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methenamine/sodium acid phosphate (Uroquid-Acid No. 2, Utac)

 

Classes: Antibiotics, Other

Dosing and uses of Uroquid-Acid No. 2, Utac (methenamine/sodium acid phosphate)

 

Adult dosage forms and strengths

methenamine/sodium acid phosphate

tablet

  • 500 mg/500 mg

 

Urinary Tract Infection Prophylaxis

Initial: 2 tablets PO q6hr with liberal fluid intake

Maintenance: 1-2 tablets PO q12hr

Use only after eradication of UTI by other appropriate antibiotic

Methenamine: Indicated for prophylaxis/suppression for chronic recurring UTIs when long-term therapy is required

Sodium acid phosphate: Urinary acidifier

 

Pediatric dosage forms and strengths

Safety/efficacy not established

 

Uroquid-Acid No. 2, Utac (methenamine/sodium acid phosphate) adverse (side) effects

1-10%

Dysuria

Gastric upset

Nausea

Rash

 

Frequency not defined

Diarrhea

Nausea

Stomach pain

Vomiting

 

Warnings

Black box warnings

Sodium acid phosphate

  • Rare reports of acute phosphate nephropathy with oral sodium phosphate products used for colon cleansing before colonoscopy
  • Some cases have resulted in permanent renal function impairment requiring long-term hemodialysis
  • Risk factors for acute phosphate nephropathy include age >55 yr, hypovolemia, baseline kidney disease, bowel obstruction, active colitis, and those using medicines that affect renal perfusion or function (eg, diuretics, ACE inhibitors, ARBs, NSAIDs)
  • Carefully follow dosing regimen as recommended (pm/am split dose) with adequate hydration

 

Contraindications

Methenamine

  • 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

Sodium acid phosphate

  • Hypersensitivity
  • Addison's disease
  • Hyperphosphatemia
  • Acidification of urine in urinary stone disease
  • Urolithiasis or struvite stone formation
  • Severe renal impairment (ie, CrCl <30 mL/min)

 

Cautions

Methenamine

  • Large doses may cause bladder irritation, urinary frequency, albuminuria, and hematuria
  • Maintain acidic pH of urine, especially when treating urea-splitting organisms (eg, Proteus, Pseudomonas)
  • Monitor LFTs, especially 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

Sodium acid phosphate

  • History of gastrointestinal pain
  • Sodium restriction
  • History of kidney stones
  • Risk of acute phosphate nephropathy

 

Pregnancy and lactation

Pregnancy category: C

Lactation: methenamine is excreted in human milk; caution advised, risk to infant cannot be ruled out

 

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 of Uroquid-Acid No. 2, Utac (methenamine/sodium acid phosphate)

Methenamine

Half-Life: 3-6 hr

Absorption: well absorbed; 10-30% hydrolyzed by gastric acid unless enteric coated tablet

Peak Urine Time: (formaldehyde) 2 hr for hippurate salt, 3-8 hr for mandelate salt

Metabolism: by liver (10-25%)

Excretion: urine (90%)

 

Sodium Acid Phosphate

Onset: 1-3 hr

Duration: 1-3 hr

Bioavailability: 66%

Excretion: urine: 90%

 

Mechanism of action

Methenamine: Hydrolyzed in acidic urine to ammonia and formaldehyde, which are bactericidal agents; does not convert to formaldehyde in serum

Sodium acid phosphate: Urinary acidifier; elicits osmotic effect in GI tract