Moxilen

Amoxicillin trihydrate.

''Moxilen'' capsules contain the equivalent of either 250 mg or 500 mg amoxicillin as amoxicillin trihydrate E.P.
Excipients/Inactive ingredients: ''Moxilen'' capsule shell contains gelatine, erythrosine (E127), red iron oxide (E172), black iron oxide (E172), and titanium dioxide (E171).
''Moxilen" capsules 500 mg contain gelatine, erythrosine (E127), brilliant blue FCF (E133), carmoisine (E122) and titanium dioxide (E171).

Pharmacology: Pharmacodynamics: Moxilen is a broad spectrum antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin. The wide range of organisms sensitive to the bactericidal action of Moxilen include: Aerobes: Gram-positive include: Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus, (Penicillin-sensitive strains only): Corynebacterium species, Bacillus anthracis, Listeria monocytogenes.
Gram-negative include: Haemophilus influenza, Escherichia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella septica.
Anaerobes: Gram-positive: Clostridium species.
Pharmacokinetics: Amoxicillin is well absorbed by both parenteral and oral routes. Oral administration, usually at convenient three times daily dosage, produces high serum levels independent of the time at which food is taken. Moxilen gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotics.
Toxicology: Preclinical Safety Data: No further information of relevance to the prescriber that is not addressed elsewhere in the monograph.

"Moxilen" is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections e.g. ear, nose and throat infections, otitis media.
Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.
Gastrointestinal tract infections e.g. typhoid and paratyphoid fever.
Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, septic abortion, puerperal sepsis.
Skin and soft tissue infections.
Billiary tract infections.
Bone infections.
Pelvic infections.
Gonorrhoea (non-penicillinase producing strains).
Septicaemia.
Endocarditis.
Meningitis.
Peritonitis.
Dental abscess (as an adjunct to surgical management).
Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.
Infections such as septicaemia, endocarditis and meningitis due to susceptible organisms should be treated initially with high doses of a parenteral therapy and, where appropriate, in combination with another antibiotic.
Prophylaxis of endocarditis: "Moxilen" may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing endocarditis. Strains of the following organisms are generally sensitive to the bactericidal action of "Moxilen" in vitro: Gram-positive: Aerobes: Emerococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, penicillin-sensitive Staphylococcus aureus, Corynebacterium species, Bacillus anthracis, Listeria monocytogenes.
Anaerobes: Clostridium species.
Gram-negative: Aerobes: Haemophilus influenzae, Eschericia coli, Proteus mirabilis, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella septica, Vibrio cholerae, Helicobacter pylori.
Amoxicillin is susceptible to degradation by beta-lactamases and therefore the spectrum of activity of Moxilen does not include organisms which produce these enzymes, including resistant staphylococci and all strains of Pseudomonas, Klebsiella and Enterobacter.

Adults (including the elderly patients): Standard adult dosage: 250 mg 3 times daily, increasing to 500 mg 3 times daily for more severe infections.
High dosage therapy (maximum recommended oral dosage is 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10 to12 hours between the doses.
Dental abscess: two 3 g doses with 8 hours between the doses.
Gonorrhoea: single 3 g dose.
Helicobacter eradication in peptic (duodenal and gastric) ulcer disease: ''Moxilen'' is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents detailed as follows: Omeprazole 40 mg daily, amoxicillin 1 g twice a day, clarithromycin 500 mg twice a day for 7 days; or Omeprazole 40 mg daily, amoxicillin 750 mg to 1 g twice a day, Metronidazole 400 mg 3 times a day for 7 days.
Children's dosage (up to 10 years of age): Standard children first dosage: 125 mg 3 times daily, increasing to 250 mg 3 times daily for more severe infections.
''Moxilen" powder for oral suspension is recommended for children under 6 months of age.
In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for 2 days may be used as an alternative course of treatment in children aged 3 to 10 years.
The use of Moxilen 750 mg Sachets Syrup Forte is recommended.
Patients with renal impairment: 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 according to the following scheme: Adults and children over 40 kg: Mild Impairment (creatinine clearance greater than 30 ml/min): No change in dosage.
Moderate Impairment (creatinine clearance 10 to 30 mL/min): 500 mg twice a day maximum.
Severe Impairment (creatinine clearance less than 10 mL/min): 500 mg/day maximum.
Children under 40 kg: Mild Impairment (creatinine clearance greater than 30 mL/min): No change in dosage.
Moderate Impairment (creatinine clearance 10 to 30 mL/min): 15 mg/kg twice a day (maximum 500 mg twice daily).
Severe Impairment (creatinine clearance less than 10 mL/min):15 mg/kg once a day (maximum 500 mg).
Patients receiving peritoneal dialysis: Dosing as for patients with severe renal impairment (creatinine clearance less than 10 ml/min). Amoxicillin is not removed by peritoneal dialysis
Patients receiving haemodialysis: Dosing as for patients with severe renal impairment (creatinine clearance less than 10 ml/min). Amoxicillin is removed from the circulation by haemodialysis. Therefore, 1 additional dose (500 mg for adults or 15 m g/kg for children under 40 kg) may be administered during dialysis and at the end of each dialysis.
Prophylaxis of endocarditis: See table as follows.

