Co-Amoxiclav (Amoxicillin And Clavulanic Acid)

What Is Amoxicillin and Clavulanic Acid?

Amoxicillin is a penicillin-type antibiotic that halts the growth of infection-causing bacteria. It’s used to treat pneumonia, as well as oral, ear, urinary tract infections, and more.

Clavulanic acid works as a supplement to amoxicillin. It protects it from being destroyed by bacteria. The acid is in the beta-lactamase inhibitor class.

Overview

Amoxicillin prevents bacteria from multiplying by making them unable to build surrounding walls. Those are essential for bacteria to be able to thrive in an organism, protected from the environment. When used alone, amoxicillin isn’t that effective since bacteria may be resistant to it. That’s where clavulanic acid comes in handy, increasing the effect.

How Supplied

The combination comes in 4 forms:

• Regular tablets.
  Taken right before a meal every 8 or 12 hours.
• Chewable tablets.
  Taken right before a meal every 8 or 12 hours. Chew them thoroughly; do not swallow while it’s still whole.
• Extended-release tablets.
  Taken with a meal or snack every 12 hours. They shouldn’t be chewed or crushed, so take a whole tablet and drink sufficient amounts of water afterward (one glass should be fine).
• Oral suspension.
  Taken right before a meal every 8 or 12 hours. Shake it well to make sure the medication is mixed.

It’s recommended to take the tablets or suspension at the same time every day to make sure you remember the next dose. You shouldn’t take more or less than prescribed by the doctor.

Take amoxicillin and clavulanic acid regularly as prescribed, even if you feel better prior to the end of the prescription. By finishing too soon or skipping doses, you risk not finishing the treatment process properly and falling ill again. Besides, bacteria may become resistant to the combination, and you’ll have to take a stronger medication with potential complications.

Indications and Uses of Amoxicillin and Clavulanic Acid

It’s crucial to know what the amoxicillin and clavulanic acid combination is used for. Before taking the medicine, you have to be sure that the infection you’re fighting was caused by bacteria treatable by Augmentin or other similar medications. Otherwise, drug-resistant bacteria might increase in quantity, making future treatment unlikely to succeed.

It’s best when the doctor has information as to the culture, but if not, local epidemiology patterns may help select the proper medication.

So, what does the combination treat?

Lower Respiratory Tract Infections

Lower respiratory tract infections damage the lungs and all parts of the respiratory apparatus below the voice box. Bronchitis and pneumonia are some of the most common ones. They are caused by isolates of Moraxella catarrhalis and Haemophilus influenzae.

Acute Bacterial Otitis Media

Acute bacterial otitis media can be a complication after allergies, a sinus infection, a cold or the flu, excess cigarette smoke exposure, etc. The condition can also be caused by isolates of Haemophilus influenzae (H. influenzae) and Moraxella catarrhalis (M. catarrhalis).

Sinusitis

Sinusitis is an inflammation, acute or chronic, in the paranasal sinuses. The condition may be a result of strong allergies, bacteria (beta-lactamase-producing isolates of H. influenzae and M. catarrhalis), fungi, and other causes.

Skin and Skin Structure Infections

Skin and skin structure infections, complicated or uncomplicated, are usually caused by beta-lactamase-producing isolates of other bacteria, such as:

• Escherichia coli;
• Staphylococcus aureus;
• Klebsiella species.

Urinary Tract Infections

Urinary tract infections, affecting ureters, urethra, bladder, or kidneys, are usually caused by isolates of:

• Klebsiella species;
• Escherichia coli;
• Enterobacter.

Limitations of Use

Clavulanic acid and amoxicillin shouldn’t be taken if, during tests, the doctor finds susceptibility to the latter.

Dosage

The dosage of amoxicillin & clavulanic acid differs, depending on the age, weight, and the dosage type of medication you buy.

Some dosage recommendations for an adult or a pediatric patient that weighs over 40 kg are:

• A 500 mg tablet every 8 to 12 hours (2-3 times a day);
• A 250 mg tablet every 8 hours (3 times a day);
• 875 mg every 12 hours (2 times a day);
• 2000 mg every 12 hours (2 times a day) for complicated conditions.

The dosage is based solely on the amount of amoxicillin needed to fight the infection.

If a pediatric patient weighs less than 40 kg, the recommended dosage will fall somewhere between 20-45 mg per kilogram 2-3 times a day.

To avoid amoxicillin and clavulanic acid side effects like stomach upset, take your doses with food, and make sure you don’t take more than one tablet. Excess clavulanic acid might cause stomach upset as well. Also, keep in mind that:

• Both 250 mg and 500 mg tablets have the same amount of acid, so it’s unwise to take two 250 mg tablets if the prescription says to take one 500 mg;
• You should not substitute regular tablets for chewable ones.

