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Flucloxacillin manufacturers

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Country of origin : Romania

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Powder for solution for injection/infusion 500 mg

Dossier type
Dossier status
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Country of origin
European Union
GMP approvals
Unavailable markets
Serbia , Vietnam
Reference product: Floxapen, Aurobindo
Manufacturer #3436

A pharmaceutical manufacturer based in the EU that has been active in 70+ countries selling its products in Europe, the Middle East, LATAM, North America, Africa, and Asia for 60+ years. Key production lines are Rx, OTC, and nutraceuticals. The company's production lines are EU GMP-compliant. Main therapeutic areas include the cardiovascular system, CNS, and dermatology. Main dosage forms include solid, topical, and suppositories.

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Flucloxacillin is used to treat infections caused by susceptible Gram-positive bacteria. Also known as Floxacillin, it is a narrow-spectrum beta-lactam antibiotic of the penicillin class. Flucloxacillin works against beta-lactamase-producing organisms such as Staphylococcus aureus because it is beta-lactamase stable, unlike other penicillins. However, it is not effective against methicillin-resistant Staphylococcus aureus. With its bactericidal properties, it is most commonly used to treat infections of the chest, ear, nose, and throat like tonsillitis, sinusitis, pneumonia. In treating skin and soft tissue like boils, burns, wounds, abscesses, infected eczema, infected acne. It is also used for other infections including endocarditis, bones and osteomyelitis, meningitis, guts, septicemia, and the kidney, bladder, or urethra. And finally, it is also used to prevent infections during major surgical procedures, particularly in heart or orthopedic surgeries.
Flucloxacillin is traded under the Brand or Trade names like Floxapen, Flopen, Staphylex amongst others. Leo Pharm Prod Ltd filed for its first patent in 1961 and got FDA approval. There are several other companies with other patents. This medicine due it is applications, is manufactured and sold by several companies around the world.

Forms and dosage:

Flucloxacillin is available as sodium salt flucloxacillin sodium, as capsules of 250 or 500 mg strength, oral suspensions of 125 mg/5 ml or 250 mg/5 ml sizes, and injections for powder for reconstitution in 250, 500, and 1000 mg vials. The dosage is calculated based on age, weight, and renal function, as well as on the severity of the infection. The recommended usual adult oral dosage is 250mg, taken four times a day. However, in serious infections, the dosage may be doubled. In the treatment of Osteomyelitis, endocarditis, the standard dose is 8g daily, given every 6 to 8 hours. In Surgical prophylaxis, the patients are given 1 to 2g intravenously at the induction of anesthesia followed by 500mg, at six hourly intervals, or orally for up to 72 hours. While treating the Pediatric population aged between 2-10 years old, the standard recommended dose is 125mg, taken four times a day. For kids under 2 years, the dose is 62.5mg, taken four times daily.

The cost of Flucloxacillin:

In the USA, the consumers have to pay an average retail price of $65.09. the price of this medicine is much lower in India, where the consumers pay US$7.2 for a supply of 40 capsules of 500 mg.

How does Flucloxacillin work?

Flucloxacillin actions kill bacteria. As a β-lactam antibiotic, its actions inhibit the synthesis of bacterial cell walls. It does this by inhibiting the cross-linkage between the linear peptidoglycan polymer chains. These chains make up a major component of the cell wall of Gram-positive bacteria. Flucloxacillin is insensitive to beta-lactamase enzymes secreted by many penicillin-resistant bacteria. Flucloxacillin has isoxazolyl group on the side chain of the penicillin nucleus, which facilitates the β-lactamase resistance since they are relatively intolerant of side-chain steric hindrance. As a result, it binds to penicillin-binding proteins and inhibits peptidoglycan crosslinking, however, it is not bound by or inactivated by β-lactamases.

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