Phenazopyridine Plus

Generic Name: phenazopyridine hydrochloride, butabarbital, and hyoscyamine hydrobromide
Dosage Form: tablet, coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Phenazopyridine Plus TABLETS

Rx Only

Phenazopyridine Plus Description

Each Phenazopyridine Plus Tablet contains:

Phenazopyridine Hydrochloride 150 mg
Butabarbital 15 mg
Hyoscyamine Hydrobromide 0.3 mg

Inactive Ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Povidone K-30, Maize Starch, Magnesium Stearate, Hypromellose, Polyethylene Glycol 400, 1FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 40 and Titanium Dioxide.

1
This product contains FD&C Yellow No. 6 as a color additive.

Phenazopyridine Plus - Clinical Pharmacology

Phenazopyridine Plus 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 Phenazopyridine Plus 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.

Indications and Usage for Phenazopyridine Plus

Phenazopyridine Plus 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 sounds or catheters.

Therapy with Phenazopyridine Plus does not interfere with antibacterial therapy and can help to relieve symptoms of pain and discomfort before definitive treatment is effective. The use of Phenazopyridine Plus for symptomatic relief should not delay definitive diagnosis and treatment. Treatment of a urinary tract infection with Phenazopyridine Plus should not exceed 2 days because there is a 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, Phenazopyridine Plus may be the only medication required.

Contraindications

Phenazopyridine Plus should not be used in patients who have previously exhibited hypersensitivity to any component. The use of Phenazopyridine Plus is contraindicated in patients with renal or hepatic insufficiency, glaucoma, bladder neck obstruction, porphyria.

Warnings

Drowsiness or dizziness may occur. Patients should be instructed to use caution in driving or operating machinery.

Not to be used by persons having glaucoma or excessive pressure within the eye, by elderly persons (where undiagnosed glaucoma or excessive pressure within the eye occurs most frequently), or by children under 6 years of age, unless directed by a physician. Discontinue use if blurring of vision, rapid pulse, or dizziness occurs. Do not exceed recommended dosage. Not for frequent or prolonged use. If dryness of the mouth occurs, decrease dosage. If eye pain occurs, discontinue use and see your physician immediately as this may indicate undiagnosed glaucoma.

Precautions

General

A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion of phenazopyridine hydrochloride and the need to discontinue therapy.

The decline in renal function associated with advanced age should be kept in mind.

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 Test 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

Phenazopyridine Plus 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 C

Animal reproduction studies have not been conducted with Phenazopyridine Plus. It is also not known whether Phenazopyridine Plus can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenazopyridine Plus should be given to a pregnant woman only if clearly needed.

Nursing Mothers

No information is available on the appearance of the components of Phenazopyridine Plus in human milk.

Pediatric Use

This product is not indicated for use in the pediatric population.

Adverse Reactions

Headache, rash, pruritus and occasional gastrointestinal disturbance. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been described for phenazopyridine, usually at overdose 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.

Overdosage

Phenazopyridine Plus 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 intraocular 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.

Phenazopyridine Plus 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 Phenazopyridine Plus should not exceed 2 days.

How is Phenazopyridine Plus Supplied

Phenazopyridine Plus tablets are dark brown, coated, imprinted B-251 and are supplied in bottles of 30, NDC 51991-251-33.

Warning: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Lehigh Valley Technologies, Inc., Allentown, PA 18102

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Rev. 11/08

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-251-33

Phenazopyridine
Plus

Rx Only

30 Tablets

Phenazopyridine Plus 
phenazopyridine hydrochloride, butabarbital, and hyoscyamine hydrobromide tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-251
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenazopyridine Hydrochloride (Phenazopyridine) Phenazopyridine Hydrochloride 150 mg
Butabarbital (Butabarbital) Butabarbital 15 mg
Hyoscyamine Hydrobromide (Hyoscyamine) Hyoscyamine Hydrobromide 0.3 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Croscarmellose Sodium  
Povidone  
Starch, Corn  
Magnesium Stearate  
Hypromelloses  
Polyethylene Glycol 400  
FD&C Yellow No. 6  
FD&C Blue No. 1  
FD&C Red No. 40  
Titanium Dioxide  
Product Characteristics
Color BROWN (Dark Brown) Score no score
Shape OVAL (oval) Size 11mm
Flavor Imprint Code B;251
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-251-33 30 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/01/2005 02/28/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Lehigh Valley Technologies 113290444 MANUFACTURE
Revised: 01/2011
 
Breckenridge Pharmaceutical, Inc.
Hide
(web1)