Amflux

Uses

Amoxicillin is used for the treatment of the following bacterial infections when caused by susceptible organisms:

• Respiratory tract, ENT infections: Acute and chronic bronchitis, pneumonia, otitis media, sinusitis, tonsillitis, pharyngitis & laryngitis, lobar & bronchopneumonia, chronic bronchial sepsis.
• Urinary tract infections: Pyelonephritis, cystitis and urethritis.
• Obstetric & gynaecological infections: Bacteriuria in pregnancy, septic abortion, intra-abdominal sepsis and puerperal sepsis.
• Gastro-intestinal infections: Typhoid and paratyphoid.
• Skin & soft tissue infections: Cellulitis, infected wounds and abscesses.
• Generalized infections: Septicemia, bacterial endocarditis, meningitis, peritonitis and osteomyelitis.
• Venereal infections: Gonorrhea and syphilis. Amoxicillin may also be used as prophylactic cover for patients at risk of developing endocarditis when undergoing dental surgery.

Flucloxacillin is used for the treatment of infections due to Gram-positive organisms, including infections caused by β-lactamase producing staphylococci.

Skin and Soft Tissue Infections: Boils, abscesses, carbuncles, furunculosis,infected wounds, infected burns, protection of skin grafts, otitis media and externa, impetigo.

Infected Skin Conditions: Ulcer, eczema and acne.

Respiratory Tract Infections: Pneumonia, lung abscess, empyema, sinusitis,pharyngitis, tonsillitis, quinsy.

Other infections caused by Flucloxacillin-sensitive organisms such as osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia.

Flucloxacillin is also used for use as a prophylactic agent during major surgical procedures where appropriate, for example, cardiothoracic and orthopaedic surgery

Amflux is also used to associated treatment for these conditions: Acute Bacterial Sinusitis (ABS), Acute Otitis Media, Acute Otitis Media (AOM), Bacterial Infections, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Genitourinary infections, Helicobacter Pylori Infection, Lower Respiratory Tract Infection (LRTI), Peptic Ulcer With H. Pylori Infection, Sinusitis, Skin and Subcutaneous Tissue Bacterial Infections, Urinary Tract Infection, Acute, uncomplicated Gonorrhea, Ear, nose, and throat infectionsSusceptible infections

How Amflux works

Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins. Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.

By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, flucloxacillin inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that flucloxacillin interferes with an autolysin inhibitor.

Dosage

Amflux dosage

Ear/Nose/ThroatInfection (Mild to Moderate):

• Adult:500 mg every 12 hours or 250 mg every 8 hours
• Children:25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours

Ear/Nose/ThroatInfection (Severe):

• Adult: 875 mg every 12 hours or 500 mg every 8 hours
• Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

Lower respiratory tractInfection (Mild/ Moderate/Severe):

• Adult: 875 mg every 12 hours or 500 mg every 8 hours
• Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

Skin/skin structureInfection (Mild/Moderate):

• Adult: 500 mg every 12 hours or 250 mg every 8 hours
• Children: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours

Skin/skin structureInfection (Severe):

• Adult: 875 mg every 12 hours or 500 mg every 8 hours
• Children: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours

Genitourinary tractInfection (Mild/ Moderate):

• Adult: 500 mg every 12 hours or 250 mg every 8 hours
• Children: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours

Genitourinary tractInfection (Severe):

• Adult: 875 mg every 12 hours or 500 mg every 8 hours
• Children: 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:

• Adult: 3 g as single oral dose
• Prepubertal children: 50 mg/Kg/Amoxycillin, combined with 25 mg/kg Probenecid as a single dose. Since Probenecid is contraindicated in children under 2 years, do not use this regimen in these cases.

Oral administration:

Adult or Elderly:

• Usual dosage: 250 mg four times daily. In severe infections, dosage should be doubled.
• In osteomyelitis and endocarditis: up to 8 gm daily, in divided doses 6 to 8 hourly.
• In case of secondary bacterial infection in chicken pox: Flucloxacillin 500 mg six hourly should be prescribed.

Children:

• Usual dosage: 2-10 years: half of the adult dose. Under 2 years: quarter of the adult dose.

Parenteral administration:

Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• Usual dosage: 2-10 years : half of the adult dose. Under 2 years : quarter of the adult dose.

