Betamox

Betamox

amoxicillin

Manufacturer:

Duopharma (M)

Distributor:

Duopharma Marketing
Full Prescribing Info
Contents
Amoxicillin trihydrate.
Description
Betamox Capsule 250 mg: Each capsule contains Amoxycillin Trihydrate equivalent to Amoxycillin 250 mg.
Betamox Capsule 500 mg: Each capsule contains Amoxycillin Trihydrate equivalent to Amoxycillin 500 mg.
BETAMOX 500MG TABLET: Each tablet contains Amoxycillin Trihydrate equivalent to Amoxycillin 500mg.
Betamox Granule 125 mg/5 mL: Each 5 ml syrup contains Amoxycillin Trihydrate equivalent to Amoxycillin 125 mg.
Betamox Granule 250 mg/5 mL: Each 5 ml syrup contains Amoxycillin Trihydrate equivalent to Amoxycillin 250 mg.
Action
Pharmacology: Tab: Amoxycillin is bactericidal and acts by inhibiting bacterial cell wall synthesis. Its action is dependent on its ability to reach and bind penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall. PBPs are enzymes responsible for the assembling and reshaping of the bacterial cell wall during growth and division. PBPs inactivation by amoxycillin results in the weakening and lysis of the bacterial cell wall.
Cap/Granules: Pharmacodynamics: Amoxycillin differs in vitro from benzylpenicillin in the Gram-negative spectrum. Amoxycillin has the same Gram-positive and Gram-negative spectrum as ampicillin. In vitro most strains of Haemophilus influenzae, Neisseria gonorrhoea, Neisseria meningitidis, Proteus mirabilis, Salmonellae, alpha- and beta-haemolytic streptococci, Diplococcus pneumoniae, non-penicillinase producing Staphylococci and Streptococcus faecalis, are sensitive to amoxycillin at serum concentrations which may be expected following the recommended doses. However, some of the organisms were sensitive to amoxycillin only at concentrations achieved in the urine (see Indications).
Escherichia coli isolates are becoming increasingly resistant to amoxycillin in vitro due to the presence of penicillinase-producing strains.
Strains of gonococci which are relatively resistant to benzylpenicillin may be sensitive to amoxycillin.
Amoxycillin is not effect against penicillinase-producing bacteria, particularly resistant staphylococci, which now have a high prevalence.
All strains of Pseudomonas, Klebsiella, Enterobacter, indole-positive Proteus, Serratia marcescens, Citrobacter, penicillinase-producing N.gonorrhoea and penicillinase-producing H.influenzae are also resistant.
Like benzylpenicillin, amoxycillin is bactericidal against sensitive organisms during the stage of active multiplication. It is believed to act through the inhibition of biosynthesis of cell wall mucopeptide.
Pharmacokinetics: Amoxycillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food. Amoxycillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid except when meninges are inflamed.
Amoxycillin has been shown to diffuse into sputum and saliva and is excreted mainly via the urine where it exists in a high concentration.
The amount to be found in the bile is variable depending on normal biliary secretory function.
The half-life of amoxycillin is 61.3 minutes with normal renal function and in the absence of renal function 16-20 hours.
Amoxycillin is excreted in the urine both unchanged and as penicilloic acid. About 75% of a 1 g dose is excreted in the urine in 6 hours in the presence of normal renal function (60% is biologically active and 15% is penicilloic acid). However about 32% of a 3 g dose is excreted via the urine as the biologically active component in 8 hours (by which time most of the urinary excretion is complete). This proportional difference in the amount excreted from the different doses reflects a lack of linearity between doses and extent of absorption with a levelling off at higher doses of oral amoxycillin.
Excretion of amoxycillin can be delayed by concurrent administration of probenecid thus prolonging its therapeutic effect.
Amoxycillin is not highly protein-bound, being only 17% protein-bound in serum as measured by ultrafiltration or equilibrium dialysis.
Orally administered doses of 250 mg and 500 mg amoxycillin result in average peak serum levels one to two hours after administration of 5.0 mcg/mL and 6.6 - 10.8 mcg/mL respectively. Detectable serum levels of amoxycillin are present 8 hours after ingestion of a single dose.
Tab: Amoxycillin is fairly well absorbed from the GIT. It is more rapidly and more completely absorbed than ampicillin orally. Amoxycillin is acid-stable. Peak plasma concentrations of about 5 microgram per ml have been observed 1-2 hours after a dose of 250mg, with detectable amounts present for up to 8 hours. Doubling the dose can double the concentration. Total amount absorbed is not significantly affected by food. About 20% is plasma protein bound. The plasma half-life is about 1-1.5 hours and this increases (7-20 hours) in renal failure, neonates and the elderly. Amoxycillin is widely distributed at varying concentrations in body tissues and fluids, including peritoneal fluid, blister fluid, pleural fluid, middle ear fluid, intestinal mucosa, bone, gallbladder, urine (high concentrations), lung, female reproductive tissue and bile. It croses the placenta and small amounts are excreted in breast milk. Little amoxycillin passes into the CSF unless the meninges are inflamed. Amoxycillin is metabolised to a limited extent to penicilloic acid which is excreted in the urine. About 60% of an oral dose is excreted unchanged in the urine in 6 hours by glomerular filtration and tubular secretion; urinary concentrations above 300 microgram per ml have been reported after a dose of 250mg. High concentrations have been reported in bile; some may be excreted in the faeces.
