Amoxicillin

• General information
• Resistance
• Interactions
• Side Effects
• Forms
• Precautions
• Dosages
• Uses
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Amoxicillin, initially introduced in the early 1970s for oral use in the UK, has gradually become a regular broad-spectrum antibacterial used to treat infections of various diseases.

It is more effective against gram-positive than gram-negative microorganisms and demonstrated greater efficacy than penicillin and penicillin V. Moreover, it is comparable to other antibiotics, e.g., ampicillin, azithromycin, clarithromycin, cefuroxime, and doxycycline, in treating various infections/diseases.

What is Amoxicillin?

Amoxicillin is a semi-synthetic penicillin antibiotic that disrupts the synthesis of bacterial cell walls, leading to the death of the bacteria. It is effective against a broad spectrum of bacteria and is commonly prescribed for both adults and children.

Drug Nomenclature

International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):

History and Challenges in Development

Historically, infectious diseases have been the most important contributor to human morbidity and mortality until recent times, when non-communicable diseases began to rival and sometimes exceed infections.

Today, infectious diseases still account for a large proportion of death and disability worldwide and, in certain regions, remain the most important cause of ill health. Infectious diseases are major public health issues for both developed and developing countries.

Acute respiratory infections are the leading infectious cause of death in all ages worldwide. Current key community and hospital bacterial disease burdens include pediatric infections and multiple drug resistance in Gram-positive and Gram-negative organisms.

An increasing prevalence of antibiotic resistance has led to a progressive decrease in the effectiveness of narrow-spectrum agents and an increase in difficult-to-treat infections.

In the 1960s, a limited range of non-beta-lactam antibacterials was available; most had certain limitations in terms of toxicity, e.g., sulphonamides (rashes and renal toxicity); streptomycin and kanamycin (ototoxicity and nephrotoxicity); chloramphenicol (bone marrow aplasia); erythromycin (gastrointestinal side effects); tetracyclines (concentrate in developing bones and teeth) and colistin (neuro and nephrotoxicity).

A number of beta-lactams, penicillins: penicillin G and V (gastric acid-labile), ampicillin, methicillin (nephrotoxicity), and cephalosporins: cephaloridine and cephalothin (nephrotoxicity) were reported. These agents were generally given as four-times-daily doses and were associated with rashes and, rarely, anaphylaxis.

At the end of the 1960s, challenging infections requiring hospital treatment included meningitis, endocarditis, neonatal infections, penicillin-resistant staphylococcal infections, and infections caused by Gram-negative organisms. In primary care, infections of the urinary tract, respiratory tract, skin, and soft tissues are common causes of morbidity and sometimes mortality.

Further problem areas emerging in the 1970s included mixed infections, antibiotic-resistant bacteria, new pathogens and infections in immunocompromised patients, those undergoing surgery, and infections in hemodialysis patients.

Broad-spectrum antibiotics active against resistant organisms and in mixed infections were required. The 1970s saw the introduction of a number of important new antimicrobial agents, some of which were still associated with adverse events, such as co-trimoxazole (rashes and sulphonamide toxicity), tobramycin and amikacin (aminoglycoside toxicity), and metronidazole (neuropathy).

Certain new beta-lactam antibiotics were also introduced, including the cephalosporins ― cefamandole, cefuroxime; the cephamycin, cefoxitin; and the penicillins -amoxicillin, flucloxacillin, mezlocillin, azlocillin, and ticarcillin. All could be associated with rashes and, rarely, anaphylaxis. In 1972, amoxicillin was introduced in the UK, which maintained the broad-spectrum activity of ampicillin but with increased bioavailability. As beta-lactamase production by both gram-positive and gram-negative pathogens became a clinically relevant issue, efforts were made to develop an orally bioavailable, broad-spectrum penicillin that was also effective against these strains, resulting in the combination of amoxicillin and clavulanic acid (amoxicillin/clavulanate).

In 1981, SmithKline Beecham patented amoxicillin or amoxicillin/clavulanate potassium tablets and sold the antibiotic in 1998 under the trade names Amoxicillin, Amoxil, and Trimox. At the close of the decade, a range of requirements for a new antibacterial still remained.

