Flumox

Flumox

Manufacturer:

Zifam Pinnacle

Distributor:

Pyrex
Full Prescribing Info
Contents
Amoxicillin trihydrate, flucloxacillin sodium.
Description
Each capsule contains amoxicillin trihydrate 250 mg and flucloxacillin sodium 250 mg.
Each vial contains sterile amoxicillin sodium 250 mg and sterile flucloxacillin sodium 250 mg.
Action
Pharmacology: Pharmacokinetics: Flumox offers an advantage due to similar pharmacokinetic profile of both the antibiotics. Amoxicillin is rapidly absorbed upon oral administration and diffuses into most body fluids and tissues, except brain where it crosses the barrier only when meninges are inflamed. Amoxicillin is 20% serum bound and 56-65% is excreted unchanged in urine within 6 hrs. Flucloxacillin is almost completely absorbed upon oral administration and has similar distribution as seen with amoxicillin. Flucloxacillin is highly serum protein-bound ≥95.2%, however, rapidly excreted unchanged in urine via glomerular filtration. The combination in Flumox achieves therapeutic concentrations at 50 min to 1 hr of oral administration with peak at 2 hrs and half-life at 1.4-2 hrs. Peak levels after IM or IV injection are quickly achieved within 30 min.
Microbiology: Spectrum of Activity: Flumox offers extended spectrum of activity, greater than either of the antibiotics and superior activity against few important pathogens.
Gram-Positive: α- and β-Hemolytic Streptococci, Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus both penicillin-sensitive and penicillinase-producing pathogens, Diplococcus pneumoniae, Bacillus anthracis and most strains of enterococci and Clostridia.
Gram-Negative: Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria catarrhalis, Escherichia coli, Proteus mirabilis, Bacteroides fenduliformis, Salmonella and Shigella.
Indications/Uses
Skin and soft tissue infections, empyema, toxic shock syndrome due to Staphylococcus aureus. Treatment of hospital-acquired Staphylococcus epidermidis infection. Pre- and postoperative care with advantage of parenteral to oral single antibiotic therapy. For chronic administration in bone and joint infections eg, osteomyelitis, endocarditis, along with aminoglycosides, eg amikacin in open heart surgery as prophylaxis. Mild to moderate infections of respiratory tract, genitourinary and gastrointestinal tract.
Dosage/Direction for Use
Mild to Moderately Severe Infections: 1 cap up to 3-4 times a day for 5-7 days. Severe Infections: 1 vial every 4-6 hrs and upon reduction in severity switch to oral Flumox capsule 3-4 times a day. Chronic Conditions: 1 cap up to thrice daily. Surgical Prophylaxis: 500 mg to 1 g of Flumox injection.
Contraindications
Patients with known hypersensitivity to penicillins and cephalosporins.
Special Precautions
Flumox may reduce the reabsorption of oral contraceptives leading to increased breakthrough bleeding and contraceptive failure is possible.
Use in pregnancy & lactation: Although safe even at 10 times the normal dose in animal studies, no controlled studies have been conducted in pregnant women; therefore, Flumox should be prescribed with caution during pregnancy, only if strongly needed.
Low levels of Flumox are excreted in milk, therefore, caution should be exercised when Flumox is administered to nursing mothers.
Use In Pregnancy & Lactation
Although safe even at 10 times the normal dose in animal studies, no controlled studies have been conducted in pregnant women; therefore, Flumox should be prescribed with caution during pregnancy, only if strongly needed.
Low levels of Flumox are excreted in milk, therefore, caution should be exercised when Flumox is administered to nursing mothers.
Adverse Reactions
Hypersensitivity to Penicillins: Caution should be exercised in using Flumox in patients with history of hypersensitivity to penicillins.
Gastrointestinal: Oral administration may occasionally cause nausea or diarrhoea.
Hepatotoxicity: Flumox may be occasionally associated with abnormal liver function test especially SGOT. However, infants with acute jaundice should not be prescribed with Flumox.
Others: Although rarely reported, neutropenia and agranulocytosis at very high doses for a prolonged period.
Storage
Store in a dry place, at a temperature below 25°C.
MIMS Class
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Cap 500 mg x 10 x 10's. Inj (vial) 500 mg x 1's.
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