Generic Actonel Risedronate

 

Generic Actonel Risedronateis a bisphosphonate drug used to treat and prevent bone resorption. By doing so it strengthens bones. Its applications include Osteoporosis, generally treating Paget's disease of bone and postmenopausal osteoporosis.

Inactive Ingredients 

All the tablets, there are some common ingredients like crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.  But they also have some different key ingredients. For example: in 5 mg dose strength, specific ingredients include: ferric oxide yellow, lactose monohydrate; in 30 mg—lactose monohydrate; in 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.

Fast Facts:           

• Taken orally
• If lodged in the esophagus can cause esophageal ulcers
• Usual dosage: 5 mg daily or 35 mg weekly
• Take with a full glass of water
• Take when standing upright, to help movement into the stomach
• Take at least two hours after and thirty minutes before meals
• Can cause osteonecrosis of the jaw in very rare cases

Use in Specific Population

Pregnancy

Pregnancy Category C: According to a clinical test in rats treated with oral doses ≥ 16 mg/kg/day, incomplete ossification and unossified sternebrae were increased. This dose was approximately 5.2 times the 30 mg/day human dose based on surface area, mg/m 2. A small incidence of cleft palate was observed in fetuses from female rats treated with oral doses ≥ 3.2 mg/kg/day (approximately 1 time the 30 mg/day human dose based on surface area, mg/m 2). But the impact of this medication in human is unclear. No significant fetal ossification effects were seen in rabbits treated with oral doses up to 10 mg/kg/day during gestation.

There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied.

There are no adequate and well-controlled studies of Actonel in pregnant women. Actonel should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use

The safety and effectiveness of Actonel use in pediatric patients have not been established.

Geriatric Use

Around 47% of women between 65 and 75 years of age were using g eneric Actonel Risedronatein postmenopausal osteoporosis studies. The corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in Paget's disease trials. In these studies no overall differences in effectiveness between geriatric and younger patients were experimental.

In the male osteoporosis trial, 28% of patients using g eneric Actonel Risedronatewere between 60 and 75 years of age and 9% were over 75. There were no overall differences in safety between geriatric and younger patients observed in the Actonel trials. But some older individuals showed greater sensitivity.