Pill Identifier App

Atropine, Hyoscyamine, Methenamine, Methylene Blue, Phenyl Salicylate, and Benzoic Acid (Systemic)


VA CLASSIFICATION
Primary: GU201

Commonly used brand name(s): Atrosept; Dolsed; Hexalol; Prosed/DS; Trac Tabs 2X; UAA; Uridon Modified; Urimed; Urinary Antiseptic No. 2; Urised; Uriseptic; Uritab; Uritin; Uro-Ves.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Anticholinergic-antibacterial-analgesic (urinary tract)—

Indications

Accepted

Irritative voiding, symptoms of (treatment)—Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. {01} {08}

Diagnostic procedure–induced symptoms, urinary (treatment)—Indicated for the relief of urinary tract symptoms caused by diagnostic procedures. {01}

Unaccepted
This combination has a labeled indication for the treatment of cystitis, urethritis, and trigonitis caused by organisms that maintain or produce an acid urine and are susceptible to formaldehyde. {05} In addition, it has a labeled indication for the prevention of recurring urinary tract infections. However, the main value of this medication consists in the management of the symptomatology of lower urinary tract infections and it is best used when the acute infection has been destroyed by other antibacterial agents. It is not intended as the primary drug for treatment or as prophylactic therapy in these conditions.


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:


Anticholinergic:

Atropine; hyoscyamine: Relax smooth muscle spasm by inhibiting the muscarinic actions of acetylcholine on autonomic effectors innervated by postganglionic cholinergic nerves as well as on smooth muscle, which responds to endogenous acetylcholine but is not so innervated. {31}



Antibacterial:

Methenamine: Hydrolyzation of methenamine, in acidic urine, releases formaldehyde, which provides bactericidal or bacteriostatic action, depending on urine pH, volume, and flow rate. {06} {08}

Methylene blue: Mild antiseptic activity {31} may inhibit bacterial proliferation; relatively ineffective in the treatment of urinary tract infections.

Benzoic acid: Mild antibacterial and antifungal action. It also helps maintain an acid pH in the urine necessary for the degradation of methenamine. {01}



Analgesic:

Phenyl salicylate: Produces analgesia through a peripheral action by blocking pain impulse generation and via a central action, possibly in the hypothalamus.



Other actions/effects:

Phenyl salicylate—May produce antipyresis by acting centrally on the hypothalamic heat-regulating center to produce peripheral vasodilation, resulting in increased cutaneous blood flow, sweating, and heat loss.

Absorption:

Well absorbed from gastrointestinal tract. {01}

Distribution:

Methenamine—Freely distributed to body tissues and fluids, but not clinically significant because methenamine does not hydrolyze at pH greater than 6.8 {01}

Protein binding:

Atropine; hyoscyamine—Moderate. {01}

Methenamine—Some formaldehyde is bound to substances in the urine and the surrounding tissues. {01}

Biotransformation:

Atropine; hyoscyamine—Hepatic. {01}

Methenamine—Urine (70 to 90% of methenamine reaches the urine unchanged where it is hydrolyzed if the urine is acidic). {01}

Elimination:
    Renal. {01}
    Atropine—30 to 50% excreted unchanged. {01}
    Hyoscyamine—Majority excreted unchanged. {01}
    Methenamine—Almost completely (90%) excreted within 24 hours; of this amount at pH 5, approximately 20% is formaldehyde. {01} {08}
    Methylene blue—75% excreted unchanged. {01}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other belladonna alkaloids or other salicylates may be sensitive to this medication also. {01}

Pregnancy/Reproduction

Pregnancy—
Atropine, hyoscyamine, and methenamine cross the placenta. Studies have not been done in humans. {01}

Studies have not been done in animals.

