Amix Capsules 250mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amix Capsules 250mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin Trihydrate BP
equivalent to amoxicillin 250mg per capsule.
3 PHARMACEUTICAL FORM
Capsules.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Amix Capsules 250mg are indicated for the oral treatment of bacterial infections caused by amoxicillin sensitive organisms. Such indications include infections of the upper and lower respiratory tract, the genito-urinary tract and the gastro-intestinal tract. Specific indications include ear and soft tissue infections and gonorrhoea. Amoxicillin may be used for the prevention of bacteraemia associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis. In the acute stages of life-threatening infections, a period of parenteral anti-infective therapy would be essential before initiating oral continuation therapy.
4.2 Posology and method of administration
For oral administration.
Adults:
250mg every 8 hours. In severe infections the dosage may be doubled. Severe or recurrent purulent respiratory infection:
3g every 12 hours.
Dental abscess: 3g repeated after 8 hours.
Urinary tract infections:
3g repeated after 10-12 hours.
Gonorrhoea:
single dose of 2-3g with probenecid 1g.
Prophylaxis of Endocarditis in Patients with Heart-Valve Lesion, Septal Defect, Patent Ductus or Prosthetic Valve:
Dental procedures under local or no anaesthesia:
patients who have not received more than a single dose of penicillin in the previous month, including those with a prosthetic valve (but not those who have had endocarditis): a single 3g oral dose 1 hour before procedure.
patients who have had endocarditis:
1g intravenous amoxicillin plus 120mg intravenous gentamicin at the time of administration of the local anaesthetic (or immediately before the procedure if no anaesthetic is used) followed by an oral dose of 500mg amoxicillin 6 hours later.
Dental procedures under general anaesthesia:
patients who have not received more than a single dose of penicillin in the previous month, excluding those with a prosthetic valve and those who have had endocarditis: a single 3g oral dose 4 hours before the procedure followed by a second 3g oral dose as soon as possible after the procedure.
patients with a prosthetic valve and those who have had endocarditis: 1g intravenous amoxicillin plus 120mg intravenous gentamicin at the time of induction followed by an oral dose of 500mg amoxicillin 6 hours later.
Elderly:
The normal adult dose is appropriate.
Paediatric population:
Children under 6 years and older children who cannot swallow capsules should be prescribed an amoxicillin suspension.
Children weighing <40kg:
The daily dosage for children is 40 - 90mg/kg/day in two to three divided doses* (not exceeding 3g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and Sections 4.4, 5.1 and 5.2).
*PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.
Children weighing more than 40kg should be given the usual adult dosage. Special dosage recommendation
1. Tonsillitis:
50mg/kg/day in two divided doses.
2. Acute otitis media:
In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.
3. Early Lyme disease (isolated erythema migrans):
50mg/kg/day in three divided doses, over 14-21days.
4. Prophylaxis for endocarditis:
50mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.
Dosage in impaired renal function:
The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see Section 4.4 and 5.2).
Renal impairment in children under 40kg:
|
Creatinine clearance (ml/min) |
Dose |
Interval between administration |
|
> 30 |
Usual dose |
No adjustment necessary |
|
10 - 30 |
Usual dose |
12 h (corresponding to 2/3 of the dose) |
|
24 h | ||
|
< 10 |
Usual dose |
(corresponding to 1/3 of the dose) |
4.3 Contraindications
Amix should not be used in patients with known or suspected hypersensitivity to penicillins,
semi-synthetic penicillins or cephalosporins.
4.4 Special warnings and precautions for use
Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective. Amoxicillin should be given with caution to patients with any history of allergy, especially to drugs. Patients with chronic lymphatic leukaemia may be at increased risk of developing skin rashes. Amoxicillin should be used with caution in patients with impaired renal function.
Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.
4.5 Interaction with other medicinal products and other forms of interaction
Probenecid inhibits the excretion of amoxicillin leading to increased serum levels and a prolonged half-life.
There is an increased risk of rash in patients taking both amoxicillin and allopurinol. Treatment should be discontinued if a rash develops.
Amoxicillin may decrease the efficacy of combined oral contraceptives. It is advisable for patients to use a barrier method of contraception during antibiotic therapy and for seven days after. If the course of antibiotics runs into the seven-day break from pill taking then the patient should start the next pack immediately and skip the pill-free break. The patient should again use a barrier method of contraception during antibiotic therapy and for seven days after completing the course of antibiotics.
