Monaclox-F
Generic Name
Amoxicillin and Flucloxacillin
Manufacturer
Opsonin Pharma Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| monaclox f 125 mg suspension | ৳ 65.00 | N/A |
Description
Overview of the medicine
Monaclox-F 125 mg Suspension is an oral antibiotic suspension containing a combination of Amoxicillin and Flucloxacillin. Amoxicillin is a broad-spectrum penicillin, and Flucloxacillin is a penicillinase-resistant penicillin. This combination provides synergistic antibacterial activity against a wide range of gram-positive and gram-negative bacteria, including those producing penicillinase.
Uses & Indications
Dosage
Adults
Not typically recommended for adults as a 125 mg/5 ml suspension; adults usually take higher strength tablets/capsules. If used, dosage would be adjusted, e.g., 250-500 mg every 8 hours, requiring multiple spoonfuls.
Elderly
Same as adults, but dose adjustment may be required in elderly patients with reduced renal function.
Renal_impairment
Dosage adjustment is necessary. For mild to moderate impairment (CrCl >30 ml/min), no significant change. For severe impairment (CrCl <30 ml/min), dose reduction or increased dosing interval may be required, consult physician.
How to Take
Administer orally, preferably at the beginning of a meal for optimal absorption and to minimize gastrointestinal discomfort. Shake the bottle well before each use. Use a measuring spoon or oral syringe for accurate dosing.
Mechanism of Action
Amoxicillin and Flucloxacillin are bactericidal antibiotics that inhibit bacterial cell wall synthesis. They bind to penicillin-binding proteins (PBPs) located in the bacterial cell wall, thereby inhibiting the transpeptidation step of peptidoglycan synthesis. This leads to impaired cell wall formation and ultimately bacterial cell lysis. Flucloxacillin's resistance to penicillinase enzyme ensures its activity against beta-lactamase producing staphylococci, while Amoxicillin covers a broader spectrum.
Pharmacokinetics
Onset
Clinical effects usually seen within a few hours of administration.
Excretion
Primarily excreted unchanged by the kidneys via glomerular filtration and tubular secretion. A small amount is excreted in bile. Renal impairment prolongs half-life.
Half life
Approximately 1-1.5 hours for both components in individuals with normal renal function.
Absorption
Both Amoxicillin and Flucloxacillin are well absorbed from the gastrointestinal tract after oral administration, with peak plasma concentrations typically achieved within 1-2 hours. Food may slightly delay absorption but does not significantly affect the extent of absorption.
Metabolism
Limited hepatic metabolism for both drugs. Amoxicillin is primarily excreted unchanged, while Flucloxacillin undergoes some metabolism.
Side Effects
Contraindications
- Hypersensitivity to penicillin antibiotics or any component of the formulation
- History of penicillin-associated cholestatic jaundice/hepatic dysfunction
- Infectious mononucleosis
Drug Interactions
Warfarin
May increase the anticoagulant effect, requiring close monitoring of INR.
Probenecid
Concomitant use prolongs the half-life of amoxicillin by decreasing its renal tubular secretion.
Methotrexate
Increased plasma levels of methotrexate, increasing risk of toxicity.
Oral Contraceptives
Reduced efficacy of oral contraceptives may occur, advising additional contraceptive methods.
Storage
Store the dry powder below 30°C, protected from light and moisture. After reconstitution, store the suspension in a refrigerator (2-8°C) and do not freeze. Discard any unused suspension after the specified period.
Overdose
Symptoms of overdose may include gastrointestinal disturbances (nausea, vomiting, diarrhea) and disturbances of fluid and electrolyte balance. In isolated cases, renal tubular damage and convulsions have been reported. Treatment is symptomatic and supportive. Gastric lavage or activated charcoal may be considered soon after ingestion. Hemodialysis can aid in the removal of the drugs from the circulation.
Pregnancy & Lactation
Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Both Amoxicillin and Flucloxacillin are excreted in breast milk; caution should be exercised when administered to a nursing mother. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to penicillin antibiotics or any component of the formulation
- History of penicillin-associated cholestatic jaundice/hepatic dysfunction
- Infectious mononucleosis
Drug Interactions
Warfarin
May increase the anticoagulant effect, requiring close monitoring of INR.
Probenecid
Concomitant use prolongs the half-life of amoxicillin by decreasing its renal tubular secretion.
Methotrexate
Increased plasma levels of methotrexate, increasing risk of toxicity.
Oral Contraceptives
Reduced efficacy of oral contraceptives may occur, advising additional contraceptive methods.
Storage
Store the dry powder below 30°C, protected from light and moisture. After reconstitution, store the suspension in a refrigerator (2-8°C) and do not freeze. Discard any unused suspension after the specified period.
Overdose
Symptoms of overdose may include gastrointestinal disturbances (nausea, vomiting, diarrhea) and disturbances of fluid and electrolyte balance. In isolated cases, renal tubular damage and convulsions have been reported. Treatment is symptomatic and supportive. Gastric lavage or activated charcoal may be considered soon after ingestion. Hemodialysis can aid in the removal of the drugs from the circulation.
Pregnancy & Lactation
Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Both Amoxicillin and Flucloxacillin are excreted in breast milk; caution should be exercised when administered to a nursing mother. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Unreconstituted dry powder: 2-3 years (refer to package for exact expiry date). Reconstituted suspension: 7-14 days when stored in a refrigerator (2-8°C).
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
As a combination of two well-established antibiotics, extensive clinical trials have confirmed the efficacy and safety of Amoxicillin and Flucloxacillin in various bacterial infections. Ongoing post-marketing surveillance continues to monitor its safety profile.
Lab Monitoring
- Liver function tests (especially in prolonged treatment or in patients with hepatic impairment)
- Kidney function tests (in patients with renal impairment or prolonged high-dose therapy)
- Complete blood count (in prolonged therapy)
Doctor Notes
- Consider patient's history of hypersensitivity to penicillins or cephalosporins before prescribing.
- Monitor liver function tests in patients with pre-existing hepatic impairment or during prolonged treatment.
- Advise patients on the importance of completing the full course of therapy.
- Dose adjustment required in severe renal impairment.
Patient Guidelines
- Complete the full course of antibiotics even if symptoms improve to prevent antibiotic resistance.
- Shake the bottle well before each use.
- Use the provided measuring device for accurate dosing.
- Store as directed by your pharmacist.
- Inform your doctor if you experience any severe side effects or allergic reactions.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Generally, this medicine does not impair the ability to drive or operate machinery. However, if you experience dizziness or other side effects that affect your concentration, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- Eat a balanced diet. Probiotics may help manage antibiotic-associated diarrhea.
- Avoid self-medication and complete the prescribed course.
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