What Is Uribel Used For

DESCRIPTION

Uribel ™ capsules for oral administration

Each capsule contains:
Methenamine	118 mg
Sodium Phosphate Monobasic	40.viii mg
Phenyl Salicylate	36 mg
Methylene Blue	ten mg
Hyoscyamine Sulfate	0.12 mg

HYOSCYAMINE SULFATE. [620-61-i] [3(S)- endo]-α-(Hydroxymethyl)-benzeneacetic acid viii-methyl-8-azabicyclo[3.2.i]oct-iii-yl ester sulfate(ii:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate (ester) sulfate(2:ane)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C 34H 48N 2O 10Due south. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists equally a white crystalline powder. Its solutions are alkaline to litmus. Affected past light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.

METHENAMINE. [100-97-0] 1,three,five,7-Tetraazatricyclo [3.3.1.-i 3,seven] decane; hexamethylenetetramine; HMT; HMTA; hexamine; ane,3,v,seven-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C half-dozenH 12N 4; mol wt 140.19; C 51.40%, H eight.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkali metal to litmus. Freely soluble in water, soluble in alcohol and in chloroform.

METHYLENE Blue. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-v-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,vii-bis(dimethylamino) phenazathionium chloride. C sixteenH 18ClN 3S; mol wt 319.85, C threescore.08%, H 5.67%, Cl xi.08%, North 13.xiv%, S 10.03%. Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C 13H tenO iii; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Fabricated by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acrid. 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 booze.

SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:i); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; H 2NaO fourP; mol wt 119.98, H ane.68%, Na xix.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly dissolve crystals or granules. At 100° C loses all its water; when ignited information technology converts to metaphosphate. Information technology is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 tooth aqueous solution at 25° C: 4.v.

Uribel ™ capsules incorporate inactive ingredients: Dicalcium Phosphate, FD&C Blueish #i, FD&C Reddish #3, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Shellac, Silicon Dioxide, Sodium Hydroxide, Stearic Acid, and Titanium Dioxide.

CLINICAL PHARMACOLOGY

HYOSCYAMINE SULFATE is a parasympatholytic 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 inside 12 hours, xiii% to fifty% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.

METHENAMINE degrades in an acidic urine surroundings releasing formaldehyde which provides bactericidal or bacteriostatic activeness. It is well absorbed from the gastrointestinal tract. 70%-ninety% reaches the urine unchanged at which point information technology is hydrolyzed if the urine is acidic. Inside 24 hours it is almost completely (90%) excreted; of this at a pH of 5, approximately twenty% is formaldehyde. Protein bounden – some formaldehyde is jump to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids just is not clinically significant as it does non hydrolyze at pH greater than half-dozen.8.

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

PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.

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

INDICATIONS AND USAGE

Uribel ™ capsules indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which back-trail lower urinary tract infections. Indicated for the relief of urinary tract symptoms acquired past diagnostic procedures.

CONTRAINDICATIONS

Hypersensitivity to whatever of the ingredients is possible. Risk benefits should be carefully considered when the following medical issues be: cardiac disease (especially cardiac arrhythmias, congestive center failure, coronary heart disease, and mitral stenosis); alimentary canal obstructive disease; glaucoma; myasthenia gravis, acute urinary retentiveness may be precipitated in obstructive uropathy (such equally float neck obstruction due to prostatic hypertrophy).

WARNINGS

Do non exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue employ immediately.

PRECAUTIONS

Cross sensitivity and/or related bug

patients intolerant of belladonna alkaloids or salicylates may exist 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 concerning the upshot of hyoscyamine and methenamine on pregnancy and reproduction have not been washed in animals or humans. Thus it is not known whether Uribel ™ capsules cause fetal harm when administered to a pregnant adult female or can touch on reproduction capacity. Uribel ™ capsules should be given to a meaning woman but if clearly needed.