Suspension: Shake the bottle well before adding water. Then add 12 tea spoonful (60 ml) of boiled and cooled water to the bottle and shake well to make 100 ml suspension.

Amoxycillin 500 mg Injection:

• Intramuscular : Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous : Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

Doses should be administered half an hour before meals.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Side Effects

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

There have been some common side effects of GIT such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported

Toxicity

Patients experiencing an overdose may present with hematuria, oliguria, abdominal pain, acute renal failure, vomiting, diarrhea, rash, hyperactivity, and drowsiness. Treat overdose with symptomatic and supportive treatment, which may include emesis or hemodialysis.

Precaution

In renal impairment, the excretion of antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dose.

Patient with spirochaete infections (e.g. syphilis, leptospirosis), history of hypersensitivity to β-lactam antibiotics. Newborn infants. Hepatic or renal impairment. Pregnancy and lactation.

Interaction

The simultaneous use of Amoxicillin and an oral contraceptive might cause breakthrough bleeding or pregnancy on rare occasions. Concurrent administration of probenecid delays the excretion of Amoxicillin.

The administration of probenecid with Flucloxacillin results in higher serum peak concentrations and prolongs the time that therapeutic concentrations of Flucloxacillin are achieved in serum. Physical incompatibility and/or loss of activity of Flucloxacillin in solution has been reported when given with gentamycin sulphate, streptomycin sulphate, vitamin mixtures. Flucloxacillin should not be added to intravenous lipids, blood products and protein hydrolysates or other proteinaceous fluids.

Volume of Distribution

The central volume of distribution of amoxicillin is 27.7L.

Elimination Route

Amoxicillin is approximately 60% bioavailable. A 250mg dose of oral amoxicillin reaches a C_max 3.93±1.13mg/L with a T_max 1.31±0.33h and an AUC of 27.29±4.72mg*h/L. A 875mg dose of oral amoxicillin reaches a C_max 11.21±3.42mg/L with a T_max 1.52±0.40h and an AUC of 55.04±12.68mg*h/L.

Bioavailability is 50–70% following oral administration.

Half Life

The half life of amoxicillin is 61.3 minutes.

0.75–1 hour

Clearance

The mean clearance of amoxicillin is 21.3L/h.

Elimination Route

125mg to 1g doses of amoxicillin are 70-78% eliminated in the urine after 6 hours.

Pregnancy & Breastfeeding use

Because of its lack of teratogenicity, Amoxicillin can beused safely throughout pregnancy at the normal adult dose. The small amount of Amoxicillin secreted in maternal milk rarely causes problem in the infant. It can therefore be used safely during lactation in most instances.

The use of Flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician. Use of the drug in the second and third trimesters may result in the sensitisation of the fetus. During lactation, trace quantities of penicillins can be detected in breast milk.

Contraindication

Amoxicillin is contraindicated for patients hypersensitive to penicillin, infectious mononucleosis, neonatal period or babies born of mothers hypersensitive to penicillin

Flucloxacillin is contraindicated for those who have hypersensitivity to penicillins.

Special Warning

Dose adjustment in renal impairment : As common with other penicillins, Flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or an extension of dose interval should be considered. Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosages need to be administered either during or at the end of the dialysis period.

Acute Overdose

If encountered, gastro-intestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They may be treated symptomatically and supportive with attention to the water/ electrolyte balance. In the absence of an adequate fluid intake and urinary output, crystalluria is a possibility and the antibiotic may be removed from the circulation by haemodialysis. Oral administration can cause gastro intestinal symptoms such as transient diarrhoea, nausea and colic which are dose related and a result of local irritation not toxicity.

Symptoms: Neurotoxicity (e.g. convulsions, encephalopathy), GI effects (e.g. nausea, vomiting, diarrhoea), blood disorders (e.g. neutropenia, haemolytic anaemia, prolongation of bleeding time, defective platelet function), electrolyte disturbances.

Management: Symptomatic treatment.

Storage Condition

Store in a cool & dry place protected from light. Amoxicillin suspension and drops should be freshly prepared, stored in a cool dry place preferably in a refrigerator. Reconstituted suspension and drops should be used within 5 days if kept at room temperature or within 7 days if kept in a refrigerator.

Store below 25° C. Reconstituted solution: Store between 2-8°C.

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