Symax Duotab

Name: Symax Duotab

What should I discuss with my healthcare provider before taking Symax Duotab (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.

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.

What other drugs will affect Symax Duotab (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

  • amantadine (Symmetrel);

  • haloperidol (Haldol);

  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  • phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What do I need to tell my doctor BEFORE I take Symax Duotab?

  • If you have an allergy to hyoscyamine or any other part of Symax Duotab (hyoscyamine extended-release tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Bowel block, bleeding problems, diarrhea, enlarged colon, glaucoma, heart problems, myasthenia gravis, slow-moving GI (gastrointestinal) tract, a swallowing tube (esophagus) that is not normal, ulcerative colitis, or trouble passing urine.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Symax Duotab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

Indications and Usage for Symax Duotab

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.

Precautions

General: Use caution in patients with hiatal hernia associated with reflex esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate.

Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.

Information for Patients: This medication should be taken 30 minutes to one hour before meals. Tablets should be swallowed whole.

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.

Drug Interactions: Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying.

Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, and potassium chloride.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers: This product is excreted in human milk. This product should not be administered to a nursing mother.

Pediatric Use: This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications’ suppression of sweat gland activity.

A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.

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 LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine is dialyzable.

How is Symax Duotab Supplied

Purple and white, bilayered, capsule-shaped tablets debossed "SYMAX" on one side, "DUOTAB" on the opposite side. Bottles of 90 tablets NDC 64543-118-90, and professional physician starter packages of 1 tablet NDC 64543-118-02.

Storage and Handling

Store at controlled room temperature, 20°-25°C (68°-77°F), see USP Controlled Room Temperature.

Dispense in tight, light-resistant containers as defined in the USP/NF.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Manufactured for:

Capellon Pharmaceuticals, LLC
Fort Worth, TX 76118

Rev. 05/2016

500157-03

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 Symax Duotab) 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 Symax Duotab) 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 Symax Duotab) 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 Symax Duotab) on the CNS.[Ref]

Ocular

Ocular side effects due to the anticholinergic activity of hyoscyamine (the active ingredient contained in Symax Duotab) 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 Symax Duotab 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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