amoxicillin + clavulanic acid


Laboratorio Reig Jofre


Full Prescribing Info
Co-amoxiclav (amoxicillin and clavulanic acid).
Each vial contains 1000 mg amoxicillin (as amoxicillin sodium) and 200 mg clavulanic acid (as potassium clavulanate).
SALACLAV is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins" that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.
SALACLAV is used in adults and children to treat the following infections: Severe ear, nose and throat infections; Respiratory tract infections; Urinary tract infections; Skin and soft tissue infections including dental infections; Bone and joint infections; Intra-abdominal infections; Genital organ infections in women.
SALACLAV is used in adults and children to prevent infections associated with major surgical procedures.
Dosage/Direction for Use
The patient should never self-administer this medicine. A qualified person, like a doctor or nurse, will administer this medicine. The usual doses are: Adults, and children weighing 40 kg and over: Standard dose: 1000 mg/200 mg every 8 hours.
To stop infections during and after surgery: 1000 mg/200 mg before the surgery when the patient is given the anaesthetic. The dose can differ depending on the type of operation the patient is having. The doctor may repeat the dose if the surgery takes longer than 1 hour.
Children weighing less than 40 kg: All doses are worked out depending on the child's bodyweight in kilograms.
Children aged 3 months and over: 25 mg/5 mg for each kilogram of bodyweight every 8 hours.
Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg for each kilogram of bodyweight every 12 hours.
Patients with kidney and liver problems: If the patient has kidney problems they may be given a different dose. A different strength or a different medicine may be chosen by the doctor.
If the patient has liver problems the doctor will keep a close check on them and the patient may have more regular liver function tests.
How SALACLAV will be given to the patient: SALACLAV will be given as an injection into a vein or by intravenous infusion.
Make sure the patient drinks plenty of fluids while taking this medicine.
The patient will not normally be given SALACLAV for longer than 2 weeks without the doctor reviewing the treatment.
If the patient takes more SALACLAV than they should: It is unlikely the patient will be given too much, but if the patient thinks too much SALACLAV has been given, the doctor or nurse should be told immediately. Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.
If there are any further questions on the use of SALACLAV, ask the doctor or nurse.
Do not take SALACLAV: If allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in Description).
If patient has had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck.
If patient has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take SALACLAV if any of the previously mentioned applies. If unsure, talk to the doctor or nurse before having this medicine.
Special Precautions
Talk to the doctor or nurse before taking SALACLAV: If glandular fever is present; If being treated for liver or kidney problems; If not passing water regularly.
If unsure, if any of the previously mentioned applies, talk to the doctor or nurse before taking SALACLAV. In some cases, the doctor may investigate the type of bacteria that is causing the infection. Depending on the results, the patient may be given a different strength of SALACLAV or a different medicine.
Conditions the patient needs to look out for: SALACLAV can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. The patient must look out for certain symptoms while they are given this medicine, to reduce the risk of any problems. See Conditions the patient needs to look out for under Side Effects.
Blood and urine tests: If having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that SALACLAV is being given. This is because SALACLAV can affect the results of these types of tests.
Use In Pregnancy & Lactation
If patient is pregnant or breast-feeding, thinks they may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.
Side Effects
Like all medicines, SALACLAV can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Conditions the patient need to look out for: Allergic reactions: Skin rash; Inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body; Fever, joint pain, swollen glands in the neck, armpit or groin; Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing; Collapse.
Contact a doctor immediately if any of these symptoms appears. Stop taking SALACLAV.
Inflammation of large intestine: Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
Contact the doctor as soon as possible for advice if any of these symptoms appears.
Common side effects (may affect up to 1 in 10 people): Thrush (candida - a yeast infection of the vagina, mouth or skin folds); Diarrhoea.
Uncommon side effects (may affect up to 1 in 100 people): Skin rash, itching; Raised itchy rash (hives); Feeling sick (nausea), especially when taking high doses (if affected take SALACLAV before food); Vomiting; Indigestion; Dizziness; Headache.
Uncommon side effects that may show up in the blood tests: Increase in some substances (enzymes) produced by the liver.
Rare side effects (may affect up to 1 in 1000 people): Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme).
If any of these symptoms appears contact the doctor urgently: Swelling and redness along a vein which is extremely tender when touched.
Rare side effects that may show up in the blood tests: Low number of cells involved in blood clotting; Low number of white blood cells.
Other side effects: Other side effects have occurred in a very small number of people but their exact frequency is unknown: Allergic reactions (see as previously mentioned).
Inflammation of the large intestine (see as previously mentioned).
Serious skin reactions: A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).
Widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis).
A red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).
Contact a doctor immediately if any of these symptoms is present: Inflammation of the liver (hepatitis); Jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make the skin and whites of the eyes appear yellow; Inflammation of tubes in the kidney; Blood takes longer to clot; Convulsions (in people taking high doses of SALACLAV or who have kidney problems).
Side effects that may show up in the blood or urine tests: Severe reduction in the number of white blood cells; Low number of red blood cells (haemolytic anaemia); Crystals in urine.
If any side effects are present or if any of the side effects become severe or troublesome, talk to the doctor or nurse. This includes any side effects not listed in this monograph.
Drug Interactions
Tell the doctor if taking, have recently taken or might take any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.
If the patient is taking allopurinol (used for gout) with SALACLAV, it may be more likely that the patient will have an allergic skin reaction.
If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of SALACLAV.
If medicines to help stop blood clots (such as warfarin) are taken with SALACLAV then extra blood tests may be needed.
SALACLAV can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Caution For Usage
SALACLAV is for use in hospital only. The doctor, pharmacist or nurse will prepare the medicine. It should be used within at least 5 minutes after reconstitution.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
The following information is intended for healthcare professionals only: Instructions for use: SALACLAV is intended for intravenous use.
Reconstitution and dilution: Preparation of solution for intravenous injection: Water for injection is the normal solvent. SALACLAV should be dissolved in 10 ml of solvent. SALACLAV is stable during 5 minutes at least, then it is recommended to administer it after reconstitution.
Preparation of solution for intravenous infusion: SALACLAV should be reconstituted as described previously for injection. Without delay the reconstituted solution should be added to 50 ml of water for injection or 50 ml sodium chloride 9 mg/ml (0.9%) solution using a mini-bag or in-line burette.
Incompatibilities: SALACLAV should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates or with intravenous lipid emulsions.
If SALACLAV 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 Instructions for use: Reconstitution and dilution.
Store below 30°C.
Store in the original package in order to protect from light and moisture.
Shelf-life: Prior to reconstitution: 3 years.
After reconstitution: Chemical and physical in-use stability has been demonstrated for 4 hours at 4°C when reconstituted with 50 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C and for 4 hours at 4°C when reconstituted with 50 ml water for injection.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Powd for soln for inj (vial) (white or almost white) 1 x 10's.
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