Drug Interaction:
Drug interactions- summary-
Metoclopromide-
when coadministered, metoclopropamide increase gastro-intestinal motility, lowers the serum
concentration and urinary excretion of fosfomycin .
Cimetidine -
cimetidine does not affect the pharmcokinetics of fosfomycin when coadministered
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
221. Fosfomycin Tromethamine Sachet 3gms 09-10-08
(Addl.Indication)
For the treatment of uncomplicated urinary tract
infections(acute cystitis ) in women due to susceptible
strains of E.coli and Enterococcus faecalis
Urinary tract infections
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Fosfomycin Tromethamine Sachet 09-10-2008
3gms
For the treatment of uncomplicated urinary tract infections
(acute cystis) in women due to susceptible strains of E.Coli
and enterococcus faecalis
Adverse Reaction:
Adverse reactions-
CNS- headache 9% nervousness, somnolence, parathesia, insomnia , migraine ( < 1%)
GI - diarrhea 9% nausea, 4%, dyspepsia, 1.2%
abnormal stools, dry mouth, flatulence,anorexia, constipation, vomiting < 1% )
Dermatologic - rash 1.2% skin disorder, pruritus < 1% )
GU - vaginitis 6% dysmenorrhea, 2%, hematuria, menstrual disorder, dysuria, < 1%
Respiratory - rhinitis 4%, pharyngitis 2%
Miscellaneous- back pain 2.5% dizziness ,abdominal pain,pain 2% , asthenia 1.5%
myalgia, ear disorder, fever, flusyndrome, infection, lymphadenopathy,
AST increase, < 1%
Contra-Indications:
Hypersensitivity
Special Precautions-
Acute cystitis- do not use more than 1 single dose of fosfomycin tromethamine to treat single
episode of acute cystitis. Repeated dose did not improve conditions, but increased incidence of
adverse reactions
Pregnancy- To be used during pregnancy only if clearly needed.
Lactation- decide whether to discontinue nursing or the drug taking into consideration the
importance of the drug to the mother.
Children- safety and efficacy for use in children 12 year and under have not been established
Elderly- start at a low dose, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function
Dosages/ Overdosage Etc:
Indication-
Urinary tract infections
Dosage-
Women - 3g ( 1 sachet ) as a single dose
Patient Information:
1.Fosfomycin can be taken with or without food.
2. Symptoms should be improved in 2 to 3 days, if not patient should contact her doctor
Interaction with Food:
Fosfomycin can be taken with or without food.
Pregnancy and lactation:
Pregnancy-
To be used during pregnancy only if clearly needed.
Lactation-
Decide whether to discontinue nursing or the drug taking into consideration the
importance of the drug to the mother.
Children-
Safety and efficacy for use in children 12 year and under have not been established
Elderly-
Start at a low dose, reflectingg the greater frequency of decreased hepatic, renal,
or cardiac function
Manufacturer Details