Uroday Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Fosfomycin trometamol

Indications/Uses

Acute uncomplicated lower UTI caused by E. coli & Enterococcus faecalis in females ≥18 yr. Peri-op prophylaxis for transrectal prostate biopsy in adult men.

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Dosage/Direction for Use

Acute uncomplicated lower UTI 1 sachet as single dose. Recurrent or other clinically problematic cystitis Up to 2 doses at 24-hr interval. Peri-op prophylaxis for transrectal prostate biopsy 1 sachet 3 hr before & 24 hr after procedure.

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Overdosage

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Administration

Should be taken on an empty stomach: Take preferably at bedtime. Dissolve in a glass of water & drink immediately.

Contraindications

Hypersensitivity.

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Special Precautions

Discontinue use if hypersensitivity reactions occur. Not indicated for men w/ complicated UTI. Clostridium difficile-associated diarrhoea. Not recommended in patients w/ fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency. Concomitant use w/ anti-peristaltic drugs. May affect ability to drive & use machines. Not recommended in renal impairment (CrCl <10 mL/min). Pregnancy & lactation. Not to be given in childn <12 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Vulvovaginitis; headache, dizziness; diarrhoea, nausea, dyspepsia, abdominal pain.

Drug Interactions

Lowered serum & urine conc w/ metoclopramide & other drugs increasing GI motility. Decreased plasma & urinary levels w/ food. Increased anti-vit K antagonist activity.

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Storage

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Description

View Uroday description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Other Antibiotics / Urinary Antiseptics

ATC Classification

J01XX01 - fosfomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Uroday granules for oral soln 3 g

Packing/Price

1's

Uroday

fosfomycin

Manufacturer:

Neutec

Distributor:

Averroes Pharma