Amoxicillin trihydrate potassium clavulanate

One study that has followed hundreds of children up to age 11 years did not find that prenatal exposure amoxicillin for stomach infection to amox/clav was linked to learning or amoxicillin for tooth infection 500mg behavior problems.

Amox/clav enters the breast milk, however, based on a small number of studies; it has not been shown to cause problems for a nursing baby. A study of 67 mothers taking this product found that there were no serious health effects in the breastfeeding infants.

While some babies had a possible allergic reaction, such as rash, diarrhea, irritability and constipation, the reactions did not last long. If you think your baby has developed a side effect from medication that might be in your milk, talk to your child’s healthcare provider.

Talk to your healthcare provider about all your breastfeeding questions.

If a man takes amox/clav, could it affect his fertility (ability to get partner pregnant) or increase the chance of birth defects?

There are no studies looking at possible risks to a pregnancy when the father takes amox/clav. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

Fixed does combination of Amoxicillin and Flucloxacillin is available in both oral and parenteral formulation.

Their usage is determined on the basis of severity of infections. Flucloxacillin is an isoxazolyl penicillin of the beta-lactam group of antiboitics, which exerts a bacetericidal effect upon many Gram positive organism including streptococci and beta- lactamase producing staphylococci.

It has a relatively narrow spectrum of antibacterial activity.

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 and as sodium salt for parenteral use.

Composition: Each capsule contains: Amoxicillin Trihydrate B.P.

equivalent to …………………………………… 250 mg Flucloxacillin.

Amoxicillin is similar to ampicillin in its bactericidal action agianst susceptible organisms during the stage of active multiplication.

It acts through the inhibition of biosynthesis of cell wall mucopeptide.

Amoxicillin has been shown to be active against most strains of the following microorganism, both in vitro and in clinical infections. Flucloxacillin is a narrow spectrum antibiotic of the group of isoxazolylpenicillins: It is not inactivated by staphylococcal beta-lactamases. Flumox exhibits in vitro and in experimental animals in vivo bactericidal activity against a wide commonly encountered sensitive organism: (ii) Synergism: Flumox exhibits synergistic bactericidal activity in vitro, and in experimental animals in vivo against some ampicillin resistant organism. Gram-positive bacteria Gram-negative bacteria Streptococcus pyogens Neisseria gonorrhoeae amoxicillin dicloxacillin capsules Strep.faecalis Neisseria Meningitidis Strep.Viridans Haemophilus influenzae Strep.pneumoniae Escherichia coli Staphylococcus aureus Salmonella typhi Salmonella species Staphylococcus aureus(penicillinase producing) Proteus mirabilis Bordetella pertussis Corynebacterium species Shigella species Clostridium species Brucella Species Bacillus anthracis.

(iii) Additive effects: The two components of Flumox i.e.

amoxycillin and flucloxacillin generally exhibit an additive effect against sensitive bacteria and bacteria that are sensitive to amoxycillin or to flucloxacillin or remain sensitive to the combinationl, showing that antagonism does not occur when the two components are combined. Flucloxacillin, by its action on the synthesis of the bacterial wall, exerts a bactericidal effect on streptococci, Staphylococci, including the beta-lactamase-producing strains, clostridia and neissieria.

It is not active against methicillin-resistant staphylococci.

Strains of the following organisms are generally sensitive to the bactericidal action of flucloxacillin in vitro. (The minimal inhibitory concentration (MIC) of flucloxacillin are quoted below) flucloxacillin is bactericidal with a mode of action similar to that of benzylpenicillin, but is resistant to staphylococcal penicillinase.

It is active therefore against penicillinase-producing and non-peniclillinase-producing staphylococci, with minimum inhibitory concentration in range of 0.25 to 0.5mcg per ml.

Its

Flucloxacillin is virtually ineffective against Enterococcus faecalis. Micro-organisms MIC (mg/l) Streptococcus aureus 0.1-0.25 Streptococcus aureus(beta-lactamase producing) 0.25-0.5 Streptococcus pneumoniae 0.25 Streptococcus pyogens 0.1 Streptococcus viridans group 0.5 Clostridium tetani 0.25 Clostridium welchii 0.25 Neisseria meningitidis 0.1 Neisseria gonorrhoeae 0.1 Neisseria gonorrhoeae(beta-lactamase producing) 2.5. The Group A beta-haemolytic streptococci are less sensitive to the isoxazolyl penicillins than to penicillin G or penicillin V.

Abosorption: Orally administered dosage of 250 mg amoxicillin capsules result in average peak blood levels one or two hours after administration in the range of 3.5 mcg/ml to 5.0 mcg/ml respectively. Flucloxicillin is stable in acid media and can therefore be administered either by the oral or parental route.

