Digenyx

Hyoscyamine Sulfate 0.125 mg · Tablet · Oral

Prescription (Rx)

Uses

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 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.

Contraindications

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.

Warnings

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.

Precautions

PRECAUTIONS: General: Use with caution in patients with autonomic neuropathy, hyperthyroidism, heart disease, heart failure, arrhythmias, high blood pressure, or kidney disease. Hyoscyamine may increase heart rate, so check for tachycardia before using anticholinergics. Patients with hiatal hernia and reflux esophagitis should also be monitored closely. Prolonged use may decrease saliva, leading to dental issues. Information for Patients: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets can cause drowsiness, dizziness, and blurred vision. Avoid driving or operating machinery until you know how the medication affects you. During hot weather or exercise, be cautious as this medication can reduce sweating, increasing the risk of heat stroke. Patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness. Take the medication 30 minutes to 1 hour before meals and swallow the tablets whole. 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. Pediatric Use: Infants and young children are especially sensitive to its effects, including increased body temperature in hot environments. Close supervision is required for children with brain conditions as they may react more strongly to the medication. Geriatric Use: Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Side effects

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.

Drug interactions

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

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.

Pediatric use

Pediatric Use: Infants and young children are especially sensitive to its effects, including increased body temperature in hot environments. Close supervision is required for children with brain conditions as they may react more strongly to the medication.

Geriatric use

Geriatric Use: Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Overdosage

OVERDOSAGE: The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation. Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.

Description

DESCRIPTION: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets are off-white to light beige round tablet containing 0.125 mg hyoscyamine sulfate formulated for oral administration. Each tablet also contains inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid, Sodium Starch Glycolate. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 ) 2
• H 2 SO 4
• 2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid,α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: figure a

How supplied

HOW SUPPLIED: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) are off-white to light beige round tablets. Each bottle contains 30 tablets (NDC 59088-150-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture and avoid excessive heat. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Patient information

Information for Patients: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets can cause drowsiness, dizziness, and blurred vision. Avoid driving or operating machinery until you know how the medication affects you. During hot weather or exercise, be cautious as this medication can reduce sweating, increasing the risk of heat stroke. Patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness. Take the medication 30 minutes to 1 hour before meals and swallow the tablets whole.

Label text from the FDA structured product label by PureTek Corporation (revised May 12, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Hyoscyamine Sulfate in 1 product

Digenyx NDC products (1)

NDC	Strength & form	Labeler	Type
59088-150	Hyoscyamine Sulfate .125 mg/1 Tablet	PureTek Corporation	UNAPPROVED DRUG OTHER

Frequently asked questions

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Who makes Digenyx?

Digenyx is listed by 1 labeler in the FDA NDC directory, including PureTek Corporation.