Актуальная Медицина - TRIMOX (AMOXICILLIN)

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TRIMOX (AMOXICILLIN)


DESCRIPTION
CAPSULES 250 mg and 500 mg  

à      SUSPENSION 125 mg per 5 mL, 250 mg per 5 mL

à      PEDIATRIC DROPS 50 mg per mL

TRIMOX is a semisynthetic penicillin, an analogue of ampicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against Gram-positive organisms and many Gram-negative pathogens.

The capsules contain amoxicillin trihydrate equivalent to 250 mg or 500 mg of amoxicillin, respectively. Each 5 mL of reconstituted oral suspension contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin, respectively. Each 1 mL of the reconstituted pediatric drops contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin.

Inactive ingredient in TRIMOX capsules is magnesium stearate.

CLINICAL PHARMACOLOGY

TRIMOX is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tract and may be given with no regard to food. It diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of amoxicillin is 61.3 minutes.

Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels one to two hours after administration in the range of 3.5 to 5.0 µg/mL and 5.5 to 7.5 µg/mL, respectively.

Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels one to two hours after administration in the range of 1.5 to 3.0 µg/mL and 3.5 to 5.O µg/mL, respectively.

PRIVATEINDICATIONS

TRIMOX (amoxicillin, USP) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Venereal Diseases: Amoxicillin is indicated for the treatment of uncomplicated infections (urethral, endocervical or rectal) due to N. gonorrhea in males and females.

Upper Respiratory Tract Infections caused by nonpenicillinase-producing staphylococci, Streptococci sp., and H. influenzae. Amoxicillin is indicated for treating otitis media caused by H. influenzae.

Urinary Tract Infections caused by E. coli, Proteus mirabilis, and Streptococcus faecalis.

Skin and Skin Structure Infections caused by nonpenicillinase-producing Staphylococcus sp. and Escherichia coli.

Therapy may be instituted prior to obtaining results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to amoxicillin.

Indicated surgical procedures should be performed.

DOSAGE AND ADMINISTRATION

Infections of the ear, nose, and throat due to streptococci, pneumococci, nonpenicillinase-producing staphylococci, and H. Influenzae;

Infections of the genitourinary tract due to E. coli, Proteus mirabilis, and Streptococcus faecalis;

Infections of the skin and soft tissues due to streptococci, susceptible staphylococci, and E. coli;

Usual Dosage: Adults—250 mg every 8 hours

Children—20 mg/kg/day in divided doses every 8 hours. Children weighing 20 kg or more should be dosed according to the adult recommendations. In severe infections or those caused by less susceptible organisms: 500 mg every 8 hours for adults, and 40 mg/kg/day in divided doses every 8 hours for children may be needed.

Infections of the lower respiratory tract due to streptococci, pneumococci, nonpenicillinase-producing staphylococci, and H. influenzae;

Usual Dosage: Adults—500 mg every 8 hours

Children—40 mg/kg/day in divided doses every 8 hours. Children weighing 20 kg or more should be dosed according to the adult recommendations. Larger doses may be required for stubborn or severe infections. The children’s dosage is intended for individuals whose weight will not cause a dosage to be calculated greater than that recommended for adults.

Dosage and Administration of Pediatric Drops:

Usual dosage for all indications except infections of the lower respiratory tract:

Under 6 kg (13 lbs): 0.5 mL every 8 hours

6 to 8 kg (13 to 18 Ibs): 1 mL every 8 hours

Infections of the lower respiratory tract:

Under 6 kg (13 lbs): 1 mL every 8 hours

6 to 8 kg (13 to 18 lbs): 2 mL every 8 hours

Children weighing more than 8 kg (18 lbs) should receive the appropriate dose of the Oral Suspension 125 mg or 250 mg/5 mL.

After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

CONTRAINDICATIONS

A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

PRECAUTIONS

General

The possibility of superinfections with mycotic organisms or bacterial pathogens should be kept in mind during therapy. In such cases, discontinue the drug and substitute appropriate treatment.

Pregnancy Category B

Reproduction studies have been performed in mice and rats at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

TRIMOX is excreted in human milk in very small amounts. Therefore caution should be exercised when amoxicillin is administered to a nursing woman.

Pediatric Use

Guidelines for administration of TRIMOX to pediatric patients are presented in DOSAGE AND ADMINISTRATION..

ADVERSE REACTIONS

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

Gastrointestinal

Glossitis, stomatitis, black "hairy” tongue, nausea, vomiting, and diarrhea. (These reactions are usually associated with oral dosage forms.)

Hypersensitivity Reactions

Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form.

NOTE: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, penicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life threatening and amenable only to penicillin therapy. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids.

Liver

A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is unknown.

Hemic and Lymphatic Systems

Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

DRUG INTERACTIONS

No information available.

OVERDOSAGE

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required. Amoxicillin can be removed from circulation by hemodialys

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