FDA Pregnancy Category C. {01}

Breast-feeding

Methenamine {03} and traces of atropine and hyoscyamine are distributed into breast milk. However problems in humans have not been documented. {01} {03}

Pediatrics

No information is available on the relationship of age to the effects of this combination in pediatric patients. However, it is known that infants and young children are especially susceptible to the toxic effects of the belladonna alkaloids. {01}

Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required.

When anticholinergics are given to children where the environmental temperature is high, there is risk of a rapid increase in body temperature because of these medications' suppression of sweat gland activity.

A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.


Geriatrics


No information is available on the relationship of age to the effects of this combination in geriatric patients. However, it is known that geriatric patients may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion. {01} {03} Also, geriatric patients are especially susceptible to anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). {03}

In addition, caution is recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma.

Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of atropine and hyoscyamine since these medications block the action of acetylcholine, which is responsible for many functions of the brain, including memory functions. {07} {11}


Dental

Prolonged use of belladonna alkaloids may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort. {04}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Only specific interactions between this combination medication and other oral medications have been identified in this monograph. However, because of atropine's and hyoscyamine's effects on gastrointestinal motility and gastric emptying, absorption of other oral medications may be decreased during concurrent use with this combination medication. {01}

» Alkalizers, urinary, such as:{01}{15}{17}
Antacids, calcium- and/or magnesium-containing
Carbonic anhydrase inhibitors{03}
Citrates
Sodium bicarbonate or{03}{08}
» Diuretics, thiazide{13}{14}    (may cause the urine to become alkaline, thereby reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde; concurrent use is not recommended {15} {17})


» Anticholinergics, other, or other medications with anticholinergic action (See Appendix II )    (concurrent use of these medications may intensify anticholinergic effects of atropine and hyoscyamine; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy {01} {15} {22})


» Antacids or
» Antidiarrheals, adsorbent    (simultaneous use of these medications with this combination medication may reduce absorption of atropine and hyoscyamine, resulting in decreased therapeutic effectiveness; doses of these medications should be spaced 2 to 3 hours apart from doses of atropine and hyoscyamine {01} {26} {27})

    (concurrent use of this combination medication with antacids, especially calcium carbonate–, magnesium-, or sodium bicarbonate–containing, may cause the urine to become alkaline, thereby reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde; simultaneous use may reduce absorption of atropine and hyoscyamine, resulting in decreased therapeutic effectiveness {01} {16} {17})


» Ketoconazole    (atropine and hyoscyamine may cause increased gastrointestinal pH; concurrent administration of ketoconazole with atropine and hyoscyamine may result in a marked reduction in absorption of ketoconazole; patients should be advised to take this combination at least 2 hours after ketoconazole {01} {18})


Metoclopramide    (concurrent use of metoclopramide with atropine and hyoscyamine may antagonize the effects of metoclopramide on gastrointestinal motility {19} {21})


Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (concurrent use may result in intensified anticholinergic side effects because of these medications' secondary anticholinergic activities; also, concurrent use of MAO inhibitors may block detoxification of anticholinergics, thus potentiating their action {01} {02} {20})


Opioid (narcotic) analgesics    (concurrent use of opioids with atropine and hyoscyamine may result in increased risk of severe constipation, which may lead to paralytic ileus, and/or urinary retention {01} {29} {30})


» Potassium chloride, especially wax matrix preparations    (concurrent use with atropine and hyoscyamine may increase severity of potassium chloride–induced gastrointestinal lesions {23} {24} {25})


» Sulfonamides    (in acid urine, methenamine breaks down into formaldehyde, which may form an insoluble precipitate with certain sulfonamides and may also increase the danger of crystalluria; concurrent use is not recommended {01} {08} {15} {16})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Catecholamine determinations, urinary and{03}
17-hydroxycorticosteroid (17-OHCS) determinations, urinary and{08}
Vanillylmandelic acid (VMA), urinary{08}    (methenamine may cause a false increase {03})


Estriol determinations, urinary and{08}
5-Hydroxy indoleacetic acid (5-HIAA) determinations, urinary{08}    (methenamine may cause a false decrease)


