Demoxiclave
Generic Name
Amoxicillin 125 mg + Clavulanic Acid 31.25 mg per 5 mL Oral Suspension
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| demoxiclave 125 mg suspension | ৳ 200.00 | N/A |
Description
Overview of the medicine
Demoxiclave 125 mg Suspension is a combination antibiotic containing amoxicillin and clavulanic acid. It is used to treat a wide range of bacterial infections, particularly those caused by beta-lactamase-producing bacteria, in children. This includes infections of the respiratory tract, urinary tract, skin, and soft tissues.
Uses & Indications
Dosage
Adults
This 125mg/31.25mg per 5mL suspension is primarily for pediatric use. Adults typically require higher strength formulations (e.g., 250mg/125mg or 500mg/125mg tablets or higher strength suspensions) and their dosage would be different.
Elderly
Use with caution; renal function should be monitored. Dosage adjustment may be necessary if renal impairment is present. Higher strength formulations are typically used for elderly adults.
Renal_impairment
Dosage adjustment is required based on creatinine clearance. For CrCl <30 mL/min, consultation with a physician is necessary. Not recommended for patients on dialysis without strict medical supervision.
How to Take
Shake the bottle well before each use. Administer the prescribed dose using the provided measuring spoon or oral syringe. Can be taken with or without food; however, taking it at the start of a meal may reduce potential gastrointestinal discomfort.
Mechanism of Action
Amoxicillin acts by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. Clavulanic acid is a beta-lactamase inhibitor that protects amoxicillin from degradation by beta-lactamase enzymes produced by resistant bacteria, thereby extending amoxicillin's antibacterial spectrum.
Pharmacokinetics
Onset
Therapeutic effects are typically observed within hours to days, depending on the type and severity of the infection.
Excretion
Both amoxicillin and clavulanic acid are primarily excreted unchanged by the kidneys via tubular secretion and glomerular filtration. A small amount is excreted in feces.
Half life
The elimination half-life is approximately 1-1.3 hours for amoxicillin and about 1 hour for clavulanic acid in healthy adults.
Absorption
Amoxicillin and clavulanic acid are well absorbed from the gastrointestinal tract. Peak plasma concentrations are usually reached within 1-2 hours after oral administration. Food generally has minimal effect on amoxicillin absorption but may reduce clavulanic acid absorption slightly.
Metabolism
Both components are partially metabolized in the liver. Amoxicillin is primarily metabolized to an inactive penicilloic acid. Clavulanic acid is extensively metabolized to inactive metabolites.
Side Effects
Contraindications
- Known history of hypersensitivity to penicillin or any other beta-lactam antibiotic
- Previous history of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate therapy
- Infectious mononucleosis (due to increased risk of rash)
Drug Interactions
Probenecid
Concomitant use may increase and prolong amoxicillin blood levels by reducing renal tubular secretion. Avoid co-administration if possible.
Allopurinol
Increased incidence of rash, especially in hyperuricemic patients, when co-administered with amoxicillin.
Oral Contraceptives
May decrease the efficacy of oral contraceptives. Advise additional non-hormonal contraceptive methods.
Anticoagulants (e.g., Warfarin)
May prolong prothrombin time and increase the risk of bleeding. Close monitoring of INR is advised.
Storage
Store the dry powder below 25°C (77°F) in a dry place, protected from moisture and direct sunlight. Keep out of reach of children. After reconstitution, store the suspension in a refrigerator (2-8°C / 36-46°F) and discard any unused portion after 7-10 days. Do not freeze.
Overdose
Symptoms of overdose may include gastrointestinal upset (nausea, vomiting, diarrhea), fluid and electrolyte imbalance, and convulsions (especially in patients with impaired renal function or those receiving very high doses). Treatment is symptomatic and supportive. Hemodialysis can effectively remove amoxicillin and clavulanic acid from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but adequate and well-controlled studies in pregnant women are lacking. Use during pregnancy only if clearly needed. Both amoxicillin and clavulanic acid are excreted into breast milk in small amounts; use with caution in breastfeeding mothers, monitoring for potential adverse effects in the infant (e.g., diarrhea, candidiasis, sensitization).
Side Effects
Contraindications
- Known history of hypersensitivity to penicillin or any other beta-lactam antibiotic
- Previous history of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate therapy
- Infectious mononucleosis (due to increased risk of rash)
Drug Interactions
Probenecid
Concomitant use may increase and prolong amoxicillin blood levels by reducing renal tubular secretion. Avoid co-administration if possible.
Allopurinol
Increased incidence of rash, especially in hyperuricemic patients, when co-administered with amoxicillin.
Oral Contraceptives
May decrease the efficacy of oral contraceptives. Advise additional non-hormonal contraceptive methods.
Anticoagulants (e.g., Warfarin)
May prolong prothrombin time and increase the risk of bleeding. Close monitoring of INR is advised.
Storage
Store the dry powder below 25°C (77°F) in a dry place, protected from moisture and direct sunlight. Keep out of reach of children. After reconstitution, store the suspension in a refrigerator (2-8°C / 36-46°F) and discard any unused portion after 7-10 days. Do not freeze.
Overdose
Symptoms of overdose may include gastrointestinal upset (nausea, vomiting, diarrhea), fluid and electrolyte imbalance, and convulsions (especially in patients with impaired renal function or those receiving very high doses). Treatment is symptomatic and supportive. Hemodialysis can effectively remove amoxicillin and clavulanic acid from circulation.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but adequate and well-controlled studies in pregnant women are lacking. Use during pregnancy only if clearly needed. Both amoxicillin and clavulanic acid are excreted into breast milk in small amounts; use with caution in breastfeeding mothers, monitoring for potential adverse effects in the infant (e.g., diarrhea, candidiasis, sensitization).
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Unreconstituted powder: typically 2-3 years from manufacturing date. Reconstituted suspension: 7-10 days when stored in a refrigerator (2-8°C).
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
The efficacy and safety of amoxicillin/clavulanate combination have been extensively studied in numerous clinical trials, establishing its role as a widely used broad-spectrum antibiotic for various bacterial infections in pediatric and adult populations.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) should be monitored, especially in patients with pre-existing hepatic impairment or during prolonged therapy.
- Renal function tests (creatinine, BUN) are advisable for prolonged therapy or in patients with known renal impairment.
- Complete blood count (CBC) may be monitored during prolonged therapy.
Doctor Notes
- Emphasize the importance of completing the full course of therapy, even if symptoms improve, to minimize resistance.
- Educate parents/caregivers on proper reconstitution, storage, and accurate administration of the suspension using the provided measuring device.
- Advise monitoring for signs of allergic reactions (e.g., rash, difficulty breathing) and potential superinfections (e.g., persistent diarrhea, oral thrush).
- Counsel on potential drug interactions, especially with anticoagulants and oral contraceptives.
Patient Guidelines
- Complete the full prescribed course of medication, even if symptoms improve, to prevent the recurrence of infection and the development of antibiotic resistance.
- Shake the bottle well before each use to ensure even distribution of the medicine.
- Use the provided measuring device (spoon or syringe) for accurate dosing, and do not use household spoons.
- Reconstituted suspension should be stored in the refrigerator (2-8°C) and discarded after 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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or headache in some individuals. If you experience these symptoms, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- Practice good personal hygiene to prevent the spread of infection.
- Avoid alcohol during the course of treatment, as it may exacerbate certain side effects.
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