Fimox Capsule
Amoxicillin
500mg
Popular Pharmaceuticals Ltd.
| Pack size | 50's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 6.78 AED |
Available as:
Indications
Fimox Capsule is used for:
Bacterial infections, Pharyngitis, Acute otitis media, Acute bacterial sinusitis, Endocarditis, Anthrax, Chlamydial cervicitis, Chlamydial urethritis, Lyme disease, Dental abscess, Salmonellosis, Typhoid fever, Acute Uncomplicated gonorrhea, Infections of the Lower Respiratory Tract, Skin and Skin Structure, Genitourinary Tract, Ear, Nose, Throat
Adult Dose
Adult:
Oral
Ear, Nose, & Throat Infections
Mild to moderate infections
500 mg 12 hourly or 250 mg 8 hourly for 10-14 days
Severe infections
875 mg 12 hourly or 500 mg 8 hourly for 10-14 days
Genitourinary Tract Infections
Mild to moderate infections
500 mg 12 hourly or 250 mg 8 hourly
Severe infections
875 mg 12 hourly or 500 mg 8 hourly
Spectrum of action
E coli, P mirabilis, or E faecalis
Skin & Skin Structure Infections
Mild to moderate infections
500 mg 12 hourly or 250 mg 8 hourly
Severe infections
875 mg 12 hourly or 500 mg 8 hourly
Lower Respiratory Tract Infections
875 mg 12 hourly or 500 mg 8 hourly for 10-14 days
Helicobacter Pylori
H pylori infection and an active or 1-year history of duodenal ulcer
Triple therapy
1 g 12 hourly for 14 days with lansoprazole (30 mg) and clarithromycin (500 mg)
Dual therapy
1 g 8 hourly for 14 days with lansoprazole (30 mg) in patients intolerant of, or resistant to, clarithromycin
Anthrax
Postexposure inhalational prophylaxis
500 mg 8 hourly
Infective Endocarditis
Prophylaxis
2 g PO 30-60 min before the procedure
IV/IM
Susceptible infections 500 mg 8 hrly.
Listerial meningitis W/ other antibiotics: 2 g 4 hourly for 10-14 days.
Child Dose
Child:
Oral
Ear, Nose, & Throat Infections
Mild to moderate infections
<3 months: <30 mg/kg/day PO divided q12hr for 48-72 hours; for ?10 days for S pyogenes infections
>3 months and <40 kg: 25 mg/kg/day PO divided q12hr or 20 mg/kg/day PO divided q8hr
>40 kg: 500 mg PO q12hr or 250 mg PO q8hr for 10-14 days
Severe infections
<3 months: <30 mg/kg/day PO divided q12hr for 48-72 hours; for ?10 days for S pyogenes infections
>3 months and <40 kg: 45 mg/kg/day PO divided q12hr or 40 mg/kg/day PO divided q8hr
>40 kg: 875 mg PO q12hr or 500 mg PO q8hr for 10-14 days
Acute Otitis Media
>2 months and children: 80-90 mg/kg/day PO in divided doses q12hr
Consider amoxicillin-clavulanate in patients who have received amoxicillin in the previous 30 day or who have the otitis-conjunctivitis syndrome
Duration
Recommended by Guidelines for the Diagnosis and Management of Acute Otitis Media
Age <2 years or severe symptoms (any age): Standard 10-day course
>2 years with mild or moderate AOM: 5-7-day course
Lower Respiratory Tract Infections
Mild, moderate, or severe infections
<3 months: ?30 mg/kg/day PO divided q12hr for 48-72 hours; for ?10 days for S pyogenes infections
>3 months and <40 kg: 45 mg/kg/day PO divided q12hr or 40 mg/kg/day PO divided q8hr
>40kg: 875 mg PO q12hr or 500 mg PO q8hr for 10-14 days
Pneumonia, community-acquired (Off-label)
<3 months: Safety and efficacy not established
>3 months:
Immediate release
Empiric treatment: 90 mg/kg/day PO divided q12 hr for 10 days; not to exceed 4,000 mg/day
Group A Streptococcus: 50-75 mg/kg/day PO divided q12hr for 10 days; not to exceed 4,000 mg/day
H. influenza: 75-100 mg/kg/day PO divided q8hr for 10 days; not to exceed 4,000 mg/day
S. pneumoniae (mild infection or step-down therapy or when MICs to penicillin <2.0 mcg/mL): 90 mg/kg/day PO divided q12hr or 45 mg/kg/day divided q8hr for 10 days; not to exceed 4,000 mg/day
Renal Dose
Renal impairment
Mild-to moderate (CrCl >30 mL/min): No dosage adjustment necessary
Severe (CrCl 10-30 mL/min): 250-500 mg q12hr, depending on severity of infection; should not receive 875 mg
Severe (CrCl <10 mL/min) or patients on hemodialysis: 250-500 mg q24hr, depending on severity of infection; patients on hemodialysis should receive an additional dose both during and at the end of dialysis
Administration
May be taken with or without food. May be taken w/ meals for better absorption & to reduce GI discomfort.
