Amoxicillin Capsules

COMPOSITION

DESCRIPTION:

Amoxicillin is a semi-synthetic penicillin derived fromthe penicillin nucleus 6-APA(6-amino-penicillanic acid).

MODE OF ACTION

Amoxicillin exerts a bactericidal action by interferingwith the synthesis of bacterial cellwall.

PHARMACOKINETICS

Amoxicillin is well absorbed after oral administration.After a 500mg dose, a peak serumlevel of 8-10mcg/ml is reached at two hours. Presence of food does not affect the absorption of Amoxicillin.​

Amoxicillin is distributed in various tissues and tissue fluids, including bronchial secretions and sputum. About 58-68 percent of the oral dose is eliminated unchanged in urine.High levels of 115 to 1850mcg/ml occur after a 500mg dose in adults.​

ANTIBACTERIAL SPECTRUM

Thewide range of organisms sensitive to the bactericidal action of Amoxicillin include:

• Gram-positive

  TStreptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus aureus, (penicillin-sensitive), Clostridium, species,Corynebacteriumspecies, Bacillus anthracis, Listeriamonocytogenes.

• Gram-negative

  Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae,Neisseriameningitidis, Vibrio cholerae, Pasteurella septica

INDICATIONS

• TREARMENT OF INFECTION

  Amoxicillin, being a broad spectrumantibiotic, is indicated forthe treatment of commonly occurring bacterial infections such as:

  Tonsillitis, Pharyngitis, Sinusitis,Otitismedia,Acute andChronicBronchitis.Chronic BronchialSepsis Lobar and Bronchopneumonia Cystitis, Urethritis, Pyelonephritis Bacteriuria in pregnancy, Gynaecological infections including puerperal sepsis and septic abortion,Gonorrhoea, Peritonitis Intra-abdominal sepsis,Septicaemia, Bacterial endocarditis,Typhoid andParatyphoid fever.

  Skin andSoft Tissue Infections,Osteomyelitis,Dental abscess (as an adjunct to surgicalmanagement).

• PROPHYLAXIS OF ENDOCARDITIS

  Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae,Neisseriameningitidis, Vibrio cholerae, Pasteurella septica

CONTRAINDICATIONS

Amoxicillin is contraindicated in individualwith a history of allergic reactions to Penicillins andCephalosparins.

OVERDOSAGE & ANTIDOTE

Interstitial nephritis resulting in oliguric renal failure has been reported in small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because ofi mpaired renal clearance of amoxicillin. Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomaticallywith attention to thewater/electrolyte balance.

In case of overdosage discontinue medication, treat symptomatically and institute supportivemeasures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or othermeans of removal of drug fromthe stomachmay be performed.

DOSAGE AND ADMINISTRATION

• Treatment of Infection

  Standard Adult Dosage: 250mg three times daily, increasing to 500mg three times daily for more severe infections.

• High Dosage Therapy:

  (maximum recommended oral dosage 6 g daily in divided doses).A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of
  severe or recurrent purulent infection of the respiratory tract

• Typhoid Fever

  100mg/kg/day in three divided doses till defervescence is achieved, followed by 50mg/kg/day for further five days.

• Short Course Therapy

  Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses.

  Dental abscess : two 3 g, doseswith 8 hours between the doses.

  Gonorrhoea : single 3 g dose.

• Standard Children’s Dosage

  125mg three times daily, increasing to 250mg three times daily formore severe infections.

The administration of Amoxicillin on a bodyweight basis should be done as follows:

• Mild infections:

  20mg/kg/day in three divided doses administered 8-hourly.

• Moderate to severe infections:

  40mg/kg/day in three divided doses administered 8-hourly.

• Prophylactic Usage

  Dental Procedures : 3 g. orally 1 hour before procedure.A second dose may be given 6 hours later, if considered necessary.

  For Children under 10, half the above dosage, and for children under 5, a quarter of the above dosage is recommended.

  IMOX may be prophylactically used for providing an antibacterial cover during genito-urinary or gynaecological procedures.

SIDE-EFFECTS AND PRECAUTIONS

Before initiating treatment with penicillins, it is necessary to have a careful history about previous sensitivity reactions. Prolonged use of penicillins, as with all other antibiotics,can foster the growth of non-susceptible organisms including: Fungi, which require the adoption of adequate therapeutic measures.

As with other penicillins, side-effects are uncommon and mainly of amild and transitory nature; they may include diarrhoea, indigestion, or occasionally rash, either urticarial or erythematous.An urticarial rash suggests penicillin hypersensitivity and treatment should be discontinued.

• Usage in Pregnancy & Lactation

  If an antimicrobial agent must be used during pregnancy, amoxycillin is recommended for the treatment of asymptomatic bacteriuria or simple cysitis, bronchitis orfor the prophylaxis of endocarditis.

  Amoxicillin may be given during lactation.With the exception of the risk of sensitization associated with the excretion of trace quantities of amoxicillin in breast milk, there are no detrimental effects for the breast-fed infant. Caution should be exercised when amoxicillin is administered to a nursing woman.

• Hepatic effects:

  Adverse effects reported with amoxicillin are similar to those reported with other aminopenicillins.A moderate increase in serum concentration of AST (SGOT) and/or ALT (SGPT) have been reported rarely during therapy with aminopenicillins, especially when the drugs were administered to infants. Hepatic dysfunction (cholestatic, hepatocellular, or mixed cholestatic-hepatocellular) has been reported rarely in patients receiving aminopenicillins; signs and symptoms may appear during or after therapy and resolve completely with time.

• Hematological effects:

  In addition to eosinophilia and hemolytic anemia, other adverse hematologic effects like anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and thrombocytopenic purpura have been reported in patients receiving aminopenicillins. These adverse hematologic effects are usually reversible following discontinuance of drugs. Although these hematologic effects are generally considered hypersensitivity reactions to the drugs, an immunologic mechanism has not been definitely established

  Abnormal platelet aggregation, prolongation of bleeding time, and prolongation of activated partial thromboplastin time (APTT) have been reported in children and healthy adults receiving ampicillin or amoxicillin.

• CNS effects :

  CNS effects have been seen rarely. They include reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes, and/or dizziness, have been repoted rarely.Convulsions may occur in patients with impaired renal function or in those receiving high doses.

DRUGINTERACTIONS

• Drug-drug interaction:

  In common with other broad spectrumantibiotics, amoxicillinmay reduce the efficacy of oral contraceptives and patient should be warned accordingly. Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

  It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods. Probenecid decreases the renal tubular secretion of amoxicillin.Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. Chloramphenicol, macrolides, sulphonamides and tetracy lines may interfere with bactericidal effects of penicillin. This has been demonstrated in vitrohowever the clinical significance of this interaction is not well documented.

• Drug-food interaction:

  Although presence of food in the GI tract reportedly results in lower and delayed peak serum concentrations of amoxicillin, the total amount of drug absorbed does not appear to be affected.

STORAGE

Store below30°C, in a dry place
KEEP OUT OF REACH OF CHILDREN

PRESENTATION

AMOXICILLIN CAPSULES- Blister strips of 21