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RIMOXALLIN SYRUP (IN POWDER FORM) 250MG/5ML

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1.

NAME OF THE MEDICINAL PRODUCT
Amoxicillin Mixture BP (Powder for) 250mg/5ml
Rimoxallin Syrup (in Powder from) 250mg/5ml

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin Trihydrate BP (equivalent to 250mg Amoxicillin per 5ml)

3.

PHARMACEUTICAL FORM
Powder for Oral Suspension.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
The treatment of bacterial infections caused by amoxicillin-susceptible organisms.
It is principally indicated for respiratory, middle ear and urinary tract infections.
Respiratory tract - pneumonia, bronchitis
ENT - otitis media
Urinary tract - cystitis, pyelonephritis
Biliary and intra-abdominal infections
Gynaecological infections
Gonorrhoea
Septicaemia
Bacterial endocarditis
Skin and soft tissue infections
Meningitis (seek expert advice)
Enteric fevers (typhoid and paratyphoid fevers - seek expert advice)
Dental abscess (as an adjunct to surgical management)
The prevention of bacteraemia, associated with procedures (e.g. dental), in patients at risk of
developing bacterial endocarditis.

4.2

Posology and method of administration
Route of Administration: Oral

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 pathogens (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).
*PK/KD 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
Tonsilitis: 50mg/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): 50mg/kg/day in three divided doses over
14-21 days.
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
30
10-30

Dose
Usual dose
Usual dose

< 10

Usual dose

Interval between
administration
No adjustment necessary
12 h
(corresponding to 2/3 of
the dose)
24 h
(corresponding to 1/3 of
the dose)

Adults: 250mg every 8 hours, increasing to 500mg every 8 hours in severe infection.
In those with severely impaired renal function dose reduction may be necessary.
Prophylaxis of Endocarditis
Dental procedures under local or no anaesthesia:
Patients who have not received more than a single dose a penicillin in the previous month,
including those with a prosthetic valve (but not those who have had endocarditis): oral
amoxicillin 3g 1 hour before procedure.

Patients who have had endocarditis, amoxicillin + gentamicin, as under general anaesthesia.
Dental procedures under general anaesthesia:
No special risk (including patients who have not received more than a single dose of a
penicillin in the previous month): either i/m or i/v amoxicillin 1g at induction, then oral
amoxicillin 500mg 6 hours later. Or oral amoxicillin 3g 4 hours before induction then oral
amoxicillin 3g as soon as possible after procedure.
Or oral amoxicillin 3g+oral probenecid 1g 4 hours before procedure.
Special risk (patients with a prosthetic valve or who have had endocarditis): i/v amoxicillin
1g+i/v gentamicin 120mg at induction, then oral amoxicillin 500mg 6 hours later.
This product should not be used in patients who have received more than a single dose of
penicillin in the previous month, or whom are allergic to penicillin.

Upper respiratory-tract procedures:
As for dental procedures: post-operative dose may be given parenterally if swallowing is
painful.
Genito-urinary procedures:
As for special risk patients undergoing dental procedures under general anaesthesia. If urine
infected, prophylaxis should also cover infective organism.
Obstetric, gynaecological and gastro-intestinal procedures:
(prophylaxis required for patients with prosthetic valves or those who have had endocarditis
only) As for genito-urinary procedures.

4.3.

Contra-Indications
Amoxicillin is contra-indicated in patients with hypersensitivity to penicillins.
Attention should also be paid to possible cross-reactivity with other beta-lactam antibiotics
e.g. cephalosporins.
It should not be given to patients with infectious mononucleosis (glandular fever) since they
are especially susceptible to amoxicillin-induced skin rashes.

4.4

Special warnings and precautions for use
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported
in patients on penicillin therapy. These reactions are most likely in those with a history of
hypersensitivity to beta-lactam antibiotics.
Amoxicillin should be used with caution in those with impaired renal function and dose
reduction may be necessary in severe impairment.
Patients with infectious mononucleosis (glandular fever), lymphatic leukaemia and possibly
with HIV infection are particularly prone to developing erythematous rashes with
amoxicillin. Amoxicillin should be discontinued if a skin rash occurs.

Prolonged use of an anti-infective may result in the overgrowth of non-susceptible
organisms (superinfection).
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
Prolongation of prothrombin time has been reported in patients taking amoxicillin.
Appropriate monitoring should be undertaken when anticoagulants are prescribed
concurrently.
In common with other broad spectrum antibiotics Amoxicillin may reduce the efficacy of
the oral contraceptive pill and patients should be warned appropriately, and extra
precautions taken.
Excretion of penicillins is reduced by probenecid.

