|
|
|
|
|
|
|
SIZE:
|
|
|
|
GENERIC NAME:
|
|
|
|
MANUFACTURER:
|
THE ARAB DRUG MANUFACTURING CO.
|
|
UNIT:
|
|
|
|
ADMINISTRATION ROUTE:
|
|
|
|
FDA PREGNANCY GROUP:
|
|
C
|
|
INDICATIONS:
|
|
Anthrax |
|
Bronchitis, chronic, acute exacerbation |
|
Conjunctivitis, infectious |
|
Diarrhea, infectious |
|
Gonorrhea |
|
Infection, bone |
|
Infection, intra- abdominal |
|
Infection, joint |
|
Infection, lower respiratory tract |
|
Infection, sexually transmitted |
|
Infection, sinus |
|
Infection, skin and skin structure |
|
Infection, upper respiratory tract |
|
Infection, urinary tract |
|
Neutropenia, febrile |
|
Pneumonia |
|
Prostatitis |
|
Pyelonephritis |
|
Typhoid fever |
|
Ulcer, corneal |
| |
|
|
SIDE EFFECTS:
|
|
confusion |
|
conjunctival hyperemia |
|
corneal deposits |
|
crystalluria |
|
depression |
|
diaphoresis |
|
diarrhea |
|
diplopia |
|
dizziness |
|
drowsiness |
|
dysesthesia |
|
dysgeusia |
|
dyspepsia |
|
dysphagia |
|
dyspnea |
|
eosinophilia |
|
epistaxis |
|
erythema |
|
erythema nodosum |
|
fever |
|
flushing |
|
hallucinations |
|
headache |
|
hearing loss |
|
hemolytic anemia |
|
hemoptysis |
|
hepatitis |
|
hiccups |
|
hypertension |
|
hypoesthesia |
|
hypotension |
|
increased intracranial pressure |
|
insomnia |
|
interstitial nephritis |
|
irritability |
|
jaundice |
|
laryngeal edema |
|
lethargy |
|
lymphadenopathy |
|
maculopapular rash |
|
mania |
|
migraine |
|
myalgia |
|
nausea/vomiting |
|
nightmares |
|
ocular pain |
|
palpitations |
|
paranoia |
|
paresthesias |
|
peripheral neuropathy |
|
peripheral vasodilation |
|
petechiae |
|
phlebitis |
|
phobia |
|
photosensitivity |
|
polyuria |
|
pruritus |
|
pseudomembranous colitis |
|
psychosis |
|
pulmonary edema |
|
pulmonary embolism |
|
QT prolongation |
|
rash (unspecified) |
|
rhinitis |
|
seizures |
|
sinus tachycardia |
|
skin hyperpigmentation |
|
abdominal pain |
|
acute generalized exanthematous pustulosis (AGEP) |
|
agitation |
|
anaphylactic shock |
|
anaphylactoid reactions |
|
angioedema |
|
anorexia |
|
anxiety |
|
arthralgia |
|
arthropathy |
|
ataxia |
|
atrial flutter |
|
back pain |
|
blurred vision |
|
bone pain |
|
bronchospasm |
|
candidiasis |
|
chills |
|
cholestasis |
|
suicidal ideation |
|
tendon rupture |
|
thrombocytopenia |
|
tinnitus |
|
torsade de pointes |
|
toxic epidermal necrolysis |
|
tremor |
|
urinary retention |
|
urticaria |
|
vaginitis |
|
vertigo |
|
visual impairment |
|
weakness |
|
|
ABSOLUTE
CONTRAINDICATIONS :
|
|
|
|
RELATIVE
CONTRAINDICATIONS : |
|
arteriosclerosis |
|
atrial fibrillation |
|
bradycardia |
|
breast-feeding |
|
cerebrovascular disease |
|
children |
|
colitis |
|
dehydration |
|
elderly |
|
GI disease |
|
heart failure |
|
hepatic disease |
|
myasthenia gravis |
|
pregnancy |
|
renal impairment |
|
seizures |
|
syphilis |
|
|
ADULT DOSE:
|
|
Anthrax, inhalational (treatment) -
Oral, 500 mg (base) every 12 hours for 60 days.
Bone and joint infections-
Mild or moderate: Oral, 500 mg (base) every twelve hours for at least four to six weeks .
Severe or complicated: Oral, 750 mg (base) every twelve hours for at least four to six weeks .
Diarrhea, infectious-
Mild to severe: Oral, 500 mg (base) every twelve hours for five to seven days .
Gonorrhea, endocervical and urethral-
Oral, 250 mg (base) as a single dose .
Intra-abdominal infections-
Oral, 500 mg (base) every twelve hours for seven to fourteen days, in combination with oral metronidazole .
Lower respiratory tract infections-
Mild to moderate: Oral, 500 mg (base) every twelve hours for seven to fourteen days .
Severe or complicated: Oral, 750 mg (base) every twelve hours for seven to fourteen days .
[Meningococcal carriers ]-
Oral, 750 mg (base) as a single dose .
