URIBEL

Star Pharmaceuticals, LLC

Uribel

FULL PRESCRIBING INFORMATION: CONTENTS*

• URIBEL DESCRIPTION
• CLINICAL PHARMACOLOGY
• URIBEL INDICATIONS AND USAGE
• URIBEL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Cross sensitivity and/or related problems
  • Pregnancy/Reproduction (FDA Pregnancy Category C)
  • Breast feeding
  • Prolonged use
  • Pediatric
  • Geriatric Use
• URIBEL ADVERSE REACTIONS
  • Drug interactions
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• URIBEL DOSAGE AND ADMINISTRATION
  • Adults
  • Older Children
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only
100 Capsules

URIBEL DESCRIPTION

Uribel^™ capsules for oral administration

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. C₃₄H₄₈N₂O₁₀S. 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.

METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1 ^3,7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C₆H₁₂N₄; 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.

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. C₁₆H₁₈ClN₃S; 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.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C₁₃H₁₀O₃; 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.

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; H₂NaO₄P; 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.

Uribel^™ capsules contain inactive ingredients: Dicalcium Phosphate, FD&C Blue #1, FD&C Red #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 within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70%-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 at a pH of 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 pH greater than 6.8.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal tract and rapidly reduced to leukomethylene blue 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.

URIBEL 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 accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

URIBEL CONTRAINDICATIONS

Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully 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).

WARNINGS

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

PRECAUTIONS

Cross sensitivity and/or related problems

patients intolerant of belladonna alkaloids or 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 concerning the effect of hyoscyamine and methenamine on pregnancy and reproduction have not been done in animals or humans. Thus it is not known whether Uribel^™ capsules cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uribel^™ capsules should be given to a pregnant woman only if clearly needed.

Breast feeding

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

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

use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness or confusion.

URIBEL 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 trouble breathing

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 Star Pharmaceuticals, LLC at 1-800-845-7827 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.

Drug interactions

because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be advised that the urine may become blue to blue-green and the feces may be discolored as a result of the excretion of the Methylene blue.

DRUG ABUSE AND DEPENDENCE

A dependence on the use of Uribel^™ capsules has not been reported and due to the nature of its ingredients, abuse of Uribel^™ capsules is not 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 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 your local poison center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

URIBEL DOSAGE AND ADMINISTRATION

Adults

one capsule orally 4 times per day followed by liberal fluid intake.

Older Children

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

HOW SUPPLIED

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

STORAGE

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

Store at controlled room temperature 15°-30°C (59°- 86°F).

Keep in a cool, dry place.
Keep container tightly closed.

WARNING: Keep this and all drugs out of reach of children.

Rx Only

Uribel^™ is a trademark of Star Pharmaceuticals, LLC

Distributed by:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230

Manufactured for:
STAR PHARMACEUTICALS, LLC
New Brunswick, NJ 08901

Rev. 11101-20 04/10

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

NDC 0076-0111-01

Uribel^™

EACH CAPSULE CONTAINS

Rx ONLY

100 Capsules

Uribel^™ is a trademark of Star Pharmaceuticals, LLC

Distributed by:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230

Manufactured for:
STAR PHARMACEUTICALS, LLC
New Brunswick, NJ 08901