Augmentin 625

Therapeutic Indications

Augmentin 625 is an antibiotic capsule containing amoxicillin and clavulanic acid. It is used in the treatment and management of infections of the skin, urinary tract, and respiratory system. Amoxicillin is a penicillin-like antibiotic and clavulanic acid extends the anti-bacterial effects of amoxicillin. Augmentin 625 is used in the treatment and management of the following conditions:

• Throat infection such as pharyngitis and tonsillitis
• Nose infection (acute sinusitis)
• Ear infection such as otitis media
• Urinary Tract Infection(UTI)
• Dental abscess
• Lower respiratory tract infection such as pneumonia, chronic bronchitis
• Typhoid
• Gonorrhoea
• Stomach ulcers
• Cystitis
• Infections of the skin and soft tissues like cellulitis, impetigo
• Infections of joints and bones such as osteomyelitis
• Pyelonephritis
• Febrile neutropenia
• Acne
• Diverticulitis
• Endocarditis

Do I need a prescription?

Augmentin 625 can be bought from pharmacies close to you and from online drug stores. A doctor’s prescription is mandatory for buying it.

Dosage

The dosage prescribed by the doctor for Augmentin 625 depends on the condition being treated, its severity, other underlying conditions such as weight, age, and kidney function. The duration for treatment depends on how you respond to the medication but should not extend to more than two weeks. The recommended dosage for Augmentin 625 is:

• Adult dose (40 kg and above):500 mg/ 125 mg tablet taken three times a day (after eight hours)
• Pediatric dose (above 40 kg):Use the adult dose of 500 mg/125 mg three times a day
• Children less than 40 kg: 20 mg/5 m/ kg/day to 60 mg/15mg/kg/day. The dose should be divided three times to be given after eight hours.
• Renal impairment:The dose is adjusted if the creatinine clearance is less than 30ml/min.
• Adults and children (40 kg and above): Creatinine clearance of 10-30 ml/min: 500 mg/125 mg two times a day. Creatinine clearance of less than 10 ml/min: 500 mg/125 mg once a day
• Hemodialysis: 500 mg/125 mg once a day in addition to 500 mg/125 mg as dialysis is done that is repeated at the end as concentrations in serum reduce

Children less than 40 kg

Creatinine clearance of 10-30 ml/min: 15 mg/3.75 mg/kg two times a day

Creatinine clearance of less than 10 ml/min: 15 mg/3.75 mg/kg once a day.

Hemodialysis: 15 mg/3.75 mg/kg once a day should be given as dialysis occurs and repeated at the end.

The first number is the amount of amoxicillin and the second that of clavulanic acid.

Chemical composition

Augmentin 625 contains tow active ingredients. These are:

• 500 mg amoxicillin
• 125 mg clavulanic acid as potassium clavulanate

Mechanism of Action (MOA)

Amoxicillin is a penicillin that is semi-synthetic or a beta-lactam. It works by inhibiting the action of one or more enzymes known as the penicillin-binding proteins(PBPs). These enzymes are involved in the synthesis of bacterial peptidoglycan a component of the bacterial cell wall. When taken orally, amoxicillin prevents the formation of peptidoglycan preventing the formation of the cell wall. This leads to the formation of a weakened cell wall, causing the bacteria to lyse and die eventually.

Resistant bacteria to amoxicillin produce beta-lactamases that degrade it preventing it from being effective. Such bacteria are not susceptible to amoxicillin. To ensure that the effect of amoxicillin remains, clavulanic acid is added.

Clavulanic acid a beta-lactam has a structure related to that of penicillin. Clavulanic acid inactivates the enzymes, beta-lactamases, as a result, the action of amoxicillin is enhanced. Clavulanic acid does not have anti-bacterial effects when taken alone.

Facts on Augmentin

• When taken orally, the effects of Augmentin 625 can be felt after 1-2 hours and last for 1.5 – 2 hours.
• Augmentin 625 is frequently prescribed for two times a day.
• Augmentin 625 is a broad spectrum antibiotic.
• The maximum dose for Augmentin per kilogram of the body weight should not exceed 1200 mg in a day.
• When used for long durations, Augmentin 625 may cause the overgrowth of organisms that are non-susceptible like the yeast.
• Alterations in Penicillin Binding Proteins (PBPs) can result in resistance agaisnts Augmentin 625.

