Risedronate resources


DRUG INFO
Risedronate

Drug Name: Risedronate

Indication: For the treatment of Paget's disease of the bone (osteitis deformans); Postmenopausal and glucocorticoid-induced osteoporosis



Pharmacology: Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism and is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Mechanism Of Action: The action of Risedronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Risedronate also targets farnesyl pyrophosphate (FPP) synthase. Nitrogen-containing bisphosphonates (such as pamidronate, alendronate, risedronate, ibandronate and zoledronate) appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting FPP synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signalling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Drug Category: Antiresorptives; Bisphosphonates; Antihypocalcemic Agents;

Brand Names/Synonyms: Actonel; Pyridine N-Oxide; Pyridostigmine Bromide; Pyridostigmine Bromine; Risedronate; Risedronate Sodium; Risedronic Acid

Dosage Forms: TABLET

Absorption: Rapid absorption (~1 hr) after an oral dose, occurs throughout the upper gastrointestinal tract

Interactions: DrugBank: Interactions for Risedronate

Interactions for Risedronate:


No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (Cytochrome P450).

Calcium Supplements/Antacids

Co-administration of ACTONEL and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of ACTONEL.

Hormone Replacement Therapy

One study of about 500 early postmenopausal women has been conducted to date in which treatment with ACTONEL (5 mg/day) plus estrogen replacement therapy was compared to estrogen replacement therapy alone. Exposure to study drugs was approximately 12 to 18 months and the primary endpoint was change in BMD. If considered appropriate, ACTONEL may be used concomitantly with hormone replacement therapy.

Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Of over 5700 patients enrolled in the ACTONEL Phase 3 osteoporosis studies, aspirin use was reported by 31% of patients, 24% of whom were regular users (3 or more days per week). Forty-eight percent of patients reported NSAID use, 21% of whom were regular users. Among regular aspirin or NSAID users, the incidence of upper gastrointestinal adverse experiences in ACTONEL-treated patients (24.5%) was similar to that in placebo-treated patients (24.8%).

H2 Blockers and Proton Pump Inhibitors (PPIs)

Of over 5700 patients enrolled in the ACTONEL Phase 3 osteoporosis studies, 21% used H2 blockers and/or PPIs. Among these patients, the incidence of upper gastrointestinal adverse experiences in the ACTONEL-treated patients was similar to that in placebo-treated patients.

Drug/Laboratory Test Interactions

Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ACTONEL have not been performed.





Chemical IUPAC Name: (1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonicacid

Chemical Formula: C7H11NO7P2

Half Life: 1.5 hours

Drug Type: Approved Drug

# Accession No: APRD00410

CAS Registry Number: 105462-24-6



Risedronate News
(When available)


GRAY HAIR AND ACNE EMBARRASS TEEN  15 Jan 2006
Charlotte Sun-Herald, DEAR DR. DONOHUE: I take Actonel for osteoporosis. My dentist says it leads to bone resorption. ... Actonel (risedronate) stops bone resorption, and it works well. ...

Actonel makers sue GSK and Roche over Boniva ads  Jan 5, 2006
Pharma Times (subscription), P&G and Sanofi-Aventis, which market a bisphosphonate called Actonel (risedronate sodium), allege that claims made in the advertisements are misleading and ...

PROCTER & GAMBLE PHARMACEUTICALS AND SANOFI-AVENTIS US LLC FILE ...  Jan 4, 2006
PR Newswire (press release), January 4, 2006, Procter & Gamble Pharmaceuticals and sanofi-aventis US LLC, a member of the sanofi-aventis Group, co-marketers of Actonel(R) (risedronate ...

FDA OKs First IV Osteoporosis Drug  Jan 13, 2006
WebMD However, men can also develop osteoporosis. Boniva belongs to a family of drugs called biphosphonates, which also include Actonel and Fosamax. ...

Procter & Gamble Pharmaceuticals and Sanofi-Aventis Us LLC File ...  Jan 4, 2006
Yahoo! News (press release) 4, 2006, Procter & Gamble Pharmaceuticals and sanofi-aventis US LLC, a member of the sanofi-aventis Group, co-marketers of Actonel® (risedronate sodium tablets ...

P&G sues rivals over ads touting osteoporosis drug  Jan 5, 2006
Cincinnati Post, Procter & Gamble and its marketing partner in the sale of the osteoporosis drug Actonel claim in a lawsuit filed Wednesday that two drug companies that sell a ...

Did a British university sell out to Procter & Gamble?  Dec 22, 2005
Slate Blumsohn and Eastell were to evaluate the effectiveness of P&G's osteoporosis drug, Actonel. The goal was not to win FDA approval ...

Osteoporosis drug backed  Jan 8, 2006
Trade Arabia, It is the latest entrant in the multibillion-dollar osteoporosis market that includes Sanofi-Aventis' Fosamax and Procter & Gamble's Actonel.

Procter & Gamble alleges Boniva ads are misleading  Jan 4, 2006
Reuters.uk, Procter & Gamble, the US consumer products company that also markets prescription drugs, sells a rival osteoporosis drug, Actonel, in partnership with Sanofi ...

P&G sues drug maker over Boniva ads  Jan 4, 2006
Cincinnati Business Courier, Procter & Gamble Pharmaceuticals and Sanofi-Aventis, co-marketers of the osteoporosis drug Actonel, alleges that advertising for Boniva falsely claims ...

Rivals sue Glaxo and Roche  Jan 5, 2006
Telegraph.co.uk, US group Procter & Gamble and Paris-listed Sanofi-Aventis, who together market competing brittle bone drug Actonel, this week filed a lawsuit seeking to block ...

