UNAIRA 3 G 1 SACHET

Indications

Approved Uses

Uncomplicated lower urinary tract infections (acute cystitis) in adult women caused by susceptible strains of Escherichia coli and Enterococcus faecalis

Off-Label Uses

Off-label: complicated lower UTI (including MDR organisms) and, in selected cases, prostatitis or recurrent UTI using multi-dose regimens under specialist guidance; catheter-associated UTI and use in men are also off-label depending on local guidance and organism susceptibility.

Dosage & Administration

Maximum Dose

3g per dose; for off-label multi-dose regimens, 3g every 48 hours

Dose Adjustment Notes

No dose adjustment is needed for a single 3 g dose in mild-moderate renal impairment; avoid/use with caution in severe renal impairment (e.g., CrCl <10 mL/min) or dialysis because efficacy may be reduced and data are limited; no hepatic dose adjustment is required.

How to Prepare

Dissolve the entire contents of 1 sachet in about 90-120 mL of cold/cool water, stir until dissolved, and drink immediately (do not store the prepared solution).

Safety & Warnings

Contraindications

Hypersensitivity to fosfomycin or any component of the formulation.

Warnings & Precautions

Do not use for pyelonephritis/complicated UTI unless specifically directed; monitor for hypersensitivity and C. difficile-associated diarrhea; use caution in renal impairment; if symptoms persist/worsen after 48-72 hours seek medical review; check excipients (e.g., sucrose) if relevant to metabolic intolerance.

Driving Warning

Safe

Drug Interactions

Interaction Severity

MODERATE: Metoclopramide (and other strong prokinetics) may reduce fosfomycin absorption/urinary concentrations-avoid concurrent use if possible. Other interactions (e.g., warfarin, live bacterial vaccines) are not established as clinically significant for single-dose oral fosfomycin and are not routinely listed as moderate for this agent.

Special Populations

Breastfeeding

Caution

Elderly

Standard adult dosing; monitor renal function as age-related decline in renal function may affect drug clearance

Kidney Impairment

No adjustment typically needed for mild-moderate renal impairment; avoid/use not recommended in severe renal failure (e.g., CrCl <10 mL/min) and in hemodialysis unless specialist-directed

Storage & Patient Advice

Storage Conditions

Store below 30°C; keep sachet dry/in original packaging; once dissolved, take immediately and do not store.

Preparation Instructions

Dissolve the entire contents of 1 sachet in about 90-120 mL of cold/cool water, stir until dissolved, and drink immediately (do not store the prepared solution).

Missed Dose

Single-dose regimen: if you missed the dose, take it as soon as you remember the same day; if it is close to the next day or symptoms are not improving/worsen, contact the prescriber-do not take two sachets at once unless instructed.

Stopping the Medicine

Single-dose regimen; no tapering required

Overdose

Likely GI symptoms (nausea, vomiting, diarrhea, abdominal pain); manage with supportive care and hydration; consider hemodialysis in severe cases/renal failure as fosfomycin is dialyzable; seek urgent medical attention.

Patient Counseling

Single-dose antibiotic for bladder infection: dissolve the whole 3 g sachet in ~90-120 mL cold/cool water and drink immediately (do not use hot water or store the mixture); take on an empty stomach (2-3 hours before/after food, often at bedtime after urinating); symptoms should improve within 2-3 days-seek care if not improving/worsening, fever/flank pain occurs, or symptoms recur; report severe/persistent diarrhea (possible C. difficile); tell your clinician if pregnant/breastfeeding or if you have significant kidney disease.

Pharmacology

Duration of Effect

After a single 3 g oral dose, urinary concentrations typically remain high/therapeutic for about 24-48 hours (and may persist longer in some patients).

Bioavailability

Oral bioavailability is approximately 30-40% (commonly cited ~37% fasting) for fosfomycin trometamol.

Excretion

Primarily eliminated unchanged by the kidneys (urinary excretion); a smaller fraction is recovered in feces.

Protein Binding

Negligible/none (approximately 0% protein binding).

Product Information

Available Dosage Forms

For UNAIRA specifically: granules for oral solution (sachet). (Fosfomycin also exists in other products as IV powder for solution for infusion, but that is not this product.)

Composition per Dose

Each sachet: 3g fosfomycin as fosfomycin trometamol (equivalent to 5.631g fosfomycin trometamol salt)

Spectrum

Broad-spectrum

Antibiotic Class

Phosphonic acid derivative

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