Contraindications

The use of Augmentin 625 is not recommended in a number of conditions. This is because it could lead to the conditions worsening or the occurrence of adverse reactions. Inform your doctor if you have any of the following conditions as they could affect the prescription. The conditions include:

• Hypersensitivity: If you are allergic to penicillin, beta-lactamase or the active ingredients of Augmentin 625.
• Liver disease and jaundice.
• Kidney disease
• Viral infection( infectious mononucleosis)
• Cholestasis
• Pregnant or planning to be pregnant.
• Breastfeeding.
• Phenylketonuria. The tablets might have aspartame that has phenylalanine.
• Asthma
• Ulcerative colitis
• Acute lymphoblastic leukaemia (ALL)
• HIV/AIDS
• Decreased output of urine.

Side effects

Augmentin 625 might cause some undesirable effects apart from the desired effects.  The side effects do not occur in everyone. The side effects can be common and less serious in some. Immediately consult your doctor any side effects you experience especially if they tend to persist for a longer time. Common side effects of Augmentin 625 include:

• Nausea
• Vomiting
• Diarrhea
• Rashes
• Vaginal yeast infection
• Oral thrush
• Stomach ache
• Headache
• Indigestion
• Dizziness
• Tooth discolouration, yellowing in children
• Muscle pain
• Joint pain
• Sleeplessness
• Heavy menstrual bleeding
• Altered taste
• Agitation
• Loss of appetite
• Weakness
• Confusion

Serious side effects include

• Reduction in platelets and white blood cells
• Vomiting and nausea that is persistent.
• Urine that is dark
• Easy bruising and bleeding
• Unusual tiredness
• Convulsions
• Intercourse being painful
• Black stool
• Yellowing of skin and eyes
• Severe pain in the abdomen or stomach
• Signs of a new infection such as a fever and  persistent sore throat
• Clostridium difficile-associated diarrhoea signs such as diarrhoea that is persistent, stomach cramping and bloody stool.
• Hairy or black tongue

If you suffer an allergic reaction to Augmentin 625, immediately inform your doctor and rush to the nearest emergency centre. Signs for allergicreactions include difficulty breathing, rashes, dizziness that is severe, swelling of face,throat, hands and legs, blood vessels inflammation( vasculitis).

You can reduce on the side effects such as nausea, vomiting and thrush by having good mouth care routine, taking several small meals, sucking hard sugar free candy, taking yoghurt and probiotics.

If an overdose is taken accidentally, immediately inform your doctor to be advised on what to do. If you experience severe reactions rush into the nearest hospital’s emergency centre. Carry the drug package with you for identification.An overdose of Augmentin 625 can manifest the following symptoms; skin rash that is severe, changes in behaviour, convulsions, stomach pain, dizziness, vomiting, nausea and damage to the kidney.

Drug interactions

Taking more than two drugs at the same times may result in the drugs interacting. Drug interactions may reduce the effectiveness of the medication you are taking or increase the likelihood of severe reactions.Tell your doctor of all medications you are using, both prescription drugs and over the counter drugs, dietary supplements and herbal preparations. Augmentin 625 interacts with the following drugs and products:

• Doxycycline
• Methotrexate. Augmentin 625 lowers its clearance from the body increasing occurrence of adverse effects.
• Anticoagulants such as warfarin. When used together with Augmentin can cause an increase in their anticoagulant effect.
• Ethinyl Estradiol( Oral contraceptive pills)
• Urine sugar test. Augmentin 625 may result in a false positive test. Inform your laboratory specialist before taking the test.
• Liver function test and red blood cell status test
• Alcohol. When used concomitantly it might result in increased dizziness or drowsiness and liver problems.
• Allopurinol. Increase the chances of skin rashes.
• Exenatide
• Chloroquine
• Magnesium citrate
• Omeprazole, esomeprazole and rabeprazole (Proton Pump Inhibitors(PPIs))
• Tramadol
• Mycophenolate mofetil
• Bupropion
• Grape juice
• Live vaccines ( typhoid vaccine)
• Probenecid

