risedronate sodium 30 mg/1
risedronate sodium · TABLET, FILM COATED · Sun Pharmaceutical Industries, Inc.
Risedronate sodium is a prescription medication taken by mouth that helps treat and prevent osteoporosis by slowing bone loss. It belongs to a class of drugs called bisphosphonates, which work by strengthening bones and reducing the risk of fractures.
Key Facts
- Brand Name
- risedronate sodium
- Generic Name
- risedronate sodium
- NDC Code (Product)
47335-667- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 30 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090886
- Marketing Start
- 11/30/2015
Recall History
Macleods Pharma Usa Inc
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Teva Pharmaceuticals USA
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Teva Pharmaceuticals USA
Failed Dissolution Specifications
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Risedronate sodium delayed-release tablets are 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). 1.1 Postmenopausal Osteoporosis Risedronate sodium delayed-release tablets are 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) ]. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets 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 disc…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION One 35 mg delayed-release tablet once-a-week (2.1) Instruct patients to: • Take risedronate sodium delayed-release tablets 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 delayed-release tablets (2.2) • Take supplemental calcium and vitamin D if dietary intake is inadequate (2.3) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1) ] The recommended regimen is: • one 35 mg delayed-release tablet orally, taken once-a-week [see Indications and Usage (1.1)] 2.2 Important Administration Instructions Instruct patients to do the following: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast. Risedronate sodium delayed-release tablets should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting. • Swallow risedronate sodium delayed-release tablets whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30…
Contraindications
4 CONTRAINDICATIONS Risedronate sodium delayed-release tablets contraindicated in patients with the following conditions: 1. Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions (5.2) ] 2. Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration (2), Warnings and Precautions (5.2) ] 3. Hypocalcemia [ see Warnings and Precautions (5.3) ] 4. Known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported [ see Adverse Reactions (6.2) ] • 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)
Drug Interactions
7 DRUG INTERACTIONS Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium supplements, antacids, proton pump inhibitors (PPIs), H 2 blockers, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of risedronate sodium (7.1, 7.2) 7.1 Calcium Supplements/Antacids When risedronate sodium was administered following breakfast, the co-administration of a tablet containing 600 mg of elemental calcium and 400 international units vitamin D reduced risedronate bioavailability by approximately 38% [ see Clinical Pharmacology (12.3) ]. Calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of risedronate sodium and should not be taken together. 7.2 Histamine 2 (H 2 ) Blockers and Proton Pump Inhibitors (PPIs) Drugs that raise stomach pH (for example, PPIs or H 2 blockers) may cause faster drug release from enteric coated (delayed-release) drug products such as risedronate sodium. Co-administration of risedronate sodium with the PPI, esomeprazole, increased risedronate bioavailability. The maxim…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (greater than 5%) include: diarrhea, influenza, arthralgia, back pain, and abdominal pain (6.1) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Postmenopausal Osteoporosis Once-a-Week Dosing with Risedronate Sodium Delayed-Release tablets The safety of risedronate sodium delayed-release 35 mg once-a-week in the treatment of postmenopausal osteoporosis was assessed in a 1-year, double-blind, multicenter study comparing risedronate sodium delayed-release 35 mg once-a-week to risedronate sodium immediate-release 5 mg daily i…
Frequently Asked Questions
What is risedronate sodium used for?
Risedronate sodium is a prescription medication taken by mouth that helps treat and prevent osteoporosis by slowing bone loss. It belongs to a class of drugs called bisphosphonates, which work by strengthening bones and reducing the risk of fractures.
Is risedronate sodium a controlled substance?
risedronate sodium is not classified as a controlled substance by the DEA.
What is the generic name for risedronate sodium?
The generic name for risedronate sodium is risedronate sodium. There are 9 other brand versions of risedronate sodium.
What is the NDC code for risedronate sodium 30 mg/1?
The NDC (National Drug Code) for risedronate sodium 30 mg/1 is 47335-667, listed by Sun Pharmaceutical Industries, Inc..
Other risedronate sodium Dosages
Other Risedronate Brands
See all →- Risedronate Sodium35 mg/10093-3098
- RISEDRONATE SODIUM35 mg/163304-440
- Risedronate Sodium150 mg/165862-870
- Risedronate Sodium30 mg/133342-108
- Risedronate Sodium150 mg/160505-3097
- Risedronate Sodium35 mg/160723-041
- Risedronate Sodium35 mg/171205-714
- Risedronate Sodium35 mg/133342-109
- Risedronate Sodium129 mg/159762-0406
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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