» Gastric acid secretion test    (atropine and hyoscyamine may antagonize the effect of pentagastrin and histamine in the evaluation of gastic acid secretory function; {33} administration of this combination is not recommended during the 24 hours preceding the test)


» Phenolsulfonphthalein (PSP) excretion test    (methylene blue may cause a false positive {34})


Radionuclide gastric emptying studies    (atropine and hyoscyamine may result in delayed gastric emptying {10} {12})


Urinary free formaldehyde and
Urine pH    (methylene blue may interfere with analysis)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist {01} {08}
Brain damage, in children{28}    (CNS effects may be exacerbated by atropine and hyoscyamine)


» Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis{01} or
» Hemorrhage, acute, with tachycardia or{38}
Hyperthyroidism or{01}
Tachycardia{35}    (increase in heart rate caused by atropine and hyoscyamine may be undesirable {01} {12} {15} {16})


Dehydration, severe or
Renal function impairment    (inadequate concentrations of this combination medicine may be achieved in urine; {03} salts of methenamine may precipitate, causing crystalluria in patients with low urine output {08})


» Esophagitis, reflux{37}    (decrease in esophageal and gastric motility {39} and relaxation of lower esophageal sphincter caused by atropine and hyoscyamine may promote gastric retention by delaying gastric emptying and may increase gastroesophageal reflux through an incompetent sphincter)


Fever    (may be increased through suppression of sweat gland activity caused by atropine and hyoscyamine {37})


» Gastrointestinal tract obstructive disease{01}    (decrease in motility and tone caused by atropine and hyoscyamine may result in obstruction and gastric retention)


» Glaucoma, angle-closure, or predisposition to    (mydriatic effect caused by atropine and hyoscyamine may result in increased intraocular pressure and may precipitate an acute attack of angle-closure glaucoma {15} {16})


» Glaucoma, open-angle    (mydriatic effect of atropine and hyoscyamine may cause a slight increase in intraocular pressure; glaucoma therapy may need to be adjusted {15} {16})


Glucose-6-phosphate dehydrogenase (G6PD) deficiency    (use of methylene blue may induce hemolysis {06})


Hepatic function impairment    (decreased metabolism of atropine and hyoscyamine; methenamine may facilitate ammonia production in the intestinal tract {08})


» Hernia, hiatal, associated with reflux esophagitis    (atropine and hyoscyamine may aggravate condition {38})


Hypertension{38}    (atropine and hyoscyamine may aggravate condition)


» Intestinal atony in the elderly or debilitated patient or{37}
» Paralytic ileus{37}    (atropine and hyoscyamine may result in obstruction)


Lung disease, chronic, especially in infants, small children, and debilitated patients    (reduction in bronchial secretion {39} caused by atropine and hyoscyamine can lead to inspissation and formation of bronchial plugs {37})


» Myasthenia gravis{01}    (condition may be aggravated because of inhibition of acetylcholine action {16})


Neuropathy, autonomic{38}    (urinary retention and cycloplegia may be aggravated by atropine and hyoscyamine)


» Prostatic hypertrophy, nonobstructive or
» Urinary retention or{01}
» Uropathy, obstructive, such as bladder neck obstruction due to prostatic hypertrophy{01}    (urinary retention may be precipitated or aggravated by atropine and hyoscyamine {12} {15})


Sensitivity to any of the medications in this combination
Spastic paralysis, in children{38}    (response to atropine and hyoscyamine may be increased)


Toxemia of pregnancy{38}    (hypertension may be aggravated by atropine and hyoscyamine)


Ulcerative colitis{38}    (large doses of atropine and hyoscyamine may suppress intestinal motility, possibly causing paralytic ileus; also, use may precipitate or aggravate toxic megacolon)


Xerostomia    (prolonged use of atropine and hyoscyamine may further reduce limited salivary flow {37})


