HyoMax DT

Name: HyoMax DT

Descriptions

The anticholinergics and antispasmodics are a group of medicines that include the natural belladonna alkaloids (atropine, belladonna, hyoscyamine, and scopolamine) and related products.

The anticholinergics and antispasmodics are used to relieve cramps or spasms of the stomach, intestines, and bladder. Some are used together with antacids or other medicines in the treatment of peptic ulcers. Others are used to prevent nausea, vomiting, and motion sickness.

Anticholinergics and antispasmodics are also used in certain surgical and emergency procedures. In surgery, some are given by injection before anesthesia to help relax you and to decrease secretions, such as saliva. During anesthesia and surgery, atropine, glycopyrrolate, hyoscyamine, and scopolamine are used to help keep the heartbeat normal. Scopolamine is also used to prevent nausea and vomiting after anesthesia and surgery. Atropine is also given by injection to help relax the stomach and intestines for certain types of procedures.

Anticholinergics are used to treat poisoning caused by medicines such as neostigmine and physostigmine, certain types of mushrooms, and “nerve” gases or organic phosphorous pesticides (eg, demeton [Systox®], diazinon, malathion, parathion, and ronnel [Trolene®]). Anticholinergics can be used for painful menstruation, runny nose, and to prevent urination during sleep.

The anticholinergics and antispasmodics are available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule, Liquid Filled
  • Solution
  • Tablet
  • Capsule
  • Syrup
  • Elixir
  • Suppository
  • Capsule, Extended Release
  • Gel/Jelly
  • Patch, Extended Release
  • Tablet, Extended Release
  • Spray
  • Liquid
  • Tablet, Disintegrating
  • Tablet, Chewable

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of the mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly. The elderly are usually more sensitive than younger adults to the effects of anticholinergics. Also, eye pain may occur, which may be a sign of glaucoma.

Pregnancy

If you are pregnant or if you may become pregnant, make sure your doctor knows if your medicine contains any of the following:

  • Atropine—Atropine has not been shown to cause birth defects or other problems in animals. However, when injected into women during pregnancy, atropine increased the heartbeat of the fetus.
  • Belladonna—Belladonna has not been studied in pregnant women or animals.
  • Clidinium—Clidinium has not been studied in pregnant women. However, clidinium has not been shown to cause birth defects or other problems in animals.
  • Dicyclomine—Dicyclomine has been associated with a few cases of human birth defects, but dicyclomine has not been confirmed as the cause.
  • Glycopyrrolate—Glycopyrrolate has not been studied in pregnant women. However, glycopyrrolate did not cause birth defects in animal studies, but did decrease the chance of becoming pregnant and the newborn's chance of surviving after weaning.
  • Hyoscyamine—Hyoscyamine has not been studied in pregnant women or animals. However, when injected into women during pregnancy, hyoscyamine increased the heartbeat of the fetus.
  • Mepenzolate—Mepenzolate has not been studied in pregnant women. However, studies in animals have not shown that mepenzolate causes birth defects or other problems.
  • Propantheline—Propantheline has not been studied in pregnant women or animals.
  • Scopolamine—Scopolamine has not been studied in pregnant women or animals.

What should I discuss with my healthcare provider before taking HyoMax DT (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have:

  • kidney disease;

  • an enlarged prostate or problems with urination;

  • intestinal blockage;

  • severe ulcerative colitis, or toxic megacolon;

  • glaucoma; or

  • myasthenia gravis.

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.

HyoMax DT (hyoscyamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

  • diarrhea;

  • confusion, hallucinations;

  • unusual thoughts or behavior;

  • fast, pounding, or uneven heart rate;

  • rash or flushing (warmth, redness, or tingly feeling); or

  • eye pain.

Less serious side effects may include:

  • dizziness, drowsiness, feeling nervous;

  • blurred vision, headache;

  • sleep problems (insomnia);

  • nausea, vomiting, bloating, heartburn, or constipation;

  • changes in taste;

  • problems with urination;

  • decreased sweating;

  • dry mouth; or

  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Description

Each purple and white, biphasic, capsule shaped tablet for oral administration is specially formulated to release 0.125 mg of hyoscyamine sulfate immediately and 0.250 mg of hyoscyamine sulfate over the remaining 8 to 12 hours of the dosing period.

I-Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids.

Hyoscyamine sulfate is Benzeneacetic acid, α-(hydroxymethyl)-, 8 methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate.

hyoscyamine sulfate

Inactive ingredients include calsium phosphate, D&C Red #30, FD&C Blue #1, lactose monohydrate, magnesium stearate, methylcullulose, povidone, silicified microcrystalline cellulose, sodium starch glycolate.

Geriatric Use

Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion.

Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued.

Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma.

Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics since these drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions.

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 is dialyzable.

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 HyoMax DT) 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 HyoMax DT) 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 HyoMax DT) 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 HyoMax DT) on the CNS.[Ref]

Ocular

Ocular side effects due to the anticholinergic activity of hyoscyamine (the active ingredient contained in HyoMax DT) 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 HyoMax DT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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