Manufacturer of Actonel
Procter and Gamble Pharmaceuticals
Also know under brand names: Actonel
Active ingredient / generic name: risedronate
Approximate US Retail Price for Actonel 35 mg (1 disp pack, 4 ea): $90.97
5 mg (30 ea): $99.99
30 mg (10 ea): $215.71
75 mg (1 disp pack, 2 ea): $97.47
Short leafletActonel sodium (Actonel) is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Procter & Gamble and Sanofi-Aventis.
Actonel is taken orally, usually 5 mg daily or 35 mg weekly. Notably, if Actonel lodges in the esophagus, it can lead to esophageal ulcers. Therefore, it is recommended that Actonel be taken with the body upright, and followed by a glass of water. Moreover, Actonel is poorly absorbed when taken with food, so it is recommended that no food or drink other than water be taken for 2 hours before and 30 minutes after taking Actonel. Actonel has a faster esophageal transit time and different chemical chain which results in less gastrointestinal side-effects than other drugs in this class. The dosage instructions also show that Actonel can be taken with less water than other drugs in the class.
In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on on September 7 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".
In 2006 P&G faced controversy over its handling of clinical research involving Actonel (News Reports and discussion).
In common with other bisphosphonate drugs, Actonel appears to be associated with the rare side effect osteonecrosis of the jaw, often preceded by a dental procedures.
Actonel: Patient Education
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.
Take the risedronate 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 risedronate tablet.
For at least the first 30 minutes after taking a risedronate 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 risedronate 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.
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.
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 other than those listed in this medication
guide.
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.
Before using risedronate, 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
risedronate, or you may need a dosage adjustment or special tests during treatment.
Some people using medicines similar to risedronate 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 risedronate 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.
Take risedronate exactly as it was prescribed for you. Do not use the medication in larger
amounts or for longer than recommended by your doctor.
Risedronate 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 risedronate 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 risedronate tablet only once a week, take
it on the same day each week and always first thing in the morning.
Take each risedronate tablet with a full glass (6 to 8 ounces) of water. Use only plain
water (not mineral water) when taking a risedronate tablet.
Do not crush, chew, or suck the risedronate tablet. Swallow the pill whole.
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.
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.
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 risedronate tablets at room temperature away from moisture and heat.
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: 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.
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 risedronate 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.
Do not take any other medicines including vitamins, calcium, or antacids for at least
30 minutes after taking an risedronate tablet.
Do not lie down for at least 30 minutes after you take a risedronate tablet.
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 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 risedronate 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.
Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or
other minerals can interfere with how your body absorbs risedronate. If you use these other
medicines, do not that take them for at least 30 minutes after taking a risedronate tablet.
Before using risedronate, 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 risedronate. 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.
Your pharmacist has more information about risedronate written for health professionals
that you may read.
Actonel: Dosingosteoporosis, postmenopausal: 35 mg PO qwk: Alt: 5 mg PO qd; 75 mg PO on 2 consecutive days/mo; Info: for tx and prevention; give w/ water >30min before first meal, remain upright x30min; calcium and vitamin D supplementation recommended if inadequate dietary intake
osteoporosis, steroid-induced: 5 mg PO qd: Info: for tx and prevention in pts on >7.5 mg/day prednisone or equiv.; give w/ water >30min before first meal, remain upright x30min; calcium and vitamin D supplementation recommended if inadequate dietary intake
osteoporosis, male: 35 mg PO qwk: Info: give w/ water >30min before first meal, remain upright x30min; calcium and vitamin D supplementation recommended if inadequate dietary intake
Paget's dz, bone: 30 mg PO qd x 2mo: Info: may repeat course x1 after 2 mo post-tx observation period; give w/ water >30min before first meal, remain upright x30min; calcium and vitamin D supplementation recommended if inadequate dietary intake
renal dosing: see below: CrCl <30: avoid use
Actonel: Drug Interactions
Actonel vs antacids: give bisphosphonate 2h before: combo may decr. bisphosphonate efficacy and absorption decreased. Antacids: also know as aluminum hydroxide, aluminum hydroxide/magnesium hydroxide, aluminum hydroxide/magnesium hydroxide/simethicone
Actonel vs calcium salts: give bisphosphonate 2h before: combo may decr. bisphosphonate efficacy and absorption decreased. Calcium salts: also know as calcium acetate, calcium carbonate, calcium gluconate, risedronate/calcium carbonate
Actonel vs aspirin: caution advised: combo may incr. risk of upper GI adverse effects and additive effects
Actonel vs aspirin, buffered/pravastatin: caution advised: combo w/ aspirin may incr. risk of upper GI effects and additive effects
Actonel vs aspirin/caffeine/CNS depressant combos: caution advised: combo w/ aspirin may incr. risk of upper GI adverse effects and additive effects. Aspirin/caffeine/CNS depressant combos: also know as aspirin/butalbital/caffeine, aspirin/butalbital/caffeine/codeine, aspirin/caffeine/dihydrocodeine
Actonel vs aspirin/caffeine/orphenadrine: caution advised: combo w/ aspirin may incr. risk of upper GI adverse effects and additive effects
Actonel vs aspirin/dipyridamole: caution advised: combo w/ aspirin may incr. risk of upper GI adverse effects and additive effects
Actonel vs aspirin/muscle relaxant combos: caution advised: combo w/ aspirin may incr. risk of upper GI adverse effects and additive effects. Aspirin/muscle relaxant combos: also know as aspirin/carisoprodol
Actonel vs aspirin/opiate combos: caution advised: combo w/ aspirin may incr. risk of upper GI adverse effects and additive effects. Aspirin/opiate combos: also know as aspirin/carisoprodol/codeine, aspirin/codeine, aspirin/oxycodone
Actonel vs diclofenac topical: caution advised: combo may incr. risk of upper GI adverse effects and additive effects; up to 10% systemic absorption of diclofenac topical gel; minimal absorption w/ patch. Diclofenac topical: also know as diclofenac epolamine topical, diclofenac topical
Actonel vs hydrocodone/ibuprofen: caution advised: combo w/ NSAIDs may incr. risk of upper GI adverse effects and additive effects
Actonel vs ibuprofen/oxycodone: caution advised: combo w/ NSAIDs may incr. risk of upper GI adverse effects and additive effects
Actonel vs lansoprazole/naproxen: caution advised: combo w/ NSAIDs may incr. risk of upper GI adverse effects and additive effects
Actonel vs NSAIDs: caution advised: combo may incr. risk of upper GI adverse effects and additive effects. NSAIDs: also know as diclofenac potassium, diclofenac sodium, diclofenac/misoprostol, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, ibuprofen lysine, indomethacin, ketoprofen, ketorolac, meclofenamate, mefenamic acid, meloxicam, nabumetone, naproxen, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin
Actonel: Adverse Reactions
dysphagia
esophagitis
esophageal ulcer
gastric ulcer
hypersensitivity rxn (rare)
angioedema (rare)
skin rxns, severe (rare)
uveitis (rare)
iritis (rare)
osteonecrosis, jaw (rare)
musculoskeletal pain, severe (rare)
arrhythmias (males)
nephrolithiasis (males)
arthralgia
back pain
infection
diarrhea
headache
abdominal pain
nausea
rash
flu-like sx
HTN
peripheral edema
dyspepsia
dizziness
constipation
chest pain
depression
myalgia
asthenia
URI
insomnia
flatulence
neuralgia
prostate hypertrophy
leg cramps
myasthenia
colitis
cataracts
neoplasm
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