{"adverse_reactions":["ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been associated with phenazopyridine, usually at toxic levels (see OVERDOSAGE section). An anaphylactoid-like reaction has been described. Hyoscyamine hydrobromide is an atropinic drug that may produce adverse effects characteristic of this class of drugs. Dry mouth, drowsiness or dizziness is noted in more than one-third of patients (and may occur in half of the patients of older age groups). Other atropine-like effects such as blurred vision may occur. There may be occasional gastrointestinal disturbances. Butabarbital is a short-to-intermediate acting barbiturate which has the potential for adverse reactions attributable to barbiturates, such as drowsiness, nausea, vomiting, abdominal pain, dizziness, and shortness of breath."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Pyrelle ® HB has not undergone adequate studies relating to carcinogenesis, mutagenesis, or impairment of fertility, however the component phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pyrelle® HB relieves lower urinary symptoms of pain, frequency, urgency, burning and dysuria, arising from inflammation of the urothelium, the mucosal lining of the lower urinary tract. Lower urinary tract pain can cause reflex spasm of the detrusor. Pain and spasm are often aggravated by apprehension to promote a pain-spasm-apprehension cycle. Each of the three pharmacologic components of Pyrelle ® HB acts against a phase of this cycle. Phenazopyridine hydrochloride, excreted in the urine, is a topical analgesic for the relief of pain and discomfort. Hyoscyamine hydrobromide, a parasympatholytic, acts to relieve detrusor muscle spasm. Butabarbital, a short-to-intermediate acting sedative, helps to allay associated anxiety and apprehension."],"contraindications":["CONTRAINDICATIONS Pyrelle ® HB should not be used in patients who have previously exhibited hypersensitivity to any component. The use of Pyrelle ® HB is contraindicated in patients with renal or hepatic insufficiency, glaucoma, bladder neck obstruction, porphyria, enlarged prostate, myasthenia gravis, obstructive gastrointestinal tract disease, paralytic ileus, toxic megacolon, ulcerative colitis, and certain cardiac disease (unstable cardiovascular status in acute hemorrhage, myocardial ischemia)."],"description":["DESCRIPTION Each Pyrelle ® HB tablet contains: 150 mg phenazopyridine hydrochloride, 0.3 mg hyoscyamine hydrobromide, 15 mg butabarbital. Also contains: FD&C Blue #1 Lake, FD&C Blue #2 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hypromellose, Lactose, Magnesium Stearate, Magnesium Silicate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Silica, Sodium Starch Glycolate, Starch, Stearic Acid and Titanium Dioxide."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adult dosage: One tablet 4 times a day (after meals and at bedtime). When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Pyrelle ® HB should not exceed 2 days."],"drug_interactions":["DRUG INTERACTIONS Before using Pyrelle ® HB, inform your doctor of any over-the-counter or prescription medication you take, including but not limited to: antidepressants, anticholinergics, pramlintide, secretin, potassium salts, calcium channel blockers, chloramphenicol, cyclosporine, disopyramide, doxycycline, griseofulvin, lamotrigine, methadone, propafenone, quinidine, warfarin, voriconazole, sedatives, tranquilizers, narcotic pain relievers, and sleeping pills. Pyrelle ® HB may also interfere with the effectiveness of birth control medication, therefore, consult with your doctor on additional forms of birth control."],"effective_time":"20100510","general_precautions":["General A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion of phenazopyridine and the need to discontinue therapy. The elderly are at a greater risk of accumulation due to declining renal function associated with age, therefore, use with caution in elderly."],"how_supplied":["HOW SUPPLIED Pyrelle ® HB tablets are dark maroon capsule-shaped, coated tablets with P-009 debossed on one side and are available in bottles of 30. NDC 66663-702-01 Store at controlled room temperature 15º to 30º C (59º to 86º F). KEEP OUT OF THE REACH OF CHILDREN. AZUR PHARMA Distributed by: Azur Pharma, Inc. • 1818 Market Street • Suite 2350 Philadelphia, PA 19103 • www.azurpharma.com Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788 • www.cpc.com To report a serious adverse event or obtain product information, contact (800) 890 3098. PYRL-09/01 R 08/09"],"id":"b5c22ac0-3fd2-422c-856c-189908dcfbc9","indications_and_usage":["INDICATIONS AND USAGE Pyrelle ® HB is indicated for the symptomatic relief of pain, burning, frequency, urgency and dysuria, particularly when accompanied by the detrusor muscle spasm and apprehension. These symptoms may arise from infection, trauma, surgery, endoscopic procedures, or the passage of stones or catheters. Therapy with Pyrelle ® HB does not interfere with antibacterial therapy and can help to relieve symptoms of pain and discomfort before definitive treatment is effective. The use of Pyrelle ® HB for symptomatic relief should not delay definitive diagnosis and treatment. Treatment of a urinary tract infection with Pyrelle ® HB should not exceed 2 days because there is lack of evidence that the combined administration of phenazopyridine hydrochloride and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION Section). In the absence of infection, Pyrelle ® HB may be the only medication required."],"information_for_patients":["Information for Patients Phenazopyridine hydrochloride produces an orange to red color in the urine and may stain fabric. Staining of contact lenses has been reported. Butabarbital may cause drowsiness or dizziness; patients should be