Nemoxil Amoxicillin Capsule and Syrup

NEMOXIL®

QUALITATIVE AND QUANTITATIVE COMPOSITION (active Ingredient only)

NEMOXIL Capsules 250mg contain 250mg amoxicillin per capsule

NEMOXIL Capsules 500 mg contain 500mg amoxicillin per capsule

NEMOXIL Syrup 125 mg contains 125mg amoxicillin per 5 ml dose

NEMOXIL Syrup Forte 250mg contains 250mg amoxicillin per 5 ml dose

The amoxicillin is present as the trihydrate in NEMOXIL oral presentations.

 
PHARMACEUTICAL FORM

NEMOXIL Capsules: maroon and yellow capsules presented in tropicalised blisters.

NEMOXIL Syrup and Syrup Forte: presented as dry powder in glass bottles.
Not all presentation are available in every market

 
CLINICAL PARTICULARS

Therapeutic indications

NEMOXIL 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 parathyroid 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 parenteral therapy and where appropriate, in combination with another antibiotic.

Prophylaxis of endocarditis: NEMOXIL may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing of endocarditis.

Strains of the following organisms are generally sensitive to the bactericidal action of NEMOXIL in vitro:

Gram-positive

Aerobes: Streptococcus faecalis, streptococcus pneumonia, Streptococcus pyogenes, Streptococcus viridans, penicillin-sensitive Staphylococcus aureus. Corynebacterium species, Bacillus anthracis, Listeria monocytogenes.

Anaerobes: Closiridium species.

Gram-negative

Aerobes: Haemophilus influenza, Eschericia coli, Proteus mirabilas, Salmonella species, Shigella species, Bordetella pertussis, Brucella species, Neisseria gonorrhoeae, Neisseria meningitides, Pasteurella septic, Vibrio cholerae, Helicobacter pylori.

Amoxicillin is susceptible to degradation by beta-lactamases and therefore the spectrum of activity of NEMOXIL does not include organisms which produce these enzymes, including resistant staphylococci and all strains of Pseudomonas, Klebsiella and Enterobacter.

 
POSOLOGY AND METHOD OF ADMINISTRATION

Adult dosage (including elderly patients)

Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

High dosage therapy (maximum recommended oral dosage 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 – 12 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:

NEMOXIL is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below:

Omeprazole 40mg daily, Amoxicillin 1Gm BID, Clarithromycin 500mg BID x 7 days or

Omeprazole 40mg daily, Amoxicillin 750mg – 1Gm BID, Metronidazole 400mg TID x 7 days

Children’s dosage: (up to 10 years of age):

Standard children’s dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.

In severe of recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years. The use of NEMOXIL 750mg Sachets SF 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:

 

OVERDOSE

Poblems of overdosage with amoxiclllin are unlikely to occur. If encountered, gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance.
During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimize the possibility of amoxicillin crystalluria.

Amoxicillin can be removed from the circulation by hemodialysis.

Adults and Children over 40 kg

Mild impairment (creatinine clearance > 30 ml/mm)
– No change in dosage

Moderate impairment (creatinine clearance 10-30 ml/min)
– 500 mg b.i.d. maximum

Severe impairment (creatinine clearance <10 ml/min)
– 500mg/day maximum

Children under 40 kg

Mild impairment (creatinine clearance >30 ml/min)
– No change in dosage

Moderate impairment (creatinine clearance 10-30 ml/min)
– 15mg/kg b.i.d

Severe impairment (creatinine clearance <10 ml/min)
– 15mg/kg o.d

Patients receiving peritoneal dialysis

Dosing as for patients with Severe renal impairment (creatinine clearance < 10 ml/mm).

Amoxicillin is not removed by peritoneal dialysis.

Patients receiving haemodialysis

Dosing as for patients with severe renal impairment (creatinine clearance < 10 ml/mm). Amoxicillin is removed from the circulation by haemodialysis. Therefore, one additional dose (500mg for adults or 15 mg/kg for children under 40kg) may be administered during dialysis and at the end of each dialysis.

