Amoxil 400 mg

For

use

pregnancy

The women who were treated with amox/clav were found to have a small increased chance for a serious bacterial infection known as necrotizing enterocolitis (NEC) in their newborns.

This is a condition that can injure a baby’s intestines. Further review has found some studies that confirm this chance

and

Overall, the chance that the use of amox/clav increases the risk of NEC is low.

Does taking amox/clav in pregnancy cause any long-term problems in behavior or learning for the baby? One study that has followed hundreds of children up to age 11 years did not find that prenatal exposure to amox/clav was linked to learning or 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

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

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 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 activity against streptococci such as Streptococcus pneumoniae and Str. pyogenes is less than that of benzylpenicillin but sufficient to be useful when these organisms are present with penicillin-resistant staphylococci. 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 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

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

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 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

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.