Caution in use is also recommended in patients over 40 years of age because of the danger of precipitating undiagnosed glaucoma.{12}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Intraocular pressure determinations    (recommended at periodic intervals because atropine and hyoscyamine may increase the intraocular pressure by producing mydriasis {35})


Urine pH    (monitoring recommended before start of treatment and throughout therapy since the effectiveness of methenamine is increased if a pH of 5.5 or below is maintained. {08} To check urine pH, phenaphthazine paper, which has a pH range of 4.5 to 7.5, may be used. However, the presence of methylene blue may interfere with urinary pH determination)




Side/Adverse Effects

Note: This medication should be discontinued immediately if dizziness, increased pulse, or blurring of vision occurs.
Geriatric or debilitated patients may respond to usual doses of atropine and hyoscyamine with excitement, agitation, drowsiness, or confusion. {03}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare {01} {03} {08}
    
Allergic reaction (skin rash or hives){08}
    
difficulty in eye accommodation (blurred vision){01}
    
increased intraocular pressure (eye pain)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Difficult urination —more frequent with large doses over a prolonged period of time{01}
    
dryness of mouth, nose, or throat
    
nausea or vomiting {01}
    
stomach upset or pain —more frequent with large doses over a prolonged period of time{08}



Those not indicating need for medical attention
Incidence more frequent
    
Blue or blue-green urine and/or stools —due to excretion of methylene blue
{01}




Overdose
For specific information on the agents used in the management of this combination product overdose, see:

   • Physostigmine (Systemic) monograph; and/or
   • Diazepam in Benzodiazepines (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)–not necessarily inclusive:
    
Anticholinergic effects (severe drowsiness; dizziness; fast heartbeat; flushing or redness of face; shortness of breath or troubled breathing)
    
hematuria {08}
    
crystalluria (blood in urine; lower back pain; pain or burning while urinating)—due to methenamine{01}
    
salicylate effects (bloody stools; diarrhea; severe or continuing headache; dizziness; ringing or buzzing in ears; sweating; unusual tiredness or weakness)



Treatment of overdose
Recommended treatment for overdose includes: {37}


To decrease absorption:
Emesis or gastric lavage. {32}



Specific treatment:
Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), {32} repeated as needed in one to two hours, to reverse severe anticholinergic symptoms; use of physostigmine with caution and only with cardiac monitoring {36}. Administration of small doses of diazepam to control excitement and seizures.



Supportive care:
Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. {32} Symptomatic treatment as necessary. Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Atropine, Hyoscyamine, Methenamine, Methylene Blue, Phenyl Salicylate, and Benzoic Acid (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to any of the belladonna alkaloids or salicylates

Pregnancy—Crosses the placenta





Breast-feeding—Atropine, hyoscyamine, and methenamine distributed into breast milk





Use in children—Increased susceptibility to toxic effects of belladonna alkaloids; increased response to anticholinergics in children with spastic paralysis or brain damage; suppression of sweat gland activity in children; possibility of paradoxical reaction characterized by hyperexcitability






Use in the elderly—Increased susceptibility to CNS and anticholinergic effects of belladonna alkaloids; danger of precipitating undiagnosed glaucoma; possible impairment of memory





Dental—Possible development of dental problems because of decreased salivary flow
Other medications, especially antacids, other anticholinergics, antidiarrheals, ketoconazole, potassium chloride, sulfonamides, thiazide diuretics, or urinary alkalizers
Other medical problems, especially cardiac disease, fever, glaucoma, hemorrhage, hiatal hernia, intestinal atony or paralytic ileus, lung disease, myasthenia gravis, obstruction in gastrointestinal or urinary tract, prostatic hypertrophy, reflux esophagitis, ulcerative colitis, or xerostomia

Proper use of this medication
» Importance of not taking more medication than the amount prescribed

Maintaining fluid intake for adequate urinary output

» Compliance with full course of therapy

» Importance of maintaining acidic urine (pH 5.5 or below)

