Amoxicillin and Flucloxacillin we care

Amoxicillin and Flucloxacillin we care

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Full Prescribing Info
Contents
Amoxicillin, flucloxacillin.
Description
Each hard gelatin capsule contains: Amoxicillin Trihydrate BP equivalent to Amoxicillin 250 mg, Flucloxacillin Sodium BP equivalent to Flucloxacillin 250 mg.
Amoxicillin and Flucloxacillin capsules 500 mg is a penicillin antibiotic combination.
Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S, 5R, 6R)-6-[[3-(2-chloro-6-fluoropheny)-5-methyl 1,2-oxazole-4- carbonyl] amino]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid monohydrate for oral use.
Flucloxacillin is an isoxazolyl penicillin of the beta-lactam group of antibiotics, which exerts a bactericidal effect upon many Gram positive organism including streptococci and beta-lactamase producing staphylococci.
Excipients/Inactive Ingredients: Talc USP, Magnesium Stearate BP, Sodium starch glycolate BP.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Bacteriology: Spectrum: This product exhibits in vitro and in experimental animals in vivo, bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. The following are among the more commonly encountered sensitive organisms: (See Table 1.)

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Synergism: It exhibits synergistic bactericidal activity in vitro, and in experimental animals in vivo against some ampicillin-resistant organisms.
Additive effects: The two components of this product-amoxicillin and flucloxacillin - generally exhibit an additive effect against sensitive bacteria and bacteria that are sensitive to amoxicillin or to flucloxacillin remain sensitive to the combination, showing that antagonism does not occur when the two components are combined.
Pharmacokinetics: Absorption: It is well absorbed orally. Peak serum levels are achieved 1 to 2 hours after dosing.
Absorption is more efficient when taken on empty stomach. The total quantity absorbed by the oral route represents approximately 79% of the quantity administered.
Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine.
Its excretion can be delayed by concurrent administration of probenecid. Flucloxacillin diffuses well into most tissues specifically, active concentration of flucloxacillin have been recovered in bones: 11.6 mg/l (Compact bone) and 156 mg/l (spongy bone), with a mean serum level of 8.9 mg/l. Crossing the meningeal barrier: flucloxacillin diffuses in only small proportion into cerebrospina1 fluid of subjects whose meninges are not inflamed.
Excretion: Approximately 50% of the dose is excreted unchanged into the urine within 6 hours, resulting in high urine levels of active drug.
The combination of amoxicillin and flucloxacillin not only widens the spectrum of pathogenic organisms covered by either of the substances alone; synergy has also been observed, particularly against beta-lactamase-producing organisms. For this reason, the possible interaction of these two penicillins regarding their pharmacokinetics was investigated with respect to therapeutic application. The parameters were calculated on the basis of an open two compartment model. The highest serum levels of amoxicillin from 551 to 1074 mg/l when 4 g were administered alone, and from 403 to 1133 mg/l when administered together with 1 g flucloxacillin. Flucloxacillin concentrations ranged from 118 to 357 mg/l when administered alone, and from 151 to 226 mg/l in the presence of amoxicillin. Thus, there is no significant difference in the peak levels of either substance when given alone or in combination. The pharmacokinetic parameters of both substances basically do not depend on the presence of the other. A slight decrease was observed in the distribution rate of amoxicillin from the central to the peripheral compartment in the presence of flucloxacillin. Its relevance is questionable, however, since the effect was only minor.
Protein Binding: The serum protein binding rate is 95% in case of flucloxacillin whereas 20% of amoxicillin is protein bound.
Indications/Uses
It is indicated for the treatment of a wide range of bacterial infections, caused by susceptible organisms; in particular infections of mixed origin where penicillin-resistant staphylococci may be implicated or where the causative organism is unknown.
Typical Indications Include: Acute and chronic bronchitis; Pelvic inflammatory disease; Pneumonia; Urinary tract infections; Ear, nose and throat infections; Skin and soft tissue infections; Gynaecological infections.
Dosage/Direction for Use
Adults: One 500 mg capsule three times a day.
In severe infections these dosages may safely be increased.
To ensure maximal absorption this product should be given in the fasting state, i.e. approximately 1 hour before a meal.
Overdosage
No known symptoms of over dosage. As with all penicillins, oral administration can cause gastro-intestinal symptoms such as transient diarrhea, nausea and colic which are dose related and a result of local irritation not toxicity.
Contraindications
It should not be given to those subjects hypersensitive to penicillin. As there is currently no neonatal formulation this capsule should not be given to neonates.
Special Precautions
As with other penicillins, side-effects are rare and usually of a mild and transitory nature.
Allergic reactions may occur, and these are normally mild in nature, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of this drug and administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, the drug should be discontinued and the patient treated with the usual agents: (adrenaline, corticosteroids and antihistamines). Treatment with this drug may give rise to a maculopapular rash during therapy or within a few days after completion thereof. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should, therefore, be carried out wherever possible, to ensure the appropriateness of the therapy.
Hepatitis and cholestatic jaundice have been reported rarely.
Effects on ability to drive and use machines: No special precautions need to be taken.
Use In Pregnancy & Lactation
Pregnancy: Penicillins are generally considered safe for use in pregnancy. Animal studies with Amoxicillin and Flucloxacillin have shown no teratogenic effects. As limited information is available concerning the results of the use of Amoxicillin and Flucloxacillin in pregnancy. Should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Lactation: Trace quantities of amoxicillin and flucloxacillin are excreted in breast milk. Amoxicillin and Flucloxacillin may be administered during the period of lactation. With the exception of the risk of sensitization there are no detrimental effects for the breastfed infant.
Adverse Reactions
Side effects are the same as per the individual components, with stomach or bowel upset from flucloxacillin being the most common. Both parts are members of the penicillin family of antibiotics, so should not be taken by patients allergic to penicillin.
Drug Interactions
See Table 2.

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Storage
Store below 25°C in a dry place.
Protect from light and moisture.
Shelf Life: 24 Months.
MIMS Class
ATC Classification
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 (red/white, '0' size, hard gelatin, containing white to off-white granular powder) 10 x 10's.
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