usual Adult Dose for Osteoporosis:

Treatment of Postmenopausal Osteoporosis:
Immediate release:
-5 mg orally once a day or
-35 mg orally once a week or
-75 mg orally on two consecutive days for a total of two tablets each month or
-150 mg orally once a month

Treatment to Increase Bone Mass in Men with Osteoporosis:
Immediate release:
-35 mg orally once a week

Treatment of Glucocorticoid-Induced Osteoporosis:
Immediate release:
-5 mg orally once a day

Comments:
-Refer to administration advice for details on how to take this drug.
-Reevaluate bisphosphonate therapy periodically.
-Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Uses:
-Treatment to reduce the incidence of vertebral fractures and composite endpoint of nonvertebral osteoporosis-related fractures in postmenopausal women
-Treatment to increase bone mass in men with osteoporosis
-Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases

Usual Adult Dose for Prevention of Osteoporosis:

Prevention of Postmenopausal Osteoporosis:
-5 mg orally once a day or
-35 mg orally once a week or
-75 mg orally on two consecutive days for a total of two tablets each month or
-150 mg orally once a month

Prevention of Glucocorticoid-Induced Osteoporosis:
-5 mg orally once a week

Comments:
-Refer to administration advice for details on how to take this drug.
-Reevaluate bisphosphonate therapy periodically.
-Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Uses:
-Prevention of osteoporosis in postmenopausal women
-Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases

Usual Adult Dose for Paget's Disease:

-30 mg orally once a day for 2 months

Comments:
-Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase.
-For retreatment, the dose and duration of therapy are the same as for initial treatment.
-There is no data available on more than 1 course of retreatment.

Use: Treatment of Paget's disease of bone in men and women

How it works

Actonel is a brand (trade) name for risedronate. Risedronate belongs to a group of medicines known as bisphosphonates. Bisphosphonates inhibit osteoclasts which are responsible for breaking down and reabsorbing bone (by a process known as bone resorption). Bisphosphonates strengthen bones by slowing down bone loss and allowing osteoblasts (bone building cells) to work more effectively, improving bone mass.

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