Symax SR

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson's disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for purposes not listed in this medication guide.

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.

Each sustained-release tablet for oral administration contains:

Hyoscyamine Sulfate . . . 0.375 mg

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.

(C 17H 23NO 3) 2•H 2SO 4•2H 2O
M.W. 712.85

Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.

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

The formulation for Symax®-SR is a non-eroding, non-gelling sustained release matrix. The drug releases from the tablet while the tablet remains intact. Therefore, it is possible that a tablet may appear in your stool.

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.

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.

Symax®-SR is supplied as green, capsule shaped tablets debossed “SR 375” on one side and plain on the opposite side. Available in bottles of 100 tablets, NDC 64543-112-01.

Storage and Handling

Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°- 77°F), see USP Controlled Room Temperature.

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
Ft. Worth, TX 76118

Rev. 01/2016

500020-03