Risedronate

ACTONEL is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.5 ) 1.1 Postmenopausal Osteoporosis ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. …

Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month ( 2.1 ) Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week ( 2.2 ) Men with Osteoporosis: 35 mg once-a-week ( 2.3 ) Glucocorticoid-Induced Osteoporosis: 5 mg daily ( 2.4 ) Paget’s Disease: 30 mg daily for 2 months ( 2.5 ) Instruct patients to: Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day Avoid lying down for 30 minutes ( 2 ) Take supplemental calcium and vitamin D if dietary intake is inadequate ( 2.7 ) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1 ) ] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month or one 150 mg tablet orally, taken once-a-month 2.2 Prevention of Postmenopausal Osteoporosis [ see Indications and Usage ( 1.1 ) ] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered or alternatively, one 150 mg tablet orally, taken once-a-month may be considered 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis [ see Indications and Usage ( 1.2 ) ] The recommended regimen is: one 35 mg tablet orally, taken once-a-week 2.4 Treatment and Prevention of Glucocor …

5 mg film-coated, oval, yellow tablet with RSN on 1 face and 5 mg on the other. 30 mg film-coated, oval, white tablet with RSN on 1 face and 30 mg on the other. 35 mg film-coated, oval, orange tablet with RSN on 1 face and 35 mg on the other. 75 mg film-coated, oval, pink tablet with RSN on 1 face and 75 mg on the other. …

• ACTONEL is not indicated for use
• In pediatric patients
• The safety and effectiveness of risedronate was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143
• Pediatric patients (94 received risedronate) with osteogenesis imperfecta (OI)
• The enrolled population was predominantly patients with mild osteogenesis imperfecta (85% Type-I), aged 4 to less than 16 years, 50% male and 82% Caucasian, with a mean lumbar spine BMD Z-score of -2.08 (2.08 standard deviations below the mean for age-matched controls). …

Of the patients receiving ACTONEL in postmenopausal osteoporosis studies [ see C linical S tudies ( 14 ) ] , 47% were between 65 and 75 years of age, and 17% were over 75. The corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in Paget’s disease trials. No overall differences in efficacy between geriatric and younger patients were observed in these studies. …

• See FDA-approved patient labeling ( Medication Guide ) Instruct patients to read the Medication Guide before starting therapy with ACTONEL and to re-read it each time the prescription is renewed
• Instruct patients that Atelvia and ACTONEL contain the same active ingredient and if they are taking Atelvia, they should not take ACTONEL [ see Warnings and Precautions ]
• Instruct patients to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions
• Specifically, ACTONEL should be taken at least 30 minutes before the first food or drink of the day other than water. …

ACTONEL is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions ( 5.1 ) ] Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ) ] Hypocalcemia [ see Warnings and Precautions ( 5.2 ) ] Known hypersensitivity to ACTONEL or any of its excipients. …

No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL ( 7.1 ) 7.1 Calcium Supplements/Antacids Co-administration of ACTONEL and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of ACTONEL. …

Products Containing Same Active Ingredient : Patients receiving Atelvia should not be treated with ACTONEL ( 5.1 ) Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) Osteonecrosis of the J aw has been reported ( 5.4 ) S evere B one, J oint , M uscle P ain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) Atypical Fractures Including Femoral F ractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. …

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions ( 5.1 ) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 ) ] Mineral Metabolism [see Warnings and Precautions ( 5.3 ) ] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 ) ] Musculoskeletal Pain [see Warnings and Precautions ( 5.5 ) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.6 ) ] Renal Impairment [see Warnings and Precautions ( 5.7 ) ] Glucocorticoid-Induced Osteoporosis [see Warnings and Precautions ( 5.8 ) ] Laboratory Test Interactions [see …

8.1 Pregnancy Risk Summary Available data on the use of ACTONEL in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue ACTONEL when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommend …

Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind ACTONEL and reduce absorption of the drug. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. …

Tómala en cuanto te acuerdes, salvo que falte poco para la siguiente. En ese caso, sáltate la olvidada. Nunca tomes dos dosis a la vez para compensar. Revisa tu prospecto, porque algunos medicamentos son distintos.