Name: HyoMax SL
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What should I discuss with my healthcare provider before taking HyoMax SL (hyoscyamine)?
Do not take hyoscyamine if you are allergic to it, or if you have:
an enlarged prostate or problems with urination;
severe ulcerative colitis, or toxic megacolon;
To make sure you can safely take hyoscyamine, tell your doctor if you have any of these other conditions:
heart disease, congestive heart failure;
a heart rhythm disorder;
high blood pressure;
overactive thyroid; or
hiatal hernia with GERD (gastroesophageal reflux disease).
FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Indications and usage
This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.
Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia.
This product is not recommended for use in children under six years of age.
Information for Patients
This medication should be taken 30 minutes to one hour before meals.
This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke.
Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness.
Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported 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; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; 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); and decreased sweating.
Dosage and administration
Usual adult and adolescent dose:
Oral or sublingual, 1 to 2 tablets three or four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.
Usual dose for children 6 to under 12 years of age:
Oral or sublingual, 1/2 to 1 tablet three or four times a day, thirty minutes to one hour before meals and at bedtime. Dosage should be individualized by physician according to patient's needs and tolerance.
Note: This product is not recommended for use in children under six years of age.
For the Consumer
Applies to hyoscyamine: oral conventional tablets and sublingual tablets, oral extended-release capsules and tablets, oral oral solution and elixir, oral orally disintegrating tablets, parenteral injection
Side effects include:
Most adverse effects are manifestations of pharmacologic effects at muscarinic-cholinergic receptors and usually are reversible when therapy is discontinued.
Severity and frequency of adverse effects are dose related and individual intolerance varies greatly; adverse effects occasionally may be obviated by a reduction in dosage but this also may eliminate potential therapeutic effects.
Adverse effects include dry mouth, urinary hesitancy and retention, blurred vision, tachycardia, palpitations, mydriasis, increased ocular tension, loss of taste, headache, nervousness, drowsiness, weakness, fatigue, dizziness, insomnia, nausea, vomiting, impotence, constipation, bloated feeling, abdominal pain, diarrhea, allergic reactions or drug idiosyncrasies, urticaria and other dermal manifestations, ataxia, speech disturbance, mental confusion and/or excitement (especially in geriatric patients), short-term memory loss, hallucinations, and decreased sweating.