Contra Indications
Documented hypersensitivity to penicillins, cephalosporins, imipenem
Precautions
Anaphylaxis has been reported rarely but is more likely to occur following parenteral therapy with penicillins
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents; severity may range from mild diarrhea to fatal colitis; CDAD may occur over 2 months after discontinuation of therapy; if CDAD is suspected or confirmed, discontinue immediately and begin appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation
Do not administer in patients with infectious mononucleosis because of risk of development of erythematous skin rash
Do not administer to patients in the absence of a proven or suspected bacterial infection because of risk of development of drug-resistant bacteria
Superinfections with bacterial or fungal pathogens may occur during therapy; if suspected, discontinue immediately and begin appropriate treatment
Chewable tablets contain aspartame, which contains phenylalanine
Use caution in patients with allergy to cephalosporins, carbapenems
Endocarditis prophylaxis: use for only high-risk patients, as per recent AHA guidelines
High doses may cause false urine glucose test by some methods
May cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP); if patients develop a skin rash they should be monitored closely and therapy discontinued if lesions progress
Drug-induced enterocolitis syndrome (DIES)
DIES reported with most cases occurring in pediatric patients ≤18 years of age; DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1-4 hr after drug ingestion in the absence of skin or respiratory symptoms
Pregnancy-Lactation
Pregnancy
Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with amoxicillin use have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
No adverse developmental effects were observed in animal reproduction studies with administration of amoxicillin to pregnant mice and rats at doses up to 12.5 and 25 times the recommended human dose
Lactation
Data from a published clinical lactation study reports that amoxicillin is present in human milk; published adverse effects with amoxicillin exposure in breastfed infant include diarrhea
There are no data on effects of amoxicillin on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breast-fed child from drug or from underlying maternal condition
Interactions
Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin.
Concomitant use of Amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time.
Coadministration with allopurinol increases the risk of rash.
Amoxicillin may reduce the efficacy of oral contraceptives.
Contraindicated (0)
Serious - Use Alternative (14)
BCG vaccine live
cholera vaccine
demeclocycline
doxycycline
eravacycline
microbiota oral
minocycline
mycophenolate
omadacycline
pexidartinib
pretomanid
sarecycline
tetracycline
typhoid vaccine live
Adverse Effects
Side effects of Amoxicillin :
Frequency Not Defined
Anaphylaxis
Anemia
AST/ALT elevation
Mucocutaneous candidiasis
Diarrhea
Headache
Nausea
Vomiting
Rash
Pseudomembranous colitis
Serum sickness-like reactions
Potentially Fatal: Neuromuscular hypersensitivity; pseudomembranous colitis.
Mechanism of Action
Derivative of ampicillin and has similar antibacterial spectrum (certain gram-positive and gram-negative organisms); similar bactericidal action as penicillin; acts on susceptible bacteria during multiplication stage by inhibiting cell wall mucopeptide biosynthesis; superior bioavailability and stability to gastric acid and has broader spectrum of activity than penicillin; less active than penicillin against Streptococcus pneumococcus; penicillin-resistant strains also resistant to amoxicillin, but higher doses may be effective; more effective against gram-negative organisms (eg, N meningitidis, H influenzae) than penicillin.
Note
Fimox 500mg Capsule manufactured by Popular Pharmaceuticals Ltd.. Its generic name is Amoxicillin. Fimox is availble in Bangladesh.
Farmaco BD drug index information on Fimox Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.