FOSAMAX PLUS D

FOSAMAX PLUS D- alendronate sodium and cholecalciferol tablet
Organon LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Osteoporosis in Postmenopausal Women

FOSAMAX® PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).]

1.2 Treatment to Increase Bone Mass in Men with Osteoporosis

FOSAMAX PLUS D is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2)].

1.3 Important Limitations of Use

FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.

The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four 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.

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly. For most osteoporotic women, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D3 ) once weekly.

2.2 Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly. For most osteoporotic men, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D3 ) once weekly.

2.3 Important Administration Instructions

Instruct patients to do the following:

  • Take FOSAMAX PLUS D at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2)]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking FOSAMAX PLUS D with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body.
  • Take FOSAMAX PLUS D upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX PLUS D tablet should be swallowed with a full glass of water (6-8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS D should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see Warnings and Precautions (5.1) and Patient Counseling Information (17.2)].

2.4 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

The recommended intake of vitamin D is 400-800 international units daily. FOSAMAX PLUS D 70 mg/2800 international units and 70 mg/5600 international units are intended to provide seven days’ worth of 400 and 800 international units daily vitamin D in a single, once-weekly dose, respectively.

2.5 Administration Instructions for Missed Doses

If a once-weekly dose of FOSAMAX PLUS D is missed, instruct patients to take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.

3 DOSAGE FORMS AND STRENGTHS

  • 70 mg/2800 international units tablets are white to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other.
  • 70 mg/5600 international units tablets are white to off-white, modified rectangle-shaped tablets with code 270 on one side and an outline of a bone image on the other.

4 CONTRAINDICATIONS

FOSAMAX PLUS D is contraindicated in patients with the following conditions:

5 WARNINGS AND PRECAUTIONS

5.1 Upper Gastrointestinal Adverse Reactions

FOSAMAX PLUS D, 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 FOSAMAX PLUS D is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers).

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 including FOSAMAX PLUS D. 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 FOSAMAX PLUS D 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 including FOSAMAX PLUS D and/or who fail to swallow oral bisphosphonates including FOSAMAX PLUS D with the recommended full glass (6-8 ounces) of water, and/or who continue to take oral bisphosphonates including FOSAMAX PLUS D 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 (2.3)]. In patients who cannot comply with dosing instructions due to mental disability, therapy with FOSAMAX PLUS D 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 [see Adverse Reactions (6.2)].

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