4.6.

Pregnancy and Lactation
Use in pregnancy:
There is no evidence that amoxicillin is teratogenic or foetotoxic in humans. The product
has been in extensive clinical use form any years and is considered safe in pregnancy.
Use in lactation:
Amoxicillin is considered safe in lactation. However it should be noted that amoxicillin is
excreted in breast milk in small quantities with the possible risk of sensitisation and
subsequent allergic reactions in a sensitised infant.

4.7.

Effects on Ability to Drive and Use Machines
Not applicable.

4.8.

Undesirable Effects
Hypersensitivity reactions:
When amoxicillin is administered to a hypersensitive patient anaphylactic shock with
collapse and sometimes death may occur within minutes.
If any hypersensitivity reaction occurs the treatment should be discontinued.
Skin rashes are the most common side effects with pruritus and urticaria. Rarely skin
reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis and bullous and exfoliative dermatitis have been reported.
Severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness and
vasculitis have been reported rarely.
Interstitial nephritis can occur rarely.
Gastrointestinal reactions:

Mild gastrointestinal upsets: nausea, vomiting diarrhoea. Muco-cutaneous candidiasis.
Antibiotic-associated colitis (including pseudo-membranous colitis).
Hepatic effects:
Transiently raised liver enzymes (AST and/or ALT) has been noted. As with other betalactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely.
Haematological effects:
As with other beta-lactams reversible leucopenia (including agranulocytosis),
thrombocytopenia and haemolytic anaemia, and coagulation disorders (prolonged
prothrombin and bleeding times) have been reported rarely.
CNS effects:
Rare effects include dizziness, convulsions and paraesthesia. Convulsions may occur in
patients with impaired renal function or in those receiving high doses.

4.9.

Overdose
Problems of overdosage with amoxicillin are unlikely to occur. If encountered,
gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be
treated symptomatically.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
Amoxicillin is bactericidal. Like all penicillins it acts by interfering with the synthesis of
the cell wall of the bacterium.
Amoxicillin is inactivated by penicillinase. Penicillinase-producing strains of
Staphylococcus aureus and Gram negative organisms (e.g. Escherichia coli, Proteus,
Klebsiella) are resistant.
Complete cross-resistance occurs with ampicillin and amoxicillin.

5.2

Pharmacokinetic properties
Amoxicillin is stable in the acid gastric secretion and is rapidly absorbed from the
gastrointestinal tract after oral administration. The presence of food does not interfere with
this process. Peak plasma concentrations are obtained in about two hours, producing around
2.5 times the peak concentration resulting from comparable doses of ampicillin.
Protein binding is similar to that of ampicillin: up to 25%.
Effective levels in the cerebrospinal fluid are obtained only in the presence of inflammation
and then irregularly. About 60% of an orally administered dose is excreted unchanged in the
urine. It penetrates well in to purulent and mucoid sputum.

In preterm infants with gestational age 26-33 weeks, the total body clearance after
intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75-2ml/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 maybe 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
There are no pre-clinical data of relevance to the prescriber which are additional to that
already included in other sections of the SPC

6.

Pharmaceutical Particulars

6.1

List of Excipients
Sodium Benzoate BP
Sodium Citrate BP
Colloidal Anhydrous Silica BP
Dispersible Cellulose (Avicel RC591)
Saccharin Sodium BP
Lemon Powder Flavour HSE
Quinoline Yellow HSE
Sucrose BP

6.2

Incompatibilities
None stated.

6.3

Shelf Life
Shelf Life
3 years
14 days

6.4

-

before reconstitution
after reconstitution

Special Precautions for Storage
Store unreconstituted product in a dry place at or below 25°C.
Keep tightly closed. Store mixture in a refrigerator.

6.5

Nature and Contents of Container
Amber glass bottle (Type III) with Ropp cap (aluminium closure/expanded polyethylene
liner): 60ml and 100ml.

6.6

Instruction for Use, Handling and Disposal
None stated.

7.

MARKETING AUTHORISATION HOLDER
Ranbaxy Ireland Ltd
Spafield, Cork Road,
Cashel, Co. Tipperary
Ireland

8.

MARKETING AUTHORISATION NUMBER(S)
PL 6809/0025

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19th October 1987

10

DATE OF REVISION OF THE TEXT
26/10/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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