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Claims for Patent: 5,248,505

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Claims for Patent: 5,248,505

Title: Method for treating gastrointestinal distress
Abstract:This invention relates to a pharmaceutical composition for treating gastrointestinal distress comprising an effective amount of an antidiarrheal composition, e.g. loperamide, and an antiflatulent effective amount of simethicone and methods of treating gastrointestinal distress comprising administering such pharmaceutical compositions.
Inventor(s): Garwin; Jeffrey L. (Paoli, PA)
Assignee: McNeil-PPC, Inc. (Milltown, NJ)
Application Number:07/852,355
Patent Claims: 1. A method for treating a human suffering from an intestinal disorder characterized by the symptoms of diarrhea and flatulence or gas comprising administering to said human in a combined pharmaceutical composition, an effective amount of an antidiarrheal compound selected from the group consisting of loperamide, bismuth subsalicyclate, diphenoxylate, polycarbophil, their pharmaceutically acceptable salts and mixtures thereof; and an antiflatulent effective amount of simethicone.

2. The method of claim 1 wherein the amount of simethicone administered is in the range of from about 20 mg to about 125 mg per dosage unit.

3. The method of claim 2 wherein the amount of loperamide administered is in a dosage range of from about 0.5 mg to about 8.0 mg.

4. The method of claim 3 wherein the loperamide is administered in the form of a hydrochloride salt.

5. The method of claim 2 wherein the amount of bismuth subsalicylate administered is in a dosage range of from about 120 mg to about 1200 mg.

6. The method of claim 2 wherein the amount of diphenoxylate administered is in a dosage range of from about 0.7 mg to about 10 mg.

7. The method of claim 6 wherein the diphenoxylate is administered in the form of a hydrochloride salt.

8. The method of claim 2 wherein the amount of polycarbophil is in a dosage range of from about 150 mg to about 2000 mg.

9. The method of claim 8 wherein the polycarbophil is provided as calcium polycarbophil.

10. The method of claim 3 wherein the loperamide administered is provided in an enterically coated form.

11. The method of claim 10 wherein the loperamide and simethicone are provided in a solid dosage form.

12. The method of claim 11 wherein the solid dosage form consisting of at least a first layer and a second layer and the enterically coated loperamide is present in the first layer and the simethicone is present in the second layer.

13. The method of claim 2 wherein the amount of simethicone administered is 80 mg per dosage unit and the amount of loperamide administered is 2 mg per dosage unit.

14. The method of claim 2 wherein the amount of simethicone administered is 125 mg per dosage unit and the amount of loperamide administered is 2 mg per dosage unit.

15. The method of claim 2 wherein the amount of bismuth administered is 300 mg per dosage unit and the amount of simethicone administered is 80 mg per dosage unit.

16. A method for treating a human suffering from an intestinal disorder characterized by diarrhea and flatulence and or gas comprising administering to said human in a combined pharmaceutical composition, 4 mg of loperamide and an antiflatulent effective amount of simethicone; thereafter administering to said human in a combined pharmaceutical composition, 2 mg of loperamide and an antiflatulent effective amount of simethicone until the diarrhea is controlled.
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