Co-amoxiclav, Amoxycillin sodium 1000mg/ clavulanate potassium 200mg
Powder for solution for injection or infusion
Antibiotic, Penicillin incl. beta-lactamase inhibitors
What is the medicine prescribed for?
For short-term treatment of bacterial infections at the following sites when caused by co-amoxiclav-sensitive organisms:
- Upper respiratory tract infections (including ear, nose and throat) eg, recurrent tonsillitis, sinusitis and otitis media.
- Lower respiratory tract infections eg, acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.
- Genitourinary tract infections eg, cystitis, urethritis, pyelonephritis.
- Skin and soft tissue infections eg, bolis, abscesses, cellulitis, wound infection.
- Bone and joint infections eg, osteomyelitis.
- Other infections eg, intra-abdominal sepsis.
Augmentin IV is also indicated for prophylaxis against infection which may be associated with major surgical procedures eg, GI, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract.
Infections caused by amoxicillin-susceptible organisms are amenable to Augmentin treatment due to its amoxicillin content.
Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Augmentin-susceptible β-lactamase-producing organisms may therefore be treated with Augmentin.
Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.
How to take medication?
The suitable dosage for each patient should be prescribed by a doctor.
Method of Administration:
Augmentin may be administered either by slow IV injection over a period of 3-4 min directly into a vein or via a drip tube or by infusion over 30-40 min.
Augmentin is not suitable for IM administration.
IV Injection: The stability of Augmentin IV solution is concentration dependent, thus Augmentin IV should be used immediately upon reconstitution and given by slow IV injection over a period of 3-4 min. Augmentin IV solutions should be used within 20 min of reconstitution. Augmentin may be injected directly into a vein or via a drip tube.
IV Infusion: Alternatively, Augmentin IV may be infused in Water for Injections BP or Sodium Chloride IV injection BP (0.9% w/v). Add without delay*, 600 mg reconstituted solution to 50 mL infusion fluid or 1.2 g reconstituted solution to 100 mL infusion fluid (eg, using a minibag or in-line burette). Infuse over 30-40 min and complete within 4 hrs of reconstitution. For other appropriate infusion fluids, see Stability and Compatibility.
*Solutions should be made up to full infusion volume immediately after reconstitution. Any residual antibiotic solutions should be discarded.
Intravenous administration can cause local irritation, induration and phlebitis at the injection site.
Children aged less than 3 months should be administered Augmentin by infusion only.
If the parenteral administration of high doses is necessary, the sodium content must be taken into account in patients on a sodium restricted diet. (Each 1.2 g vial of Augmentin contains 1 mmol (39.3mg) of potassium and 2.7 mmol (62.9mg) of sodium (approximately.))
No information is available about the concurrent use of Augmentin and. alcohol. However, the ingestion of alcohol whilst being treated with some other ß-lactam antibiotics has precipitated a disulfiram (antibuse) like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with Augmentin.
Treatment of Infection:
Adults and Children >12 years ( ≥ 40 kg): Usually 1.2 g 8 hourly.
In more serious infections, increase frequency to 6-hourly intervals.
Adults: The usual dose is 1.2 g IV given at the induction of anesthesia.
Operations where there is a high risk of infection eg, colorectal surgery, may require 3, and up to 4 doses of 1.2 g IV in a 24-hr period.
These doses are usually given at 0, 8, 16 (and 24) hrs. This regimen can be continued for several days if the procedure has a significantly increased risk of infection.
Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.
Treatment of Infection:
Children < 12 years ( less than 40kg) should be dosed by body-weight
3 months-12 years: –> Usually 30mg/kg every 8 h. (In more serious infections, increase frequency to every 6 h),
0-3 months: in premature (less than 4kg) –> 30mg/kg every 12 hrs
in full-term (greater than 4kg) infants during the perinatal period, increasing to 8 hrs thereafter.
How does it work?
Amoxicillin is an acid stable aminopenicillin that is susceptible to hydrolysis by common β-lactamase enzymes.
Clavulanic acid is a β-lactam molecule that is able to inhibit many of the most commonly occurring β-lactamases such as staphylococcal penicillinases and enzymes of the TEM, OXA, SHV families (including many of the extended spectrum β-lactamases of these group). Thus, the combination of amoxicillin with clavulanic acid maintains the activity of the aminopenicillin against organisms that produce sufficient quantities of these enzymes that would otherwise render it inactive.
Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Important safety information
Changes in liver function tests have been observed in some patients receiving Augmentin.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely.
Augmentin should be avoided if infectious mononucleosis is suspected, since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving Augmentin and oral anticoagulants.
If the parenteral administration of high doses is necessary, the sodium content must be taken into account in patients on a sodium restricted diet.
Convulsions may occur in patients with impaired renal function or in those receiving high doses.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During 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.
The presence of clavulanic acid in Augmentin may cause a nonspecific binding of IgG and albumin by red cell membranes leading to a false-positive Coombs test.
If you miss a dose
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
Amoxicillin-clavulanate has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal any evidence of teratogenicity. There are no controlled data in human pregnancies. The results of a study suggest an increased risk of necrotizing enterocolitis in neonates if amoxicillin-clavulanate is given prophylactically to women with premature rupture of membranes. Amoxicillin-clavulanate should only be given during pregnancy when need has been clearly established.
Amoxicillin is excreted into human milk in small amounts and is considered compatible with breast-feeding by the American Academy of Pediatrics. Clavulanate has not been detected in human milk. Adverse effects in the nursing infant are unlikely. The manufacturer recommends caution when amoxicillin-clavulanate is administered to a nursing woman. ยาขับออกทางน้ำนมได้ แต่ไม่พบความเป็นพิษต่อทารก จึงสามารถให้นมบุตรในระหว่างที่ใช้ Co-Amoxyclav ได้ อย่างไรก็ตาม ยาอาจมีผลกระทบต่อแบคทีเรียในลำไส้ (Normal Flora) และยังอาจทำให้เกิดปฏิกิริยาการแพ้ในทารกได้ จึงควรเฝ้าระวังอาการอันไม่พึงประสงค์ที่อาจเกิดขึ้น เช่น ผื่นแพ้ยา หากพบ ให้หยุดให้นมบุตรระหว่างที่ใช้ยานี้ และต่อไปห้ามใช้ยากลุ่มนี้ในเด็ก
Possible side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Side effects may include:
Very common (≥10%)
Diarrhea (3%-34%; incidence varies upon dose and regimen used)
Dernmatologic:skin rash, urticaria. GI tract: abdominal discomfort, loose stools, nausea, vomiting. Genitourinary: vaginitis, vaginal mycosis Miscellaneous: Moniliasis
Serious ADR (<1%)
Cholestatic jaundice, Skin/Appendages: Pruritus, rarely serious skin reactions including erythema multiforme, Stevens-Johnson Syndrome and toxic epidermal necrolysis.
The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Interaction with other medication
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe.
store in a dry place below 25°C
This information is a merely a general guideline and is not a substitute for a consultation with your doctor. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.