Prophylaxis of endocarditis: see table below.

CONDITION ADULTS DOSAGE (INCLUDING ELDERLY) CHILDREN’S DOSAGE NOTES
Dental procedures:
prophylaxis for patients undergoing extraction, scaling for surgery involving gingival tissues and who have not received penicillin in the previous month. (NB Patients with prosthetic heart valves should be referred to hospital – see below
Patient not having general anaesthetic.
Patient having generel anaesthetic: if oral antibiotics considered to be appropriate.
Patient having general anaesthetic if oral antibiotics not appropriate.
3 g NEMOXIL orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.
Initially 3g NEMOXIL orally 4 hours prior to anaesthesica, followed by 3g orally (or 1g IV or IM if oral dose not tolerated)
as soon as possible after the operation.1 g NEMOXIL IV or IM immediately before induction; with 500 mp orally after 6 hours Iater.
Under 10: half adult dose. Under 6: quarter adult dose.

The use of NEMOXIL 500 mg Dispersible Tablets or 750 mg Sachets SF is recommended.

NOTE 1
If prophylaxis with NEMOXIL is given twice within one month, emergence of resistant streptococci is unlikely to be a problem.
Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month.
Note 2
To minimise pain on injection, NEMOXIL may be given as two injections of 500 mg dissolved in sterile 1% lignocaine solution.
Dental patients for whom referral to hospital is recommended:
(a) Patients to be given a general anaesthetics who have been given a penicillin in the previous month.
(b) Patients to be given a general anaesthetic who have a prosthetic heart valve.(c) Patients who have had one or more attacks of endocarditis.
Initially, 1 g NEMOXIL IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure.
Followed by (6 hours later):
500 mg NEMOXIL orally.
Under 10: the dose of NEMOXIL should be half the adult dose; the gentamicin dose should be 2 mg/kg.
Under 6: the dose of NEMOXIL should be quarter the adult dose; the dose of gentamicin should be 2mg/kg.
See Note 2

Note 3

NEMOXIL and gentamicin
should not be mixed in the same syringe.
Note 4
Please consult the appropriate data sheet for full prescribing information about gentamicin.

Genitourinary Surgery or Instrumentation: prophylaxis for patients who have no urinary tract infection and who are to have genitor-urinary surgery or instrumentation under general anaesthesia.

Obsteric and Gynaecological Procedures: routine prophylaxis is recommended only for patients with prosthetic.

Gatsrointestinal Procedure: hear valves

Initially 1 g NEMOXIL IV or IM with 120mg gentamicin IV or IM immediately before induction.

Followed by (6 hours later):
500mg NEMOXIL orally or IV or IM according to clinical condition.

See Notes 2, 3 and 4 above.
Surgery or instrumentation of the Upper Respiratory Tract Patients other than those with prosthetic hear valves 1 g NEMOXIL IV or IM immediately before induction 500mg NEMOXIL IV or IM 6 hours later. Under 10: half adult dose.
Under 5: quarter adult dose.
See Note 2 above.

Note 5
The second dose of NEMOXIL may be administered orally as NEMOXIL Syrup sucrose free

Patients with prosthetic heart valves. Initially: I g NEMOXIL IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg NEMOXIL IV OR IM. Under 10: the doses of
NEMOXIL should be half the
adult dose: the dose of
gentanmicin should be 2 mg/kg.
Under 5: the doses of
NEMOXIL should be quarter
the adult dose; the dose of
gentamicin should be 2 mg/kg.
See Notes 2, 3, 4 and 5 above.

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.