Side Effects

Amoxicillin & clavulanic acid side effects are plenty. Here are some of the most common ones:

• Abdominal discomfort;
• Diarrhea;
• Excess gassing;
• Bloating;
• Heartburn;
• Nausea and vomiting;

All the side effects can be divided into two categories: those requiring immediate medical attention and those not requiring it.

Side effects requiring immediate medical attention

If you have the following amoxicillin / clavulanic acid side effects, it’s crucial to get medical attention as soon as possible:

• Severe itching and skin rash;
• Discomfort when swallowing or breathing;
• Excess vaginal itching and discharge;
• Yellowing of your eyes and/or skin;
• Bloody diarrhea;
• Darker urine than usual;
• High fever;
• Weakness, drowsiness, and confusion;
• Severe swelling of your tongue and/or face;
• Other unusual allergic reactions;
• Easy bruising, etc.

Keep in mind that in case you have a complication of side effects or a rare side effect after taking amoxicillin and clavulanic acid, you can report the occasion to the Food and Drug Administration's (FDA). Consult your doctor on the best way to describe your condition.

There are also rare side effects, including seizures, anaphylaxis, lack of red blood cells, colon inflammation, etc. Antibiotics of any kind don’t only kill the harmful bacteria but the useful ones as well. This may cause all kinds of complications related to your digestive system. Make sure you take probiotics during or right after finishing the antibiotic prescription. But it’s always better to ask a doctor for advice rather than choosing medication yourself.

Side effects not requiring immediate medical attention

There are also side effects that don’t require immediate medical help. They are usually mild, but you have to tell your doctor about them, just to make sure they don’t deteriorate:

• Regular diarrhea;
• Nausea and vomiting;
• Upset stomach;
• Mild bloating;
• Mild skin rash.

If you think about taking additional medication to fight the side effects mentioned above, be sure to consult a doctor first.

Drug Interactions

Medications containing amoxicillin and clavulanic acid can interact with certain substances. Never take any additional medicine before consulting with your doctor on their interaction.

Here are some drugs that interact with Augmentin and similar medications:

• Probenecid is a common drug for gout treatment. Its side effect, though, is preventing amoxicillin from being processed by kidneys. The buildup will cause toxic levels of amoxicillin, leading to complications.
• Birth control pills.
  The combination may decrease or eliminate the effect of birth control through pills. If you’re not using other ways of protection as well, an unwanted pregnancy may be a result.
• If you’re taking Zyloprim, Aloprim, or other medications with allopurinol, the combination of amoxicillin and clavulanic acid will more likely cause skin rash as a side effect.
• Oral Anticoagulants.
  Combining oral anticoagulants with amoxicillin may lead to an increased International Normalized Ratio (INR). To ensure both medications achieve their goals in treating the respective conditions, see if your doctor can adjust the dose of the anticoagulant.

It’s useful to write down all the medications and dietary supplements you’re taking before starting your amoxicillin and clavulanic acid course. You won’t forget anything, and the doctor will be able to adjust the dosage according to your needs.

Warnings & Precautions

There’s a large list of amoxicillin and clavulanic acid warnings and precautions to be taken before use. Here are the key points every patient should know:

• Know your allergies.
  If you happen to have an allergy to medications like Trimox, Amoxil, Wymox, and others containing amoxicillin, clavulanic acid, penicillin, etc., definitely tell your doctor about it. If you’re not sure as to the type of medication or the name, remember all allergic reactions you usually have.
• Remember all medications you’re taking.
  As you can see, there are lots of substances amoxicillin and clavulanic acid may interact with. Some you may not know about, so be sure to have a list with all the medication and supplements, no matter how light, when visiting a doctor. This will ensure the treatment process will go smoothly, and there will be none to mild side effects.
• Tell the doctor about your diseases.
  If you suffer from severe allergies, asthma, liver or kidney disease, mononucleosis, hay fever, hives, or other conditions, tell your doctor about them before the testing.
• Think if you plan to become pregnant.
  If you plan or already are pregnant/breastfeeding, notify your doctor about it beforehand. And if you become pregnant in the middle of the amoxicillin course, visit the doctor as soon as possible. Remember that you should use other ways of contraception than birth control pills while taking amoxicillin.
• Plan your diet.
  Ask the doctor if you have to make changes to your diet. While there are no dramatic needs for change, in combination with supplements and other medications, it might become an important topic. As to alcohol intake, there are no known issues related to the reaction with amoxicillin clavulanic acid.
• Visit the doctor regularly.
  Don’t be late for your appointments in the lab. There might be additional tests needed to see if the treatment is going fine, and there’s no additional medication/dosage change needed.
• Change the test if you’re diabetic.
  For urine glucose tests, use TesTape or Clinistix. Avoid using Clinitest as it might give wrong results if you take amoxicillin regularly.
• Don’t give anyone your medicine.
  Usually, the prescription for amoxicillin and clavulanic acid is not refillable. So if you give someone a tablet, you will lack the final dose, jeopardizing your recovery. In case you’ve finished the course, but the symptoms of the infection are still present, contact your doctor as soon as possible.

