Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
RISEDRONATE SODIUM (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z)
Mylan Pharmaceuticals Inc.
RISEDRONATE SODIUM
RISEDRONATE SODIUM 5 mg
ORAL
PRESCRIPTION DRUG
Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2) ]. Risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis. Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. Risedronate sodium tablets are indicated for treatment of Paget’s disease of bone in men and women. The optimal duration of use has not been determined. The safety and effectiveness of risedronate
Risedronate Sodium Tablets, USP are available containing 5 mg, 30 mg, 35 mg or 150 mg risedronate sodium, USP. The 5 mg tablets are light beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and 44 on the other side. They are available as follows: NDC 0378-4044-93 bottles of 30 tablets NDC 0378-4044-05 bottles of 500 tablets The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 114 on the other side. They are available as follows: NDC 0378-4114-93 bottles of 30 tablets NDC 0378-4114-05 bottles of 500 tablets The 35 mg tablets are light orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and 714 on the other side. They are available as follows: NDC 0378-4714-99 unit of use blister card containing 4 tablets NDC 0378-4714-92 carton of 10 cards each containing 4 tablets NDC 0378-4714-96 unit of use blister card containing 12 tablets NDC 0378-4714-78 carton of 10 cards each containing 12 tablets The 150 mg tablets are light blue, film-coated, round, unscored tablets debossed with M over RE on one side of the tablet and 150 on the other side. They are available as follows: NDC 0378-4150-32 unit of use blister card containing 1 tablet NDC 0378-4150-97 carton of 10 cards each containing 1 tablet NDC 0378-4150-53 unit of use blister card containing 3 tablets NDC 0378-4150-93 carton of 10 cards each containing 3 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE RISEDRONATE SODIUM TABLETS, USP (ris″ e droe′ nate soe′ dee um) 5 mg, 30 mg, 35 mg and 150 mg Read the Medication Guide that comes with risedronate sodium tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. Talk to your doctor if you have any questions about risedronate sodium tablets, there may be new information about it. What is the most important information I should know about risedronate sodium tablets? Risedronate sodium tablets can cause serious side effects including: 1. Esophagus problems 2. Low calcium levels in your blood (hypocalcemia) 3. Severe jaw bone problems (osteonecrosis) 4. Bone, joint, or muscle pain 5. Unusual thigh bone fractures 6. Esophagus problems. Some people who take risedronate sodium tablets may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed. 1. It is important that you take risedronate sodium tablets exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take risedronate sodium tablets?”) 2. Stop taking risedronate sodium tablets and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow. 7. Low calcium levels in your blood (hypocalcemia). Risedronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking risedronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take risedronate sodium tablets. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you ha Lesen Sie das vollständige Dokument
RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RISEDRONATE SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISEDRONATE SODIUM TABLETS. RISEDRONATE SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Contraindications (4) 03/2015 Warnings and Precautions (5.4) 04/2015 INDICATIONS AND USAGE Risedronate sodium tablets are a bisphosphonate indicated for: • • • • 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) DOSAGE AND ADMINISTRATION Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 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: • • • DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 30 mg, 35 mg and 150 mg (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS 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) 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) Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (4, 5.1) Inability to stand or sit upright for at least 30 minutes (4, 5.1) Hypocalcemia (4, 5.2) Known hypersensitivity to any component of this product (4, 6.2) _Pro Lesen Sie das vollständige Dokument