When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
SPC
4.4 Special Warnings and Special Precautions for Use …….. Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. ………… 4.8 Undesirable Effects ……………….. 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 time (See Warnings and Precautions). ……………….
4.4 Special Warnings and Special Precautions for Use
……..
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. ………… 4.8 Undesirable Effects ……………….. 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 time (See Warnings and Precautions). ……………….
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
…………
4.8 Undesirable Effects
………………..
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 time (See Warnings and Precautions).
……………….
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
500mg amoxicillin per vial.
The amoxicillin is present as the sodium salt in ‘Amoxil’ injection.
For a full list of excipients, see section 6 .1.
4.4 Special warnings and special precautions for use
6.2 Incompatibilities
‘Amoxil’ should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions.
If ‘Amoxil’ is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3 and 6.6.
6.3 Shelf life
Unopened: 18 months (reconstitution: see below) 2 Years
Reconstituted:
When prepared for intramuscular or direct intravenous injection, ‘Amoxil’ should be administered immediately after reconstitution. Infusions should be administered over a period of one-half to one hour although ‘Amoxil’ maintains a satisfactory degree of activity at room temperature in various infusion fluids as follows:
Intravenous Fluids Stability Time
Sodium Chloride Injection (Normal saline) 6 hours
Compound Sodium Chloride Injection (Ringer`s solution) 6 hours
Sodium Lactate Injection 3 hours
Compound Sodium Lactate Injection (Hartmann`s solution) 3 hours
Dextrose Injection (5%) 1 hour
Sodium Chloride and (4%) Dextrose Injection 1 hour
Amoxicillin is less stable in infusions containing carbohydrate. Reconstituted solutions of amoxicillin may be injected into the drip tubing over a period of one-half to one hour.
Any residual antibiotic solution should be discarded.
Amoxicillin vials are not suitable for multi-dose use.
6.4 Special precautions for storage
Do not store above 250C.
For reconstituted product, see section 6.3.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Instructions for use/handling
Preparation of Injections
500mg Vial For IM use, add 2.5ml Water for Injections BP and shake vigorously.
For IV use, dissolve contents in 10 ml Water for Injections BP.
For other routes: A 500mg adult dose may be prepared as follows:
Intraperitoneal: Dissolve in 10 ml Water for Injections BP.
Intrapleural: Dissolve in 5-10 ml Water for Injections BP.
Intra-articular: Dissolve in up to 5ml Water for Injections BP 0.5% procaine
hydrochloride, or a sterile 1% solution of lignocaine hydrochloride.
A transient pink coloration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour.
4.5 Interaction with other medicinal products and other forms of interaction
Probenecid decreases the renal tubular excretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives
4.8: Undesirable effects
Infections and Infestations
Very rare:Mucocutaneous candidiasis
Gastrointestinal disorders
#Common: Diarrhoea and nausea.
#Uncommon: Vomiting.
Black hairy tongue