Roche, Glaxo hit with lawsuit over Boniva  Jan 4, 2006
United Press International ...treatment Boniva has been proven to reduce the risk of non-spinal fractures and has demonstrated efficacy compared to other drugs, such as Actonel, which is co ...

Pharmaceutical companies sued over adverts  Jan 11, 2006
Legalbrief (subscription), ...makers said Boniva adverts implied the pill would help prevent non-vertebral fractures, when in fact it only protects the spine – unlike Actonel, which also ...

Garden State Business Briefs  Jan 5, 2006
Newark Star Ledger, Procter & Gamble and Sanofi- Aventis, which jointly market Actonel, yesterday filed a lawsuit in US District Court in New York against two rivals: Roche ...

UC doctors study osteoporosis drug therapy  Jan 5, 2006
Cincinnati Business Courier, ...director of UC's Bone Health and Osteoporosis Center, is leading a two-year study to compare an investigational monthly dose of risedronate (Actonel) with a ...

The Medicare mess  Jan 4, 2006
The Jackson Citizen-Patriot, For example, within a few minutes we were able to get a list of 78 plans that provide three drugs we listed (Lisinopril, Actonel, Triamterene). ...

Osteoporosis drug fights knee arthritis  Jan 4, 2006
Macleans, British researchers have found that high doses of risedronate (brand name Actonel), an osteoporosis drug called a bisphosphonate, can preserve the underlying ...

Swiss company defends drug ad challenged by P&G  Jan 5, 2006
The State, ...medication had been proven to reduce the risk of nonspinal fractures and that the drug had proven to be more effective than other drugs such as Actonel. ...

Boniva for injection cleared in USA  Jan 9, 2006
Pharma Times (subscription), ...drugs was illustrated last week when Procter & Gamble Pharmaceuticals and Sanofi-Aventis, which make a rival drug called Actonel (risedronate sodium), asked a ...

P&G Declares Common Stock Dividend  Jan 10, 2006
PR Newswire (press release), R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R ...

Smell & Taste Expert Confirms Nosey Preferences Hold Key to ...  Jan 10, 2006
Hispanic PR Wire (press release), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Bounty(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Actonel(R), Olay(R ...

New year brings lawsuits for pharma  Jan 6, 2006
United Press International ...that Boniva has been proven to reduce the risk of non-spinal fractures and has demonstrated efficacy compared to other drugs, including Actonel, which is co ...

P&G Declares Common Stock Dividend  Jan 10, 2006
Yahoo! News (press release) Whisper®, Pantene®, Mach3®, Bounty®, Dawn®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay ...

UPDATE 1-Roche, Glaxo: US OKs new use for osteoporosis drug  Jan 6, 2006
Reuters ...osteoporosis market that includes Sanofi-Aventis' (SASY.PA: Quote, Profile, Research) Fosamax and Procter & Gamble's (PG.N: Quote, Profile, Research) Actonel. ...

AFX European summary - late  Jan 4, 2006
Forbes ...the risk of nonspinal fractures and that it has demonstrated efficacy against nonspinal fracture comparable to other bisphosphonates, such as Actonel, which is ...

Euroshares outlook - higher after Wall St gains, news still thin ...  Jan 4, 2006
Forbes ...osteoporosis medication, Boniva. Sanofi-Aventis SA and Procter & Gamble co-market the osteoporosis drug Actonel. Meanwhile, BAE ...

Newspaper round-up  Jan 5, 2006
Reuters.uk, Procter & Gamble and Sanofi-Aventis, who market Actonel, are now seeking to block adverts they have said are "false and misleading", adding that the adverts ...

Swiss company defends drug ad challenged by P&G  Jan 5, 2006
WWAY NewsChannel 3, ...drug. The ads say Boniva has been proven to be more effective than others -- such as P-and-G's Actonel (AK'-tuh-nehl). GlaxoSmithKline ...

P&G buys Colgate-Palmolive's laundry detergent brands in SEA, HK  Jan 3, 2006
The Edge Daily, SK-II, Rejoice, Ariel, Always, Whisper, Pantene, Mach3, Bounty, Dawn, Pringles, Folgers, Charmin, Downy, Lenor, Iams, Crest, Oral-B, Actonel, Duracell, Olay ...

ChemoCentryx Announces Key Senior Management Team Additions; Susan ...  Jan 5, 2006
Business Wire (press release), ...spent nearly seven years at Procter & Gamble Pharmaceuticals where he played a key role in the clinical development of the osteoporosis drug Actonel(R). Dr ...

David Akers and Shayne Graham Score Points During the Holidays ...  Jan 3, 2006
Finanzen.net, R), Pantene(R), Mach3(R). Bounty(R), Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R ...

On the Move: GSK, VW, France Telecom  Jan 5, 2006
BusinessWeek ...osteoporosis drug, Boniva. Procter & Gamble sells a rival drug, Actonel, with the company as its marketing partner. They are seeking ...

... Go to the Article  Jan 4, 2006
CancerWise ...loss. Bisphosphonates, a family of drugs used to prevent and treat osteoporosis, include Fosamax®, Actonel® and Boniva®. The ...

Preventing bone loss is best protection  Dec 13, 2005
Newsday, Boniva reminds me of two similar drugs on the market, Actonel and Fosamax. They work by slowing down the activity of cells in your body that cause bone loss. ...

Program helps seniors navigate choices  Dec 18, 2005
Salt Lake Tribune, But he wanted to find the best plan for his long list of medications: Mirapex and Carbid/Levod for Parkinson's disease, Actonel for osteoporosis, Clonazepam ...

Alimentary Health Ltd. Announces Gastrointestinal Licensing ...  Dec 14, 2005
Emediawire (press release), Bounty®, Dawn®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay®, Head & Shoulders®, Wella ...


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