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CEMOXIN

Trade Name : CEMOXIN

Generic Name : Amoxycillin Trihydrate

Description:

CEMOXIN contains Amoxycillin a semisynthetic antibiotic of penicillin group with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms.

Microbiology:

CEMOXIN acts through the inhibition of biosynthesis of cell wall mucopeptide. Amoxycillin has been shown to be active against most strains of the following microorganisms.

Aerobic Gram- positive microorganisms:

Enterococcus

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Staphylococcus SPP.

(ß Lactamase- negative)

Staphylococcus pneumoniae.

Staphylococcus SPP.

(a and ß - hemolytic strains).

Aerobic Gram–negative microorganisms:

ß-lactamase-negative strains of–Escherichia coli.

Haemophilus influenzae

Neisseria gonorrhoeae.

Proteus mirabilis.

Helicobacter.

Helicobacter pylori.

Composition:

Cemoxin Capsule: Each capsule contains Amoxycillin Trihydrate BP eqv. to 250 mg and 500 mg of Amoxycillin.

Cemoxin Dry Powder for suspension: After reconstitution each 5 ml contains Amoxycillin Trihydrate BP eqv. to Amoxycillin 125 mg.

Indications and Use:

CEMOXIN is indicated in the treatment of infection due to susceptible microorganisms in the conditions listed below.

Infection of the ear, nose and throat.
Infection of the genitourinary tract
Infection of the skin and skin structure
Infection of the lower respiratory tract
Gonorrhea, acute Uncomplicated urogential and urethral infections
H. Pylori eradication to reduce the risk of duodenal ulcer recurrence.
Prophylaxis of bacterial Endocraditis.

Contraindications:

A history of allergic reaction to penicillin or hypersensitivity to penicillin.

Warnings:

Serious and occasionally fatal hypersensitivity reactions have been reported in patients on penicillin therapy.

Pseudomembranous colitis has been reported with nearly all antibacterial agents including Amoxycillin and may range in severity from mild to life threatening.

Precautions:

The possibility of superinfection with mycotic or bacterial pathogens should be kept in mind during therapy. If super infections occur, Amoxycillin should be discontinued and appropriate therapy instituted.

Pregnancy & Lactation:

Long-term studies in animals have not been performed to evaluate carcinogenic potential and have on evidence of impaired fertility or harm to the fetus. Amoxycillin have been shown to be excreted in human milk, there fore caution should be exercised when Amoxycillin is administered to a nursing mother.

Dosage and Administration:

Infection	Severity	Usual adult dose	Usual dose for children
Ear/ Nose/ Throat	Mild/ Moderate Severe	500 mg every 12 hours or, 250 mg every 8 hours 875 mg every 12 hours or 500 mg every 8 hours	20 mg/kg/day in 3 divided doses every 8 hours 40 mg/kg/day in 3 divided doses every 8 hours
Lower respiratory tract	Mild/Moderate Severe	875 mg every 12 hours or, 500 mg every 8 hours.	40 mg/kg/day in 3 divided doses every 8 hours 20 mg/kg/day in 3 divided doses every 8 hours
Skin and skin structure	Mild/Moderate severe	500 mg every 12 hours or, 250 mg every 8 hours 875 mg every 12 hours or 500 mg every 8 hours	20 mg/kg/day in 3 divided doses every 8 hours 40 mg/kg/day in 3 divided doses every 8 hours
Genitourinary tract	Mild/Moderate severe	500 mg every 12 hours or, 250 mg every 8 hours 875 mg every 12 hours or 500 mg every 8 hours	20 mg/kg/day in 3 divided doses every 8 hours 40 mg/kg/day in 3 divided doses every 8 hours
Gonorrhea acute, Uncomplicated urogenital and urethral infections in male and female		3 gm as single oral dose	50 mg/kg Amoxycillin combined with 25 mg/kg Probenecides as single dose
Helicobacter pylori		500 mg every 6 hours with 500 mg clarithromycin and 30 mg lansoprazole for 14 days or with 400 mg Metronidazole and 40 mg Omeprazole for 14 days.

Infants age 3 months or less the recommended upper dose is 30 mg/kg/day in 2 divided doses every 12 hours.

Adverse Reactions:

The following adverse reactions have been reported associated with the use of CEMOXIN.

Gastrointestinal: Nausea, vomiting, Diarrhoea, and Pseudomembraneous colitis.

Hypersensitivity reactions: Erythematous maculopapular rashes, erythem multiform, steven’s Johnson-syndrome, toxic epidermal necrolysis and urticaria have been reported.

Central Nervous system: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, dizziness have been reported rarely.

Haemic and lymphatic system: Reversible anemia, thrombocytopenia, leukopenia, eosinophilia, agranulocytosis has been reported.

Storage:

CEMOXIN should be stored in cool, dry place, away from light and out of the reach of children.

Package quantities:

l. Cemoxin capsule 250 mg: Each box contains 10 x 10’s capsules in blister pack.

ll. Cemoxin capsule 500 mg: Each box contains 5 x 10’s capsules in blister pack.

lll. Cemoxin Dry Powder for suspension: Bottle containing dry powder to yield 100 ml suspension when reconstituted.

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