Monurol (fosfomycin tromethamine)

Dosage of fosfomycin tromethamine is expressed in terms of fosfomycin.

Fosfomycin tromethamine is administered orally. Although fosfomycin has been administered IV+ as the disodium salt, a parenteral formulation of the drug is not commercially available in the US.

Fosfomycin tromethamine for oral administration is available as granules for oral solution that must be dissolved in water prior to administration. The drug should not be ingested as dry granules.

The oral solution should be prepared by pouring the entire contents of a single-dose packet (sachet) containing 3 g of fosfomycin into 90-120 mL (3-4 ounces) of water and stirring until the granules dissolve. The entire oral solution should be ingested immediately after preparation. Hot water should not be used to dissolve fosfomycin tromethamine granules.

Although food decreases oral bioavailability of fosfomycin tromethamine, the manufacturer states that the drug may be administered without regard to food since the cumulative amount of fosfomycin excreted in urine is similar whether the drug is given with or without food. (See Pharmacokinetics.)

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in more than 1% of patients receiving oral fosfomycin in clinical studies include adverse GI effects (diarrhea, nausea, dyspepsia), headache, dizziness, asthenia, and vaginitis.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of fosfomycin have not been established in children 12 years of age or younger.

There are no adequate and well-controlled studies using fosfomycin in pregnant women. Fosfomycin should be used during pregnancy only if clearly needed.

It is not known whether fosfomycin is distributed into milk.

Because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or not administer fosfomycin, taking into account the importance of the drug to the woman.

Dosage adjustments are not usually necessary in geriatric patients; however, dosage should be selected with caution because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy. (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Clinical studies of fosfomycin did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. Although other clinical experience has not identified age-related differences in response or tolerance, dosage for geriatric patients should be selected with caution and the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in this age group should be considered.