Hectamox
Amoxycillin Capsule/Suspension/Drops

DISCRIPTION
Hectamox contains Amoxycillin BP as trihydrate which is chemically D (-) - - amino-p-hydroxy-benzylpenicillin. It is a broad spectrum, bactericidal antibiotic similar to ampicillin in the spectrum of activity but is better absorbed when taken orally and produces a higher blood level.

INDICATION
Hectamox is indicated in the following bacterial infections :

--> Infections of the respiratory tract & ear : Laryngitis, Pharyngitis, Tonsillitis, Sinusitis.
--> Infections of the billiary and G.I. tract : Salmonellosis including the carrier stage, Choleccystitis, Peritonitis.
--> Infections of the genito-urinary tract : Nephritis, Pyelitis, Pyelonephritis, Cystitis, Urethritis and Gonorrhea Bacteriuria in pregnancy Gynecological infections including puerperal sepsis and septic abortion.
--> Skin and soft tissue infections : Boils, Carbuncles, Cellulitis, pre-and post-operative prophylaxis.
--> Bacterial endocaditis
--> Septicemia
--> Osteomyelitis
--> Prophylaxis of endocarditis : Hectamox may be used for the prevention of bacteraemia, associated with procediures such as dental extraction, in patients at risk of developing bacterial endocarditis.

CLINICAL PHARMACOLOGY
Amoxycillin is an orally active semi-synthetic penicillin. amoxycillin is readily hydrolysed by the staphylococcal penecillinase. Benzyl ring in the side chain of amoxycillin extends the renge of antimicrobial activity into the Gram-negerive bacteria. Amoxicillin kills bacteria by interfering with the synthesis of the bacterial cell wall. Peptidoglycan provides the mechanical stability of cell wall. The final stage of peptidoglycan synthesis involves the completion of the pentaglycine bridge is linked to the fourth residue of the pentapetide (d-alanine). The transpeptidase enzyme that performs this step is inhibited by penicillins. As a result the bacterial cell wall is weakened, the cell swells and ruptures.

Amoxycillin is more acid stable than benzylpenicillin. It is more rapidly and completely absorbed from the gastrointestinal tract after oral administration (90%). Peak plasma concentration of about 5 mg per ml have been observed. About 20% is bound to plasma proteins in the circulations and plasma half-life is 1 to 1.5 hours. The half-life may be longer in neonates and in the elderly. Amoxycillin is widely distributed in body tissues and fluids. It crosess the placenta and small amounts are excreted unchanged in the breast milk. and fluids. It crosses the plecenta and small amounts are excreted in breast milk.

Amoxycillin is metabolized to a limited extent and about 60% of an oral dose of Amoxycillin is excreted unchanged in the urine. Some may be excreted in the faces.

DOSAGE AND ADMINISTRATION
ADULT (Including elderly patients) :

--> Standard dosage : 250 mg 8 hourly daily, increasing upto 500 mg 8 hourly daily for more severe infections.
--> Severe or recurrent purulent infection of the respiratory tract : A dosage of 3g twice daily is recommended in appropriate cases.
--> Maximum recommended oral dosage : 6 g daily in divided doses.
--> Uncomplicated acute urinary tract infection : A single dose of 3 g.

--> Gonorrhea : Single 3 g dose, often with 1 g Probenecid in the treatment of uncomplicated gonorrhea in areas where the pathogen is sensitive to amoxycillin.

--> Prophylaxis for endocarditis in susceptible patients : Single dose of 3 g about 1 hour before dental extraction.

CHILDREN
--> Children upto 10 years of age may be given the equavalent of 250 mg 8 hourly daily; under 20 kg body weight, a dose of 20 to 40 mg per kg daily has been suggested.

--> Children weighting 20 kg or more should be given doses according to the recommended dosage for adults.

--> In prophylaxis of endocarditis, children may be given half the adult dose i.e. 1.5 g about before dental extraction.

CONTRAINDICATIONS
Hectamox is contraindicated in patients with known hypersensitivity to penicillins.

SIDE EFFECTS
Side Effects, as with other penicillins are rare and usually mild and transient in nature. Skin rashes may appear to some patients. This must be reported to the physician and treatment should be discontinued. Gastrointestinal complains like diarrhea have occasionally been observed. These usually subside on continuation of therapy. Incidence of persistent diarrhea should be reported to the physician.

PRECAUTIONS
In presence of gastrointestinal disease like diarrhea and vomiting, absorption of oral preparation is doubtful. Like all broadspectrum antibiotics, superinfection may occur with Amoxycillin. In such cases treatment with Amoxycillin should be discontinued and appropriate therapy to combat superinfection should be instituted.

DIRECTION FOR RECOSTITUTION
Suspension : Add 65 ml ( 13 measuring spoonfuls) of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Pediatric Drop : Add 10 ml (2 measuring spoonfuls) boiled and cooled water shake well until al the powder is in suspension.

Note : Shake the oral suspension well before use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool place, preferably in a refrigerators and used within 7 days of preparation.

PACKAGING
Hectamox Capsule : Box containing 100 Capsules in 10X10's blster strip, each capsule contains Amoxycillin Thrihydrate BP equivalent to 250 mg Amoxycillin.

Hectamox suspension : Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution, each 5 ml contains Amoxycillin Trihydrate BP equivalent to 125 mg Amoxycillin.

Hectamox Pediatric Drops : Dry powder in amber glass bottle for reconstitution into 15 ml suspension. After reconstitution each 1.25 ml contains Amoxycillin Trihydrate BP equivalent to 125 mg Amoxycillin.