Magnapen (Ampicillin,Flucloxacillin)

Uses

Ampicillin is used for the treatment of infections caused by susceptible strains of the designated organism listed below:

• Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase-producing N. gononhoeae.
• Infections of the Respiratory Tract: Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae.
• Infections of the Gastrointestinal Tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
• Meningitis: O. Meningitides.

Bacteriology studies to determine the causative organisms and their sensetivity to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.

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

Magnapen (Ampicillin,Flucloxacillin) is also used to associated treatment for these conditions: Bacterial Infections, Bloodstream Infections, Endocarditis, Gastrointestinal Infections, Genitourinary tract infection, Infection, Infection caused by eikenella corrodens, Listeria infection, Meningitis, Bacterial, Pertussis, Respiratory Tract Infections (RTI), Salmonella, Salmonella Typhi Infection, Shigella, Skin Infections, Bacterial, Subcutaneous bacterial infection, Urinary Tract Infection, Perinatal group B streptococcus, Susceptible Bacterial InfectionsSusceptible infections

How Magnapen (Ampicillin,Flucloxacillin) works

By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, Ampicillin 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 Ampicillin interferes with an autolysin inhibitor.

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

Magnapen (Ampicillin,Flucloxacillin) dosage

Intra-articular:Supplement in systemic therapy for treatment of susceptible infections-

• Adult:500 mg daily.
• Child:<10 yrHalf of adult routine dosage.

Intraperitoneal:

Supplement in systemic therapy for treatment of susceptible infections-

• Adult:500 mg daily.
• Child:<10 yrHalf of adult routine dosage.

Intrapleural:

Supplement in systemic therapy for treatment of susceptible infections-

• Adult:500 mg daily.
• Child:<10 yrHalf of adult routine dosage

Intravenous:

Meningitis-

• Adult:2 gm 6 hrly.
• Child:150 mg/kg daily in divided doses.

Intrapartum prophylaxis against group B Streptoccocal infection in neonates-

• Adult:Initially, 2 gm via IV inj followed by 1 gm 4 hrly until delivery.

Oral:

Biliary tract infections, Bronchitis, Endocarditis, Gastroenteritis, Listeriosis, Otitis media, Perinatal streptococcal infections, Peritonitis-

• Adult:0.25-1 gm 6 hrly.
• Child:<10 yrHalf of adult routine dosage.

Typhoid and paratyphoid fever-

• Adult:1-2 gm 6 hrly for 2 wk in acute infections, and 4-12 wk in carriers.

Uncomplicated gonorrhoea-

• Adult:2 gm with 1 gm of probenecid as single dose, recommended to be repeated in female patients.

Urinary tract infections-

• Adult:500 mg 8 hrly.

Parenteral:

Susceptible infections-

• Adult:500 mg 6 hrly, via IM or slow IV inj over 3-5 min or by infusion.
• Child:<10 yrHalf of adult routine dosage.

Septicaemia-

• Adult:150-200 mg/kg daily. Initiate with IV admin for at least 3 days, then continue with IM inj 3-4 hrly. Continue treatment for at least 48-72 hr after the patient has become asymptomatic or when there is evidence of bacterial eradication. Recommended treatment duration for infections caused by group-A β-haemolytic streptococci: At least 10-days, to prevent occurrence of acute rheumatic fever or acute glomerulonephritis.
• Child:Same as adult dose.

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.

Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.

Intramuscular: Add 1.5 mL water for inj to 500 mg vial contents.

Intravenous: Dissolve 500 mg in 10 mL water for inj. May be added to infusion fluids or injected, suitably diluted into the drip tube.

Intra-articular: Dissolve 500 mg in up to 5 mL of water for inj or sterile procaine HCl 0.5% soln.

Intraperitoneal: Dissolve 500 mg in up to 10 mL water for inj.

Intrapleural: Dissolve 500 mg in 5-10 mL water for inj.

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

Nausea, vomiting, diarrhoea, erythematous maculo-papular rashes, sore mouth, black/hairy tongue, rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, fever, joint pains, serum sickness-like symptoms, haemolytic anaemia, thrombocytopenia, leucopenia, neutropenia, coagulation disorders, prolonged bleeding time and prothrombin time, CNS toxicity (e.g. convulsions); paraesthesia, nephropathy, interstitial nephritis, hepatitis, cholestatic jaundice, moderate and transient increase in transaminases, Anaphylaxis, Clostridium difficile-associated diarrhoea (CDAD).

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

Precaution

Patient with history of β-lactam allergy. During renal impairment, Pregnancy and lactation.

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

May reduce the efficacy of oral contraceptives. May alter INR while on warfarin and phenindione. May reduce the efficacy of oral typhoid vaccines. May reduce the excretion of methotrexate. Reduced excretion with probenecid and sulfinpyrazone, resulting to increased risk of toxicity. Allopurinol increases ampicillin-induced skin reactions. Reduced absorption with chloroquine. Bacteriostatic antibacterials (e.g. erythromycin, chloramphenicol, tetracycline) may interfere with the bactericidal action of ampicillin.

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.

Elimination Route

Bioavailability is 50–70% following oral administration.

Half Life

0.75–1 hour

Elimination Route

Ampicillin is excreted largely unchanged in the urine.

Pregnancy & Breastfeeding use

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

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

Hypersensitivity to ampicillin and other penicillins.

Flucloxacillin is contraindicated for those who have hypersensitivity to penicillins.

Special Warning

Renal Impairment: CrCl<10: Dose reduction or increase in dose interval.

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

Symptoms: Nausea, vomiting and diarrhoea. Management: Symptomatic and supportive treatment. May be removed from the circulation by haemodialysis.

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 between 20-25° C. Reconstituted oral susp: Store between 2-8° C (discard after 14 days).

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

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