Measuring urine pH with phenaphthazine paper; adjusting urine pH with appropriate diet

» Proper dosing
Missed dose: Taking as soon as possible; if almost time for next dose, not taking at all; not doubling doses

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within a few days

Caution during exercise or hot weather; overheating may result in heat stroke

» Caution if blurred vision occurs

Possible dryness of mouth, nose, or throat; using sugarless gum or candy, ice, or saliva substitute for relief; checking with dentist if dry mouth continues for more than 2 weeks

Avoid use of antacids and antidiarrheal medications within 2 or 3 hours of taking this medication


Side/adverse effects
Signs of potential side effects, especially allergic reaction, blurred vision, or eye pain

Blue or blue-green discoloration of urine and/or stools may be alarming to patient although medically insignificant


General Dosing Information
An increase in the patient's fluid intake is not necessary; however, it is recommended that the patient drink enough liquids to satisfy normal fluid requirements and to maintain an adequate urine output.

In order to maintain a urine pH of 5.5 or below, most fruits (especially citrus fruits and juices), milk and other dairy products, and other alkalinizing foods should be avoided. {08} A protein-rich diet with liberal amounts of cranberries (especially ascorbic acid–enriched cranberry juice), plums, or prunes may be helpful. {08} {09} If these measures do not produce a sufficiently acid urine, they may be supplemented with large doses of ascorbic acid (4 grams or more per day), arginine hydrochloride, or methionine. {08} However, some brands of ascorbic acid may contain varying amounts of sodium ascorbate and may actually alkalinize the urine. Alternatively, ammonium chloride or sodium biphosphate may be given (caution—large doses of ammonium chloride may cause metabolic acidosis in patients with impaired renal function and may be contraindicated in patients with hepatic insufficiency).

Urea-splitting organisms (e.g., Proteus mirabilis and some strains of Pseudomonas and Aerobacter ) may cause an increase in urine pH and thereby decrease the effectiveness of methenamine. Care should be taken to ensure urine acidification. {03}


Oral Dosage Forms

ATROPINE SULFATE, HYOSCYAMINE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND BENZOIC ACID TABLETS

Usual adult and adolescent dose
Oral, 1 or 2 tablets (depending on strength of product) four times a day. {01}

Usual pediatric dose
Children up to 6 years of age
Use is not recommended. {01}

Children 6 years of age and over
Dosage must be individualized by physician. {01}


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


30 mcg (0.03 mg) of atropine sulfate, 30 mcg (0.03 mg) of hyoscyamine, 40.8 mg of methenamine, 5.4 mg of methylene blue, 18.1 mg of phenyl salicylate, and 4.5 mg of benzoic acid, per tablet (Rx) [Atrosept] [Dolsed] [Hexalol] [UAA] [Uridon Modified] [Urimed] [Urinary Antiseptic No. 2] [Urised (sugar-coated)] [Uriseptic] [Uritab] [Uritin] [Uro-Ves]


60 mcg (0.06 mg) of atropine sulfate, 30 mcg (0.03 mg) of hyoscyamine, 120 mg of methenamine, 6 mg of methylene blue, 30 mg of phenyl salicylate, and 7.5 mg of benzoic acid, per tablet (Rx) [Trac Tabs 2X]


60 mcg (0.06 mg) of atropine sulfate, 60 mcg (0.06 mg) of hyoscyamine, 81.6 mg of methenamine, 10.8 mg of methylene blue, 36.2 mg of phenyl salicylate, and 9 mg of benzoic acid, per tablet (Rx) [Prosed/DS]

Note: Exact strengths of specific products may vary slightly, depending on manufacturer.


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Take with a full glass of water.
   • May discolor urine and/or stools. {01} {15}

Note: Instruct patient on taking adequate amounts of fluids with each dose and during therapy.




Revised: 05/11/1993



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