Phenazopyridine/ butabarbital/ hyoscyamine

Generic Name: phenazopyridine/butabarbital/hyoscyamine (fen-AY-zoe-PIR-i-deen/BUE-ta-BAR-bi-tal/HYE-oh-SYE-a-meen)
Brand Name: Examples include PhenazoForte Plus and Urelief Plus

Phenazopyridine/ butabarbital/ hyoscyamine is used for:

Relieving pain, burning, urgency, frequent urination, and discomfort caused by irritation of the lower urinary tract. It may also be used for other conditions as determined by your doctor.

Phenazopyridine/butabarbital/hyoscyamine is an analgesic, anticholinergic, and antianxiety combination. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use phenazopyridine/ butabarbital/ hyoscyamine if:

  • you are allergic to any ingredient in phenazopyridine/butabarbital/hyoscyamine
  • you have the blood disease porphyria; decreased liver or kidney function; severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
  • you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
  • you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using phenazopyridine/ butabarbital/ hyoscyamine:

Some medical conditions may interact with phenazopyridine/butabarbital/hyoscyamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), lung or breathing problems, hiatal hernia, kidney or liver problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
  • if you have diarrhea or fever, have been very ill, or are in poor health
  • if you have an enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency, a family history of this deficiency, or a history of certain blood problems (eg, hemolysis)
  • if you have a history of substance abuse or dependence, mental or mood problems (eg, depression), or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with phenazopyridine/butabarbital/hyoscyamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of phenazopyridine/butabarbital/hyoscyamine's side effects
  • Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by phenazopyridine/butabarbital/hyoscyamine
  • Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, micronized estradiol), griseofulvin, ketoconazole, metronidazole, oral contraceptives (birth control pills), phenytoin, quinidine, theophylline, or valproic acid because their effectiveness may be decreased by phenazopyridine/butabarbital/hyoscyamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if phenazopyridine/butabarbital/hyoscyamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use phenazopyridine/ butabarbital/ hyoscyamine:

Use phenazopyridine/butabarbital/hyoscyamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take phenazopyridine/butabarbital/hyoscyamine by mouth after meals.
  • Taking phenazopyridine/butabarbital/hyoscyamine at the same time(s) each day will help you remember to take it.
  • If you miss a dose of phenazopyridine/butabarbital/hyoscyamine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use phenazopyridine/butabarbital/hyoscyamine.

Important safety information:

  • Phenazopyridine/butabarbital/hyoscyamine may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use phenazopyridine/butabarbital/hyoscyamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using phenazopyridine/butabarbital/hyoscyamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use for longer than 2 days without checking with your doctor.
  • Phenazopyridine/butabarbital/hyoscyamine may change the color of your urine to orange or red. It may also stain fabric. This is normal and not a cause for concern.
  • Do not wear soft contact lenses while taking phenazopyridine/butabarbital/hyoscyamine; permanent staining of the lenses may occur.
  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
  • Phenazopyridine/butabarbital/hyoscyamine may cause dry mouth. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using phenazopyridine/butabarbital/hyoscyamine. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Phenazopyridine/butabarbital/hyoscyamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
  • Tell your doctor or dentist that you take phenazopyridine/butabarbital/hyoscyamine before you receive any medical or dental care, emergency care, or surgery.
  • Do not use phenazopyridine/butabarbital/hyoscyamine for future urinary tract problems without first checking with your doctor.
  • Phenazopyridine/butabarbital/hyoscyamine may interfere with certain lab tests, including urinalysis. Be sure your doctor and lab personnel know you are taking phenazopyridine/butabarbital/hyoscyamine.
  • Use phenazopyridine/butabarbital/hyoscyamine with caution in the ELDERLY; they may be more sensitive to its effects, agitation, confusion, drowsiness, dry mouth, especially constipation, excitability, memory problems, or trouble urinating.
  • PREGNANCY AND BREAST-FEEDING: It is not known if phenazopyridine/butabarbital/hyoscyamine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using phenazopyridine/butabarbital/hyoscyamine while you are pregnant. Phenazopyridine/butabarbital/hyoscyamine is found in breast milk. If you are or will be breast-feeding while taking phenazopyridine/butabarbital/hyoscyamine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of phenazopyridine/ butabarbital/ hyoscyamine:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excessive daytime drowsiness; excitability; headache; lightheadedness; nausea; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; blue or purple skin color; confusion; decreased urination; disorientation; fainting; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; mental or mood changes (eg, agitation, unusual behavior changes); shortness of breath; unusual tiredness or weakness; vision changes (eg, trouble focusing eyes); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blue or purple skin color; disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing; unusual fatigue.

Proper storage of phenazopyridine/butabarbital/hyoscyamine:

Store phenazopyridine/butabarbital/hyoscyamine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep phenazopyridine/butabarbital/hyoscyamine out of the reach of children and away from pets.

General information:

  • If you have any questions about phenazopyridine/butabarbital/hyoscyamine, please talk with your doctor, pharmacist, or other health care provider.
  • Phenazopyridine/butabarbital/hyoscyamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take phenazopyridine/butabarbital/hyoscyamine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about phenazopyridine/butabarbital/hyoscyamine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to phenazopyridine/butabarbital/hyoscyamine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using phenazopyridine/butabarbital/hyoscyamine.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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