RISEDRONATE SODIUM — risedronate sodium tablet, film coated
Macleods Pharmaceuticals Limited
Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women.
In postmenopausal women with osteoporosis, risedronate sodium tablets, USP 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, USP are indicated for treatment to increase bone mass in men with osteoporosis.
Risedronate sodium tablets, USP 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, USP are indicated for treatment of Pagets’s disease of bone in men and women.
The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets, USP for the treatment of osteoporosis are based on clinical data of three years 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.
Indications and Usage (1.1)]
The recommended regimen is:
•one 5 mg tablet orally, taken daily
•one 35 mg tablet orally, taken once-a-week
•one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month
[see Indications and Usage (1.1) ]
- The recommended regimen is:
one 5 mg tablet orally, taken daily
- one 35 mg tablet orally, taken once-a-week
alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered
2.3 Treatment to Increase Bone Mass in Men with Osteoporosis [see Indications and Usage (1.2)]
[see Indications and Usage (1.2)]
- one 35 mg tablet orally, taken once-a-week
2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis [see Indications and Usage (1.3)]
[see Indications and Usage (1.3) ]
The recommended regimen is:
· one 5 mg tablet orally, taken daily
[see Indications and Usage (1.4) ]
The recommended treatment regimen 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. No data are available on more than 1 course of retreatment.
Instruct patients to do the following:
· Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [see Drug Interactions (7.1) ]. Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium.
· Swallow risedronate sodium tablets whole with a full glass of plain water (6 to 8 ounces). Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.1) ]. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.
· Do not eat or drink anything except plain water, or take other medications for at least30 minutes after taking risedronate sodium tablets
Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium tablets.
Instruct patients about missing risedronate sodium tablets doses as follows:
• If a dose of risedronate sodium tablet 35 mg once-a-week is missed:
○ Take 1 tablet on the morning after they remember and return to taking 1 tablet once-a-week, as originally scheduled on their chosen day.
○ Do not take 2 tablets on the same day.
• If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away:
○ If both tablets are missed, take one risedronate sodium 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning.
○ If only one risedronate sodium 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered
○ Return to taking their risedronate sodium 75 mg on two consecutive days per month as originally scheduled.
• If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are within 7 days:
○ Wait until their next month’s scheduled doses and then continue taking risedronate sodium 75 mg on two consecutive days per month as originally scheduled.
• 5 mg yellow coloured, circular, biconvex, film coated tablet debossed with “CL 90” on one side and plain on other side.
• 30 mg white to off white, circular, biconvex, film coated tablet debossed with “CL 91” on one side and plain on other side
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 (5.1) ]
· Hypocalcemia [see Warnings and Precautions (5.2) ]
· Known hypersensitivity to risedronate sodium or any of its excipients.Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported [see Adverse Reactions (6.2)]
Risedronate sodium tablet contains the same active ingredient found in Atelvia®. A patient being treated with Atelvia should not receive risedronate sodium tablets.
Risedronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when risedronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17.1)].
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue risedronate sodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6 to 8 ounces) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see Dosage and Administration (2) ].
In patients who cannot comply with dosing instructions due to mental disability, therapy with risedronate sodium should be used under appropriate supervision.
There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.
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