Trac Tabs

In the U.S.

• Prosed EC
• Trac Tabs
• Urised

Available Dosage Forms:

• Tablet, Enteric Coated
• Tablet

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Atropine

Chemical Class: Salicylate, Non-Aspirin

Atropine , hyoscyamine , methenamine , methylene blue, phenyl salicylate , and benzoic acid 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 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 medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetazolamide
• Ambenonium
• Amitriptyline
• Amoxapine
• Amphetamine
• Benzphetamine
• Bupropion
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Citalopram
• Clomipramine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dextroamphetamine
• Doxepin
• Doxylamine
• Duloxetine
• Entacapone
• Escitalopram
• Fluoxetine
• Fluvoxamine
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Levodopa
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Mafenide
• Maprotiline
• Meperidine
• Methamphetamine
• Milnacipran
• Mirtazapine
• Nortriptyline
• Opicapone
• Paroxetine
• Phenelzine
• Phentermine
• Potassium
• Protriptyline
• Pseudoephedrine
• Rizatriptan
• Safinamide
• Selegiline
• Sertraline
• Silver Sulfadiazine
• Sulfabenzamide
• Sulfacetamide
• Sulfacytine
• Sulfadiazine
• Sulfamerazine
• Sulfamethazine
• Sulfamethoxazole
• Sulfanilamide
• Sulfapyridine
• Sulfasalazine
• Sulfathiazole
• Sulfisoxazole
• Sumatriptan
• Tapentadol
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zolmitriptan
• Zonisamide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptylinoxide
• Amtolmetin Guacil
• Atropine
• Bromazepam
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Celecoxib
• Chlorpheniramine
• Clonixin
• Cocaine
• Dexibuprofen
• Dexketoprofen
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dipyrone
• Dolasetron
• Donepezil
• Droxicam
• Eletriptan
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Frovatriptan
• Furazolidone
• Granisetron
• Hydrocodone
• Hydromorphone
• Ibuprofen
• Indomethacin
• Iobenguane I 123
• Iproniazid
• Ketoprofen
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Methadone
• Midodrine
• Moclobemide
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nepafenac
• Nialamide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ondansetron
• Opipramol
• Oxaprozin
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Palonosetron
• Parecoxib
• Pentazocine
• Periciazine
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Procarbazine
• Proglumetacin
• Propyphenazone
• Proquazone
• Rasagiline
• Remifentanil
• Rofecoxib
• Sibutramine
• St John's Wort
• Sufentanil
• Sulindac
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Tiotropium
• Tolfenamic Acid
• Tolmetin
• Valbenazine
• Valdecoxib
• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Arbutamine
• Chlorpropamide
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Metformin
• Nateglinide
• Repaglinide
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this 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

This section provides information on the proper use of a number of products that contain atropine, hyoscyamine, methenamine, methylene blue, phenyl salicylate, and benzoic acid. It may not be specific to Trac Tabs. Please read with care.

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

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:

• Blurred vision
• eye pain
• skin rash or hives

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficult urination (more common with large doses taken over a 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 prolonged period of time)

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.