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, urinarytract

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 causedby urinary tract infections; however, it will not cure the infection itself.This combination medicine may also be used for other conditions as determinedby your doctor.

This medicine is available only with your doctor's prescription in thefollowing 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 willdo. This is a decision you and your doctor will make. For this combinationmedicine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to any of the belladonna alkaloids such as atropine, hyoscyamine,and scopolamine, or to aspirin or other salicylates. Also tell your healthcare 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 ofatropine and hyoscyamine (contained in this combination medicine) pass intothe breast milk, this medicine has not been reported to cause problems innursing babies.

Children?Unusual excitement, nervousness, restlessness orirritability, and unusual warmth, dryness, and flushing of skin are more likelyto occur in children, who are usually more sensitive to the effects of atropineand hyoscyamine (contained in this combination medicine). Also, when atropineand hyoscyamine are given to children during hot weather, a rapid increasein body temperature may occur. In infants and children, especially those withspastic paralysis or brain damage, this medicine may be more likely to causesevere side effects.

Older adults?Confusion or memory loss, constipation, difficulturination, excitement, agitation, drowsiness, or dryness of mouth may be morelikely to occur in elderly patients, who are usually more sensitive than youngeradults to the effects of atropine and hyoscyamine. Also, this combinationmedicine may cause eye pain in patients who have untreated glaucoma.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingthis combination medicine, it is especially important that your health careprofessional 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, suchas acetazolamide [e.g., Diamox], calcium- and/or magnesium-containing antacids,dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazone], potassiumor sodium citrate and/or citric acid, sodium bicarbonate [baking soda])?Usewith these medicines may decrease the effects of this combination medicine

• Ketoconazole (e.g., Nizoral)?Use with this combination medicinemay reduce the effects of ketoconazole

• Other anticholinergics (medicine for abdominal or stomach spasmsor cramps)?Use with these medicines may increase the effects of atropineand hyoscyamine

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

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

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

• Bleeding problems (severe)?This combination medicine may increaseheart rate, which would make bleeding problems worse

• Brain damage (in children)?May increase the central nervoussystem (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 combinationmedicine may make these conditions worse

• Dehydration or
• Kidney disease or
• Liver disease?Higher levels of medicine may result and increasethe risk of side effects

• Overactive thyroid?May increase the heart rate

Proper Use of This Medicine

While youare taking this combination medicine, it is important for your urine to beacidic. To do this, your doctor may recommend that you eat more protein andsuch 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 otherdairy products.

Take this medicine only as directed. Do nottake more of it, do not take it more often, and do not take it for a longertime 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 otherliquid (except citrus juices and milk). Drink plenty of water or other liquidsevery day, unless otherwise directed by your doctor. Drinking enough liquidswill help your kidneys work better and lessen your discomfort.

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

In order for this medicine to work well, your urinemust 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 phenaphthazinepaper or another test to see if it is acid. If you have any questions aboutthis, check with your health care professional.
• You may need to change your diet; however, check with your doctorfirst if you are on a special diet (for example, for diabetes). To help makeyour urine more acid you should avoid most fruits (especially citrus fruitsand juices), milk and other dairy products, and other foods which make theurine more alkaline. Eating more protein and foods such as cranberries (especiallycranberry juice with vitamin C added), plums, or prunes may also help. Ifyour urine is still not acid enough, check with your doctor.

Dosing?The dose of this combination medicine willbe different for different patients. Follow your doctor'sorders or the direction on the label. The following information includesonly the average doses of this combination medicine. If your dose is different, do not change it unless your doctor tellsyou 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 tabletsfour times a day.
    • Children 6 to 12 years of age?Dose must be determined by thedoctor.
    • Children up to 6 years of age?Use is not recommended.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 breakdown.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If yoursymptoms do not improve within a few days or if they become worse, check withyour doctor.

These medicines may make you sweat less, causing your body temperatureto increase. Use extra care not to become overheatedduring exercise or hot weather while you are taking this medicine,since overheating may result in heat stroke. Also, hot baths or saunas maymake 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, usesugarless 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, checkwith your dentist. Continuing dryness of the mouth may increase the chanceof dental disease, including tooth decay, gum disease, and fungus infections.

Do not take this medicine within 2 or 3 hours of taking antacids or medicinefor diarrhea. Taking antacids or antidiarrhea medicines and this medicinetoo 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 sideeffects may occur, if they do occur they may need medical attention.

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

Less common or rare

Blurred vision; eye pain; skin rash or hives

Symptoms of overdose

Blood in urine and/or stools; diarrhea; dizziness; drowsiness(severe); fast heartbeat; flushing or redness of face; headache (severe orcontinuing); lower back pain; pain or burning while urinating; ringing or buzzingin the ears; shortness of breath or troubled breathing; sweating; unusual tirednessor weakness

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

Less common

Difficult urination (more common with large doses taken overa prolonged period of time); dryness of mouth, nose,or throat; nausea or vomiting; stomach upset or pain (more common with large doses taken over a prolongedperiod of time)

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

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