Isolated cases of increased prothrombin times and or bleeding have been seen in patients given amoxicillin. Concurrent use should be monitored so that the very occasional and unpredictable cases (increases or decreases in the anticoagulant effects) can be identified and handled accordingly.
There have been reports of reduced clearance and acute methotrexate toxicity attributed to concurrent use of amoxicillin and methotrexate.
4.6 Fertility, Pregnancy and lactation
Anti-infectives should not be used during pregnancy unless considered essential by the
physician. In animal studies amoxicillin has not been shown to be teratogenic and although
these are not always indicative of human response, amoxicillin has been used widely for a number of years and is regarded as suitable for the treatment of infections during pregnancy. Studies in breast feeding mothers have detected trace amounts of amoxicillin in human milk.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Side effects are uncommon and are mainly of a mild and transitory nature.
The following blood and lymphatic system disorders have been reported: thrombocytopenia, leucopenia and haemolytic anaemia;
There have been isolated reports of increased prothrombin times and or bleeding in patients taking amoxicillin and oral anticoagulants.
Hypersensitivity reactions have been associated with the use of all penicillins, including amoxicillin. These reactions include: urticarial rashes, erythema multiforme, serum-sickness-like reactions e.g. skin rash, hives, itching, joint pain, fever, malaise, enlarged lymph nodes, angioedema and rarely, anaphylaxis.
An urticarial rash suggests hypersensitivity to penicillin and an erythematous type rash may arise if amoxicillin is administered to patients with glandular fever. In either case the treatment should be discontinued.
There have been reports of CNS toxicity in the form of convulsions, especially where high doses have been administered or in severe renal impairment.
Gastrointestinal adverse effects such as nausea, vomiting, and diarrhoea have been reported. As with other broad-spectrum antibiotics, prolonged use may result in the overgrowth of non-susceptible organisms and anti-biotic associated colitis may develop.
Reversible interstitial nephritis has occurred in a few patients but this is very rare.
4.9 Overdose
Gross overdose will produce high urinary concentrations, thus crystalluria is a possibility, but problems are unlikely if adequate fluid intake and urinary output are maintained. More specific measures may be required in patients with impaired renal function; the antibacterial is removed by haemodialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Amoxicillin is a broad spectrum semi-synthetic penicillin. It is bactericidal against a wide range of gram-positive and gram-negative micro-organisms. It has been reported that amoxicillin predominantly inhibits cell-wall synthesis in susceptible bacteria.
5.2 Pharmacokinetic properties
Amoxicillin trihydrate is resistant to inactivation by the acid of gastric secretions and is rapidly absorbed when given orally. It is more completely absorbed than ampicillin and is reported to produce peak antibacterial plasma concentrations that are up to 2.5 times as high as those from the same dose of ampicillin. Peak plasma amoxicillin concentrations of about DDg/ml have been observed 1 to 2 hours after a dose of 250mg with detectable amounts present for up to 8 hours. Doubling the dose can produce double the concentration. The presence of food in the stomach does not seem to diminish absorption significantly.
In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 - 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.
5.3
Preclinical safety data None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium lauryl sulphate Magnesium stearate
Capsule Shell Constituents Body
Titanium dioxide (E171) Gelatin
Cap
Erythrosine (E127) Indigotine (E132)
Titanium dioxide (E171) Gelatin
Overprint ink constituents Shellac
Propylene glycol Black iron oxide (E172)
6.2 Incompatibilities
None stated.
6.3 Shelf life
Three years in the market pack.
6.4 Special precautions for storage
Store in a dry place below 25oC, protected from direct light.
6.5 Nature and contents of container
Polypropylene Securitainers with low density polyethylene caps containing 3, 100, 250, 500 or 1000 capsules.
PVdC-aluminium foil blister packs containing 15 or 21 capsules.
6.6 Special precautions for disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
uniQ Pharma Limited
3M Buckley Innovation Centre
Firth Street
Huddersfield
West Yorkshire
HD13BD
8 MARKETING AUTHORISATION NUMBER(S)
PL 42047/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7 July 2004
10 DATE OF REVISION OF THE TEXT
29/01/2014