Digenyx

INDICATIONS AND USAGE: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets are an anticholinergic agent used as adjunctive therapy for a range of gastrointestinal and genitourinary conditions. Hyoscyamine reduces gastrointestinal motility and secretions and relieves smooth muscle spasm. Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets may be used as adjunctive therapy in conditions such as: -Peptic ulcer disease -Irritable bowel syndrome and functional gastrointestinal disorders (e.g., spastic colon, mucous colitis) -Acute enterocolitis -Neurogenic bladder and bladder spasms -Biliary and renal colic (in combination with narcotic analgesics)

DOSAGE AND ADMINISTRATION: Dosage should be individualized according to the condition and severity of symptoms. Administer orally 30 to 60 minutes before meals and at bedtime, or as directed by licensed healthcare practitioner. Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

WARNINGS: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets may cause drowsiness, dizziness, or blurred vision, so patients should avoid activities that require mental alertness, such as driving or operating machinery. It should be used with caution in individuals with heart disease, high blood pressure, hyperthyroidism, or enlarged prostate, and is not recommended for patients with narrow-angle glaucoma. In hot environments, the use of this drug may lead to heat prostration (fever, heat stroke due to decreased sweating). Diarrhea could be an early sign of incomplete intestinal obstruction, especially for patients with an ileostomy or colostomy, in which case using this product may be harmful. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

CONTRAINDICATIONS: This product should not be used in patients with glaucoma, obstructive uropathy, obstructive gastrointestinal disease, paralytic ileus, severe ulcerative colitis, myasthenia gravis, or hypersensitivity to Hyoscyamine Sulfate, USP or any other ingredients in the formulation.

Drug Interactions: Hyoscyamine may interact with anticholinergics, antihistamines, antidepressants, pain medications, and antacids, which can lead to increased side effects like constipation or confusion. Inform your healthcare provider of all medications and supplements you're taking. Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.

Pregnancy: Hyoscyamine is classified as Pregnancy Category C. There are no data on its effects during pregnancy. It should only be used if clearly needed and prescribed by a licensed healthcare practitioner, as it crosses the placenta.

Nursing Mothers: Hyoscyamine passes into breast milk. It should not be used while breastfeeding unless clearly necessary.

ADVERSE REACTIONS: The following adverse reactions have been reported for hyoscyamine sulfate and for pharmacologically similar drugs with anticholinergic/antispasmodic action. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating. To report SUSPECTED ADVERSE REACTIONS, contact PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.