instructed to use caution in driving or operating machinery."],"laboratory_tests":["Laboratory Tests Interactions Due to its properties as an azo dye, phenazopyridine hydrochloride may interfere with urinalysis based on spectrometry or color reactions."],"openfda":{},"overdosage":["OVERDOSAGE Pyrelle ® HB is a combination of three active drugs and the overdosage can be expected to show the effects related to each ingredient. Management includes the usual measures to empty the stomach by emesis or lavage, administration of a charcoal slurry, and supportive measures as needed. Toxicity and management suggestions relating to the individual ingredients are as follows: Phenazopyridine hydrochloride Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients), may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg body weight intravenously, should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and \"bite cells\" (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur. Hyoscyamine hydrobromide Overdosage of hyoscyamine, a form of atropine, will cause dilated pupils, blurred vision, rapid pulse, increased intraoccular tension, hot, dry, red skin, dry mouth, disorientation, delirium, fever, convulsions, and coma. As an antidote, physostigmine salicylate may be given IV slowly. Dilute 1 mg in 5 mL of saline and use 1 mL of this dilution in children. Repeat every five minutes as needed up to a total of 2 mg in children, or 6 mg in adults every 30 minutes. Butabarbital This drug may produce sedation and respiratory depression progressing to coma, depending on the amount ingested. General and supportive measures should be instituted."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 66663-702-01 RELIEVES Pain, Burning and Frequency of Urination associated with urinary tract infections pyrelle ® H.B. RX Only 30 Tablets Description : Pyrelle ® HB tablets for oral administration are supplied as dark maroon coated capsule-shaped tablets with P-009 debossed on one side. Each Tablet Contains: phenazopyridine hydrochloride...........150 mg hyoscyamine hydrobromide..................0.3 mg butabarbital...........................................15 mg Also contains, FD&C Blue #1 Lake, FD&C Blue #2 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Hypromellose, Lactose, Magnesium Stearate, Magnesium Silicate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Silica, Sodium Starch Glycolate, Starch, Stearic Acid and Titanium Dioxide. KEEP OUT OF THE REACH OF CHILDREN Store at room temperature, USP. See package insert for more information. To report a serious adverse event or obtain product information, contact (800) 890 3098 Distributed by: AZUR PHARMA, INC. 1818 Market Street, Suite 2350, Philadelphia, PA 19103 www.azurpharma.com Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788 PYRL-09/02 Principal Display Panel - Bottle Label"],"pediatric_use":["Nursing Mothers Pyrelle ® HB contains a barbiturate. Barbiturates pass into breast milk and may have undesirable effects on nursing infants. Hyoscyamine also enters the breast milk. It is unknown whether phenazopyridine enters breast milk. Using this drug while breast-feeding is not recommended."],"precautions":["PRECAUTIONS General A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion of phenazopyridine and the need to discontinue therapy. The elderly are at a greater risk of accumulation due to declining renal function associated with age, therefore, use with caution in elderly. Information for Patients Phenazopyridine hydrochloride produces an orange to red color in the urine and may stain fabric. Staining of contact lenses has been reported. Butabarbital may cause drowsiness or dizziness; patients should be instructed to use caution in driving or operating machinery. Laboratory Tests Interactions Due to its properties as an azo dye, phenazopyridine hydrochloride may interfere with urinalysis based on spectrometry or color reactions. Carcinogenesis, Mutagenesis, Impairment of Fertility Pyrelle ® HB has not undergone adequate studies relating to carcinogenesis, mutagenesis, or impairment of fertility, however the component phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. Pregnancy Category D Animal reproduction studies have not been conducted with Pyrelle ® HB, however, barbiturates, such as butabarbital, can cross the placenta and cause harm to the fetus. Hyoscyamine can also cross the placenta, but effects to the fetus are not known. Pyrelle ® HB should only be given to a pregnant woman if clearly needed. Nursing Mothers Pyrelle ® HB contains a barbiturate. Barbiturates pass into breast milk and may have undesirable effects on nursing infants. Hyoscyamine also enters the breast milk. It is unknown whether phenazopyridine enters breast milk. Using this drug while breast-feeding is not recommended."],"pregnancy":["Pregnancy Category D Animal reproduction studies have not been conducted with Pyrelle ® HB, however, barbiturates, such as butabarbital, can cross the placenta and cause harm to the fetus. Hyoscyamine can also cross the placenta, but effects to the fetus are not known. Pyrelle ® HB should only be given to a pregnant woman if clearly needed."],"set_id":"b5c22ac0-3fd2-422c-856c-189908dcfbc9","spl_product_data_elements":["Pyrelle H.B. Phenazopyridine hydrochloride, hycosamine hydrobromide and butabarbital FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE LACTOSE MAGNESIUM STEARATE MAGNESIUM ALUMINUM SILICATE MINERAL OIL POLYETHYLENE GLYCOL SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE HYOSCYAMINE HYDROBROMIDE HYOSCYAMINE BUTABARBITAL BUTABARBITAL CELLULOSE, MICROCRYSTALLINE Dark Maroon Capsule P009"],"version":"1","warnings":["WARNING Drowsiness or dizziness may occur. Patients should be instructed to use caution in driving or operating machinery."]}