CLAVOXIL 156
-
Chemical Name:
Clavulanic Acid (Potassium Clavulanate) +Amoxicillin (Ttrihydrate) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Penicillin -
Pharmaceutical Form:
Dry powder for suspension -
Composition:
Clavulanic Acid 31.25mg+Amoxicillin 125mg
CLAVOXIL
F.C.Tablets, Dry Powder for Oral Suspension, Dry Powder for Injection (Vial)
Amoxicillin + Clavulanic Acid
Broad Spectrum Antibiotic
1. PROPERTIES:
Amoxicillin is a semi-synthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms, Amoxicillin is, however susceptible to degradation by ß-lactamases, and therefore the spectrum of activity does not include organisms which produce these enzymes. Clavulanic acid is a ß-lactam structurally related to the penicillins, which possesses the ability to inactivate a wide range of ß-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins.
2. INDICATIONS:
CLAVOXIL is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
- Lower Respiratory Tract Infections – caused by β-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
- Otitis Media – caused by β-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
- Sinusitis – caused by β-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
- Skin and Skin Structure Infections – caused by β-lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp.
- Urinary Tract Infections – caused by β-lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp.
- Mixed infections caused by Ampicillin-susceptible organisms and β-lactamase-producing organisms.
3. CONTRAINDICATIONS:
- Amoxicillin + Clavulanate is contraindicated in patients with history of hypersensitivity to penicillins or cephalosporins.
- Previous history of Amoxicillin + Clavulanate associated jaundice/hepatic dysfunction.
4. PRECAUTIONS:
- Before initiating therapy with Amoxicillin + Clavulanate, careful Inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosprins, or other allergens. If an allergic reaction occurs the drug must be discontinued and appropriate therapy must be initiated.
- Changes in liver function tests have been observed in some patients receiving Amoxicillin + Clavulanate. Thus, It should be used with caution in patients with evidence of hepatic dysfunction.
- In patients with moderate or severe renal impairment, Amoxicillin + Clavulanate dosage should be adjusted as recommended in the dosage and administration.
- Periodic assessment of renal, hepatic, and hematopoietic function, is advisable during prolonged therapy.
- Ampicillin-class antibiotics should not be administered to patients with mononucleosis.
- If super infections occur the drug should be discontinued and/or appropriate therapy instituted.
5. PREGNANCY AND LACTATION:
Pregnancy: Class B. Amoxicillin + Clavulanate can be used in pregnancy and nursing mothers only by a medical prescription.
6. INFORMATION FOR THE PATIENT:
Amoxicillin + Clavulanate may be taken 8 or 12 hours according to the product strengths. The dose should be taken with food to reduce the possibility of gastrointestinal upset. Many antibiotics can cause diarrhea. If diarrhea is severe or lasts more than 2 to 3 days, call your doctor.
Keep suspension refrigerated. Shake well before each use. When dosing a child with the suspension, use the dosing spoon. Be sure to rinse the spoon after each use. Follow your doctor's instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.
Patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment, and increase the likelihood that bacteria will develop resistance and will not be treatable by Amoxicillin + Clavulanate or other bacterial drugs in the future.
7.SIDE EFFECTS:
Amoxicillin + Clavulanate is generally well tolerated. The majority of side effects are of mild and transient nature. They consist of diarrhea, nausea, abdominal discomfort, vomiting, skin rashes, urticaria and vaginitis. These side effects disappear upon discontinuation of the therapy.
- Hemic and lymphatic systems: Anemia including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with penicillin.
- Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsion, dizziness and insomnia have been reported rarely.
8. DRUG INTERACTIONS:
- Probenecid reduces the excretion of Amoxicillin + Clavulanate ,coadministration not recommended
- An increased frequency of skin rashes in patients receiving Amoxicillin + Clavulanate with Allopurinol.
- Amoxicillin + Clavulanate may decrease the efficacy of estrogen-containing oral contraceptives.
9. DOSAGE & ADMINISTRATION:
Pediatric Patients:
Neonates and infants aged < 12 weeks (3 months):
Due to incompletely developed renal function affecting elimination of Amoxicillin in this age group, the recommended dose of CLAVOXIL is 30 mg/kg/day divided q12h, based on the Amoxicillin component. Clavulanate elimination is unaltered in this age group. The use of CLAVOXIL 156 is recommended.
Patients aged 12 weeks (3 months) and older:
|
INFECTIONS
|
DOSING REGIMEN
|
|
|
q12h
|
q8h
|
|
|
|
CLAVOXIL 228
or
CLAVOXIL 457
|
CLAVOXIL 156
or
CLAVOXIL 312
|
|
Otitis media, sinusitis, lower
respiratory tract infections,
and more severe infections
|
45 mg/kg/day q12h | 40 mg/kg/day q8h |
|
Less severe infections
|
25 mg/kg/day q12h | 20 mg/kg/day q8h |
- The q12h regimen is recommended as it is associated with significantly less diarrhea.
- Duration of therapy studied and recommended for acute otitis media is 10 days.
- Pediatric patients weighing 40 kg and more should be dosed according to the adult regimen.
- Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Adults:
- Adults who have difficulty swallowing may be given CLAVOXIL 156 or CLAVOXIL 312 suspension in place of the CLAVOXIL 625. The CLAVOXIL 228 or CLAVOXIL 457 may be used in place of CLAVOXIL 1000.
- The usual adult dose is 1 tablet of CLAVOXIL 625 every 12 hours or 1 tablet of CLAVOXIL 375 every 8 hours.
- For more severe infections and infections of the respiratory tract, the dose should be 1 tablet of CLAVOXIL 1000 every 12 hours or 1 tablet of CLAVOXIL 625 every 8 hours.
- Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
- Severely impaired patients with a glomerular filtration rate of <30 mL/min should not receive the CLAVOXIL 1000 tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive CLAVOXIOL 625 or CLAVOXIL 375 every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive CLAVOXIL 625 or CLAVOXIL 375 every 24 hours, depending on severity of the infection.
- Hemodialysis patients should receive CLAVOXIL 625 or CLAVOXIL 375 every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
For Injection:
Adults and children over 12 years old:
The usual dose: 1200 mg CLAVOXIL IV every 8 hours.
In severe infections: 1200 mg CLAVOXIL IV every 6 hours.
Children from 3 months to 12 years old:
The usual dose: 30 mg/kg every 8 hours.
In severs infections: 30 mg/kg every 6 hours.
Neonates up to 3 months old:
The usual dose in premature and newborn babies: 30 mg/kg every 12 hours, could be increased to 30 mg/kg every 8 hours afterward.
Prophylaxis dosage in adults:
The usual dose : 1200 mg CLAVOXIL IV is given at induction.
In high contaminated procedures (eg. E. coli) another 3 – 4 doses of CLAVOXIL IV may be required during the next 24 hours postoperatively, and these doses are usually given at induction, then after 8 hours, then 16 hours, and 24 hours from induction. This treatment may be continued for several days if infection is still suspected. The treatment could be continued afterward with the usual doses either IV or orally.
Dosage in patients with renal failure:
Adults:
| Creatinine Clearance | Dosage |
| > 30 mL/min | Not changed |
| 10 – 30 mL/min | 1200 mg CLAVOXIL IV followed by 600 mg CLAVOXIL IV every 12 hours |
| < 10 mL/min | 1200 mg CLAVOXIL IV followed by 600 mg CLAVOXIL IV every 24 hours |
N.B.: Renal dialysis decreases plasma concentration, therefore, it would be advised to add 600 mg CLAVOXIL IV at the beginning of the dialysis and another 600 mg CLAVOXIL IV at the end.
Children:
Similar reductions in dosage should be made for children.
CLAVOXIL is for IV use either by injection or infusion and not for IM injection.
PREPARATION :
Powder For Injection :
To prepare CLAVOXIL 600 mg IV or CLAVOXIL 1200 mg IV vial add 10 ml of injectable water.
IV injection is given slowly in (3 – 4) minutes and should be used in 20 minutes of preparation either directly into the vein or the infusion tube.
CLAVOXIL IV could be infused with venous fluid contains sodium chloride, but it is not advised to use glucose solutions, dextrose, or bicarbonate where in this case it would be better to give CLAVOXIL IV directly into the vein.
Powder For Suspension:
To prepare CLAVOXIL Dry Powder shake the bottle well to loosen granules then add total amount of water till the mark on the bottle and shake the bottle well to mix the medicine properly.
10. OVERDOSAGE:
Overdosage may be treated symptomatically with attention to serum electrolytes balance. CLAVOXIL may be removed from the circulation by haemodialysis.
11. PACKAGING & COMPOSITION:
- CLAVOXIL 375 - F.C.Tablets: A pack of 6 or 10 f.c.tablets in blister. Each f.c.tablet contains Amoxicillin 250 mg (as Trihydrate), and Clavulanic Acid 125 mg (as Potassium Clavulanate).
- CLAVOXIL 625 - F.C.Tablets: A pack of 6 or 10 or 12 f.c.tablets in blister. Each f.c.tablet contains Amoxicillin 500 mg (as Trihydrate), and Clavulanic Acid 125 mg (as Potassium Clavulanate).
- CLAVOXIL 1000 - F.C.Tablets: A pack of 6 or 10 or 14 f.c.tablets in blister. Each f.c.tablet contains Amoxicillin 875 mg (as Trihydrate), and Clavulanic Acid 125 mg (as Potassium Clavulanate).
- CLAVOXIL 156 – Dry powder for Oral Suspension: A pack of dry powder in a glass bottle of 60 mL. Each 5 mL suspension after reconstitution contains Amoxicillin 125 mg (as Trihydrate), and Clavulanic Acid 31.25 mg (as Potassium Clavulanate).
- CLAVOXIL 228 – Dry powder for Oral Suspension: A pack of dry powder in a glass bottle of 60 mL. Each 5 mL suspension after reconstitution contains Amoxicillin 200 mg (as Trihydrate), and Clavulanic Acid 28.5 mg (as Potassium Clavulanate).
- CLAVOXIL 312 – Dry powder for Oral Suspension: A pack of dry powder in a glass bottle of 60 mL. Each 5 mL suspension after reconstitution contains Amoxicillin 250 mg (as Trihydrate), and Clavulanic Acid 62.5 mg (as Potassium Clavulanate).
- CLAVOXIL 457 – Dry powder for Oral Suspension: A pack of dry powder in a glass bottle of 60 mL. Each 5 mL suspension after reconstitution contains Amoxicillin 400 mg (as Trihydrate), and Clavulanic Acid 57 mg (as Potassium Clavulanate).
- CLAVOXIL 600 – For Injection: A pack of 1 vial. Each vial contains dry powder of Amoxicillin (Sodium) 500 mg and Clavulanic Acid 100 mg (as Potassium Clavulanate).
- CLAVOXIL 1200 – For Injection: A pack of 1 vial. Each vial contains dry powder of Amoxicillin (Sodium) 1000 mg and Clavulanic Acid 200 mg (as Potassium Clavulanate).
12. STORAGE:
Store CLAVOXIL F.C.Tablets, Dry powder for Oral Suspension and for Injection tightly closed in a dry place below 25°C.
-After reconstitution, the suspension should be stored in refrigerator at temperature between (2-8)° C and used within ten days.
- After reconstitution the vial should be stored in refrigerator at temperature between (2-8)° C and used within 20 minutes.
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