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Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate

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Overview

What is UroAv-B?

UroAv-B Capsules for oral administration.

Each tablet contains: Methenamine                                 118 mg Sodium Phosphate Monobasic       40.8 mg Phenyl Salicylate                            36 mg Methylene Blue                              10 mg Hyoscyamine Sulfate                     0.12 mg

Inactive ingredients: Lactose, Polyethylene Glycol, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, FD&C Blue # 1, FD&C Red # 3, Titanium Dioxide, Gelatin.

METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 ] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C H N ; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform.

SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H NaO P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C H O ; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol.

METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C H ClN S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

HYOSCYAMINE SULFATE. [620-61-1] [3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C H N O S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.



What does UroAv-B look like?



What are the available doses of UroAv-B?

Sorry No records found.

What should I talk to my health care provider before I take UroAv-B?

Sorry No records found

How should I use UroAv-B?

UroAv-B Capsules are indicated for the treatment of symptoms of irritative voiding.

Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections.

Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Adults: One tablet orally 4 times per day followed by liberal fluid intake. 

Pediatric: Dosage must be individualized by physician for older children. Not recommended for use in children six years of age or younger.


What interacts with UroAv-B?

UroAv-B Capsules are contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).



What are the warnings of UroAv-B?

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.

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.


What are the precautions of UroAv-B?

Cross sensitivity and/or related problems: Patients intolerant of other belladonna alkaloids or other salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

Pregnancy/Reproduction (FDA Pregnancy Category C):

Hyoscyamine and methenamine cross the placenta. Studies have not been done in either animals or humans. It is not known whether UroAv-B Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  UroAv-B Capsules should be given to a pregnant woman only if clearly needed.

Nursing mothers:

Methenamine and traces of hyoscyamine are excreted in breast milk. Caution should be exercised when UroAv-B Capsules are administered to a nursing mother.

Prolonged use: There have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric:

Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric:

Use with caution in elderly patients as they may respond to the usual doses of the belladonna alkaloids with excitement, agitation, drowsiness, or confusion.


What are the side effects of UroAv-B?

Cardiovascular - rapid pulse, flushing

Central Nervous System - blurred vision, dizziness, drowsiness

Respiratory - shortness of breath or troubled breathing

Genitourinary - difficult micturition, acute urinary retention

Gastrointestinal -dry mouth, nausea and vomiting

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or

.


What should I look out for while using UroAv-B?

UroAv-B Capsules are contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Keep this and all drugs out of reach of children.

Rx Only

Manufactured for: AvKARE, Inc. Pulaski, TN  38478

Mfg. Rev. 10/14 AV 03/16 (P)


What might happen if I take too much UroAv-B?

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children) repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. 

Administration of small doses of diazepam to control excitement and seizures.

Artificial respiration with oxygen if needed for respiratory depression. 

Adequate hydration. 

Symptomatic treatment as necessary.

If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately.


How should I store and handle UroAv-B?

Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. Storage and HandlingStore in a dry place at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. Keep out of the reach of children. UroAv-B Capsules are blue capsules imprinted with 200, available in bottles of 100 capsules, (NDC: 42291-852-01).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70 to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at a pH greater than 6.8.

SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.

HYOSCYAMINE SULFATE is a parasympatholytic drug which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Protein binding for hyoscyamine sulfate is moderate and biotransformation is hepatic.

Non-Clinical Toxicology
UroAv-B Capsules are contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Keep this and all drugs out of reach of children.

Rx Only

Manufactured for: AvKARE, Inc. Pulaski, TN  38478

Mfg. Rev. 10/14 AV 03/16 (P)

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracycline may render oral contraceptives less effective.

Cross sensitivity and/or related problems: Patients intolerant of other belladonna alkaloids or other salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

Cardiovascular - rapid pulse, flushing

Central Nervous System - blurred vision, dizziness, drowsiness

Respiratory - shortness of breath or troubled breathing

Genitourinary - difficult micturition, acute urinary retention

Gastrointestinal -dry mouth, nausea and vomiting

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or

.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).