Fosfomycin Tromethamine 3 g Granule, For Solution, 1 granule
Other active recalls for Fosfomycin Tromethamine (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other antibacterials class.
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🏭 Manufacturer & labeler
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🩺 Clinical
What are antibiotics? Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply. Antibiotics can be taken in different ways: Orally (by mouth). This could be pills, capsules, or liquids. Topically. This might be a cream, spray, or ointment that you put on your skin. It could also be eye ointment, eye drops, or ear drops. Through an injection or intravenously (IV). This is usually for more serious infections. What do antibiotics treat? Antibiotics only treat certain bacterial i...
Read the full MedlinePlus article ↗- That depends on the type of infection and which form of fosfomycin you're being prescribed. The oral powder or solution (brands like Monurol or Fosfomycin Tromethamine) is a single...
- What kind of UTI is fosfomycin used for — and is it right for me?
- You pour the entire contents of the single sachet into about half a cup (3–4 ounces) of cool water, stir until it dissolves completely, and drink it right away. Don't use hot water...
- How do I take the oral powder — do I need water or food?
Patient education
Supplement & herbal interactions
Fosfomycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5EVU04N5QU
A natural or synthetic colorant that gives the medicine an orange hue. It helps identify the medication and may improve appearance.
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UNII FST467XS7D
Saccharin is an artificial sweetener derived from benzoic sulfinilanide. It's added to medicines to improve taste and make them easier to take, especially in liquid or chewable formulations.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII KH3E3096OO
A natural flavoring derived from tangerine fruit. It adds taste and aroma to make medicines more pleasant to take, especially in chewable tablets or liquids.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $26.754 | $26.75 / 1 granule |
| Medicaid paysCMS SDUD · 12 mo | $41.25 | $41.25 / 1 granule |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fosfomycin tromethamine 3 g 59651-0651-03 | Aurobindo | 1 granule | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 gthis 60219-3955-01 | Amneal | 1 granule | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 g 67877-0749-57 | Ascend | 1 granule | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 g 68094-0064-20 | Precision | 1 granule | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 g 69097-0579-67 | Cipla | 1 granule | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 g 70700-0268-94 | XIROMED | 1 dose | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 g 81033-0024-11 | Kesin | 1 granule | $26.754 | AA | Availability likely | — |
| Fosfomycin Tromethamine 3 g 50090-5826-00 | A-S | 1 dose | — | AA | FDA listed | — |
| Fosfomycin Tromethamine 3 g 50090-6130-00 | A-S | 1 granule | — | AA | FDA listed | — |
| Fosfomycin Tromethamine 3 g 73289-0067-01 | Aucta | 1 granule | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60219-3955-01 You're viewing this | 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3) | 2024-04-02 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis . Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected (see PRECAUTIONS and CLINICAL STUDIES sections).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of fosfomycin tromethamine granules for oral solution. Fosfomycin tromethamine granules for oral solution may be taken with or without food. Fosfomycin tromethamine granules for oral solution should not be taken in its dry form.
Always mix fosfomycin tromethamine granules for oral solution with water before ingesting (see PREPARATION section).
⛔ Contraindications ▾
CONTRAINDICATIONS Fosfomycin tromethamine granules for oral solution is contraindicated in patients with known hypersensitivity to the drug.
⚠️ Warnings ▾
WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including fosfomycin tromethamine, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trials In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below: Drug-Related Adverse Events (%) in Fosfomycin and Comparator Populations Adverse Events Fosfomycin N=1,233 Nitrofurantoin N=374 Trimethoprim/sulfamethoxazole N=428 Ciprofoxacin N=455 Diarrhea 9.0 6.4 2.3
3.1Vaginitis 5.5 5.3 4.7
6.3Nausea 4.1 7.2 8.6
3.4Headache 3.9 5.9 5.4
3.4Dizziness 1.3 1.9 2.3
2.2Asthenia 1.1 0.3 0.5
0.0Dyspepsia 1.1 2.1 0.7
1.1In clinical trials, the most frequently reported adverse events occurring in > 1% of the study population regardless of drug relationship were: diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%, back pain 3.0%, dysmenorrheal 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%. The following adverse events occurred in clinical trials at a rate of less than 1%, regardless of drug relationship: abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.
One patient developed unilateral optic neuritis, an event considered possibly related to fosfomycin tromethamine therapy. Post-marketing Experience Serious adverse events from the marketing experience with fosfomycin tromethamine outside of the United States have been rarely reported and include: angioedema, aplastic anemia, asthma (exacerbation), cholestatic jaundice, hepatic necrosis, and toxic megacolon. Although causality has not been established, during post-marketing surveillance, the following events have occurred in patients prescribed fosfomycin tromethamine: anaphylaxis and hearing loss.
Laboratory Changes Significant laboratory changes reported in U.S. clinical trials of fosfomycin tromethamine without regard to drug relationship include: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT, increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin, increased and decreased platelet count. The changes were generally transient and were not clinically significant.
🔄 Drug Interactions ▾
Drug Interactions Metoclopramide When co-administered with fosfomycin tromethamine, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal motility may produce similar effects. Cimetidine Cimetidine does not affect the pharmacokinetics of fosfomycin when co-administered with fosfomycin tromethamine.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. Fosfomycin tromethamine crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1,000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m 2 , respectively). When administered to pregnant female rabbits at dosages as high as 1,000 mg/kg/day (approximately 9 and 2.7 times the human dose based on body weight and mg/m 2 , respectively), fetotoxicities were observed.