What to do if you skip a dose

Take the skipped dose immediately you realize it. If it is close to your next dose, you can skip it and take the next dose as scheduled and continue with the normal schedule. Do not double the dose to compensate for the skipped dose. When you skip doses, it lowers the effectiveness of the medication. To avoid missing doses, set a reminder or have a family member remind you when it is time for the next dose. You can also talk to your doctor for a more convenient schedule of the drug.

Precautions

A number of precautions should be considered while you use Augmentin 625. The precautions include:

• Allergic reaction. Do not take Augmentin 625 if you have allergic reactions to penicillin, cephalosporin or the active ingredients.
• Inform your doctor of any drugs and products you are using to prevent the chances of drug interactions.
• Inform your doctor of any conditions you have to lower on adverse effects such as kidney diseases or liver diseases.
• Augmentin 625 lowers the effectiveness of oral contraceptive pills thus advisable to abstain from sexual intercourse or use barrier methods to prevent conception.
• To avoid stomach upset, Augmentin 625 should be taken with meals or after a meal.
• Always check the package when buying Augmentin 625 for expiry date. Expired medications have reduced effectiveness.
• Augmentin 625 should be stored at room temperature away from moisture.
• Augmentin 625 may cause dizziness or drowsiness. In such a case, do not engage in operations that require full alertness like driving or operation of heavy machinery.
• Augmentin 625 should not be used for a period longer than two weeks.
• Do not stop using the drug once you feel relieved. Complete the full course of medication to avoid development of drug resistance.
• Augmentin 625 is secreted in breast milk and should be used when the benefits outweigh the risks.
• Augmentin 625 should be used in pregnancy when the benefits outweigh the risks. Although there is no conclusive evidence of its effects on the growing fetus.
• Do not have vaccinations while using Augmentin 625 as it lowers their effectiveness.
• Augmentin 625 should be taken with a lot of water or liquid

Different brands and manufacturing companies of the drug.

Augmentin 625 is manufactured by:

• Glaxo SmithKline Beecham Pharmaceuticals
• Dr Reddy’s Laboratories Ltd

Augmentin is also manufactured with different strengths. Augmentin is manufactured as immediate-release tablets, extended-release tablets and liquid suspension. Immediate release tablets contain the same amount of clavulanic acid. Different strengths of Augmentin include:

• Immediate release tablets: 250 mg/125 mg, 875 mg/125 mg
• Extended-release tablets( Augmentin XR): 1000 mg/62.5 mg
• Suspension: 125 mg/31.25 mg in 5 ml, 250 mg/62.5 mg in 5 ml.

It is also sold under the generic name amoxicillin/clavulanate potassium.

Substitute drugs

Other drugs that can be used in place of Augmentin 625 with the same strength and composition include:

• Axcve 625 mg tablet – Axis Labs Pvt Ltd
• Acuclav 625 tablet – Macleods Pharmaceuticals Pvt Ltd
• Clamross CV 625 Duo tablet – Emami  Frank Ross Ltd
• Penom Clav 500mg/125 mg tablet – Apostle Remedies
• Symbiotic XI Plus 500mg/125 mg tablet – Cadila Pharmaceuticals Ltd
• Kilban Tablet – Profess Health Products P Ltd.
• Augmed 625 tablet – German Remedies
• Clear All 625 mg tablet – UHC Life sciences
• Clavullin 625 tablet – MHS Pharmaceuticals
• Duet 625 mg tablet –Lupin Ltd
• Bactoclav 625 tablet – Micro Labs Limited

References

1. https://www.ncbi.nlm.nih.gov/pubmed/1444674
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s051lbl.pdf
4. https://www.researchgate.net/publication/8917878_AugmentinR_amoxicillinclavulanate_in_the_treatment_of_community-acquired_respiratory_tract_infection_A_review_of_the_continuing_development_of_an_antimicrobial_agent