MOXIRENZ CV Tablet / Dry Syrup

Moxirenz is an antibiotic useful for the treatment of a number of bacterial infections . It is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor. This combination results in an antibiotic with an increased spectrum of action and restored efficacy against amoxicillin-resistant bacteria that produce β-lactamase. Side effects include an increased risk of yeast infections and diarrhea. It is on the World Health Organization's List of Essential Medicines, a list of the most important medications needed in a basic health system.

For Doctors


Moxirenz-625 Tablet

 Each Tablet contains:

 Amoxicillin Trihydrate     ……………………………………… 500 mg

 Clavulanic acid (as potassium clavulanate) ………………. 125 mg

Moxirenz-228.5 Dry syrup

 Each Dry syrup contains:

 Amoxicillin Trihydrate       ……………………………………….200 mg

 Clavulanic acid (as potassium clavulanate) ……………….. 28.5 mg

Mechanism of Action
Detail "

Amoxicillin binds to penicillin-binding proteins, thus inhibiting final transpeptidation step of peptidoglycan synthesis in bacterial cell walls; addition of clavulanate inhibits beta-lactamase-producing bacteria, allowing amoxicillin extended spectrum of action

It is a semisynthetic antibiotic with a broad spectrum of bactericidal activity, covering both gram-negative and gram-positive microorganisms

Not effective against Mycoplasma and Legionella spp


Peak plasma time: 2 hr (amoxicillin); 1.1 hr (clavulanic acid)

Peak concentration: 8-22 mcg/mL (amoxicillin); 0.8-2.6 mcg/mL (clavulanic acid)

AUC: 40-80 mcg•hr/mL (amoxicillin); 2-6 mcg•hr/mL (clavulanic acid)


Protein bound: 18% (amoxicillin); 25% (clavulanic acid)

Widely distributed (except CNS)


Partially metabolized by liver



  • Amoxicillin: 3.7 hr (full-term neonates); 1-2 hr (infants and children); 0.7-1.4 hr (adults)
  • Clavulanic acid: 0.8-1.4 hr

Excretion: Urine, unchanged; 50-70% (amoxicillin), 25-40% (clavulanic acid)


Moxirenz is widely used to treat or prevent many infections caused by susceptible bacteria, such as:

  • urinary tract infections
  • respiratory tract infections
  • skin and soft tissue infections
  • sinus infections
  • cat scratches
  • infections caused by the bacterial flora of the mouth, such as:
    • dental infections
    • infected animal bites
    • infected human bites (including uncomplicated "clenched-fist" or "reverse-bite" injuries)
Dosages & Administration

Adult -Paediatric

Dosing Forms & Strengths
Lower Respiratory Tract Infection

β-lactamase−producing strains of Haemophilus influenzae and Moraxella catarrhalis

Mild to moderate: 500/125 mg PO q12hr or 250/125 mg PO q8hr for 10 days

Severe: 875/125 mg PO q12hr or 500/125 mg PO q8hr or 2000 mg (2 extended-release tabs) PO q12hr for 7-10 days

Acute Bacterial Sinusitis

β-lactamase−producing strains of H influenzae and M catarrhalis

2000 mg (2 extended-release tablets) PO q12hr for 10 days

Animal/Human Bite Wounds

875 mg PO q12hr or 500 mg PO q8hr for 3-5 days


875 mg PO q12hr or 500 mg PO q8hr for 7-10 days


β-lactamase−producing strains of Escherichia coli, Klebsiella spp, and Enterobacter spp

875 mg PO q12hr or 500 mg PO q8hr

Skin Abscess

β-lactamase−producing strains of Staphylococcus aureus, E coli, and Klebsiella spp

875 mg PO q12hr

Diabetic Foot

Mild to moderate, localized cellulitis

875 mg PO q12hr or 500 mg PO q8hr

Dosing Modifications

Renal impairment

  • CrCl <30 mL/min: Do not use 875/125 mg tablet or extended-release tablets
  • CrCl 10-30 mL/min: 250-500/125 mg PO q12hr
  • CrCl <10 mL/min: 250-500/125 mg PO q24hr
  • Hemodialysis: 250-500/125 mg PO q24hr; administer additional dose both during and at end of dialysis

