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|Trac Tabs 2X

ATROPINE, HYOSCYAMINE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND BENZOIC ACID (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Atrosept
• Dolsed
• Hexalol
• Prosed/DS
• Trac Tabs 2X
• UAA
• Uridon Modified
• Urimed
• Urinary Antiseptic No. 2
• Urised
• Uriseptic
• Uritab
• Uritin
• Uro-Ves

† Not commercially available in Canada.

Category

• Anticholinergic-antibacterial-analgesic, urinary tract

Description

Atropine (A-troe-peen), hyoscyamine (hye-oh-SYE-a-meen), methenamine (meth-EN-a-meen), methylene (METH-i-leen) blue, phenyl salicylate (FEN-ill sa-LI-si-late), and benzoic acid (ben-ZOE-ik AS-id) combination medicine is an anticholinergic, anti-infective, and analgesic. It is given by mouth to help relieve the discomfort caused by urinary tract infections; however, it will not cure the infection itself. This combination medicine may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor"s prescription in the following dosage form:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this combination medicine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any of the belladonna alkaloids such as atropine, hyoscyamine, and scopolamine, or to aspirin or other salicylates. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in either humans or animals.

Breast-feeding—Although methenamine and very small amounts of atropine and hyoscyamine (contained in this combination medicine) pass into the breast milk, this medicine has not been reported to cause problems in nursing babies.

Children—Unusual excitement, nervousness, restlessness or irritability, and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of atropine and hyoscyamine (contained in this combination medicine). Also, when atropine and hyoscyamine are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be more likely to cause severe side effects.

Older adults—Confusion or memory loss, constipation, difficult urination, excitement, agitation, drowsiness, or dryness of mouth may be more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of atropine and hyoscyamine. Also, this combination medicine may cause eye pain in patients who have untreated glaucoma.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this combination medicine, it is especially important that your health care professional know if you are taking any of the following:

• Antacids or
• Diarrhea medicine containing kaolin or attapulgite or
• Thiazide diuretics (water pills) or
• Urinary alkalizers (medicine that makes the urine less acid, such as acetazolamide [e.g., Diamox], calcium- and/or magnesium-containing antacids, dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazone], potassium or sodium citrate and/or citric acid, sodium bicarbonate [baking soda])—Use with these medicines may decrease the effects of this combination medicine

• Ketoconazole (e.g., Nizoral)—Use with this combination medicine may reduce the effects of ketoconazole

• Other anticholinergics (medicine for abdominal or stomach spasms or cramps)—Use with these medicines may increase the effects of atropine and hyoscyamine

• Potassium chloride (e.g., Slow K or K-Dur)—May worsen or cause an increase in lesions (sores) of the stomach or intestine

• Sulfonamides (sulfa medicine)—Use with this combination medicine may increase the risk of crystals forming in the urine

Other medical problems—The presence of other medical problems may affect the use of this combination medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (severe)—This combination medicine may increase heart rate, which would make bleeding problems worse

• Brain damage (in children)—May increase the central nervous system (CNS) effects of this combination medicine

• Colitis (severe) or
• Dryness of mouth (severe or continuing) or
• Enlarged prostate or
• Fever or
• Glaucoma or
• Heart disease or
• Hernia (hiatal) or
• High blood pressure or
• Intestinal blockage or other intestinal or stomach problems or
• Lung disease or
• Myasthenia gravis or
• Toxemia of pregnancy or
• Urinary tract blockage or difficult urination—This combination medicine may make these conditions worse

• Dehydration or
• Kidney disease or
• Liver disease—Higher levels of medicine may result and increase the risk of side effects

• Overactive thyroid—May increase the heart rate

Proper Use of This Medicine

While you are taking this combination medicine, it is important for your urine to be acidic. To do this, your doctor may recommend that you eat more protein and such foods as cranberries (especially cranberry juice with vitamin C added), plums, or prunes. You should avoid foods that make the urine more alkaline, such as most fruits (especially citrus fruits and juices), milk, and other dairy products.

Take this medicine only as directed . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Each dose should be taken with a full glass (8 ounces) of water or other liquid (except citrus juices and milk). Drink plenty of water or other liquids every day, unless otherwise directed by your doctor. Drinking enough liquids will help your kidneys work better and lessen your discomfort.

To help clear up your infection completely, keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses .

In order for this medicine to work well, your urine must be acid (pH 5.5 or below) . To make sure that your urine is acid:

• Before you start taking this medicine, check your urine with phenaphthazine paper or another test to see if it is acid. If you have any questions about this, check with your health care professional.
• You may need to change your diet; however, check with your doctor first if you are on a special diet (for example, for diabetes). To help make your urine more acid you should avoid most fruits (especially citrus fruits and juices), milk and other dairy products, and other foods which make the urine more alkaline. Eating more protein and foods such as cranberries (especially cranberry juice with vitamin C added), plums, or prunes may also help. If your urine is still not acid enough, check with your doctor.

Dosing—The dose of this combination medicine will be different for different patients. Follow your doctor"s orders or the direction on the label . The following information includes only the average doses of this combination medicine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For relief of urinary tract symptoms:
    • Adults and children 12 years of age and older—1 to 2 tablets four times a day.
    • Children 6 to 12 years of age—Dose must be determined by the doctor.
    • Children up to 6 years of age—Use is not recommended.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine , since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

This medicine may cause some people to have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If your vision continues to be blurred, check with your doctor .

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take this medicine within 2 or 3 hours of taking antacids or medicine for diarrhea. Taking antacids or antidiarrhea medicines and this medicine too close together may prevent this medicine from working properly.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

This medicine may cause your urine and/or stools to turn blue or blue-green. This is to be expected while you are taking this medicine.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 05/11/1993

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