250 mg, 500 mg Capsule & 125 mg/5 ml Powder for Suspension

Halopen is a preparation of Flucloxacillin. It is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria.

  • Composition

    Halopen 250 Capsule: Each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 250 mg.

    Halopen 500 Capsule: Each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 500 mg.

    Halopen Powder for Suspension: After reconstitution, each 5 ml suspension contains Flucloxacillin Sodium BP equivalent to Flucloxacillin125 mg.

  • Indication

    Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include: Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo). Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy. It is also used for the treatment of other infections i.e. osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia caused by Flucloxacillin-sensitive organisms. As a prophylactic agent, it is used during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.
  • Dosage & Administration

    Adult:250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8g daily is used in 6-8 hourly divided doses.

    Children (2-10 years): 1/2 of adult dose.

    Children (Under 2 years): 1/4th of adult dose. In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered. Oral doses should be administered 1 hour before meal.

  • Contraindication

    Flucloxacillin is contraindicated in penicillin hypersensitive patients.
  • Precaution

    Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.
  • Side Effects

    There have been some common side effects of gastrointestinal tract 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.
  • Drug Interaction

    Concurrent use of Flucloxacillin and Probenecid may result in increased level of Flucloxacillin in blood for prolonged period.
  • Overdose

  • Pregnancy & Lactation

    US FDA Pregnancy Category of Flucloxacillin is B. There are, 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.
  • Storage Condition

    Keep in a dry place away from light and heat. Keep out of the reach of children.
  • How Supplied

    Halopen 250 Capsule: Each box contains 40 s capsules in Alu-Alu blister pack.

    Halopen 500 Capsule: Each box contains 28 s capsules in Alu-Alu blister pack.

    Halopen Powder for Suspension: Each amber glass bottle contains dry powder to reconstitute 100 ml suspension.