UVAMIN 100MG CAP

Indications

Approved Uses

Treatment of acute uncomplicated lower urinary tract infection (cystitis) caused by susceptible organisms; and prophylaxis/suppression of recurrent lower UTIs when clinically indicated.

Off-Label Uses

None-prophylaxis/suppression of recurrent UTIs is an accepted/commonly labeled use for nitrofurantoin in many jurisdictions; if not explicitly labeled locally, it is a guideline-supported use.

Dosage & Administration

Dosing by Condition

Acute uncomplicated cystitis (modified-release 100 mg): 100 mg orally every 12 hours for 5 days (some labels allow 5-7 days); recurrent UTI prophylaxis/suppression: 50-100 mg orally once daily at bedtime (typically using an immediate-release strength where available).

Initial Dose

100mg every 12 hours (for modified-release capsules).

Maintenance Dose

100mg twice daily for 5-7 days (treatment); 50-100mg once nightly (prophylaxis)

Maximum Dose

400mg per day.

Children's Dosage

Children ≥1 month: 5-7 mg/kg/day in 4 divided doses for treatment (using suspension); prophylaxis 1-2 mg/kg/day at bedtime. For this 100 mg modified-release capsule: children >12 years: 100 mg every 12 hours for 7 days. Not approved for children <1 month.

Dose Adjustment Notes

Avoid/contraindicated when CrCl <30 mL/min (or eGFR <30 mL/min/1.73 m²); use caution and assess benefit-risk in CrCl 30-44/60 depending on local policy; avoid in prior nitrofurantoin-associated cholestatic jaundice/hepatitis and use caution in significant hepatic disease.

How to Take

Swallow the 100 mg modified-release (retard) capsule whole with a full glass of water; take with food or milk to improve absorption and reduce GI upset; do not crush, chew, or open the capsule.

Side Effects

Common Side Effects

Nausea, vomiting, loss of appetite, abdominal pain, diarrhea, headache; urine discoloration (dark yellow/brown) may occur.

Side Effect Frequency

Common (≥1%): nausea, headache, flatulence (GI upset). Uncommon/rare (<1%): vomiting, diarrhea, abdominal pain/dyspepsia, dizziness/drowsiness. Rare/very rare: serious pulmonary reactions, hepatotoxicity, peripheral neuropathy, hemolytic anemia (risk increased with G6PD deficiency).

Safety & Warnings

Contraindications

Contraindications include: hypersensitivity to nitrofurantoin; anuria/oliguria or significant renal impairment (commonly CrCl <30 mL/min in current guidance); previous cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin; pregnancy at term (38-42 weeks), during labor/delivery; and infants <1 month of age.

Warnings & Precautions

Warnings/precautions: monitor for pulmonary symptoms and stop immediately if suspected; monitor/stop for hepatic injury; risk of peripheral neuropathy (higher with renal impairment, anemia, diabetes, electrolyte imbalance, vitamin B deficiency, debilitating disease); hemolysis risk in G6PD deficiency; not for pyelonephritis/systemic infection; consider C. difficile-associated diarrhea with any antibiotic; prolonged use increases risk of chronic pulmonary/hepatic toxicity and superinfection.

Age Restriction

Contraindicated in infants <1 month of age (including neonates).

Drug Interactions

Drug Interactions

Key interactions: magnesium trisilicate-containing antacids (reduced absorption); probenecid or sulfinpyrazone (reduced renal tubular secretion → higher systemic levels/toxicity and lower urinary concentrations); and possible antagonism with quinolones; live oral typhoid vaccine effectiveness may be reduced by antibiotics.

Food Interaction

Take with food or milk (food increases absorption and reduces GI intolerance).

Special Populations

Children

Children ≥1 month: 5-7 mg/kg/day in 4 divided doses for treatment (using suspension); prophylaxis 1-2 mg/kg/day at bedtime. For this 100 mg modified-release capsule: children >12 years: 100 mg every 12 hours for 7 days. Not approved for children <1 month.

Kidney Impairment

CrCl <60 mL/min (or anuria/oliguria): avoid/contraindicated.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not double the dose.

Stopping the Medicine

Complete the prescribed course; do not stop early unless advised by a clinician (e.g., if serious adverse effects occur).

Overdose

Overdose typically causes GI symptoms (nausea/vomiting); management is supportive, consider decontamination if early, maintain hydration; nitrofurantoin is dialyzable-seek urgent medical care/poison center guidance.

Patient Counseling

Take each dose with food or milk and swallow the capsule whole; complete the full course; urine may turn dark yellow/brown (harmless); seek urgent care for new/worsening cough, shortness of breath, fever, chest pain, jaundice/dark urine, severe/persistent GI symptoms, or numbness/tingling; avoid magnesium trisilicate antacids near dosing; not effective for kidney infection (pyelonephritis) or systemic infection; discuss use near term pregnancy and in G6PD deficiency.

Monitoring Requirements

Baseline and periodic renal function; with prolonged/recurrent use monitor for pulmonary toxicity (symptoms ± function if indicated) and hepatotoxicity (LFTs); monitor for peripheral neuropathy; consider CBC if prolonged therapy or risk of hemolysis (e.g., G6PD deficiency).

Pharmacology

Mechanism of Action

Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates that damage DNA, RNA, and proteins and interfere with cell wall synthesis; it is bactericidal at therapeutic urinary concentrations.

Onset of Action

Therapeutic urinary concentrations are typically achieved within a few hours after a dose (approximately 2-4 hours).

Duration of Effect

Urinary antibacterial activity is generally maintained for about 12 hours per modified-release dose (supports twice-daily dosing).

Bioavailability

Oral absorption is increased when taken with food (commonly cited ~40% increase); absolute bioavailability is variable and not reliably stated as a single fixed value.

Metabolism

Extensively metabolized by body tissues to inactive metabolites; only a minority of the dose is excreted unchanged in urine.

Product Information

Available Dosage Forms

Hard oral capsule, modified-release (retard) 100 mg (this product).

Composition per Dose

Each capsule: 100mg Nitrofurantoin (as macrocrystals and/or monohydrate for modified release).

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Narrow

Antibiotic Class

Nitrofuran

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