Risedronic acid

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Drug Info:

Risedronate

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Brand names: Actonel®

Chemical formula:



Risedronate Sodium Oral tablet

What is this medicine?

RISEDRONATE (ris ED roe nate) reduces calcium loss from bones. It helps make healthy bone and to slow bone loss in patients with Paget's disease and osteoporosis. It may be used in others at risk for bone loss.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•dental disease
•esophagus, stomach, or intestine problems, like acid reflux or GERD
•kidney disease
•low blood calcium
•problems sitting or standing for 30 minutes
•trouble swallowing
•an unusual or allergic reaction to risedronate, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

You must take this medication exactly as directed or you will lower the amount of medicine you absorb into your body or you may cause your self harm. Take this medicine by mouth first thing in the morning, after you are up for the day. Do not eat or drink anything before you take this medicine. Swallow the tablets with a full glass (6 to 8 fluid ounces) of plain water. Do not take the tablets with any other drink. Do not chew or crush the tablet. After taking this medicine, do not eat breakfast, drink, or take any other medicines or vitamins for at least 30 minutes. Stand or sit up for at least 30 minutes after you take this medicine; do not lie down. Do not take your medicine more often than directed.
 
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
 
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What may interact with this medicine?

•antacids like aluminum hydroxide or magnesium hydroxide
•aspirin
•calcium supplements
•iron supplements
•NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
•thyroid hormones
•vitamins with minerals

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. It may be some time before you see the benefit from this medicine. Your doctor or health care professional may order blood tests and other tests to see how you are doing.

You should make sure you get enough calcium and vitamin D while you are taking this medicine, unless your doctor tells you not to. Discuss the foods you eat and the vitamins you take with your health care professional.

Some people who take this medicine have severe bone, joint, and/or muscle pain. Tell your doctor if you have pain that does not go away or that gets worse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor as soon as possible:
•allergic reactions such as skin rash or itching, hives, swelling of the face, lips, throat, or tongue
•black or tarry stools
•changes in vision
•heartburn or stomach pain
•jaw pain, especially after dental work
•pain or difficulty when swallowing
•redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your doctor if they continue or are bothersome):
•bone, muscle, or joint pain
•changes in taste
•diarrhea or constipation
•eye pain or itching
•headache
•nausea or vomiting
•stomach gas or fullness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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Risedronic acid
Systematic (IUPAC) name
(1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
Clinical data
AHFS/Drugs.com International Drug Names
Pregnancy cat. B3 (AU) C (US)
Legal status POM (UK) -only (US)
Routes Oral
Pharmacokinetic data
Bioavailability 0.63%
Protein binding ~24%
Metabolism None
Half-life 1.5 h
Excretion Renal and fecal
Identifiers
CAS number 105462-24-6 YesY
ATC code M05BA07
PubChem CID 5245
DrugBank DB00884
UNII KM2Z91756Z N
ChEMBL CHEMBL923 N
Chemical data
Formula C7H11NO7P2 
Mol. mass 283.112 g/mol
SMILES eMolecules & PubChem
 N (what is this?)  (verify)

Risedronic acid (INN) or risedronate sodium (USAN) is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Warner Chilcott, Sanofi-Aventis, and in Japan by Takeda under the trade names Actonel, Atelvia, and Benet. It is also available in a preparation that includes a calcium carbonate supplement, as Actonel with Calcium.

Contents

Administration

Risedronate is taken orally, usually weekly or monthly. Notably, if risedronate lodges in the esophagus, it can lead to esophageal ulcers. Therefore, it is recommended that risedronate be taken with the body upright, and followed by a glass of water. Moreover, risedronate 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 risedronate. Risedronate 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 risedronate can be taken with less water than other drugs in the class. Risedronate is also available as a 75mg tablet to be taken on two consecutive days each month (2CDM) in order to optimize patient adherence. This formulation has been studied in a randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis.[1]

Controversies

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.[2] 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 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".[3]

In 2006, P&G faced controversy over its handling of clinical research involving risedronate (News Reports and discussion).

In common with other bisphosphonate drugs, risedronate appears to be associated with the rare side effect osteonecrosis of the jaw, often preceded by dental procedures inducing trauma to the bone.

See also

References

External links


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