ALENDRONATE SODIUM- alendronate sodium tablet
NuCare Pharmaceuticals, Inc.
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See FDA-approved patient labeling (Medication Guide).
Instruct patients to read the Medication Guide before starting therapy with alendronate sodium and to reread it each time the prescription is renewed.
Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.
Instruct patients that the expected benefits of alendronate sodium may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of alendronate sodium [see Clinical Pharmacology ( 12.3)] .
Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal ulceration.
Instruct patients to swallow each tablet of alendronate sodium with a full glass of water (6-8 ounces) to facilitate delivery to the stomach and thus reduce the potential for esophageal irritation.
Instruct patients not to lie down for at least 30 minutes and until after their first food of the day.
Instruct patients not to take alendronate sodium at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems.
Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking alendronate sodium and consult their physician.
If patients miss a dose of once weekly alendronate sodium, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
Manufactured by:
Cipla Ltd.,
Verna Goa, India.
Manufactured for:
Cipla USA, Inc.
9100 S. Dadeland Blvd.,
Suite 1500 Miami, Florida 33156
Revised: 1/2016