3 months to expiry Ghana · FDA Ghana

ADVACLAV

ANOXICILLIN/CLAVULANIC ACID

FDA/SD.233-091029 ANOXICILLIN/CLAVULANIC ACID 625MG

What it does

Anoxicillin is an antibiotic that helps treat infections caused by bacteria.

Commonly used for: bacterial infections, infections of the skin, respiratory tract infections, urinary tract infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.233-091029
Registration date
2023-12-09
Expiry date
2026-10-01
Status
3 months to expiry
Active ingredient
ANOXICILLIN/CLAVULANIC ACID
Strength
625MG
Pack size
-
Therapeutic class
-
RxNorm RxCUI
48203
Manufacturer / MAH
Reyoung Pharmaceutical
Applicant / LTR
BIOTIC COMPANY LIMITED
Country of origin
-

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:57 · updated 2026-09-29 04:00:13

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About anoxicillin

Anoxicillin is an antibiotic that helps treat infections caused by bacteria.

What it treats

  • bacterial infections
  • infections of the skin
  • respiratory tract infections
  • urinary tract infections

How it works

It stops the growth of bacteria, helping your body to fight off the infection.

Who it's for

It is for people who have certain types of bacterial infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About clavulanic

Clavulanic acid is a substance that helps antibiotics work better by preventing certain bacteria from becoming resistant to treatment.

What it treats

  • infections caused by bacteria
  • bacterial infections (e.g., pneumonia, bronchitis)

How it works

It works by blocking enzymes that bacteria produce to resist antibiotics, making the antibiotics more effective.

Who it's for

It is used for adults and children who have bacterial infections that need antibiotic treatment.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: anoxicillin

Anoxicillin is a semi-synthetic penicillin antibiotic that is effective against a variety of gram-positive and some gram-negative bacteria. It works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. Anoxicillin is used in the treatment of infections caused by susceptible organisms, particularly in respiratory, skin, and soft tissue infections.

Indications

  • Bacterial infections
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Otitis media
  • Sinusitis

Dosage

Children: Refer to the BNF for Children for appropriate dosing recommendations based on the child's age and weight.

Adults: Refer to the BNF for specific dosing information based on the type and severity of infection.

Mechanism of action

Anoxicillin exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) located within the bacterial cell wall. This binding inhibits the transpeptidation enzyme, which is crucial for cross-linking peptidoglycan layers, ultimately leading to a weakened cell wall and bacterial lysis.

Pharmacodynamics

Anoxicillin demonstrates time-dependent bactericidal activity, meaning its effectiveness is related to the duration of time that the drug concentration remains above the minimum inhibitory concentration (MIC) for the target bacteria. It is generally active against a range of aerobic gram-positive organisms, including Streptococcus pneumoniae and Staphylococcus aureus, and is less effective against gram-negative bacteria.

Pharmacokinetics

Anoxicillin is usually administered via the intravenous or intramuscular route. It is absorbed well, with peak plasma concentrations occurring rapidly. The drug is widely distributed in body tissues and fluids, including the lungs, liver, and kidneys. Anoxicillin is primarily eliminated via renal excretion, and its half-life is typically around 1 hour, necessitating multiple doses for sustained therapeutic effect.

Contra-indications

  • Hypersensitivity to anoxicillin or any penicillin antibiotics
  • Severe renal impairment
  • History of anaphylactic reactions to beta-lactams

Adverse effects

  • Allergic reactions including rash, urticaria, and anaphylaxis
  • Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
  • Hepatic dysfunction or elevated liver enzymes
  • Renal impairment
  • Superinfection with prolonged use

Interactions

  • May reduce the efficacy of oral contraceptives
  • Probenecid can increase levels of anoxicillin by decreasing renal excretion
  • May interact with methotrexate, increasing toxicity

Precautions

  • Use with caution in patients with a history of asthma or allergy
  • Monitor renal function in patients with renal impairment
  • Assess liver function prior to treatment in patients with liver disease
  • Consider potential for antibiotic resistance with prolonged use

Pregnancy

Anoxicillin is generally considered safe during pregnancy but should be used only if clearly needed. Consult with a healthcare provider for individual assessment.

Breast-feeding

Anoxicillin is excreted in breast milk. Use caution when administering to nursing mothers, weighing risks and benefits.

Storage

Store at room temperature, away from moisture and heat. Ensure the container is tightly closed.

Formulations

  • Oral tablets
  • Oral suspension
  • Injectable solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: clavulanic

Clavulanic acid is a beta-lactamase inhibitor that is often combined with penicillin antibiotics to enhance their efficacy against beta-lactamase-producing bacteria. It is structurally related to penicillins and prevents the hydrolysis of beta-lactam antibiotics, thereby extending their spectrum of activity. Clavulanic acid itself has minimal antibacterial activity but is crucial in overcoming antibiotic resistance.

Indications

  • Infections caused by beta-lactamase-producing bacteria
  • Acute bacterial sinusitis
  • Acute otitis media
  • Lower respiratory tract infections
  • Urinary tract infections

Dosage

Children: Refer to the BNF for Children for specific dosing according to age and weight; adjustments may be necessary based on the clinical scenario.

Adults: Refer to specific product guidelines for dosing; typical regimens depend on the combination antibiotic used and the severity of the infection.

Mechanism of action

Clavulanic acid works by irreversibly binding to the active site of beta-lactamase enzymes that are produced by certain bacteria to inactivate beta-lactam antibiotics. By inhibiting these enzymes, clavulanic acid protects the penicillin antibiotic from degradation, allowing it to exert its antibacterial effects.

Pharmacodynamics

Clavulanic acid has a synergistic effect when combined with other antibiotics, particularly amoxicillin. The presence of clavulanic acid allows for the effective treatment of infections caused by bacteria that would otherwise be resistant to penicillins. Its antibacterial activity is generally weak on its own but significantly enhances the efficacy of other beta-lactam antibiotics.

Pharmacokinetics

Clavulanic acid is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 hour. It is widely distributed throughout the body and has a half-life of approximately 1 hour. The drug is primarily excreted unchanged in the urine. In the presence of renal impairment, dosage adjustment may be necessary, as the elimination of clavulanic acid can be affected.

Contra-indications

  • Hypersensitivity to clavulanic acid or any of the excipients
  • History of jaundice or hepatic impairment associated with previous use of penicillins or beta-lactam antibiotics

Adverse effects

  • Nausea
  • Diarrhea
  • Rash
  • Elevated liver enzymes
  • Allergic reactions including anaphylaxis
  • Superinfection

Interactions

  • May enhance the effects of anticoagulants such as warfarin
  • Probenecid may increase plasma concentrations of clavulanic acid
  • May reduce the efficacy of oral contraceptives

Precautions

  • Caution in patients with renal impairment
  • Monitor liver function in patients receiving prolonged therapy
  • Use with caution in patients with a history of allergic reactions to beta-lactams

Pregnancy

Clavulanic acid is categorized as pregnancy category B. Animal studies have not shown any harm to the fetus, but there are no adequate and well-controlled studies in pregnant women.

Breast-feeding

Clavulanic acid is excreted in breast milk, but it is generally considered safe for use during breastfeeding. Monitor for potential effects in the infant.

Storage

Store at room temperature, away from moisture and heat. Protect from light. Keep out of reach of children.

Formulations

  • Oral tablets
  • Oral suspension
  • Injectable forms

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.