EMOXIL® – Amoxicillin Trihydrate

Chemical Name:

(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; trihydrate

Description: Amoxicillin is an antibiotic belonging to the penicillin family of the class of aminopenicillin. It is a moderate-spectrum, bacteriolytic, β-lactam antibiotic in the aminopenicillin family used to treat susceptible Gram-positive and Gram-negative bacteria.

— 500 mg 5×10 capsules
— 100 mg PFS

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EMOXIL® – Amoxicillin Trihydrate

COMPOSITION
Available in 2 different Dosage forms:
250 mg Capsule: Each capsule contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 250 mg.
500 mg Capsule: Each capsule contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 500 mg.
Powder for Suspension: After reconstitution, each 5 ml suspension contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 125 mg.

PHARMACOLOGY
Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Amoxicillin kills bacteria by interfering with the synthesis of the bacterial cell wall. Amoxicillin is stable at gastric pH. It is completely absorbed in the upper gastrointestinal tract.
Absorption is independent of meals.

INDICATION
Amoxicillin is indicated in the treatment of infections due to susceptible strains of the designated microorganisms in the condition listed below:
Infections of the ear, nose and throat due to streptococcus spp. (α and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Infections of the genitourinary tract due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure due to Streptococcus spp. (α and β-hemolytic strains only), Staphylococcus spp., or E. coli.
Infections of the lower respiratory tract due to streptococcus spp. (α and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated ano-genital and urethral infections due to N. gonorrhoeae (male and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with Clarithromycin plus Lansoprazole as triple therapy. Amoxicillin may also be used as prophylactic cover for patients at risk of developing endocarditis when undergoing dental surgery.

DOSAGE AND ADMINISTRATION

Infection Severity Usual      Adult Dose Usual Dose for Children
Ear/Nose/Throat Mild/
Moderate		 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory tract Mid/
Moderate or Severe		 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Skin/ Skin structure Mild/
Moderate		 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Genito-urinary tract Mild/
Moderate		 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Gonorrhea, Acute, uncomplicated ano-genital, and urethral infections in males and females 3 g as single oral dose Prepubertal children 50 mg/Kg Amoxicillin, combined with 25 mg/Kg Probenecid as a single dose

Note: Since Probenecid is contraindicated in children under 2 years, do not use this regimen in these cases.

SIDE EFFECT
Side effects are mild, rare and infrequent. As with other penicillin, it may induce diarrhea, indigestion or skin rashes which usually stop during treatment and rarely calls for discontinuation of therapy.

PRECAUTION
In renal impairment, the excretion of antibiotic will be delayed depending on the degree of impairment; it may be necessary to reduce the total daily dose. Caution should also be exercised in case of erythematous rashes, glandular fever, history of allergy etc.

CONTRAINDICATION
It is contra-indicated in patients hypersensitive to penicillin.

DRUG INTERACTION
Concurrent administration of probenecid delays the excretion of Amoxicillin.
Over dosage:
Problem of overdose with Amoxicillin are unlikely to occur; if encountered they may be treated symptomatically.
Direction for reconstitution of suspension:
At first, shake the bottle well to loosen the powder. Add 16 tea spoonful (80 ml) of boiled cool water to the bottle and shake well. Reconstituted suspension should be consumed within one week of preparation.

USE IN PREGNANCY AND LACTATION
Because of lack of teratogenicity, Amoxicillin can be used safely during pregnancy at normal adult dose. The small amount of Amoxicillin secreted in maternal milk rarely causes problems in infant. Therefore, it can be used safely during lactation in most instances.

STORAGE
Store capsule at 30°C and Powder for Suspension at or below 25°C. Protect from light & moisture. Keep out of the reach of children.

PACKAGING
EMOXIL®: 250 mg capsule: Each box contains 5 strips of 1O’s capsules in blister pack.
EMOXIL®: 500 mg capsule: Each box contains 5 strips of 1O’s capsules in blister pack.
EMOXIL®: Powder for Suspension: Each bottle contains powder for reconstitution of 100 ml suspension.

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