Amoxicillin 250mg Capsules Bp
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin 250 mg Capsules BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg Amoxicillin (as trihydrate).
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Red/buff size 2 hard gelatin capsule containing a white to off white powder. Printed with “AMOXY 250”
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Amoxicillin is indicated in the treatment of otitis media, chronic bronchitis, gonorrhoea, typhoid fever.
It may also be used to treat susceptible organisms in upper respiratory tract infections, lobar and bronchopneumonia, cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, gynaecological infections including puerperal sepsis and septic abortion, peritonitis, intra-abdominal sepsis, septicaemia, bacterial endocarditis, skin and soft tissue infections and osteomyelitis.
4.2 Posology and method of administration
For oral use.
Treatment of infection.
Adults (including the elderly)
Standard adult dosage
250 mg three times daily, increasing to 500 mg three times daily for more severe infections.
High dose therapy
3g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract (max daily dose 6 g).
Short course therapy
Simple acute UTI: two 3g doses with 10-12 hours between the doses. Gonorrhoea: Single 3g dose.
Children weighing < 40 kg
For these patients it is more appropriate to use the paediatric presentation, Amoxicillin Oral Suspension.
The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/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 40 kg should be given the usual adult dosage.
Special dosage recommendation Tonsillitis: 50 mg/kg/day in two divided doses.
Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.
Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days.
Prophylaxis for endocarditis: 50 mg 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 30 ml/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 40 kg:
|
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) |
|
< 10 |
Usual dose |
24 h (corresponding to 1/3 of the dose) |
4.3 Contraindications
Hypersensitivity to penicillins or to any of the excipients.
Possible cross-sensitivity with other beta-lactam antibiotics such as cephalosporins.
4.4 Special warnings and precautions for use
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 section 4.9 Overdose)
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 section 4.2).
The capsule shell colours sunset yellow (E110) and carmoisine (E122) may cause allergic reactions.
The capsule shell contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).
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.
Use with caution in patients with acute and chronic lymphocytic leukaemia.
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
The incidence of skin rashes with amoxicillin is increased by concomitant allopurinol.
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
The excretion of methotrexate can be markedly reduced by concurrent use of penicillins. There is considerable risk of methotrexate toxicity.
Very infrequently and unpredictably concurrent use with oral contraceptives may result in contraceptive failure.
Probenecid delays the excretion of Amoxicillin and dietary fibre can reduce the absorption of Amoxicillin.
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 readings are common with chemical methods.
4.6 Fertility, pregnancy and lactation
When antibiotic therapy is required during pregnancy, amoxicillin may be considered appropriate. During lactation, trace quantities of amoxicillin can be detected in breast milk.
4.7 Effects on ability to drive and use machines
This medicine may very rarely cause dizziness and convulsions. If affected do not drive or operate machinery.
4.8 Undesirable effects
There are no modern clinical studies available that can be used to determine the frequency of undesirable effects.
The following convention has been utilised for the classification of frequency: Very common, > 1/10; common, > 1/100 and < 1/10; uncommon, > 1/1000 and < 1/100; rare, > 1/10000 and < 1/1000; very rare, < 1/10000.
The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins.
Infections & 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 Section 4.5 - Interaction with other Medicinal Products and other forms of interaction).
Immune system disorders:
Very Rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).
Nervous system disorders:
Very rare: 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; indigestion; nausea. *Uncommon : Vomiting.
Post-Marketing Data
Very rare: Antibiotic associated colitis (including pseudomembraneous 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.
Hepato-biliary disorders:
Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or 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 such as erythema multiforme, Stevens Johnson
syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)
(see also immune system disorders)
Renal & urinary disorders:
Very rare : Interstitial nephritis. Crystalluria
* The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.
4.9 Overdose
Overdosage is unlikely but gross overdosage will result in very high urinary concentrations. Problems occurring as a result of this are unlikely if adequate fluid intake and urinary output are maintained, however, crystalluria is a possibility. More specific measures may be necessary in patients with impaired renal function. The antibiotic is removed by haemodialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
JO1C A04 Penicillins with extended spectrum.
Amoxicillin is a penicillinase-susceptible semisynthetic penicillin. The drug is bactericidal and is effective against the same range of organisms as ampicillin and has a similar mode of action. It has been reported that amoxicillin predominantly inhibits cell-wall synthesis in susceptible bacteria. Amoxicillin has been reported to be slightly more active than ampicillin against some streptococci and salmonella sp. but less active against shigella sp.
Amoxicillin is more rapidly and completely absorbed from the GI tract than ampicillin and peak plasma levels are 2-2.5 times greater for amoxicillin after oral administration of the same dose. Food does not interfere with absorption. MIC’s ranging from 0.01 to 5 pg/ml have been reported.
5.2 Pharmacokinetic properties
The bioavailability of amoxicillin capsules 250 mg and 500 mg was compared against that of Amoxil capsules 250 mg and 500 mg (manufactured by Smithkline Beecham). The results showed that Amoxicillin Capsules 250 mg and 500 mg were bioequivalent to Amoxil 250 mg and 500 mg respectively.
Oral bioavailability of Amoxicillin = 93 ±10%
Urinary excretion of Amoxicillin = 52 ±15%
Plasma binding 18%
Half life 1 hour (increased in uremia)
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
No data of relevance, which is additional to that already, included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium stearate
Capsule Shell:
Gelatin
Sunset Yellow (E110)
Carmoisine (E122)
Brilliant Blue (E133)
Quinoline Yellow (E104)
Titanium Dioxide (E171)
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Tablet container: Do not store above 25°C. Keep the container tightly closed. Bag: Do not store above 25°C. Keep the container tightly closed.
Blister: Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
PP or HDPE tablet containers with PP or HDPE caps containing 100, 250, 500 and 1000 capsules.
Bulk supply of 5,000 and 10,000 capsules packed in polybags, free from additives, inside a cardboard outer container.
Al/PVC blister packs enclosed in an outer carton containing 21 or 100 capsules. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special instructions for use/handling.
7 MARKETING AUTHORISATION HOLDER
Special Concept Development (UK) Ltd
Units 1-7 Colonial Way
Watford
Hertfordshire
WD24 4YR
8 MARKETING AUTHORISATION NUMBER(S)
PL 36722/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/02/2009
10 DATE OF REVISION OF THE TEXT
01/07/2011