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DRUGS & SUPPLEMENTS
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Urispas
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Urispas uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
Urispas HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Urispas HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
CONTRAINDICATIONS
Urispas HCl tablets are contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
WARNINGS
Urispas HCl should be given cautiously in patients with suspected glaucoma.
PRECAUTIONS
Information for Patients:
Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Urispas HCl have not been performed.
Pregnancy:
Teratogenic Effects–Pregnancy Category B.
Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Urispas HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urispas HCl is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness in children below the age of 12 years have not been established.
ADVERSE REACTIONS
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
Gastrointestinal: Nausea, vomiting, dry mouth.
CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.
Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).
Cardiovascular: Tachycardia and palpitation.
Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.
Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.
Renal: Dysuria.
OVERDOSAGE
The oral LD50 for Urispas HCl in rats is 4273 mg/kg. The oral LD50 for Urispas HCl in mice is 1837 mg/kg.
It is not known whether Urispas HCl is dialyzable.
DOSAGE AND ADMINISTRATION
Adults and children over 12 years of age:
One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
HOW SUPPLIED
Urispas HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed "PAD" and "0115" on one side and plain on the other side, in bottles of 100.
100 mg 100's:
NDC 0574-0115-01
Store at 20° to 25°C (68° to 77°F)
Manufactured For
Perrigo®
Minneapolis, MN 55427
Manufactured by:
Mikart, INC.
Atlanta, GA 30318
Code 917A00
7H700 RC J1
Rev 03-14 A
Urispas pharmaceutical active ingredients containing related brand and generic drugs:
Urispas available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.