Amoxicillin 625mg

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).

Certain reactions (fever, arthralgia, myalgia) sometimes develop more than 48 hours after the start of the treatment. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotic.

Although anaphylaxis is more frequently following parenteral therapy, it has occurred in patients on oral therapy. If an allergic reactions occurs, amoxicillin and flucloxacillin should be discontinued and appropriate therapy instituted.

Serious anaphylactoid reaction may require immediate emergency treatment with adrenaline, with oxygen, intravenous steroids and airway management including intubation , may also be required. As with other penicillin, it may be expected that untoward reactions will be essentially limited to sensitivity phenomenon. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma hay fever or urticaria. The following adverse reactions have been reported as associated with the use of penicillins: Erythematous maculopapular rashes, erythema multiform, Stevens-Johnson syndrome toxic epidermal necrolysis and urticaria have been reported.

NOTE: These hypersensitivity reaction may be controlled with antihistamine and, if necessary systemic corticosteroids. Whenever such reactions occur, amoxicillin and flucloxacillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin and flucloxacillin therapy. Gastrointestinal reactions: Nausea, vomiting and diarrhea. Minor gastro-intestinal disturbances may occur during treatment. As with other antibiotic, pseudomembranous collitis has been reported rarely. If this condition develops, amoxicillin and flucloxacillin treatment should be discontinued and appropriate therapy, e.g. Hepatic effects: Hepatic and cholestatic jaundice have been reported.

Hepatic and cholestatic jaundice have been reported occasionally with Flucloxacillin and may be delayed in onset: older patients and those receiving Flucloxacillin for more than two weeks are at greater risk. These may be delayed for up two months post-treatment. In some cases the course has been protracted and lasted for several months. Very rarely deaths have been reported, almost always in patients with serious underlying disease.

Change in liver function test results may occur, but are reversible when treatment is discontinued. A moderated rise in Serum glutamic oxaloacetic transaminase (SCOT) has been noted but the significance of this finding in unknown. Haematological effects: Neutropenia (including agranulocytosis) and thrombocytopenia may occur but are reversible when treatment is discontinued. Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with penicillin. These reactions are usually, reversible on discontinuation of therapy and are believed to be hypresensitivity reactions.

Neurological

Effects

May reduce absorption of oral contraceptives leading to break through bleeding or pregnancy. Parenteral therapy (Caution & Precautions) Hypersensitivity to penicillins/cephalosporins.

Cautions in preterm infants, especially extreme immaturity. Cautions in infants with liver, renal or gastrointestinal disease. Venous irritation, soft tissue injury at site IV injection.

Gastrointestinal disturbance (nausea, vomiting, diarrhoea).

Seizures (encephalopathy with high

doses

May be given concurrently with aminoglycoside for synergistic effect. Administer separately as simultaneous administration may cause inactive and precipitation.

Adjust dose in suspected renal dysfunction (usually by lengthening in dosing interval) Overdose. Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Flucloxacillin is not removed from the circulation by heaemodialysis. Loss of potency after mixing with Streptomycin has been reported.

capsules Store in a cool dry place, protected from light. Vials (dry powder): Store below 25 , protected from light. Medicine Classification Prescription Medicine Only.

Lot C6, Zone-A, Thilawa SEZ, Thanlyin and Kyaut Tan Township, Yangon, Myanmar. While a person’s genes may increase the chance that he or she will develop lupus, it takes some kind of environmental trigger to set off the illness or to bring on a flare. The following are common environmental triggers: Ultraviolet rays from the sun or from fluorescent light bulbs Sulfa drugs, which make a person more sensitive to the sun, such as: Bactrim® and

Septra®

Emotional

stress

Amoxicillin MOXATAG ® FDA Package Insert Description Clinical Pharmacology Microbiology Indications and Usage Contraindications Warnings and Precautions Adverse Reactions Overdosage Dosage and Administration How Supplied.

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY.

ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS.

BEFORE INITIATING THERAPY WITH AMOXICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS.

IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile produces toxins A and B which contribute to the development of CDAD.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy.

If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted. A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.

Prescribing amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Phenylketonurics: Each 125 mg amoxicillin tablet (chewable) contains 1.4 mg phenylalanine; each 200 mg chewable tablet contains 4.5 mg phenylalanine; each 250 mg chewable tablet contains 2.8 mg phenylalanine; each 400 mg chewable tablet contains 9 mg phenylalanine.

As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis.

Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months. Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX®) be used. Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of

total

Carcinogenesis, Mutagenesis, Impairment of Fertility.

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to

detect

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. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).

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.

Oral ampicillin-class

antibiotics

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. Penicillins have been shown to be

excreted

Caution should be exercised when amoxicillin is administered to a nursing woman.

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (? 3 months).

(See DOSAGE AND ADMINISTRATION–Neonates and infants.) Geriatric Use. An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 1,811 subjects treated with capsules of amoxicillin, 85% were 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 tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension is 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.

Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and amoxicillin for oral suspension or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

^"AMOXICILLIN (AMOXICILLIN) CAPSULE AMOXICILLIN (AMOXICILLIN) TABLET, FILM COATED AMOXICILLIN (AMOXICILLIN) TABLET, CHEWABLE AMOXICILLIN (AMOXICILLIN) SUSPENSION [RANBAXY PHARMACEUTICAL INC.]". Text " accessdate" ignored (help) Adapted from the FDA Package Insert. Adverse effects of amoxicillin may be potentially under-reported.

the Oncology Nurse Advisor take: Amoxicillin is a widely used antibiotic in the penicillin group of drugs. It is used to treat bacterial infections in patients with cancer, and may be used as prophylaxis in some patients. In a systematic review, researchers conducted a review of controlled trials to assess potential harms related to amoxicillin use.

The review included a total of 45 trials, featuring a total of 10,519 participants. The researchers found that almost twice as many patients receiving amoxicillin had diarrhea compared with patients receiving placebo, and diarrhea was more than three times more likely among participants receiving amoxicillin-clavulanate. An association between candidiasis and amoxicillin-clavulanic acid use was also observed. However, the authors acknowledge a limitation to their study. All the trials measured efficacy rather than harm as their primary outcome, and only 25 of the study included information on harms.