Pro-Banthine

Propantheline reduces the secretions of certain organs in the body, such as the stomach.

Propantheline is used to reduce stomach acid in people with stomach ulcers.

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

You should not take this medication if you are allergic to propantheline, or if you have glaucoma, myasthenia gravis, a blockage in your stomach or intestines, severe ulcerative colitis, an enlarged prostate, or if you are unable to urinate.

Before taking propantheline, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, hiatal hernia, GERD, liver disease, or thyroid problems. .

Before using propantheline, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by propantheline.

Propantheline slows the digestive tract, which can make it harder for your body to absorb any medicines you take by mouth. Tell your doctor if any of your oral medications do not seem to work as well while you are using propantheline.

There are many other medicines that can interact with propantheline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

Propantheline can cause side effects that may impair your vision, thinking, or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol. It can increase some of the side effects of propantheline.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Propantheline can decrease perspiration and you may be more prone to heat stroke.

You should not take this medication if you are allergic to propantheline, or if you have:

• a blockage in your stomach or intestines;
• a bladder obstruction or if you are unable to urinate;
• severe ulcerative colitis or toxic megacolon;
• glaucoma; or
• myasthenia gravis.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• heart disease, congestive heart failure, or a heart rhythm disorder;
• high blood pressure;
• hiatal hernia or reflux esophagitis (GERD);
• liver disease;
• kidney disease;
• thyroid problems; or
• enlarged prostate.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using propantheline, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether propantheline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of propantheline.

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

Stop using propantheline and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;

• warmth, redness, or tingly feeling under your skin;

• hot, dry skin with no sweating;

• eye pain or redness, seeing halos around lights;

• blurred vision and increased sensitivity to light;

• confusion, agitation, extreme fear, hallucinations, unusual thoughts or behavior; or

• urinating less than usual or not at all.

Less serious side effects may include:

• drowsiness, dizziness;

• headache or feeling nervous;

• nausea, vomiting, bloating, constipation;

• decreased sense of taste;

• dry mouth, stuffy nose; or

• sleep problems (insomnia).

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.

Pro-Banthine®(propantheline bromide) oral tablets contain 15 mg or 7.5 mg of the anticholinergic propantheline bromide, (2-hydroxyethyl) diisopropylmethylammonium bromide xanthene-9-carboxylate.

The structural formula of propantheline bromide is:

Propantheline bromide is very soluble in water, alcohol, and chloroform, but it is practically insoluble in ether and in benzene. Its molecular weight is 448.40.

Inactive Ingredients: include calcium carbonate, castor oil, corn starch, lactose anhydrous, light mineral oil, magnesium carbonate, magnesium stearate, saccharin sodium, sucrose, talc, titanium dioxide, and waxes. The 15-mg tablet also contains cosmetic ochre and cosmetic red as coloring agents.

Propantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the post-ganglionic nerve endings of the parasympathetic nervous system.

Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive compounds xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. After a single 30-mg oral dose given as two 15-mg tablets, the mean peak plasma concentration of propantheline was 21 ng/mL at 1 hour in 6 healthy subjects.

The plasma elimination half-life of propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of propantheline is about 3% after oral tablet administration.

Pro-Banthine® (propantheline bromide) tablets are as effective as adjunctive therapy in the treatment of peptic ulcer.

Propantheline bromide is contraindicated in patients with:

1. Glaucoma, since mydriasis is to be avoided.
2. Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.)
3. Obstructive uropathy (e.g., bladder-neck obstruction due to prostatic hypertrophy).
4. Intestinal atony of elderly or debilitated patients.
5. Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis.
6. Unstable cardiovascular adjustment in acute hemorrhage.
7. Myasthenia gravis.

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Pro-Banthine®.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with propantheline bromide would be inappropriate and possibly harmful.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).

Propantheline bromide may cause increased heart rate and, therefore, should be used with caution in patients with heart disease.

The usual initial adult dosage of Pro-Banthine®tablets is 15 mg taken 30 minutes before each meal (3 times daily), and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient's individual response and tolerance. The administration of one 7.5-mg tablet 30 minutes before each meal (3 times daily) is convenient for patients with mild manifestations, for geriatric patients, and for those of small stature.

Pro-Banthine®15-mg tablets are round, peach-colored, sugar-coated, with RPC imprinted on one side and 074 on the other side. Bottles of 100 (NDC 54092-074-01).

Pro-Banthine® 7.5-mg tablets are round, white, sugar-coated, with RPC imprinted on one side and 073 on the other side. Bottles of 100 (NDC 54092-073-01).

Store below 25°C (77°F).

Rev. 2/00 073 0117 004

Applies to propantheline: oral tablets

Side effects include:

Xerostomia, decreased sweating, adverse ophthalmic effects (e.g., blurred vision, mydriasis, cycloplegia, increased ocular tension).