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Short descriptions : Actonel (Risedronate) is used to treat or prevent osteoporosis in men and women. Actonel is also used to treat Paget's disease of bone.
Manuf: tablet, tablet oral eq 500mg base,n/a;n/a,35mg **federal register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Although our bones seem solid and stable, they actually undergo constant
renewal. Specialized cells called osteoclasts draw used calcium out
of the bones while other cells called osteoblasts replace it. Especially
after menopause, this process can get out of balance. Calcium starts
to leach out of the bones faster than it can be replaced, leading to
the brittle-bone disease called osteoporosis.
Actonel combats this problem by reducing the activity of the osteoclasts
and slowing the loss of calcium from the bones. It is prescribed for
postmenopausal women, both to prevent osteoporosis and to strengthen
the bones once the disease has begun. It is also used to prevent or
treat osteoporosis resulting from therapy with steroid medications,
and it is used in the treatment of Paget's disease, a condition in
which patches of bone become softened and enlarged.
Both Actonel and a similar drug called Fosamax are members of the
family of drugs called bisphosphonates. Most important fact about Actonel
Actonel not only stops the bone loss of osteoporosis, but actually
reverses the disease and increases bone mineral density. As the bones
grow stronger, your chances of sustaining a fracture decline. How should you take Actonel?
Three types of Actonel are available: a 5-milligram and 30-milligram
tablet that can be taken daily, and a 35-milligram tablet that's taken
once a week. The tablets should be taken at least 30 minutes before
the first food or drink of the day other than water. Take the pill
while standing or sitting in an upright position and wash it down with
a full 6 to 8 ounce glass of plain water (do not use coffee, tea, juice,
milk, or other dairy products). Swallow the tablet whole, do not chew
or suck on it. Do not lie down for 30 minutes after taking Actonel
.
Other treatment measures typically include weight-bearing exercise,
reduction of excessive smoking and drinking, and supplemental calcium
and vitamin D if you don't get enough in your diet. If you require
calcium supplements, or use any medications containing calcium, aluminum,
or magnesium, avoid taking them at the same time of day as Actonel.
--If you miss a dose...
If you realize that you missed a daily dose and have not yet had anything
to eat or drink, it's okay to take your medication. If you have already
eaten, skip the dose for that day and take your regular dose the following
morning.
If you forget to take a weekly dose, take 1 tablet on the morning
after you remember, then return to taking 1 tablet a week as originally
scheduled on the chosen day. Never take 2 tablets on the same day.
--Storage instructions...
Store at room temperature. Actonel side effects
Side effects cannot be anticipated. If any develop or change in intensity,
inform your doctor as soon as possible. Only your doctor can determine
if it is safe for you to continue taking Actonel.
* Side effects may include:
Abdominal pain, anxiety, back pain, belching, bladder irritation, bone disorders
and pain, bronchitis, bursitis, cataracts, chest pain, colitis, constipation,
depression, diarrhea, difficulty breathing, dizziness, dry eyes, eye infection,
flu-like symptoms, gas, headache, high blood pressure, infection, insomnia,
itching, joint disorders and pain, leg cramps, muscle pain, muscle weakness,
nausea, neck pain, nerve pain, pain, pneumonia, rash, ringing in ears, sinus
problems, sore throat, stomach bleeding, stuffy or runny nose, swelling,
tendon problems, tumor, ulcers, urinary tract infection, vertigo, vision
problems, weakness
Why should Actonel not be prescribed?
Your doctor will not prescribe Actonel if you have low calcium levels
in your blood or the drug gives you an allergic reaction. You also
cannot take Actonel if you are unable to stand or sit upright for at
least 30 minutes after taking the drug. In addition, the drug is not
recommended for people with severe kidney disease.
Special warnings about Actonel
The drugs in Actonel's family have been known to cause problems in
the canal between the mouth and the stomach (the esophagus). Among
the disorders that have been reported are esophageal irritation, difficulty
swallowing, esophageal ulcers, and gastric ulcers.
You can guard against such problems by taking Actonel with plenty
of water, swallowing the pill while standing or sitting upright, and
remaining upright for 30 minutes afterwards. If you experience difficulty
or pain on swallowing, chest pain, or heartburn that is severe or worse
than usual, stop taking Actonel and check with your doctor immediately. Possible food and drug interactions when taking Actonel
If Actonel is taken with certain other drugs, the effects of either
could be increased, decreased, or altered. It is especially important
to check with your doctor before combining Actonel with the following:
Antacids
Calcium supplements
Laxatives such as Milk of Magnesia Special information if you are pregnant or breastfeeding
Actonel has caused harm when tested on pregnant animals. It is not
recommended during human pregnancy unless its benefits are judged to
outweigh the potential risks. If you are pregnant or plan to become
pregnant, notify your doctor immediately.
If you are nursing a baby, you'll need to choose between discontinuing
nursing or discontinuing the drug. Recommended dosage for Actonel
ADULTS
Overdosage
A large overdose of Actonel can dramatically reduce calcium levels
in the blood. Warning signs include a tingling sensation and spasms.
If you suspect an overdose, seek medical attention immediately.
What is actonel?
Actonel is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Actonel slows bone loss while increasing bone mass, which may prevent bone fractures.
Actonel is used to treat or prevent osteoporosis in men and women. Actonel is also used to treat Paget's disease of bone.
Actonel may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about actonel?
Do not take a actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel 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.
Take the actonel tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a actonel tablet.
For at least the first 30 minutes after taking a actonel tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.
Some people using medicines similar to actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.
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.
What should I discuss with my healthcare provider before taking actonel?
Do not take a actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel 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.
Before using actonel, tell your doctor if you have:
low blood calcium (hypocalcemia);
a vitamin D deficiency;
kidney disease; or
an ulcer in your stomach or esophagus.
If you have any of these conditions, you may not be able to use actonel, or you may need a dosage adjustment or special tests during treatment.
Some people using medicines similar to actonel have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether actonel passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take actonel?
Take actonel exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.
Actonel tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day or once each week. The stronger tablets may be taken only twice 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.
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, at least 30 minutes before you eat or drink anything or take any other medicine. If you take a actonel tablet only once a week, take it on the same day each week and always first thing in the morning.
Take each actonel tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a actonel tablet. Do not crush, chew, or suck the actonel tablet. Swallow the pill whole.
After taking a actonel tablet, carefully follow these instructions:
Do not lie down or recline for at least 30 minutes after taking actonel.
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.
To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
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 actonel tablets at room temperature away from moisture and heat.
What happens if I miss a dose?
If you take actonel 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 actonel tablets once a week: If you forget to take actonel 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 if you think you have used too much of this medicine. 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.
Symptoms of a actonel overdose 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 actonel?
Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an actonel tablet. Do not lie down for at least 30 minutes after you take a actonel tablet.
Actonel 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 actonel and call your doctor at once if you have any of these serious side effects:
chest pain;
difficulty or pain when swallowing;
pain or burning under the ribs or in the back;
new or worsening heartburn;
severe joint, bone, or muscle pain; or
jaw pain, numbness, or swelling.
Continue using actonel and talk with your doctor if you have any of these less serious side effects:
mild heartburn or stomach upset;
diarrhea, gas, or constipation;
mild joint or back pain; or
headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect actonel?
Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs actonel. If you use these other medicines, do not that take them for at least 30 minutes after taking a actonel tablet.
Before using actonel, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
There may be other drugs that can affect actonel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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