Hepatic impairment

  • Dose with caution; monitor hepatic function regularly

Take with meals to avoid GI upset

Take suspension at start of meal to enhance absorption

Dysphagia: May substitute 250 mg/5 mL suspension for 500/125 mg tablet; may substitute 200 mg/5 mL or 400 mg/5 mL suspension for 875/125 mg tablet

Dosing Forms & Strengths

<40 kg

  • Dosages based on amoxicillin

<3 months old

  • 30 mg/kg/day PO (125 mg/5 mL or chewable tablets) divided q12hr

>3 months old

  • Less severe infections: 20 mg/kg/day PO (125 mg/5 mL or 250 mg/5 mL) divided q8hr or 25 mg/kg/day PO (200 mg or 400 mg chewable tablets; 200 mg/5 mL or 400 mg/5 mL) divided q12hr
  • Severe infections, lower respiratory tract infections, sinusitis, otitis media: 40 mg/kg/day PO (125 mg/5 mL or 250 mg/5 mL) divided q8hr or 45 mg/kg/day PO (200 mg or 400 mg chewable tablets; 200 mg/5 mL or 400 mg/5 mL) divided q12hr

Acute otitis media

  • S pneumoniae, nontypeable H influenzae, M catarrhalis
  • 80-90 mg/kg/day PO divided q12hr for 10 days (may be 5-7 days for children >6 years old with mild-to-moderate disease)
>40 kg

Dose according to adult recommendations

Dosing Considerations

Because of the different amoxicillin-to-clavulanate ratios in the 250-mg tablet (amoxicillin 250 mg, clavulanate125 mg) and the 250-mg chewable tablet (amoxicillin 250 mg, clavulanate 62.5 mg), the 250-mg tablet should not be used if the pediatric patient weighs <40 kg

Safety and efficacy of extended-release tablets in children <16 years old have not been established

Adverse Drug Reaction

Very common: More than 1 in 10 people who take Amoxicillin trihydrate/Potassium clavulanate

  • diarrhoea - seek immediate medical advice if you get diarrhoea during treatment or shortly after you have stopped taking Amoxicillin trihydrate/Potassium clavulanate

Common: More than 1 in 100 people who take Amoxicillin trihydrate/Potassium clavulanate

  • gastrointestinal effects such as nausea, vomiting - these can be reduced by taking Amoxicillin trihydrate/Potassium clavulanate at the start of a meal
  • skin, nails and mucous membranes infection

Uncommon: More than 1 in 1000 people who take Amoxicillin trihydrate/Potassium clavulanate

  • abnormal laboratory test results
  • feeling dizzy
  • headaches
  • indigestion
  • skin reactions such as skin rashes, urticaria, and itching - seek immediate medical advice if you get any skin reaction

Rare: More than 1 in 10,000 people who take Amoxicillin trihydrate/Potassium clavulanate

  • blood and bone marrow problems
  • erythema multiforme - seek immediate medical advice if you get a skin hypersensitivity reaction

The frequency of these side-effects is unknown

  • black hairy tongue
  • changes in blood clotting time
  • colitis - seek immediate medical advice if you get diarrhoea when taking Amoxicillin trihydrate/Potassium clavulanate or shortly after you have stopped taking it
  • convulsions - convulsions have been reported in people who have received high doses of Amoxicillin trihydrate/Potassium clavulanate or in people with kidney problems
  • hyperactivity
  • hypersensitivity reactions including angioedema, anaphylaxis, and vasculitis - some of these hypersensitivity reactions may be fatal. Stop taking Amoxicillin trihydrate/Potassium clavulanate and seek immediate medical advice if you get an allergic reaction
  • kidney problems
  • liver problems including jaundice - some of these liver problems may be fatal and may happen after you have stopped taking Amoxicillin trihydrate/Potassium clavulanate
  • may affect the results for certain tests
  • meningitis or meningitis-like symptoms
  • overgrowth of micro-organisms that are not affected by Amoxicillin trihydrate/Potassium clavulanate
  • skin problems such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and pustular drug eruption - stop taking Amoxicillin trihydrate/Potassium clavulanate and seek immediate medical advice if you have erythema with fever, fluid-filled blisters or any skin hypersensitivity reaction
  • urinary problems
Drug Interaction

Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with AUGMENTIN may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.

Oral Anticoagulants

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with AUGMENTIN. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.


The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

Oral Contraceptives

AUGMENTIN may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.


Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins) More over Amoxicillin and clavulanate potassium tablets are also contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.

Warning & Precaution

Allergy to cephalosporins, carbapenems

Different tablets are not interchangeable, because ratios of amoxicillin to clavulanate are different

Extended release tablets not for use in renal impairment (CrCl <30 mL/min)

Incidence of diarrhea is higher than with amoxicillin alone

Unknown safety and efficacy of extended-release tablets in patients <16 years old

Risk of Clostridium difficile-associated diarrhea (CDAD); consider in patients who present with diarrhea after antibiotic use; CDAD has been known to occur over 2 months after antibiotic therapy; if suspected, discontinue drug immediately and administer appropriate fluid/electrolyte therapy, protein supplementation, and C difficile antibiotic treatment

Risk of bacterial or fungal superinfections; if suspected, discontinue drug immediately and administer appropriate therapy

High percentage of patients with mononucleosis reported to develop rash during therapy; ampicillin-class antibiotics not recommended in these patients

Use caution in hepatic impairment; hypatic dysfunction (rare) is more common in elderly and/or males and prolonged therapy may increase risk; may occur after completing therapy

Pregnancy & Lactation

Pregnancy category: B

Lactation: Drug excreted in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

For Patients
Name of drug

Moxirenz CV-625mg, Moxirenz CV-228.5mg

Moxirenz CV (Co-amoxiclav) contains two medicines: amoxicillin, which is an antibiotic, and clavulanic acid, which helps the amoxicillin to work better.

What is co-amoxiclav?

Moxirenz CV (Co-amoxiclav) is an antibiotic in a group of drugs called penicillins.Moxirenz CV (Co-amoxiclav) fights bacteria in the body.

Moxirenz CV (Co-amoxiclav) is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.

Moxirenz CV (Co-amoxiclav) may also be used for purposes other than those listed in this medication guide.

What is Moxirenz CV (co-amoxiclav) available as?

·         Tablets: Amoxicillin/500 mg and  Clavulanic acid 125 mg

·         Liquid medicine: 200/28.5 mg (200 mg amoxicillin/28.5 mg clavulanic acid / 5 mL)

When should I give Moxirenz CV (co-amoxiclav)?

Moxirenz CV (Co-amoxiclav) is usually given three times a day. This should be first thing in the morning, early afternoon (or after school) and at bedtime. Ideally.

Give the medicine at about the same times each day so that this becomes part of your child’s daily routine, which will help you to remember.

Why is it important for my child to take this medicine?

It is important that your child takes this medicine in the way that your doctor has told you to so that it kills the harmful bacteria and gets rid of their infection.

How much should I give?

Your doctor will work out the amount of Moxirenz CV (co-amoxiclav-the dose) that is right for your child. The dose will be shown on the medicine label.

It is important that you follow your doctor’s instructions about how much to give.

How should I give it?

This medicine works best when the stomach is empty, so try to give it to your child ½–1 hour before they eat. However, if your child has an upset stomach, you can give it with a small amount of food.

Tablets should be swallowed with a glass of water, milk or juice. Your child should not chew the tablets.

Liquid medicine: Mix the distill water on given level mark and shake the medicine well. Measure out the right amount using an oral syringe or a medicine spoon. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.

When should the medicine start working?

Your child should start to get better after taking the medicine for 2 days. It is important that they take the whole course of the medicine that has been prescribed. Do not stop early.

What if my child is sick (vomits)?

·         If your child is sick less than 30 minutes after having a dose of Moxirenz CV (co-amoxiclav) give them the same dose again.

·         If your child is sick more than 30 minutes after having a dose of Moxirenz CV (co-amoxiclav), you do not need to give them another dose. Wait until the next normal dose.

If your child is sick again, seek advice from your GP, pharmacist or hospital. They will decide what to do based on your child’s condition and the specific medicine involved.

What if I forget to give it?

·         If you remember up to 1 hour after you should have given a dose, give the missed dose.

·         If you remember after this time, do not give the missed dose. Wait until the next normal dose.

·         If you forget to give the dose before your child has eaten, but remember during the meal, give them the dose straight after finishing the meal.

What if I give too much?

You are unlikely to do any harm if you give an extra dose of Moxirenz CV (co-amoxiclav) by mistake.