The peak serum of flucloxicillin reached after 1 hour are as follows. -After 250 mg by the oral route (in fasting subjects): approximately 8.8 mg/l. -After 500 mg by the oral route (in fasting subjects): approximately 14.5 mg/l. Absorption is more efficient when taken on empty stomach. The total quantity absorbed by the oral route represents approximately 79 % of the quantity administered. Flucloxacillin sodium, like amoxicillin and metronidazole together dicloxacillin sodium is about twice as well absorbed from the gastro-intestinal tract as cloxacillin sodium, but absorption is also reduced by the presence of food in the stomach.

After an oral dose of 250mg to 1g in fasting subjects, peak plasma concentrations in about 1 hour are usually in the range of 5 to 15 mcg per ml. Plasma concentrations following the intramuscular injection of Flucloxacillin sodium are similar, but peak concentrations are achieved in about 30 minutes. Doubling the dose can double the plasma concentration. About 95% of Flucloxacillin in the circulation is bound to plasma proteins.

In blood serum, amoxicillin is approximately 20 % protein-bound. Flucloxacillin has been reported to have plasma half-life of approximately 1 hour. Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluide, except when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine.

Metabolism: In normal subjects approximately 10% of the flucloxacillin administered is metabolised to penicilloic acid.

The elimination half-life of flucloxacillin is 30-60 minutes.

Flucloxacillin is metabolised to a limited extent and the unchanged drug and metabolites are excreted in the urine by glomerularfiltration and renal tubular secretion.

Excretion: The drug is rapidly excreted by the kidney, about 50% within 6 hours of administration.

A small portion of the dose administered is excreted in the bile. The excretion of flucloxacillin is slowed in cases of renal failure.

Metabolites are excreted in the urine by glomerular filtration and renal tubular secretion. Protein Binding: The serum protein binding rate is 95% in case of flucloxacillin whereas 20% of amoxicillin is protein bound. Therapeutic indications: Fixed dose combinations of Amoxicillin and Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by ?-lactamase producing staphylococci.

Skin and Soft Tissue Infections: Boils, abscesses, carbuncles, furunculosis, cellulitis, infected wounds, infected burns, protection of skin grafts and impetigo. Respiratory Tract Infections: Pneumonia, lung abscess, emphysema, sinusitis, pharyngitis tonsillitis, quinsy, otitis media and externa. Other infections caused by amoxicillin & flucloxacillin-sensitive organisms such as osteomyelitis, enteritis endocarditis, urinary tract infection, meningitis, septicaemia.

Oral proportions of the ?-lactamase-resistant penicillins(flucloxacillin alone or in combination with amoxicillin) should not be used as initial therapy in serious life threatning infections. Oral therapy with fixed dose combination of amoxicillin and flucloxacillin may be used to follow up the previous use of parenteral amoxicillin plus flucloxacillin combination as soon as the clinical conditions warrants. Parenteral therapy is indicated caused by susceptible pathogens. Empirical therapy for infants with suspected coagulase negative staphylococcal sepsis. Drug may be administered as combination or with netilmicin until culture results available.

Oral: Adults (Including elderly patients): 2 capsules initially and then either 1 or 2 capsules 8 -hourly, depending on severity of infection.

Children weighing 20 kg or more should be dosed according to the adult recommendations in severe infections or those caused by less susceptible organisms: 2 capsules every 6 hours for adults and 40mg/kg/ day in divided doses every 6 hours for children may be needed. Weeks Postconception 28 30 to 36 0 to 14 >14 37 to 44 0 to 7 >7 >45 All. Flucloxacillin is administered by mouth as the sodium salt, in the form of capsules. Amoxicillin is available as amoxicillin trihydrate.

It should be taken at least 30 minutes before meals as the presence of food in the stomach reduce absorption.

In severe renal failure a reduction in dosage may ciprofloxacin and amoxicillin be necessary.

Amoxicillin & Flucloxacillin are semisynthetic penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. Flucloxacillin is contraindicated in patients with a previous history of flucloxacillin-associated jaundice/hepatic function. Precautions: Dosage should be adjusted in renal impairment with other medicaments and other forms of interactions. Bacteriostatic agents may interfere with the bactericidal actions of amoxicillin and flucloxacillin. Concurrent administration of probenecid delays the renal excretion of amoxicillin and flucloxacillin.

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 flucloxicillin 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 effects on the ability to drive or operate machinery have not been observed. Before initiating therapy with amoxicillin and flucloxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactamase. Cross-sensitivity between penicillin and cephalosporins is well documented. If any hypersensitivity reaction occurs, the treatment should be discontinued. Rash, urticaria, purpura, fever, eosinophilia: sometimes angioneurotic oedema, rarely anaphylactic shock (exceptional with oral administration).