Fosfomycin Tromethamine 3g Granules for Oral Solution

Fosfomycin Tromethamine is a prescription antibacterial medicine supplied as granules for oral solution. Xiromed lists its product as Fosfomycin Tromethamine Granules for Oral Solution, equivalent to 3 grams of fosfomycin base per sachet. The product is intended for oral administration after it has been mixed with water according to the official product instructions. Xiromed identifies the product as an Rx medicine and lists it as available in a 3-gram base sachet with NDC 70700-268-94. (xiromed.com)

Fosfomycin Tromethamine is indicated for the treatment of uncomplicated urinary tract infections, also known as acute cystitis, in women aged 18 years and older when the infection is caused by susceptible strains of Escherichia coli or Enterococcus faecalis. It is not indicated for kidney infections, including pyelonephritis, or for perinephric abscesses. A healthcare professional should determine whether this medicine is appropriate based on the patient’s symptoms, medical history, laboratory results, allergies, and susceptibility information. (dailymed.nlm.nih.gov)

This page is intended to provide general product information for patients, caregivers, pharmacies, healthcare professionals, and pharmaceutical buyers. It does not replace the official prescribing information or the advice of a licensed medical professional.

What Is Fosfomycin Tromethamine?

Fosfomycin Tromethamine is an oral antibacterial formulation containing fosfomycin, an antibiotic active against certain bacteria associated with uncomplicated urinary tract infections. The medicine is supplied in granule form and must be prepared with water before it is taken. It should never be swallowed in its dry form. The approved dosage information states that the recommended treatment for women 18 years of age and older with uncomplicated acute cystitis is one sachet, unless a healthcare professional provides different instructions. (dailymed.nlm.nih.gov)

The Xiromed product is supplied as granules for oral solution in a 3-gram base sachet. The product information lists the sachet as containing sweeteners, including saccharin sodium and sucrose, and confirms that it does not contain lactose or gelatin. The product is not certified as gluten-free or soy-free, even though the listed formulation does not contain ingredients derived from gluten-containing grains or soy. Patients with allergies, sensitivities, diabetes, or dietary restrictions should review the package information with a pharmacist before use. (xiromed.com)

Fosfomycin Tromethamine may be selected by a healthcare professional when the identified bacteria are susceptible and the patient’s infection meets the criteria for uncomplicated acute cystitis. Antibiotics should not be used for viral infections, and patients should not use leftover antibiotics or share medication with another person.

Fosfomycin Tromethamine Product Details

Important product details for Xiromed Fosfomycin Tromethamine include:

• Product name: Fosfomycin Tromethamine Granules for Oral Solution
• Strength: Equivalent to 3 grams base per sachet
• Dosage form: Granules for oral solution
• Route: Oral
• Prescription status: Rx
• NDC: 70700-268-94
• Reference brand: Monurol
• Storage: Store at 25°C, or 77°F, with permitted excursions between 15°C and 30°C
• Shelf life: 24 months, according to the listed product information
• Package presentation: 1 x 3-gram sachet, with a listed case quantity of 48

Product availability, packaging, labeling, and distribution details may change. Pharmacies and purchasing organizations should confirm current information through the manufacturer, authorized distributors, or current official product documentation. (xiromed.com)

Fosfomycin Tromethamine Uses

Fosfomycin Tromethamine is used for uncomplicated urinary tract infections, specifically acute cystitis in adult women caused by susceptible bacteria. Acute cystitis commonly affects the bladder and may cause symptoms such as burning during urination, frequent urination, urgency, or discomfort in the lower abdomen. However, urinary symptoms can have several causes, and a healthcare professional should confirm the diagnosis before treatment.

The official labeling identifies susceptible E. coli and E. faecalis as the relevant organisms for the approved indication. Laboratory susceptibility testing may help healthcare professionals determine whether the bacteria are likely to respond to fosfomycin. The presence of bacteria that are not susceptible may require a different treatment.

Fosfomycin Tromethamine is not approved for every type of urinary infection. It is not indicated for pyelonephritis, a kidney infection, or a perinephric abscess. Symptoms such as fever, chills, back or side pain, vomiting, severe weakness, or worsening illness may require urgent medical evaluation because they can be associated with a more serious infection. Patients should not rely on a single oral sachet to treat symptoms that may indicate kidney involvement.

How to Take Fosfomycin Tromethamine

Fosfomycin Tromethamine should be taken exactly as prescribed. The granules should be mixed with water before ingestion. The official dosage information states that the product may be taken with or without food, but it must not be taken in dry form. Patients should follow the preparation directions on the package or those provided by the pharmacist. (dailymed.nlm.nih.gov)

Do not take more than the prescribed amount, repeat the dose without medical instruction, or combine Fosfomycin Tromethamine with another antibiotic unless a healthcare professional specifically recommends it. If symptoms continue or return after treatment, contact the prescriber. The official labeling states that if bacteriuria persists or reappears after treatment, another therapeutic agent should be selected. (dailymed.nlm.nih.gov)

Tell the prescriber about all medicines, supplements, and health conditions before taking Fosfomycin Tromethamine. Patients should also disclose any known allergy to fosfomycin or previous serious reaction to an antibacterial medicine.

Fosfomycin Tromethamine Safety Information

Fosfomycin Tromethamine is contraindicated in patients with known hypersensitivity to the drug. Allergic reactions may require immediate medical attention. Seek emergency help for difficulty breathing, swelling of the lips or face, widespread hives, fainting, or other signs of a serious allergic response.

Like other antibacterial medicines, Fosfomycin Tromethamine has been associated with Clostridioides difficile-associated diarrhea, also called CDAD. This condition can occur during or after antibiotic treatment and may range from mild diarrhea to severe inflammation of the colon. Contact a healthcare professional if significant, persistent, or bloody diarrhea develops during treatment or afterward.

Commonly reported adverse reactions may include gastrointestinal symptoms such as diarrhea, nausea, or stomach discomfort, as well as headache or other reactions listed in the current prescribing information. Patients should review the complete medication guide and report concerning symptoms to a healthcare professional.

People with reduced kidney function should speak with a healthcare professional before taking this medicine. Fosfomycin elimination may be affected by renal impairment, and the official labeling includes pharmacokinetic information for patients with varying degrees of kidney function. The prescriber should determine whether Fosfomycin Tromethamine is suitable for the individual patient.

Storage and Handling of Fosfomycin Tromethamine

Store Fosfomycin Tromethamine at the temperature stated on the product label. Xiromed’s listed product information specifies storage at 25°C, or 77°F, with permitted excursions between 15°C and 30°C, or 59°F and 86°F. Keep the sachet in its original packaging until it is ready to be prepared. Protect medicines from excessive heat, moisture, and conditions outside the labeled storage range.

Keep this prescription medicine away from children and pets. Do not use the product after its expiration date or if the sachet is damaged. Pharmacies and healthcare facilities should follow their established procedures for inventory control, dispensing, storage, and disposal.

For medical questions, suspected side effects, adverse-event reports, or product-quality concerns involving a Xiromed product, the manufacturer lists a medical information and quality contact number. Patients experiencing a medical emergency should contact emergency services or seek immediate medical attention rather than waiting for a manufacturer response.

Important: This content is for educational and product-information purposes only. Fosfomycin Tromethamine is a prescription antibiotic and should be used only under the direction of a qualified healthcare professional. It does not guarantee treatment success, and no online product page can replace diagnosis, susceptibility testing, or individualized medical advice.