However, these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration. There are, however, no adequate and 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.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.
🆘 Overdosage ▾
OVERDOSAGE In acute toxicology studies, oral administration of high doses of fosfomycin tromethamine up to 5 g/kg were well-tolerated in mice and rats, produced transient and minor incidences of watery stools in rabbits, and produced diarrhea with anorexia in dogs occurring 2 to 3 days after single-dose administration. These doses represent 50 to 125 times the human therapeutic dose. The following events have been observed in patients who have taken fosfomycin tromethamine in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception.
In the event of overdosage, treatment should be symptomatic and supportive.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Absorption Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gram dose of fosfomycin tromethamine, the mean (± 1 SD) maximum serum concentration (C max ) achieved was 26.1 (± 9.1) mcg/mL within 2 hours.
The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gram oral dose of fosfomycin tromethamine with a high-fat meal, the mean C max achieved was 17.6 (± 4.4) mcg/mL within 4 hours. Cimetidine does not affect the pharmacokinetics of fosfomycin when co-administered with fosfomycin tromethamine.
Metoclopramide lowers the serum concentrations and urinary excretion of fosfomycin when co-administered with fosfomycin tromethamine (see PRECAUTIONS, Drug Interactions ). Distribution The mean apparent steady-state volume of distribution (V ss ) is 136.1 (± 44.1) L following oral administration of fosfomycin tromethamine. Fosfomycin is not bound to plasma proteins.
Fosfomycin is distributed to the kidneys, bladder wall, prostate, and seminal vesicles. Following a 50 mg/kg dose of fosfomycin to patients undergoing urological surgery for bladder carcinoma, the mean concentration of fosfomycin in the bladder, taken at a distance from the neoplastic site, was 18 mcg per gram of tissue at 3 hours after dosing. Fosfomycin has been shown to cross the placental barrier in animals and man.
Excretion Fosfomycin is excreted unchanged in both urine and feces. Following oral administration of fosfomycin tromethamine, the mean total body clearance (CL TB ) and mean renal clearance (CL R ) of fosfomycin were 16.9 (± 3.5) L/hr and 6.3 (± 1.7) L/hr, respectively. Approximately 38% of a 3-gram dose of fosfomycin tromethamine is recovered from urine, and 18% is recovered from feces.
Following intravenous administration, the mean CL TB and mean CL R of fosfomycin were 6.1 (± 1.0) L/hr and 5.5 (± 1.2) L/hr, respectively. A mean urine fosfomycin concentration of 706 (± 466) mcg/mL was attained within 2 to 4 hours after a single oral 3-gm dose of fosfomycin tromethamine under fasting conditions. The mean urinary concentration of fosfomycin was 10 mcg/mL in samples collected 72 to 84 hours following a single oral dose of fosfomycin tromethamine.
Following a 3-gram dose of fosfomycin tromethamine administered with a high fat meal, a mean urine fosfomycin concentration of 537 (± 252) mcg/mL was attained within 6 to 8 hours. Although the rate of urinary excretion of fosfomycin was reduced under fed conditions, the cumulative amount of fosfomycin excreted in the urine was the same, 1,118 (± 201) mg (fed) vs. 1,140 mg (± 238) (fasting).
Further, urinary concentrations equal to or greater than 100 mcg/mL were maintained for the same duration, 26 hours, indicating that fosfomycin tromethamine can be taken without regard to food. Following oral administration of fosfomycin tromethamine, the mean half-life for elimination (t 1/2 ) is 5.7 (± 2.8) hours. Special Populations Geriatric: Based on limited data regarding 24-hour urinary drug concentrations, no differences in urinary excretion of fosfomycin have been observed in elderly subjects.
No dosage adjustment is necessary in the elderly. Gender: There are no gender differences in the pharmacokinetics of fosfomycin. Renal Insufficiency: In 5 anuric patients undergoing hemodialysis, the t 1/2 of fosfomycin during hemodialysis was 40 hours.
In patients with varying degrees of renal impairment (creatinine clearances varying from 54 mL/min to 7 mL/min), the t 1/2 of fosfomycin increased from 11 hours to 50 hours. The percent of fosfomycin recovered in urine decreased from 32% to 11% indicating that renal impairment significantly decreases the excretion of fosfomycin. Microbiology Fosfomycin (the active component of fosfomycin tromethamine) has in vitro activity against a broad range of gram-positive and gram-nega…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fosfomycin Tromethamine Granules for Oral Solution is supplied as a white to off-white powder in a single-dose sachet containing the equivalent of 3 grams of fosfomycin. It is available as follows: Single-Dose Sachet: NDC 60219-3955-3 One Sachet in One Carton: NDC 60219-3955-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.
📋 Description ▾
DESCRIPTION Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a white to off-white powder in a single-dose sachet. Each 8 grams granules per sachet contains 5.631 grams of fosfomycin tromethamine, USP (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.
The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1 R ,2 S )-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Fosfomycin tromethamine, USP is a white or almost white powder.
It is very soluble in water, slightly soluble in ethanol (96 %) and in methanol, practically insoluble in acetone. The molecular weight of fosfomycin tromethamine is 259.2 g/mol, molecular formula is C 3 H 7 O 4 P.C 4 H 11 NO 3 , and its chemical structure is as follows: 1