EMOXIL® – Amoxicillin Trihydrate BP

COMPOSITION

Available in two dosage forms:

Emoxil® 250 mg Capsule: Each capsule contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 250 mg. Emoxil® 500 mg Capsule: Each capsule contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 500 mg. Emoxil® 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).

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

Adults: The usual dosage range for adults is 250-750mg twice daily.

Type of Infection	Type of Severity	Unit Dose	Frequency	Usual Duration
UTI	Acute Uncomplicated	100 mg or 250 mg	b.i.d	3 Days
	Mild/Moderate	250 mg	b.i.d	7-14 Days
	Severe/Complicated	500 mg	b.i.d	7-14 Days
Lower RTI	Mild/Moderate	500 mg	b.i.d	7-14 Days
Lower RTI	Severe/Complicated	750 mg	b.i.d	7-14 Days
Acute Sinusitis	Mild/Moderate	500 mg	b.i.d	10 Days
SSTI	Mild/Moderate	500 mg	b.i.d	7-14 Days
SSTI	Severe/Complicated	750 mg	b.i.d	7-14 Days
Bone & Joint Infection	Mild/Moderate	500 mg	b.i.d	≥4-6 Weeks
Bone & Joint Infection	Severe/Complicated	750 mg	b.i.d	≥4-6 Weeks
Infectious Diarrhea	Mild/Moderate/ Severe	500 mg	b.i.d	3-5 Days
Typhoid Fever	Mild/Moderate	500 mg	b.i.d	10-14 Days
	Severe	750 mg	b.i.d	10-14 Days
	Carrier Stage	500 mg	b.i.d	28 Days
Gonococcal Infections	Uncomplicated	250	Single Dose	Single Dose

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 Amoxilillin.

OVER DOSE

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.