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FDA Approves New Dosing Option for Lansoprazole Orally Disintegrating Tablet
LAKE FOREST, Ill., July 6 /PRNewswire-FirstCall/ -- TAP Pharmaceutical Products Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved PREVACID® (lansoprazole) SoluTab™ Delayed-Release Orally Disintegrating Tablets to be given using an oral syringe or nasogastric (NG) tube. PREVACID SoluTab is the first and only orally disintegrating formulation of a proton pump inhibitor (PPI) and now is widely available nationwide.
PREVACID SoluTab is an easy-to-take tablet that has been micro-engineered to disintegrate quickly in the mouth, usually in less than 60 seconds. The tablet can be taken with or without water and is strawberry flavored. For children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can also be given in two other ways. For administration via either an oral syringe or nasogastric tube, the tablet can be dissolved in water (4mL for 15 mg tablet, 10mL for 30 mg tablet) and should be administered within 15 minutes. After administration, the syringe should be flushed according to package directions.
"PREVACID SoluTab provides patients who either dislike or find capsules difficult to swallow with an easy-to-use option so they can benefit from the power of PREVACID," said Xavier Frapaise, vice president, research and development at TAP. "PREVACID SoluTab provides a unique alternative for erosive esophagitis cases, such as patients with NG tubes, as well as for more typical patients who desire the convenience and flexibility of an orally disintegrating tablet."
"PREVACID SoluTab represents an important milestone for PREVACID," said H. Thomas Watkins, president of TAP. "It provides additional flexibility and convenience for patients, adding to PREVACID's position as a leading PPI with the most indications and most administration options of all oral PPIs on the market."
When taking PREVACID SoluTab by mouth, patients should simply place the tablet on the tongue and allow it to disintegrate with or without water until the particles can be swallowed. PREVACID SoluTab should not be chewed. PREVACID SoluTab is bioequivalent to PREVACID capsules, does not require dose conversion, and can be used to treat the same conditions.
Symptomatic response to therapy does not preclude the presence of gastric malignancy. PREVACID is contraindicated in patients with known hypersensitivity to any component of the formulation. The most frequently reported adverse events include diarrhea (3.8 percent), abdominal pain (2.1 percent) and nausea (1.3 percent). For further information about PREVACID, please see the complete prescribing information and visit http://www.prevacid.com/ .
About PREVACID® (lansoprazole)
Oral PREVACID formulations have the most approved indications and the most administration options of any PPI.
PREVACID is the only PPI approved for use in children as young as one year old, and is approved for use by children aged 1 to 17 years. Safety and efficacy in children less than one year have not been established. In patients between the ages of 1 to 11 years, the most frequently reported adverse events were constipation (5 percent) and headache (3 percent). The most frequently reported adverse events in patients aged 12 to 17 years include headache (7 percent), abdominal pain (5 percent), nausea (3 percent) and dizziness (3 percent).
PREVACID is indicated for the short-term (up to eight weeks) treatment of heartburn and other symptoms of gastroesophageal reflux disease (GERD), as well as for the following:
-- Healing and risk reduction of recurrence of gastric (stomach) ulcers associated with NSAIDs (non-steroidal anti-inflammatory drugs) in chronic NSAID users - the only PPI approved for this use. Controlled studies for healing were conducted up to eight weeks and controlled studies for risk reduction of recurrence were conducted up to 12 weeks. -- Short-term (up to eight weeks) healing and symptom relief of all grades (severe to mild) of erosive esophagitis, a condition in which the lining of the esophagus has been damaged. -- Maintenance of healed erosive esophagitis. Controlled studies were conducted up to 12 months. -- Short-term (up to eight weeks) treatment of active benign gastric ulcers. -- Short-term (four weeks) treatment of duodenal ulcers, which are ulcers found on the first part of the small intestine. -- Maintenance of healed duodenal ulcer. Controlled studies were conducted up to 12 months. -- Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, which involves the overproduction of stomach acid.
Source: Abbott Laboratories