Toxicology: Tab: Carcinogenicity and mutagenicity: No documented long-term studies in animals that evaluate the carcinogenic and mutagenic potential of amoxycillin were available.
Pregnancy/Reproduction: (FDA pregnancy category: B): Studies in mice and rats at doses up to 10 times the human dose of amoxycillin revealed no evidence of impaired fertility. Amoxycillin crosses the placenta. Adequate and well-controlled studies in humans have not been done to determine whether penicillins are teratogenic; however, penicillins are widely used in pregnant women and problems have not been documented to date. Studies in mice and rats at doses up to 10 times the human dose revealed no evidence of harm to the foetus.
Breast feeding: Amoxycillin is distributed into breast milk, usually in low concentration. Although significant problems in humans have not been documented, the use of amoxycillin by nursing mothers may lead to sensitization, diarrhoea, candidiasis, and skin rash in the infant.
Pediatrics: Penicillins, including amoxycillin have been used in pediatric patients and no pediatrics-specific problems have been documented to date. However, incompletely developed renal function of neonates and young infants may delay the excretion of renally eliminated penicillins.
Geriatrics: Penicillins, including amoxycillin have been used in geriatric patients and no geriatrics-specific problems have been documented to date. However, elderly patients are more likely to have age-related renal function impairment, which may require an adjustment in dosage in patients receiving penicillins.
Dental: Prolonged use of amoxycillin may lead to the development of oral candidiasis.
Indications/Uses
Cap/Granules: Amoxycillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.
Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.
Skin and skin structure: Staphylococcus, non-penicillinase producing; Streptococcus; E.coli.
Respiratory (Acute and Chronic): H. influenzae, Streptococcus; S. pneumoniae; staphylococcus, non-penicillinase-producing; E. coli.
Genitourinary Tract (complicated and uncomplicated, Acute and chronic):
E. coli, P. mirabilis and S. faecalis.
Gonorrhoea: N. gonorrhoea (non-penicillinase producing).
Prophylaxis of endocarditis: Amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.
Tab: Amoxycillin is an aminopenicillin, which has activity against penicillin-sensitive gram-positive bacteria, as well as Escherichia coli, Proteus mirabilis, Salmonella sp. Shigella sp. and Haemophilus influenzae. However, many Enterobacteriaceae, H. influenzae, Salmonella and Shigella species are resistant to this penicillin because of beta-lactamase production by these organisms. Amoxycillin can be administered orally for the following infections caused by susceptible bacterial organisms: Bronchitis, Biliary Tract Infections, Uncomplicated Endocervical and Urethral Gonorrhoea (caused by susceptible strains of Neisseria gonorrhoea), Acute Otitis Media, Mouth Infections, Pharyngitis, Pneumonia, Sinusitis, Urinary Tract Infections, Gastro-enteritis (including E. coli enteritis and Salmonella enteritis), Lyme Disease (early stages monotherapy and later stages in combination with probenecid), Typhoid Fever.
Amoxycillin is a possible alternative to erythromycin for chlamydial infections in pregnant women. Amoxycillin is also indicated as prophylaxis for spleen disorders (pneumococcal infection) and bacterial endocarditis and adjunct for Helicobacter pylori-associated peptic ulcer.
Dosage/Direction for Use
Upper respiratory tract infections; Genitourinary tract infections; Skin and soft tissue infections: Adults - 250 mg 8 hourly.
Children - 20 mg/kg/day in equally divided doses 8 hourly. In severe infection or those caused by less susceptible organisms 500 mg 8 hourly for adults and 40 mg/kg/day in equally divided doses 8 hourly for children may be needed.
Lower respiratory tract infections: Adults - 500 mg 8 hourly.
Children (under 20 kg) - 40 mg/kg/day in equally divided doses 8 hourly.
Urethritis, gonococcal: Adults - 3 g as single dose. Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving amoxycillin and monthly serological tests for a minimum of four months.
Acute, uncompliated lower urinary tract infections in non-pregnant adult female: Adults - 3 g as single dose.
Note: Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route.
The children's dosage is intended for individuals whose weight will not cause dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.
In renal impairment the excretion of the antibiotic will be delayed, and depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day. Amoxycillin may be removed from the circulation by haemodialysis.
It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended previously should not be used. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least ten days treatment for any infection caused by haemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Tab: The usual adult dose is 250-500mg every 8 hours.
Adults: (See Table 1).

