Phosphasal (Page 2 of 2)
Drug interactions
because of this product’s effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be advised that the urine may become blue to blue-green and the feces may be discolored as a result of the excretion of the Methylene blue.
DRUG ABUSE AND DEPENDENCE
A dependence on the use of Phosphasal ™ tablets has not been reported and due to the nature of its ingredients, abuse of Phosphasal ™ tablets is not expected.
OVERDOSAGE
Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.
Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.
If overdose is suspected, contact your local poison center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.
HOW SUPPLIED
Phosphasal ™ tablets are blue tablets imprinted with “SAT” on one side and “902” on opposite side. NDC 0076-0902-01, Bottle of 100 Tablets.
STORAGE
Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.
Store at controlled room temperature 15°-30°C (59°-86°F).
Keep in a cool, dry place.
Keep container tightly closed.
DOSAGE AND ADMINISTRATION
Adults — one tablet orally 4 times per day followed by liberal fluid intake.
Older Children — Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.
Phosphasal Bottle Label
WARNING: Keep this and all drugs out of reach of children.
Rx Only
Phosphasal ™ is a trademark of Stellar Pharmacal
Distributed by:
BIOCOMP PHARMA, INC.
San Antonio, Texas 78230
Manufactured for:
STELLAR PHARMACAL
Ft. Lauderdale, FL 33306
Rev. 90201-23-07/12
| PHOSPHASAL methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate tablet | ||||||||||||||||||||||||
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| Labeler — Star Pharmaceuticals, LLC (962184003) |
Revised: 01/2017 Star Pharmaceuticals, LLC
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