These included activity against penicillinase-producing gram-positive and gram-negative organisms (including anaerobes), a broad spectrum of activity and good tolerability, including in children, availability as both an oral and injectable formulation and activity in a range of indications, including urinary tract infections (UTIs), respiratory tract infections (RTIs), skin and soft tissue infections (SSTIs), intra-abdominal infections and septicemia.

This set the scene for developing an antibacterial agent to fulfill these requirements. Although new antibacterial compounds are currently in development, most are at a pre-clinical stage. Therefore, it is necessary to make the best use of currently available agents. The development of higher dosing regimens and pharmacokinetically enhanced formulations has allowed amoxicillin (alone and in combination) to continue to play an important role in the treatment of a range of infections, particularly those of the respiratory tract in both adults and children worldwide.

Uses of Amoxicillin

Amoxicillin is indicated for the treatment of several types of bacterial infections, including:

• respiratory tract infections, such as pneumonia and bronchitis;
• ear, nose, and throat infections, like otitis media (ear infections) and sinusitis;
• genitourinary tract infections, such as urinary tract infections (UTIs);
• skin infections, including cellulitis and skin abscesses;
• Helicobacter pylori eradication, Amoxicillin is often used with other medications to treat stomach ulcers caused by H. pylori.

It is important to note that Amoxicillin is ineffective against viral infections like colds or the flu. Learn the list of indications of Amoxicillin.

Forms, Dosage, and Administration

Amoxicillin is available in various forms, including capsules, tablets, chewable tablets, and liquid suspension.

The dosage depends on the type of infection being treated and the patient’s age. Adults are typically prescribed 250 mg to 500 mg every 8 hours or 500 mg to 875 mg every 12 hours. The dosage for children is usually calculated based on body weight (20–45 mg/kg/day), divided into two or three doses.

Patients are advised to complete the full course of Amoxicillin as prescribed, even if symptoms improve before finishing the medication.

Side Effects

While Amoxicillin is generally well-tolerated, patients should be aware of potential side effects that can occur during treatment.

Common Side Effects

The most frequently reported side effects of Amoxicillin include:

1. Gastrointestinal issues, like nausea, vomiting, and diarrhea, are common and typically resolve after completing the medication. These symptoms may arise as the body adjusts to the antibiotic.
2. Skin reactions, like mild skin rashes, may occur; however, these are usually not serious. A more severe allergic rash can develop and requires immediate medical attention.

Serious Side Effects

While Amoxicillin is effective for treating bacterial infections, awareness of its potential side effects is crucial for safe usage. Although rare, some serious side effects can occur, necessitating prompt medical intervention:

1. Severe allergic reactions. Symptoms may include difficulty breathing, swelling of the face or throat, and hives. Such reactions can be life-threatening and require emergency care.
2. Gastrointestinal complications. Amoxicillin can lead to antibiotic-associated colitis caused by Clostridioides difficile, which may manifest as severe diarrhea with blood or mucus. This condition can develop during treatment or even weeks after discontinuation.
3. Liver Dysfunction. Signs of liver problems include jaundice (yellowing of the skin or eyes), dark urine, and persistent abdominal pain. These symptoms warrant immediate medical evaluation.

Most side effects are manageable and resolve after treatment; however, patients should seek medical advice if they experience severe reactions or persistent symptoms.

Important Safety Information

Individuals with a known allergy to penicillin or cephalosporins should avoid Amoxicillin.

This medicine may interact with other medications, including anticoagulants and other antibiotics. Always inform your healthcare provider about all medications you are taking to avoid interactions.

Amoxicillin is generally considered safe during pregnancy and breastfeeding; however, precautions should be taken and it should only be used when necessary and prescribed by a healthcare professional.

Learn more about antibiotic resistance.

Due to its efficacy and safety profile, Amoxicillin remains a cornerstone in treating bacterial infections. Understanding its uses, proper dosage, potential side effects, and precautions can help patients use this antibiotic effectively while minimizing risks associated with misuse. Always consult a healthcare provider for personalized medical advice regarding Amoxicillin or other medication.