If you are concerned that you may have given your child too much Moxirenz CV (co-amoxiclav), contact your doctor or take your child to hospital. Have the medicine container or packet with you if you telephone for advice.

Are there any possible side-effects if yes what are they?

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side-effects). 

Moxirenz CV (Co-amoxiclav) is generally a safe drug. However, it sometimes has serious side effects. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have diarrhea that is severe or lasts longer than 3 days, or if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Keep taking the medication and talk with your doctor if you have any of these less serious side effects:

·         mild diarrhea, gas, stomach pain;

·         nausea or vomiting;

·         headache;

·         skin rash or itching;

·         white patches in your mouth or throat; or

·         vaginal yeast infection (itching or discharge).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Can other medicines be given at the same time as Moxirenz CV (co-amoxiclav)?

·         You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.

·         Moxirenz CV (Co-amoxiclav) should not be taken with some common drugs that you get on prescription. If your child is taking any other medicines, tell your doctor and pharmacist.

·         Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal or complementary medicines.

What other drugs will affect Moxirenz CV (co-amoxiclav)?

Before taking Moxirenz CV (co-amoxiclav), tell your doctor if you are using any of the following drugs:

·         allopurinol (Zyloprim);

·         probenecid (Benemid); or

·         another antibiotic (for the same or for a different infection).

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Amoxicillin and clavulanate overdose may include nausea, vomiting, stomach pain, skin rash, drowsiness, or hyperactivity.

What should I avoid?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Is there anything else I need to know about Moxirenz CV (co-amoxiclav)?

Moxirenz CV (Co-amoxiclav) contains amoxicillin, which is a type of antibiotic called penicillin. Your child should not have amoxicillin if they are allergic to any penicillin antibiotic. Make sure you tell your doctor if your child has ever shown any signs of penicillin allergy.

Important things to know about taking antibiotics

·         It is important that your child completes the course of antibiotic. This means that they must take the medicine for the number of days that the doctor has told you to, or until all of the medicine has been taken. If you stop giving the antibiotic too soon, the bacteria that are left will start to multiply again, and may cause another infection. There is also a risk that these bacteria will be ‘resistant’ to the first antibiotic. This means that it might not work next time, and your child might need a different antibiotic.

·         Children are sometimes sick (vomit) or get diarrhoea when taking antibiotics. Encourage them to drink water to replace the fluid they have lost.

·         Do not give your child any medicine to stop the diarrhoea unless your doctor has told you to, as this can make things worse.

·         Try to give the medicine at about the same times each day, to help you remember, and to make sure that there is the right amount of medicine in your child’s body to kill the bacteria.

·         Only give this medicine to your child for their current infection.

·         Never save medicine for future illnesses. Give old or unused antibiotics to your pharmacist to dispose of. 

·         Only give the antibiotic to the child for whom it was prescribed. Never give it to anyone else, even if their condition appears to be the same, as this could do harm.

If you think someone else may have taken the medicine by accident, contact your doctor for advice.

·         Antibiotics only kill bacteria; they do not kill viruses. This means that they do not work against colds, sore throats, flu or other infections that are caused by viruses. Your doctor will not prescribe antibiotics for these illnesses.

Store the tablets at room temperature away from moisture and heat. Store the liquid form of this medicine in the refrigerator. Throw away any unused liquid after 10 days.

Where should I keep this medicine?

·         Keep this medicine in a cupboard, away from heat and direct sunlight. It does not need to be kept in the fridge.

·         Make sure that children cannot see or reach the medicine.

·         Keep the medicine in the container it came in.

What should I discuss with my healthcare provider before taking Co-amoxiclav?

If you have ever had an allergic reaction to penicillin or to a cephalosporin, you may also be allergic to Moxirenz CV (Co-amoxiclav). Tell your doctor about any past drug allergies.

Before taking Co-amoxiclav, tell your doctor if you have:

·         liver disease (or a history of hepatitis or jaundice);

·         kidney disease; or

·         mononucleosis.

If you have any of these conditions, you may not be able to use Moxirenz CV (Co-amoxiclav), or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Amoxicillin and clavulanate can pass into breast milk and may cause a yeast infection, diarrhea, or allergic reaction in a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Who to contact for more information

Your child’s doctor, pharmacist or nurse will be able to give you more information about Moxirenz CV (co-amoxiclav) and about other medicines used to treat infections.