Actonel

Actonel is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone.

Medicinal name:
  • Risedronate sodium 5 MG Oral Tablet [Actonel]
  • Risedronate sodium 30 MG Oral Tablet [Actonel]
  • Pack [Actonel 35 4-Week]
  • Risedronate sodium 150 MG Oral Tablet [Actonel]
  • Pack [Actonel 75]

Actonel - Pharmacology:

The action of risedronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Actonel 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.

Actonel mini report

Actonel NDA
NDA - A product marketed under an approved New Drug Application
Actonel TABLET, FILM COATED
TABLET, FILM COATED
Actonel HUMAN PRESCRIPTION DRUG
HUMAN PRESCRIPTION DRUG
Actonel global name
RISEDRONATE SODIUM
Actonel global name
risedronate sodium
Start - Stop data
START DATA:
1998-Mar-27
Start - Stop data
STOP DATA
not occurred

Actonel Interactions

No specific drug-drug interaction studies were performed. Actonel 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.

Actonel Contraindications

· Hypocalcemia

· Known hypersensitivity to any component of this product

· Inability to stand or sit upright for at least 30 minutes

Manufacturers name:

  • Warner Chilcott Pharmaceuticals Inc
  • Warner Chilcott (US), LLC
  • Physicians Total Care, Inc

Actonel tags categories:

Generic name, Overdose, Half Life Actonel, Food Interactions, Chemical, etc..

Actonel see also FDA report Barrenwort

Osteoporosis