Risofos Tablets (Generic Actonel) - Active Ingredient And Chemical structure
The active ingredient contained in Risofos Tablets is Risedronate Sodium. Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions. The structure is shown below
Generic Actonel (Risofos Tablets) - Uses
Generic Actonel in the form of Risofos Tablets 35 mg is used for Treatment and prevention of postmenopausal osteoporosis, Treatment to increase bone mass in men with osteoporosis, Treatment and prevention of glucocorticoid-induced osteoporosis and Treatment of Paget's disease.
Postmenopausal Osteoporosis
Risofos is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Treatment of Osteoporosis
In postmenopausal women with osteoporosis, risedronate increases Bone Mass Density and reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.
Prevention of Osteoporosis
Risofos may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture.
Osteoporosis in Men
Risofos is indicated for treatment to increase bone mass in men with osteoporosis.
Glucocorticoid-Induced Osteoporosis
Risofos is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage equivalent to 7.5 mg or greater of prednisone) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Paget`s Disease
Risofos is indicated for treatment of Paget`s disease of bone in men and women. Treatment is indicated in patients with Paget`s disease of bone
(1) who have a level of serum alkaline phosphatase at least 2 times the upper limit of normal, or
(2) who are symptomatic, or
(3) who are at risk for future complications from their disease, to induce remission (normalization of serum alkaline phosphatase).
Generic Forms and Brand names of Actonel
Risofos Tablets manufactured by Cipla Ltd., India is an effective treatment for treating and preventing osteoporosis in certain patients. Actonel which has the active ingredient Risedronate sodium is also sold as Atelvia, Benet and under various other brand names.
Risofos Tablets Preparations
Risofos is available as tablets of 35 mg. Each Risofos Tablet for oral administration contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate.
Risofos Tablets - Storage Requirements
Risofos Tablets are to be stored at room temperature (15°C to 30°C). Store away from heat, moisture, and light.
Risofos Tablets (Generic Actonel) - Dosage
Risofos Tablets should be taken at least 30 minutes before the first food or drink of the day other than water. To facilitate delivery to the stomach, Risofos Tablets (Generic Actonel) should be swallowed while the patient is in an upright position and with a full glass of plain water (6 to 8 oz).
Patients should not lie down for 30 minutes after taking the medication. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Calcium supplements and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of Generic Actonel 35 mg and should be taken at a different time of the day.
Risofos is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min). No dosage adjustment is necessary in patients with a creatinine clearance greter than or equal to 30 mL/min or in the elderly.
Treatment and Prevention of Postmenopausal Osteoporosis
The recommended dosage is one 35 mg tablet orally, taken once a week.
Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is One 35 mg tablet orally, taken once a week
Treatment and Prevention of Glucocorticoid -Induced Osteoporosis
The recommended dosage is One 35 mg tablet orally, taken once a week.
Paget`s Disease
The recommended dosage for treatment is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment.
Risofos Tablets (Generic Actonel) - Contraindications
Risofos Tablets is contraindicated in the following cases:
Hypocalcemia, Known hypersensitivity to Risedronate Sodium or any inactive component of this medication and Inability to stand or sit upright for at least 30 minutes.
Side Effects Of Risofos Tablets (Generic Actonel)
The most common side effects of Generic Actonel are back pain, arthralgia, myalgia, abdominal pain, nausea, and dyspepsia. Rare side effects that may occur are Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis).
Further Information
Additional Info: Prescribing Information
