Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin.
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4: Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival.
Amoxicillin and potassium clavulanate was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. Pregnancy Teratogenic Effects Pregnancy category B Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Labor and Delivery Oral ampicillin-class antibiotics are poorly absorbed during labor.
Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
Nursing Mothers Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman. Pediatric Use Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed.
Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. This analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Information for Patients Amoxicillin may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed.
Patients should be counseled that antibacterial drugs, including amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets chewable , should only be used to treat bacterial infections. They do not treat viral infections e. When amoxicillin capsules, amoxicillin for oral suspension, or amoxicillin tablets chewable are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Interference with diagnostic tests Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory tests. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.
It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. The presence of amoxicillin may distort assay results for oestriol in pregnant women. Important Information about excipients This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicinal product contains sodium benzoate E which is a mild irritant to the eyes, skin and mucous membrane. May increase the risk of jaundice in newborn babies. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged levels of amoxicillin. Allopurinol Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Tetracyclines Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.
Methotrexate Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity. Oral typhoid vaccine The oral typhoid vaccine is inactivated by antibacterials. Oral Anticoagulants Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin.
If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. Moreover, adjustments in the dose of oral anticoagulants may be necessary see sections 4. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations.
You can also report side effects directly via the Yellow Card Scheme at: By reporting side effects you can help provide more information on the safety of this medicine. Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Store in a cool, dry place. Once made up the suspension should be used within 7 days.
Do not transfer your medicine to another container. Do not use this medicine if there are visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. The other ingredients are sucrose, carmellose sodium, sodium citrate, colloidal anhydrous silica, quinoline yellow E , sodium methyl parahydroxybenzoate E , lemon and apricot flavourings containing maltodextrin, citric acid, gum arabic, natural lemon oil flavour and nature identical flavouring ingredients.
What Amoxicillin Oral Suspension looks like and contents of the pack After preparation the medicine is a lime coloured suspension. The bottle contains ml of medicine. This leaflet was last revised in January If you would like this leaflet in a different format, please contact the licence holder at the above address.
You may need to read it again. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. This includes any possible side effects not listed in this leaflet. What is in this leaflet: What Amoxicillin Oral Suspension is and what it is used for 2. What you need to know before you take Amoxicillin Oral Suspension 3.
Adjustments in the dose 250 oral anticoagulants may be necessary to maintain the desired level of anticoagulation. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may 250 greater in patients with impaired renal function. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. However, undesirable effects may occur e. These may be symptoms of a type of anaemia 89mm Thrush a yeast infection of the 5ml, mouth or skin folds Increased or decreased urine output, fever, amoxicillin 250 mg 5ml, rash, swelling of any area of the body or amoxicillin gain caused by kidney problems Fits convulsions which may be seen in patients taking high doses or with kidney problems, hyperactivity, dizziness Crystals in the urine which may cause cloudy urine or difficulty or discomfort when passing urine make sure you drink plenty of fluids to reduce the chance of these symptoms 250 increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed Black hairy tongue Tooth discolouration in children which usually returns to normal with brushing. Once you finish treatment, if you still feel unwell you should go back to see the doctor. Also, if you have been told by your doctor that you have an intolerance to some sugars, contact 88mm your doctor before taking this medicine. 5ml Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. Because animal reproduction studies are not always predictive of human response, this amoxicillin should be used during pregnancy only if clearly needed. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4: Amoxicillin Oral Suspension is used to treat infections caused by bacteria in different parts of the body. CDAD why chew hydrocodone be considered in all patients who present with diarrhea following antibiotic use. However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin, amoxicillin 250 mg 5ml. Geriatric Amoxicillin An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. This leaflet 5ml last revised in January
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