These warnings aren’t difficult to remember and should be used for the best flow of your bacterial infection treatment.

Hypersensitivity Reactions

If you’ve had penicillin hypersensitivity, even if once, you must tell the doctor about it. When inattentive to such occasions, an anaphylactic reaction may lead to death. If penicillin isn’t on the list of your allergens, but the list is large, it’s useful to show it to the doctor as well.

Before starting taking Augmentin and similar medication, you must consult with the doctor to eliminate the risks of serious side effects. If you notice unusual allergic reactions, contact the doctor, and discontinue use until further notice.

Hepatic Dysfunction

Hepatitis and cholestatic jaundice are some of the serious side effects of taking amoxicillin and clavulanic acid in patients with hepatic impairment. Such hepatitis is reversible in most cases, but there have been reports about fatal outcomes.

Such patients have to be monitored regularly to make sure it’s possible to reverse hepatic toxicity. The most susceptible patient groups are:

• Male;
• The elderly;
• Patients treated with the same medications for a long time.

Even if you discontinue use without this side effect, it may appear within the next couple of months.

Clostridium difficile-associated diarrhea (CDAD)

CDAD is a very common side effect of taking almost all antibacterial medications. As you interfere with the microbiome of your organism, bacteria in your colon react, causing inflammation and other effects. CDAD may range from a mild, easily treated occasion to fatal colitis.

CDAD should be considered in anyone who’s taking an antibacterial treatment and has diarrhea as a side effect. The condition may become serious and resistant to medication treatment. Such patients will need a colectomy. Even if the problem appears within 2 months after the treatment course is over, it still might be connected. This is another reason why an accurate medical history is essential.

In case a patient is diagnosed with CDAD, all antibacterial treatments not used to fight it will have to be stopped. Potential following treatment should include protein supplements, management of electrolyte and fluids, another antibacterial medicine against Clostridium difficile (C. difficile), the bacteria responsible for CDAD. Surgical evaluation is also important if the condition gets out of control.

Skin Rash in Patients With Mononucleosis

It’s not recommended to take the combination of amoxicillin and clavulanic acid if the patient has mononucleosis. Skin rash will be 100% present as a side effect, and the complications may follow.

Potential for Microbial Overgrowth

As any antibacterial treatment is intervening with your microbiome killing certain bacteria, it may also cause an overgrowth of another culture. If not controlled properly, this may lead to a superinfection. If suspected, the current antibacterial treatment must be discontinued, and further tests must be conducted to administer a new therapy.

Phenylketonurics

People with a metabolic disorder, called phenylketonuria, should be very careful when taking amoxicillin / clavulanic acid/potassium medication like Augmentin. The chewable tablets and powder for suspension of the brand contain aspartame, and it contains phenylalanine that may cause complications in phenylketonurics (people with the disorder).

Regular and long-release tablets don’t contain the substance.

Development of Drug-Resistant Bacteria

It’s only needed to prescribe Augmentin and similar medication if the bacterial infection is confirmed. If not, the treatment won’t be useful and may cause the growth of bacteria that resist the drug. In the future, if the patient falls ill with a bacterial infection, the treatment might not be effective.

Use in Specific Populations

The dosage changes, depending on the population the patient belongs to (pregnant or breastfeeding women, pediatric patients under/over 40 kg, geriatric patients).

Pregnancy

If the patient isn’t allergic to penicillin, the use of such antibacterial treatment is allowed, and there should be no teratogenic effects. However, it’s worth mentioning that the topic isn’t well-studied. Some reproduction tests conducted on pregnant mice revealed that the dosages of even 1200 mg/kg daily don’t affect the fetus. The dosage was several times more than the maximum dose allowed for humans.

Animal reactions aren’t always identical to humans’, however. So the treatment should be prescribed only after confirming a bacterial infection.

Labor and Delivery

There’s no clear information on whether the use of amoxicillin and/or clavulanic acid or clavulanate potassium affects the fetus or changes the duration of labor.

It’s known, though, that oral ampicillin-type antibiotics aren’t well-absorbed during labor.

