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cardiovascular and peripheral vascular diseases [ulcers, gangrene and amputation], neuropathy and nephropathy) To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

This sheet talks about exposure to Amoxicillin and Clavulanate in a pregnancy and while breastfeeding.

This information should not take the place of medical care and advice from your healthcare provider.

This combination medication is an antibiotic used to treat a variety of bacterial infections.

It is a combination of amoxicillin, a penicillin-like antibiotic, and clavulanate, a drug that increases the effectiveness of amoxicillin.

Brand names include Amoclav®, Augmentin XR® and Clavamox®.

Studies have not been done to see if amox/clav could make it harder for a woman to become pregnant. If you were prescribed amox/clav by your healthcare provider, talk with them before making any changes in how you take this medication. It is important to consider the benefits of treating infections during pregnancy. Does taking amox/clav increase the chance of miscarriage? When taken in the recommended doses, amox/clav is unlikely to increase the chance for miscarriage.

Does taking amox/clav in the first trimester increase the chance of birth defects? In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect.

Most studies have not found an increased chance for birth defects when amox/clav is taken during the first trimester; however, there are very few studies available. There are more studies looking at the use of amoxicillin alone during pregnancy. A few studies have shown an higher chance of cleft lip (opening in the lip) with or without cleft palate (opening in the roof of the mouth) when amoxicillin is taken during the first trimester. However there are other studies that have not found a higher chance for cleft lip with or without cleft palate.

Based on the current information, the overall chance of a cleft in lip and/or palate is considered to be low if a woman is taking amox/clav in a pregnacy.

Could taking amox/clav in the second or third trimester cause other pregnancy complications?

There is limited information regarding the use of amox/clav during the second trimester, but studies so far do not report an increased chance for pregnancy problems when used in this time period.

For use in the third trimester, there is one large study of women who had an increased risk for preterm labor, a condition in which a woman starts the early stages of childbirth before 37 weeks of 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 others that do not. 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 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 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

Most of

the

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

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 of amoxicillin and flucloxacillin. Pregnancy: Penicillins are

generally

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.