Actonel

Actonel is a prescription medication used to treat conditions in which bones become weak and break easily such as osteoporosis and Paget's disease.

Actonel belongs to a group of drugs called bisphosphonates that work by preventing bone breakdown and increasing bone density. 

The medication comes in the form of a tablet. Depending on which dose you take, Actonel is taken daily, weekly, or monthly.

Common side effects include back and joint pain, stomach area (abdominal) pain, and heartburn. Actonel can cause esophagus (tube connecting the throat to the stomach) problems and low calcium levels in your blood (hypocalcemia).

Actonel is a prescription medicine that is used:

•  to prevent and treat osteoporosis in postmenopausal women (women that have gone through the "end of periods" or "change of life")
•  to increase bone mass in men with osteoporosis (a condition in which bones weaken and break easily)
•  to prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisone
•  to treat Paget’s disease (a condition in which bones are soft, weak, deformed, painful, or easily broken) of bone in men and women

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Actavis Pharma, Inc.

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.

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

• NSAIDS (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn)
• aspirin
• antacids
• proton pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix),
• H2 blockers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
• hormone therapy such as estrogens and estrogen agonist/blockers
• cancer chemotherapy treatments
• steroids such as dexamethasone (Decadron), methylprednisolone (Medrol) and prednisone (Deltasone)

The following medicines can lower the amount of Actonel that your body absorbs:

• antacids
• calcium supplements
• aluminum supplements
• magnesium supplements
• aspirin
• iron supplements

If you must take these medicines, wait at least 30 minutes after taking Actonel.

1. Actonel can cause esophagus (tube connecting the throat to the stomach) problems. It is important that you take Actonel exactly as prescribed to help lower your chance of getting esophagus problems including:

• irritation
• inflammation
• ulcers of the esophagus which may sometimes bleed

Stop taking Actonel and call your doctor right away if you have painful or difficult swallowing, chest pain, or new or worsening heartburn.

2. Actonel can cause low calcium levels in your blood (hypocalcemia), which can worsen already low blood calcium conditions. If you have low blood calcium before taking Actonel it must be treated before you take Actonel. You may not know you have low blood calcium, but some people may have the following symptoms:

• Spasms, twitches, or cramps in your muscles
• Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Actonel. Take calcium and vitamin D as your doctor tells you to.

3. Severe jaw bone problems may happen when you take Actonel. Your doctor and dentist may examine your mouth before you start Actonel. 

4. Some people who take Actonel develop severe bone, joint, or muscle pain.

5. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

Do not take Actonel if you:

• have certain problems with your esophagus, the tube that connects your mouth with your stomach
• cannot stand or sit upright for at least 30 minutes
• have low levels of calcium in your blood
• are allergic to Actonel any of its ingredients

Foods and some vitamin supplements and medicines can stop your body from absorbing (using) Actonel. Therefore, do not take anything other than plain water at or near the time you take Actonel and for 30 minutes after.

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. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Actonel falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor before using Actonel if you are breastfeeding or plan to breastfeed. It is not known if Actonel is excreted in human breast milk or if it can harm your baby.

The following instructions apply to all patients taking Actonel:

• Take Actonel exactly as prescribed by your healthcare provider.
• Take Actonel first thing in the morning before you eat or drink anything except plain water.
• Take Actonel while you are sitting up or standing.
• Take Actonel with 6 to 8 ounces (about 1 cup) of plain water. Do not take it with any other drink besides plain water. Do not eat or drink anything for 30 minutes after taking Actonel.
• Swallow Actonel whole. Do not chew the tablet or keep it in your mouth to melt or dissolve it.

After taking Actonel you must wait at least 30 minutes before:

• lying down. You may sit, stand, or do normal activities like read the newspaper or take a walk.
• eating or drinking anything except plain water.
• taking vitamins, calcium, or antacids. It is best to take vitamins, calcium, and antacids at a different time of the day from when you take Actonel.

If you miss a dose of Actonel, do not take it later in the day. Take your missed dose the next morning and then return to your normal schedule. Do not take 2 doses at the same time.

If you miss more than 2 doses of Actonel in a month, call your doctor for instructions.

If you take too much Actonel, call your doctor. Do not try to vomit. Do not lie down.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Treatment of Postmenopausal Osteoporosis

• 5 mg daily in the morning.
• 35 mg weekly in the morning.
• 75 mg in the morning two days in a row every month (150 mg once a month).

Prevention of Postmenopausal Osteoporosis

• 5 mg daily in the morning.
• 35 mg weekly in the morning.

Treatment to Increase Bone Mass in Men with Osteoporosis

• 35 mg weekly in the morning.

Glucocorticoid-Induced Osteoporosis

• 5 mg daily in the morning.

Treatment of Paget's Disease

• 30 mg daily for 2 months. Retreatment may be considered if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase.

If you take too much Actonel (overdose) take a full glass of milk and call your local Poison Control Center or seek emergency medical attention right away.

• 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.