 
CONTRA-INDICATIONS

NEMOXIL is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics, e.g. cephalosporins.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Before initiating therapy with NEMOXIL, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins or cephalosporins. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported on patient on penicillin therapy. These reactions are more likely to occur in individuals with a
history of hypersensitivity to beta lactam antibiotics (see
Contraindications). 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. Dosage should be adjusted in patients with renal impairment (see Posology and Method of Administration).Nemoxil oral suspension 125mg/5ml and Nemoxil oral suspension 250mg/5ml contain sodium benzoate.
INTERACTION WITH OTHER NEMOXIL MEDICAMENTS AND OTHER FORMS OF INTERACTION NEMOXIL Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with may result in increased and prolonged blood levels of amoxicillin. In common with other broad spectrum antibiotics, may reduce the efficacy or oral contraceptives and patients should be warned accordingly. Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive reading are common with chemical methods.
PREGNANCY AND LACTATION Use in Pregnancy: Animal studies with NEMOXIL 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. When antibiotic therapy is required during pregnancy, NEMOXIL may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.
Use in Lactation: Amoxicillin 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.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Adverse effects on the ability to drive or operate machinery have not been observed.

 

UNDESIRABLE EFFECTS

Side-effects, as with other penicillins, are uncommon and mainly of a mild and transitory nature.

Hypersensitivity reactions: If any hypersensitivity occurs, the treatment should be discontinued.

Skin rash, pruritis 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 (see Warnings), serum sickness and hypersensitivity vasculitis have been reported rarely.

Interstitial nephritis can occur rarely.

Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea. Intestinal candidiasis and antibiotic associated colitis (including pseudo-membranous colitis and haemorrhagic colitis) has been reported rarely.

Hepatic effects: A moderate rise in AST and/or ALT has been occasionally noted but the significance of this is nuclear. As with other beta-lactam antibiotics, hepatitis and cholostatic jaundice have been reported rarely.

Haematological effects: As with other beta-lactams, reversible leucopenia, (including severe neutropenia or agranulocytosis) reversible thrombocytopenia and haemolytic anemia have been reported rarely. Prolongation of bleeding time and prothrombin time have also been reported rarely (see Warning).

CNS effects: CNS effect have been seen rarely. They include hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function of in those receiving high doses.

Miscellaneous: Superficial tooth discolouration has been reported rarely and mostly with the suspension and chewable tablets. It can usually be removed by brushing.

 

PHARMACOLOGICAL PROPERTIES

Pharmacodymic Properties

NEMOXIL is a semi-synthetic aminopenicillin of the beta-lactam group of antibiotics. It has a broad spectrum of antibacteria activity against many Gram-positive and Gram-negative micro-organisms, acting through the inhibition of biosynthesis of cell wall mucopeptide.

It is rapidly bactericidal and possesses the safety profile of a penicillin.

Pharmacikinetic Properties

NEMOXIL is well absorbed. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. NEMOXIL gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

Amoxicillin is not highly protein bound; approximately 18% of total plasma drug content is bound to protein. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid, inflammation generally increases the permeability of the meninges to penicillins and this may apply to amoxicillin.

The elimination half-life is approximately 1 hour. The major route of elimination for amoxicillin is via the kidney. Approximately 60 – 70% of NEMOXIL is excreted unchanged in urine during the first 6 hours after administration of a standard dose. NEMOXIL is also partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to 10 – 25% of the initial dose.

Concurrent administration of probenecid delays amoxicillin excretion.

PHARMACEUTICAL PARTICULARS

Special Precaution for Storage

All presentations should be stored in a dry place, below 25oC.
Once dispensed, NEMOXIL Syrups SF should be stored at 25oC or below and used within 7 days. If dilution of the reconstituted SF product is required, water should be used.
SHELF-LIFE The expiry date is indicated on the packaging.

 

Further information is available on request.

 

MANUFACTURED BY

NEMEL PHARMACEUTICAL INDUSTRY LIMITED

PLOT 35, EMENE INDUSTRIAL LAYOUT

ENUGU, NIGERIA.

E-MAIL: NEMELPHARM@GMAIL.COM

NEMOXIL is a trademark.