Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
RISEDRONATE SODIUM HEMI-PENTAHYDRATE (UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z), RISEDRONATE SODIUM MONOHYDRATE (UNII: F67L43UT5C) (RISEDRONIC ACID - UNII:KM2Z91756Z)
Actavis Pharma, Inc.
RISEDRONATE SODIUM HEMI-PENTAHYDRATE
RISEDRONATE SODIUM ANHYDROUS 30.1 mg
ORAL
PRESCRIPTION DRUG
Risedronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1) ]. The optimal duration of use has not been determined. The safety and effectiveness of Risedronate sodium for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. Risedronate sodium 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 (5.2) ] -
Risedronate sodium delayed-release tablets are: 35 mg, yellow, oval-shaped, and engraved with EC 35 on one side. NDC 0591-3876-04 Dose pack of 4 tablets Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
New Drug Application
Actavis Pharma, Inc. ---------- Medication Guide Risedronate sodium delayed-release tablets Read this Medication Guide that comes with Risedronate sodium 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, there may be new information about it. What is the most important information I should know about Risedronate sodium? Risedronate sodium 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 1. Esophagus problems. Some people who take Risedronate sodium 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. • It is important that you take Risedronate sodium exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take Risedronate sodium?”) • Stop taking Risedronate sodium and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow. 2. Low calcium levels in your blood (hypocalcemia). Risedronate sodium may lower the calcium levels in your blood. If you have low blood calcium before you start taking Risedronate sodium , it may get worse during treatment. Your low blood calcium must be treated before you take Risedronate sodium . Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: • Spasms, twitches, or cramps in your muscles • Numbness or tingling in your fingers, toes, or around your mouth Your doctor may prescribe calcium and vitamin read_full_document
RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, DELAYED RELEASE ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RISEDRONATE SODIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RISEDRONATE SODIUM. RISEDRONATE SODIUM DELAYED-RELEASE TABLETS INITIAL U.S. APPROVAL: 1998 RECENT MAJOR CHANGES Contraindications (4) 03/2015 Warnings and Precautions (5.4) 04/2015 INDICATIONS AND USAGE Risedronate sodium is a bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1) 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 (1.2) DOSAGE AND ADMINISTRATION One 35 mg delayed-release tablet once-a-week (2.1) Instruct patients to: Take Risedronate sodium in the morning immediately _following breakfast_ with at least 4 ounces of plain water (2.2) Avoid lying down for 30 minutes after taking Risedronate sodium (2.2) Take supplemental calcium and vitamin D if dietary intake is inadequate (2.3) DOSAGE FORMS AND STRENGTHS Delayed-release tablets: 35 mg (3) CONTRAINDICATIONS Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (4, 5.2) Inability to stand or sit upright for at least 30 minutes (4, 5.2) Hypocalcemia (4, 5.3) Known hypersensitivity to any component of this product (4, 6.2) WARNINGS AND PRECAUTIONS _Products Containing Same Active Ingredient_: Patients receiving Actonel should not be treated with Risedronate sodium (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 Jaw_ has been reported (5.4) _Severe Bone, Joint, Muscle Pain_ may occur. Discontinue use if severe symptoms develop (5.5, 6.2) _Atypical Femur Fractures_ ha read_full_document