Medicine Information

fimoxyclav

Name: fimoxyclav
Brand: fimoxyclav
Rating: 4.5 (117 reviews)

Oral Suspension (Powder for Reconstitution)125 mg Amoxicillin / 31.25 mg Clavulanic Acid per 5 mLAntibiotic (Penicillin with Beta-Lactamase Inhibitor)ATC: J01CR02

Generic Name

Amoxicillin and Clavulanic Acid

Manufacturer

Various Generic Pharmaceutical Companies

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
fimoxyclav 125 mg suspension	৳ 245.74	N/A

Description

Overview of the medicine

Fimoxyclav 125 mg Suspension is a combination antibiotic used to treat a wide range of bacterial infections. It contains amoxicillin, a penicillin-type antibiotic, and clavulanic acid, which is a beta-lactamase inhibitor. Clavulanic acid prevents amoxicillin from being inactivated by certain bacteria, thereby extending its antibacterial spectrum and effectiveness.

Uses & Indications

Upper and lower respiratory tract infections (e.g., otitis media, sinusitis, tonsillitis, acute exacerbations of chronic bronchitis, pneumonia)

Urinary tract infections

Skin and soft tissue infections (e.g., cellulitis, animal bites, severe dental abscess with spreading cellulitis)

Bone and joint infections (e.g., osteomyelitis)

Other infections caused by susceptible organisms (e.g., intra-abdominal sepsis)

Dosage

Adults

This specific suspension strength (125mg/5mL) is primarily for pediatric use. Adults typically use higher strength tablets (e.g., 250mg/125mg or 500mg/125mg).

Elderly

No specific dosage adjustment for elderly patients with normal renal function. For elderly patients with impaired renal function, dosage adjustment as per renal impairment guidelines is necessary.

Children

Children 2-12 years: 20-40 mg amoxicillin/kg/day in 3 divided doses, or as directed by a physician. For severe infections, up to 45 mg amoxicillin/kg/day. Infants <2 years: Specific dosing based on weight and age, usually lower doses and under strict medical supervision.

Renal_impairment

Dosage adjustment required based on creatinine clearance. For CrCl < 30 mL/min, dose reduction or extended dosing interval is needed. Hemodialysis patients require an additional dose after dialysis.

How to Take

Shake the bottle well before each use to ensure the medicine is evenly mixed. Use the provided measuring spoon or cup to accurately measure the dose. Can be taken with or without food; however, taking it at the start of a meal may help reduce potential gastrointestinal upset.

Mechanism of Action

Amoxicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial cell lysis and death. Clavulanic acid, a beta-lactamase inhibitor, irreversibly binds to and inactivates a wide range of beta-lactamase enzymes produced by bacteria. This protects amoxicillin from degradation, allowing it to exert its bactericidal effect against beta-lactamase-producing strains.

Pharmacokinetics

Onset

Within 1 hour of administration.

Excretion

Primarily via the kidneys; approximately 60-70% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in the urine within 6 hours.

Half life

Amoxicillin: Approximately 1 to 1.5 hours; Clavulanic Acid: Approximately 1 hour.

Absorption

Rapidly and well absorbed after oral administration. Peak plasma concentrations are reached in approximately 1 to 2 hours. Bioavailability is not significantly affected by food, but taking it at the start of a meal can reduce GI upset.

Metabolism

Amoxicillin is minimally metabolized, primarily excreted unchanged. Clavulanic acid is extensively metabolized.

Side Effects

Contraindications

History of hypersensitivity to amoxicillin, clavulanic acid, or any other penicillin antibiotic.
Previous history of cholestatic jaundice or hepatic dysfunction associated with co-amoxiclav therapy.
Infectious mononucleosis (due to increased risk of erythematous rash).

Drug Interactions

Probenecid

Decreases renal tubular secretion of amoxicillin, leading to increased and prolonged blood levels of amoxicillin.

Allopurinol

May increase the incidence of skin rash, especially in patients with hyperuricemia.

Methotrexate

Reduced renal tubular secretion of methotrexate by amoxicillin may increase its toxicity.

Oral Contraceptives

May reduce the efficacy of oral contraceptives, leading to an increased risk of unintended pregnancy.

Warfarin and other oral anticoagulants

May increase INR (International Normalized Ratio); close monitoring of coagulation parameters is required.

Storage

Store unreconstituted powder below 25°C (77°F) in a dry place. Protect from moisture. Keep out of reach of children. Reconstituted suspension must be stored in a refrigerator (2-8°C / 36-46°F) and discarded after the recommended period (e.g., 7 or 10 days). Do not freeze the reconstituted suspension.

Overdose

Symptoms of overdose may include gastrointestinal symptoms (nausea, vomiting, diarrhea) and disturbances of fluid and electrolyte balance. In rare cases, renal impairment, crystalluria, or convulsions may occur. Management involves symptomatic treatment and supportive measures. Amoxicillin/clavulanic acid can be removed from circulation by hemodialysis.

Pregnancy & Lactation

Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the risks. Both amoxicillin and clavulanic acid are excreted into breast milk; caution should be exercised when administering to a nursing mother, as it may cause sensitization in the infant.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

15 mL bottle (when reconstituted)30 mL bottle (when reconstituted)50 mL bottle (when reconstituted)70 mL bottle (when reconstituted)100 mL bottle (when reconstituted)

Shelf Life

Unreconstituted powder: typically 24-36 months from manufacture date. Reconstituted suspension: 7-10 days when stored in a refrigerator (2-8°C).

Availability

Pharmacies, Hospitals

Approval Status

Approved (Generic)

Patent Status

Generic Available

WHO Essential Medicine

Yes

Clinical Trials

Amoxicillin/Clavulanic Acid has undergone extensive clinical trials demonstrating its efficacy and safety for various bacterial infections. Ongoing research continues to monitor resistance patterns and explore new therapeutic applications.

Lab Monitoring

Liver function tests (ALT, AST, bilirubin) in patients with pre-existing hepatic impairment or during prolonged therapy.
Renal function tests (creatinine, BUN) in patients with renal impairment.
Complete Blood Count (CBC) during prolonged therapy, especially if patients develop fever, sore throat, or other signs of infection.

Doctor Notes

Counsel patients on the importance of completing the full prescribed course of antibiotics, even if symptoms improve, to ensure eradication of infection and prevent resistance.
Advise parents/caregivers on proper reconstitution and storage of the suspension, emphasizing refrigeration and discard date.
Be aware of the potential for hypersensitivity reactions, including severe anaphylaxis, especially in patients with a history of penicillin allergy. Advise patients to seek immediate medical attention if allergic symptoms occur.

Patient Guidelines

Complete the entire course of medication as prescribed by your doctor, even if your symptoms improve, to prevent the recurrence of infection and the development of antibiotic resistance.
Shake the bottle well before each use to ensure proper mixing of the suspension.
Store the reconstituted suspension in the refrigerator and discard any unused portion after the recommended period (usually 7-10 days).

Missed Dose Advice

If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

Driving Precautions

Amoxicillin/Clavulanic Acid suspension generally does not impair the ability to drive or operate machinery. However, if you experience side effects such as dizziness, headache, or allergic reactions, avoid these activities.

Lifestyle Advice

Maintain good hydration by drinking plenty of fluids, especially if experiencing diarrhea.
Follow a balanced diet and avoid self-medication with other antibiotics without consulting a healthcare professional.

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