Prostatitis, chronic-
Mild or moderate: Oral, 500 mg (base) every twelve hours for twenty-eight days .
Sinusitis, mild or moderate or
Typhoid fever-
Oral, 500 mg (base) every twelve hours for ten days .
Skin and soft tissue infections-
Mild or moderate: Oral, 500 mg (base) every twelve hours for seven to fourteen days .
Severe or complicated: Oral, 750 mg (base) every twelve hours for seven to fourteen days .
Urinary tract infections-
Acute uncomplicated: Oral, 100 mg (base) every twelve hours for three days .
Mild or moderate: Oral, 250 mg (base) every twelve hours for seven to fourteen days .
Severe or complicated: Oral, 500 mg (base) every twelve hours for seven to fourteen days .
Note: Adults with impaired renal function may require a reduction in dose as follows :
Creatinine clearance (mL/min)/(mL/sec) Dose (base)
> 50/0.83 See
30-50/0.5-0.83 250-500 mg every 12 hours
5-29/0.08-0.48 250-500 mg every 18 hours
Hemodialysis or Peritoneal dialysis 250-500 mg every 24 hours after dialysis
patients
In patients with severe infection and severe renal function impairment, a unit dose of 750 mg may be administered at the intervals noted above; however, these patients should be monitored carefully and serum concentrations of ciprofloxacin should be measured periodically . |
|
MAXIMUM ADULT DOSE:
|
|
1.5 grams (base) daily .
|
|
PEDIATRIC DOSE:
|
|
Children up to 18 years of age-Use is not recommended in infants, children, or adolescents since fluoroquinolones cause arthropathy in immature animals .
However, ciprofloxacin has been given to pediatric patients, as indicated below, when alternative therapy could not be used. Based on pharmacokinetic studies, dosing for patients with cystic fibrosis should be higher and at more frequent intervals than for patients without cystic fibrosis .
Dosing for cystic fibrosis patients also should be decreased as body weight increases .
Anthrax, inhalational (treatment) -
Oral, 15 mg per kg of body weight per dose (base), not to exceed 500 mg per dose, every 12 hours for 60 days.
[Cystic fibrosis, pulmonary exacerbations] -
For children 14 to 28 kg of body weight: Oral, 28 to 20 mg (base) per kg of body weight every twelve hours, up to 2 grams per day .
For children 28 to 42 kg of body weight: Oral, 20 to 15 mg (base) per kg of body weight every twelve hours, up to 2 grams per day .
[For other infections] -
Oral, 10 to 15 mg (base) per kg of body weight twice a day, up to 1.5 grams per day . |
|
MAXIMUM PEDIATRIC
DOSE:
|
|
|
|
ELDERLY DOSE:
|
|
Anthrax, inhalational (treatment) -
Oral, 500 mg (base) every 12 hours for 60 days.
Bone and joint infections-
Mild or moderate: Oral, 500 mg (base) every twelve hours for at least four to six weeks .
Severe or complicated: Oral, 750 mg (base) every twelve hours for at least four to six weeks .
Diarrhea, infectious-
Mild to severe: Oral, 500 mg (base) every twelve hours for five to seven days .
Gonorrhea, endocervical and urethral-
Oral, 250 mg (base) as a single dose .
Intra-abdominal infections-
Oral, 500 mg (base) every twelve hours for seven to fourteen days, in combination with oral metronidazole .
Lower respiratory tract infections-
Mild to moderate: Oral, 500 mg (base) every twelve hours for seven to fourteen days .
Severe or complicated: Oral, 750 mg (base) every twelve hours for seven to fourteen days .
[Meningococcal carriers ]-
Oral, 750 mg (base) as a single dose .
Prostatitis, chronic-
Mild or moderate: Oral, 500 mg (base) every twelve hours for twenty-eight days .
Sinusitis, mild or moderate or
Typhoid fever-
Oral, 500 mg (base) every twelve hours for ten days .
Skin and soft tissue infections-
Mild or moderate: Oral, 500 mg (base) every twelve hours for seven to fourteen days .
Severe or complicated: Oral, 750 mg (base) every twelve hours for seven to fourteen days .
Urinary tract infections-
Acute uncomplicated: Oral, 100 mg (base) every twelve hours for three days .
Mild or moderate: Oral, 250 mg (base) every twelve hours for seven to fourteen days .
Severe or complicated: Oral, 500 mg (base) every twelve hours for seven to fourteen days .
Note: Adults with impaired renal function may require a reduction in dose as follows :
Creatinine clearance (mL/min)/(mL/sec) Dose (base)
> 50/0.83 See
30-50/0.5-0.83 250-500 mg every 12 hours
5-29/0.08-0.48 250-500 mg every 18 hours
Hemodialysis or Peritoneal dialysis 250-500 mg every 24 hours after dialysis
patients
In patients with severe infection and severe renal function impairment, a unit dose of 750 mg may be administered at the intervals noted above; however, these patients should be monitored carefully and serum concentrations of ciprofloxacin should be measured periodically . |
|
|
|
|
|