Click on icon to see table/diagram/image

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.
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.

Gastrointestinal effects such as nausea, vomiting and diarrhoaea may be evident and should be treated symptomatically with attention to the water or electrolyte balance. Amoxicillin crystalluria in some cases leading to renal failure has been observed (see Precautions).
Amoxicillin may be removed from the circulation by haemodialysis.

Moxilen is a penicillin and should not be given to penicillin-hypersensitive patients. Attentions should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reaction s to penicillins, cephalosporins.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy (see Contraindications). If an allergic reaction occurs, "Moxilen" therapy must be discontinued and appropriate alternative therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous (i.v.) steroids and airway management (including intubation) may also be required.
Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms. In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Overdosage).
In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly (see Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: "Moxilen" has no effect on ability to drive or use machines.

The safety of this medicinal product for use in human pregnancy has not been established by well con trolled studies in pregnant women. Reproduction studies have been performed in mice and rats at doses of up to 10 times the human dose and these studies have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin.
''Moxilen'' may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
''Moxilen'' may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.

The following convention has been utilised for the classification of undesirable effects: Very common ≥1/10, common ≥1/100, <1/10, uncommon ≥1/1000, <1/100, rare ≥1/10,000, <1/1000, very rare <1/10,000.
The majority of side effects listed as follows are not unique to amoxicillin and may occur when using other penicillins.
Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.
Infections and infestations: Very rare: Mucocutaneous candidiasis.
Blood and lymphatic system disorders: Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and prothrombin (see Interactions).
Immune system disorders: Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Precautions), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See Skin and Subcutaneous Tissue Disorders as follows.)
Nervous system disorders: Very rare: Aseptic meningitis, hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders: Clinical Trial Data: *Common: Diarrhoea and nausea.
*Uncommon: Vomiting.
Post-marketing data: Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis); black hairy tongue.
Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Hepatobiliary disorders: Very rare: Hepatitis and cholestatic jaundice. A moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT).
The significance of a rise in AST and/or ALT is unclear.
Skin and subcutaneous tissue disorders: Clinical trial data: *Common: Skin rash. *Uncommon: Urticaria and pruritus.
Post-marketing data: Very rare: Skin reactions eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliating dermatitis and acute generalized exanthematous pustulosis (AGEP). (See Immune System Disorders as mentioned previously.)
Renal and urinary tract disorders: Very rare: Interstitial nephritis, crystalluria (see Overdosage).
*The incidence of these adverse effects was derived from clinical studies involving a total of approximately 6000 adults and paediatric patients taking amoxicillin.

Allopurinol: concurrent administration may increase the incidence of rash and other allergic skin reactions.
Anticoagulants: there are rare reports of prolongation of prothrombin time in patients concomitantly on amoxicillin. It is recommended that appropriate monitoring is carried out when amoxicillin is prescribed concurrently with anticoagulants.
Oral contraceptives: In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Probenecid: decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
Laboratory Tests: Glucose in Urine: Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.
The use of enzymatic glucose oxidase methods is recommended, as there is no interference from amoxicillin.

Instruction for Use/Handling: For oral administration only.

"Moxilen" capsules should be stored below 25°C in the original packaging in order to be protected from moisture.
Shelf life: Moxilen capsules have a shelf life of three (3) years.
Moxilen has a shelf life of fifteen (15) days if kept in a refrigerator (2°C - 8°C) or seven (7) days if kept at room temperature (<25°C).

Penicillins

J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.

POM