Nursing Mothers

Amoxicillin and clavulanic acid are excreted in breast milk and may cause digestion issues in infants. It’s recommended to prescribe medication with any of the substances to nursing women with caution and only if it’s absolutely necessary.

Pediatric Use

The dosage must be changed according to the age and/or weight of the pediatric patient:

• Infants younger than 3 months old should only have 30 mg/kg daily, 2 times a day;
• 3-month-old and older patients’ dosage is different, depending on the diagnosis and weight;
• Patients that weigh over 40 kg can get adult doses according to the prescription.

Keep in mind that chewable tablets and oral suspension shouldn’t be prescribed to phenylketonurics. But it’s not recommended to use regular tablets before the child weighs 40 kg due to a different ratio of components. Keep in mind that amoxicillin elimination from the organism is delayed in infants.

Geriatric Use

In clinical studies analysis of amoxicillin and clavulanic acid-containing medication (Augmentin) there were around 3,100 patients overall. 32% of those were 65 years old and older, and there were even patients of 75 years+.

There were no drastic response changes found, comparing the elderly to the younger patients. No safety hazards or effectiveness changes were found unless the patient had greater sensitivity to one or more components of the drug, metabolic, or renal dysfunction.

Separate patients have to be tested for those conditions before being prescribed the drug.

If the patient of any age has renal function impairment, the reaction to amoxicillin can be complicated. The substance is mostly excreted by kidneys, so they have to be at least relatively healthy to avoid undesirable effects. The dose selection should be guided by the presence or absence of kidney conditions.

Undesirable Effects

The undesirable effects are connected to overdose or missing a dose of amoxicillin and clavulanic acid. Make sure you have a schedule and follow it precisely. Some symptoms of penicillin overdose:

• Severe stomach pain;
• Diarrhea;
• Skin rash;
• Nausea and vomiting;
• Drowsiness or hyperactivity;

Remember that taking medication at the same time every day will decrease the possibility of overdose or missing a dose.

Overdose

If an overdose happens:

• Discontinue use immediately;
• Treat the symptoms to ease the condition;
• Drink lots of fluids;
• Take other measures to support your stable condition;
• Call the doctor.

If the dose wasn’t over 250 mg per kg, there should be no serious symptoms and consequences, but it’s still recommended to contact the doctor and get further instructions. If the dose was much larger, there might be interstitial nephritis with a consequence of kidney failure if the condition is not treated immediately.

Crystalluria is another sign of penicillin overdose, which may also lead to kidney failure.

It’s important to maintain steady fluid intake and diuresis in case of an overdose.

There is a possibility to reverse kidney impairment due to an overdose of the drug by discontinuing the use and removal of excess amoxicillin and/or clavulanic acid by means of hemodialysis.

You can find more information at https://www.poisonhelp.org/help. If there’s an emergency, there’s a poison control helpline at 1-800-222-1222. If the poisoning is severe and the person has/had a seizure or collapsed, dispatch emergency services at 911 as soon as possible.

Missed Dose

Missing a dose isn’t as dangerous as an overdose, but be sure to take it immediately when remembered unless it’s time for the next one soon. Never take a double dose to compensate as it may lead to an overdose.

Storage

Here are some key points as to the storage of amoxicillin/clavulanic acid-containing medication:

• Keep the drug in its original container;
• Keep it out of the reach of children and pets;
• Keep the container closed tightly all the time;
• Keep it in a place that’s not too hot or humid (room temperature is preferred);
• If using liquid drugs, store them in the fridge but don’t freeze;
• Dispose of the liquid if not used for over 10 days.

It’s very important to keep your children out of the place where you store medication. A lot of drops, creams, and drugs don’t have child-proof lids on them, so no matter how tightly you close it, it’s possible to open it.

Choose the place for storage carefully, somewhere too high and away from the reach of a small child. According to Up and Away, about 50,000 children are brought to emergency rooms because of their “experiments” with unknown containers of drugs.

It’s also necessary to know about the proper disposal of unneeded drugs. You have to do it in a way that no child, animal, or person can consume them after disposal. You also shouldn’t flush medication down the toilet, especially in a large quantity.

There are take-back programs created specifically for unneeded drug disposal. You can find out more about them at a pharmacy or your doctor. The information may also be available at a local recycling company. There’s also info online on the FDA's Safe Disposal of Medicines website for those who live in areas with no take-back programs available.

The Bottom Line

Overall, the combination is safe for pregnant women, pediatric and geriatric patients if the right dosage is administered. Be sure to finish the whole treatment course, don’t share the medication with anyone, and dispose of the remaining tablets or suspension, if any, according to the FDA’s guide.