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Children: (See Table 2).

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Route of Administration: Oral.
Overdosage
Cases of overdosage with amoxycillin are usually asymptomatic. If encountered, gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water/electrolyte imbalance should be treatment symptomatically. During the administration of high doses of amoxycillin, adequate fluid intake and urinary output must be maintained to minimize the possibility of amoxycillin crystalluria.
Amoxycillin can be removed from the circulation by haemodialysis.
Tab: There is no specific antidote, treatment of amoxycillin overdose should be symptomatic and supportive. Amoxycillin may be removed from circulation by haemodialysis. Serious hypersensitivity reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with parenteral epinephrine, oxygen, intravenous corticosteroids or air management (including intubation).
For Clostridium difficile colitis, mild cases may respond to discontinuation of the medication alone. Moderate to severe cases may require fluid, electrolyte, and protein replacement. In cases not responding to the previously mentioned measures, oral doses of the following may be used: (See Table 3).

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If diarrhoea occurs, administration of antiperistaltic antidiarrhoeals (e.g. opioids, diphenoxylate and atropine combination, loperamide, paregoric) is not recommended since they may delay the removal of toxins from the colon, thereby prolonging and/ or worsening the condition.
Up-to-date information on the treatment of overdose can be obtained from The National Poison Centre, University Sains Malaysia.
Contraindications
Amoxycillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (eg. penicillins, cephalosporins).
Tab: Risk-benefit should be considered when amoxycillin is administered in the presence of bleeding disorders, GI disease, infectious mononucleosis and renal function impairment.
Special Precautions
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and Amoxicillin therapy discontinued.
Serious anaphylactic reactions require immediate treatment with adrenaline. Oxygen, intravenous steroids and an airway management, including intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxycillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, eg. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Amoxycillin, an aminopenicillin, is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infections mononucleosis, in the presence of which there is a high incidence of rash if amoxycillin is used.
Amoxycillin should be given with caution to patients with lymphatic leukaemia since they are especially susceptible to ampicillin-induced skin rashes.
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxycillin.
Dosage should be adjusted in patients with renal impairment (see Dosage & Administration).
Amoxycillin paediatric drops and sugar free syrups contain sodium benzoate.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reaction) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with BETAMOX, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, BETAMOX must be discontinued immediately and appropriate alternative therapy instituted.
Tab: Before initiating therapy with Betamox, careful inquiry should be made concerning previous hypersensitivity reaction to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, Betamox should be discontinued and appropriate therapy instituted. Caution should be practised for use in children, or if given concurrently with other medication or the existence of other medical problems.
High urinary concentrations of a penicillin may produce false-positive or falsely elevated glucose in the urine with copper sulfate test; glucose enzymatic tests are not affected.
False-positive result may occur during therapy with any penicillin in the Direct antiglobulin (Coombs') test.
Physiology/laboratory test values of Alanine aminotransferase (ALT[SGPT]), Alkaline phosphatase, Aspartate aminotransferase (AST[SGOT]) and serum Lactate dehydrogenase (LDH) may be increased.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with Betamox, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, Betamox must be discontinued immediately and appropriate alternative therapy instituted.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines.
Use In Pregnancy & Lactation
Use in pregnancy: Animal studies with amoxycillin have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies.
Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Use in lactation: Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxycillin is administered to a nursing woman.
Adverse Reactions
