Urasal Granules

Name: Urasal Granules

Adverse Effects

1-10%

Dysuria

Gastric upset

Nausea

Rash

Warnings

Contraindications

Hypersensitivity to methenamine or tartrazine (FD&C Yellow No. 5)

Renal or severe hepatic insufficiency

Concurrent sulfonamides or acetazolamide may form insoluble precipitate in urine

Cautions

Large doses may cause bladder irritation, urinary frequency, albuminuria, hematuria

Maintain acidic pH of urine, especially when treating urea-splitting organisms, e.g. Proteus, Pseudomonas

Monitor LFTs, especially in patients with history of liver impairment

Safe use not established during pregnancy, especially 1st and 2nd trimester

May precipitate uric acid stones in patients with gout

Pregnancy & Lactation

Pregnancy Category: C

Lactation: excreted in breast milk; no adverse effects documented

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Pharmacology

Half-Life: 4.3 hr

Onset: 30 min

Peak Plasma Time: 3-8 hr

Vd: 0.56 L/kg

Excretion: urine; methenamine 90% excreted w/in 24 hr; mandelic or hippuric acid may accumulate in pts. with severe renal impairment

Mechanism of Action

Methenamine hydrolyzes to ammonia and formaldehyde (nonspecific antibacterial) in acidic urine

Mandelic acid or hippuric acid acidify the urine

Patient Handout

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