Chest feeding

problems in humans have not been documented; even so, methenamine and traces of hyoscyamine are excreted in breast milk. Appropriately, Uribel ™ capsules should exist given to a nursing mother with caution and only if clearly needed.

Prolonged utilise

in that location have been no studies to constitute the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric

infants and immature children are especially susceptible to the toxic outcome of the belladonna alkaloids.

Geriatric Use

utilize with circumspection in elderly patients every bit they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.

ADVERSE REACTIONS

Cardiovascular: rapid heartbeat, flushing

Central Nervous System: blurred vision, dizziness, drowsiness

Genitourinary: difficulty micturition, acute urinary retention

Gastrointestinal: dry mouth, nausea and vomiting

Respiratory: shortness of breath or problem animate

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

This medication tin can cause urine and sometimes stools to turn blue to blue-green. This effect is harmless and volition subside afterwards medication is stopped.

Call your doctor or dr. for medical communication almost side furnishings. To study SUSPECTED ADVERSE REACTIONS, contact Star Pharmaceuticals, LLC at 1-800-845-7827 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug interactions

because of this production's consequence on gastrointestinal move and gastric elimination, it may subtract the absorption of other oral medications during concurrent use such every bit: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent utilize may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce assimilation of hyoscyamine, concurrent utilise with antacids may cause urine to become alkaline metal, reducing effectiveness of methenamine past inhibiting its conversion to formaldehyde). Doses of these medications should be spaced i hour apart from doses of hyoscyamine; antimyasthenics (concurrent apply with hyoscyamine may further reduce abdominal motility); ketoconazole (patients should be advised to take this combination at least ii hours later on ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may upshot in increased adventure of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be brash that the urine may become blue to blue-greenish and the feces may be discolored as a result of the excretion of the Methylene blue.

DRUG ABUSE AND DEPENDENCE

A dependence on the employ of Uribel ™ capsules has not been reported and due to the nature of its ingredients, corruption of Uribel ™ capsules is non expected.

OVERDOSAGE

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 ii hours to contrary severe antimuscarinic symptoms.

Assistants of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory low. Acceptable hydration. Symptomatic handling as necessary.

If overdose is suspected, contact your local poison middle or emergency room immediately. Usa residents can contact the US National Poison Hotline at 1-800-222-1222.

DOSAGE AND ADMINISTRATION

Adults

i sheathing orally 4 times per day followed by liberal fluid intake.

Older Children

Dosage must be individualized by physician. Not recommended for use in children vi years of historic period or younger.

HOW SUPPLIED

Uribel ™ capsules are majestic/regal capsules imprinted "Southward 111". NDC 0076-0111-01, Bottle of 100 Capsules and NDC 0076-0111-02, Carton of 20 individually pouched capsules.

STORAGE

Manipulate in a tight, light-resistant container as divers in the USP/NF with a child resistant closure.

Store at controlled room temperature fifteen°-30°C (59°- 86°F).

Keep in a cool, dry place.
Continue container tightly airtight.

Alarm: Continue this and all drugs out of reach of children.

Rx Only

Uribel ™ is a trademark of Star Pharmaceuticals, LLC

Distributed past:

MISSION PHARMACAL COMPANY

San Antonio, TX 78230

Manufactured for:

STAR PHARMACEUTICALS, LLC

Ft. Lauderdale, FL 33306

Rev. 11101-24 06/12

SPL Unclassified Section 100 Capsule Bottle Label

NDC 0076-0111-01

Uribel ™

EACH Sheathing CONTAINS

Methenamine 118 mg

Sodium Phosphate Monobasic 40.8 mg

Phenyl Salicylate 36 mg

Methylene Blueish 10 mg

Hyoscyamine Sulfate 0.12 mg

Rx Just

100 Capsules

Uribel ™ is a trademark of Star Pharmaceuticals, LLC

Distributed past:

MISSION PHARMACAL Visitor

San Antonio, TX 78230

Manufactured for:

STAR PHARMACEUTICALS, LLC

Ft. Lauderdale, FL33306

Uribel