Gastrointestinal: nausea, vomiting, diarrhoea, intestinal candidiasis and antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported rarely (see Precautions).
Hypersensitivity reactions: Erythematous maculopapular rash, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous and exfoliative dermatitis have been reported. As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness, hypersensitivity vasculitis and interstitial nephritis have been reported rarely.
Whenever such reactions occur, amoxycillin should be discontinued (Note: Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines, and if necessary, systemic corticosteroids). Anaphylaxis is the most serious reaction experienced (see Precautions).
Liver: A moderate rise in AST and/or ALT has occasionally been noted, but the significance of this finding is unknown. As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely.
Haemic and Lympathic systems: Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia and leucopenia (including neutropenia or agranulocytosis) have been reported during therapy with other penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been reported rarely.
CNS effects: CNS effects have been seen rarely. They include hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Skin and subcutaneous tissue disorders: Frequency 'very rare': Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Tab: Minor side effects like GIT reactions (mild diarrhoea, nausea or vomiting) may occasionally occur. There have also been reports of headache, oral candidiasis (sore mouth or tongue, white patches in mouth and/or tongue), vaginal candidiasis (vaginal itching and discharge) and pseudomembranous colitis.
Allergic reactions, specifically anaphylaxis (fast or irregular breathing; puffiness around the face; shortness of breath; sudden severe decrease in blood pressure), exfoliative dermatitis (red, scaly skin), skin rash, hives, itching and serum sickness-like reactions (skin rash, joint pain, fever) are uncommon adverse reactions.
There have been rare reports of hepatotoxicity (fever, nausea and vomiting, yellow eyes or skin); interstitial nephritis (fever, possibly decreased urine output, skin rash); leucopenia or neutropenia (sore throat and fever); mental disturbances (anxiety, confusion, agitation or combativenes, depression, seizures, hallucinations, or expressed fear of impending death); platelet dysfunction or thrombocytopenia (unusual bleeding or bruising); Clostridium difficile colitis or seizure.
Skin and subcutaneous tissue disorders: Frequency 'very rare': Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Drug Interactions
Drug/Laboratory Test Interactions: Oral administration of amoxycillin will result in high urine concentrations of amoxycillin. Since high urine concentrations of amoxycillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict's Solution or Fehling's Solution, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix, or Testape) be used.
Tab: There have been case reports of reduced oral contraceptive effectiveness, resulting in unplanned pregnancy. An alternative or additional method of contraceptive should be advised.
An increased frequency of skin rashes has been reported in patients receiving amoxycillin together with allopurinol, but this is yet to be confirmed.
Probenecid decrease renal tubular secretion of amoxycillin when used concurrently and may increase the risk of toxicity.
Amoxycillin may decrease the clearance of methotrexate and may cause methotrexate toxicity.
Other drugs which interaction may occur: Angiotensin-converting enzyme (ACE) inhibitors, potassium-sparing diuretics, potassium supplements.
Caution For Usage
Instruction for Reconstitution of Betamox Granules 125 mg/5 mL and 250 mg/5 mL: Add water to 60 ml mark. Shake well and make up to 60 ml mark if needed. Shake well before taking each dose. To be used within 7 days after mixing.
To remove bottle from aluminium pouch when ready to use.
Storage
Capsule: Store below 30°C. Protect from light.
Tablet: Store in a dry place below 30°C.
Protect from light.
Take at regular intervals. Complete the prescribed course unless otherwise directed.
May be taken on a full or empty stomach.
May be taken with baby formulas, milk, fruit juice, water, or other cold drinks.
Granule: Store below 30°C. Protect from light. After reconstitution, store between 2-8°C.
MIMS Class
Penicillins
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Presentation/Packing
Cap 250 mg (a size 2, grey/yellow with marking 'DUO 861') x 100 x 10's. 500 mg (a size 0, grey/yellow with marking 'DUO 861') x 50 x 10's. Tab 500 mg (capsule shape, scored, marked 'UP500' yellow) x 50 x 10's. Granules for oral soln (white granules, on constitution it forms a white syrup) 125 mg/5 mL x 60 mL. 250 mg/5 mL x 60 mL.
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