A-Spaz

Name: A-Spaz

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Very loose stools (diarrhea).
  • Feeling confused.
  • Mood changes.
  • Change in how you act.
  • Hallucinations (seeing or hearing things that are not there).
  • Memory problems or loss.
  • Not able to sleep.
  • Change in speech.
  • Change in balance.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Very nervous and excitable.
  • Trouble passing urine.
  • Not sweating during activities or in warm temperatures.
  • Fever.
  • Flushing.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Change in sex ability.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out A-Spaz?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

For Healthcare Professionals

Applies to hyoscyamine: compounding powder, injectable solution, oral capsule extended release, oral liquid, oral solution, oral spray, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, sublingual tablet

Cardiovascular

Cardiovascular side effects have included tachycardia, premature ventricular depolarizations, and ventricular tachycardia.[Ref]

Gastrointestinal

Gastrointestinal side effects due to the anticholinergic effects of hyoscyamine (the active ingredient contained in A-Spaz) have commonly included dry mouth and mucous membranes. Other reported side effects include delayed gastric emptying time, reduced gastric acid secretion, constipation, and gastroesophageal reflux.[Ref]

General

Hyoscyamine (the active ingredient contained in A-Spaz) toxicity (anticholinergic side effects) often presents as fever, tachycardia, agitation, and dry skin/mucous membranes.[Ref]

Genitourinary

Genitourinary complications include urinary retention (due to anticholinergic effects on the urinary sphincter), which is common and dose-related, and impotence in male patients.[Ref]

Hypersensitivity

Hypersensitivity reactions to hyoscyamine (the active ingredient contained in A-Spaz) are rare. Reactions can include urticaria, eczema, papillary hyperplasia, mucopurulent discharge, eosinophilia, pruritus, edema, hypotension, abdominal pain, tachypnea, nausea and vomiting.[Ref]

Nervous system

Nervous system side effects have included lethargy and somnolence. Higher doses may be associated with mental confusion and/or excitement. The elderly appear to be more prone to the anticholinergic effects of hyoscyamine (the active ingredient contained in A-Spaz) on the CNS.[Ref]

Ocular

Ocular side effects due to the anticholinergic activity of hyoscyamine (the active ingredient contained in A-Spaz) have included inhibition of the iris sphincter muscle (possibly resulting in mydriasis), follicular conjunctivitis, and inhibition of the ciliary muscle (which can produce blurred vision). All muscarinic antagonists can precipitate glaucoma.[Ref]

Endocrine

Endocrine side effects have included inhibition of exocrine sweat glands. This is usually not clinically significant except when perspiration becomes a major factor in body temperature control.[Ref]

Some side effects of A-Spaz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Irritable Bowel Syndrome

Immediate-release Tablets: 0.125 to 0.25 mg orally or sublingually every 4 hours or as needed. Do not take more than 12 tablets in 24 hours.

Extended-release Tablets: 0.375 to 0.75 mg orally every 12 hours. Do not exceed 4 tablets in 24 hours.

Timecaps: 0.375 to 0.75 mg orally every 12 hours. Do not exceed 4 capsules in 24 hours

Biphasic tablets: 0.375 to 0.75 mg orally every 12 hours. Dosage may be adjusted to 0.375 mg every 8 hours if needed. Do not exceed 4 tablets in 24 hours.

Elixir: 5 to 10 mL (0.125 to 0.25 mg) every 4 hours or as needed. Do not take more than 12 teaspoonfuls in 24 hours.

Drops: 1 to 2 mL (0.125 to 0.25 mg) every 4 hours as needed. Do not take more than 12 mL in 24 hours.

Usual Pediatric Dose for Urinary Incontinence

Greater than or equal to 2 to less than 12 years:
Immediate-release Tablets: 0.0625 to 0.125 mg sublingually, orally, chew, every 4 hours or as needed. Do not take more than 6 tablets in 24 hours.

Elixir: 1.25 to 5 mL (10 kg to 50 kg child) every 4 hours or as needed. Increase dose by 1.25 mL increments for a 20 kg child, and again for a 40 kg child. Do not take more than 6 teaspoonfuls in 24 hours.

Drops: 0.25 to 1 mL (0.0312 to 0.125 mg) every 4 hours as needed. Do not give more than 6 mL in 24 hours.

Biphasic tablets: 0.375 mg orally every 12 hours. Do not exceed 2 tablets in 24 hours.

Less than 2 years:
Drops: 4 drops for a 3.4 kg child (Do not give more than 24 drops in 24 hours)
5 drops for a 5 kg child (Do not give more than 30 drops in 24 hours),
6 drops for a 7 kg child (Do not give more than 36 drops in 24 hours),
8 drops for a 10 kg child (Do not give more than 48 drops in 24 hours)

Usual Pediatric Dose for Irritable Bowel Syndrome

Study (n=28)
Greater than 9 years: 0.375 mg orally at bedtime, up to 0.75 mg, for up to 6 months.

Other Comments

Extended release tablets, timecaps, and biphasic tablets should be swallowed whole. Do not crush or chew. The tablets are scored and may be broken to allow for easy dose titration.

Hyoscyamine sulfate injection may be administered subcutaneously, IM, or IV without dilution.

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