NEWCLAV 642GM SUSP 100ML; amoxicillin, clavulanic acid, antibacterials .
ACTIVE-INGREDIENT OF NEWCLAV 642GM SUSP 100ML
Each 5 ml contains: Amoxicillin trihydrate 688.73 mg (equivalent to 600 mg amoxicillin Base) Potassium clavulanate/ silicon dioxide mixture (1:1) eq. to 50.5 mgPotassium clavulanate ( 42.9 mg clavulanic acid).
INDICATION OF NEWCLAV 642GM SUSP 100ML
New – Clav Extra is indicated in the treatment of pediatric patients with recurrent or persistant acute otitis media due to S. pneumoniae (penicillin MICs = 2 mcg/ml), H. influenzae (including ß-lactamase-producing strains ), M. catarrhalis ( including ß-lactamase-producing strains ),or chjaracterized by the following risk factors: antibiotic exposure for acute otitis media within the preceding 3 moths, and either of the following : - age = 2 years. - daycare attendance. Other New - Clav formulations are indicated for short-term treatment of bacterial infections at the following sites when caused by New - Clav susceptible organisms: Upper respiratory tract infection (including ENT) : e.g. recurrent tonsilitis, sinusitis, otitis media typically caused by Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis and Streptococcus pyogens. Lower respiratory tract infections : e.g. acute extrcerbations of chronic bronchitis, lobar and bronchopneumonia typically caused by Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis . Genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections typically caused Enterobacteriaceae ( mainly Eschericia coli) Staphylococcus saprophyticus & Enterococcus species, and gonorrhea caused by Neisseria gonorrhoeae. Skin and soft tissue infections typically caused by Streptococcus pyogens & Bacteriodes species.
DOSAGE OF NEWCLAV 642GM SUSP 100ML
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Pediatric patients 3 months and older: The recommended dose for New – Clav Extra is 90/6.4 mg/kg/day. In two divided doses at 12-hourly intervals for 10 days. There is no experience in paediatric patients weighing > 40 kg. or in adults. There are no clinical data on New – Clav Extra in children under 3 months of age. Body weight : 8 kg 3.0 ml twice daily 12 kg 4.5 ml twice daily 16 kg 6.0 ml twice daily 20 kg 7.5 ml twice daily 24 kg 9.0 ml twice daily 28 kg 10.5 ml twice daily 32 kg 12.0 ml twice daily 36 kg 13.5 ml twice daily Hepatic impairment: Dose with caution; monitor hepatic function at regular intervals. There are insufficient data on which to base a dosage recommendations. Renal impairment : There are no dosing recommendations for New-Clav Extra in patients with renal impairment. Method af administration: To minimize the potential for gastrointestinal intolerance , New-Clav Extra should be taken at the start of meal. Treatment should not be extended beyond 14 days without review.
OVER-DOSAGE OF NEWCLAV 642GM SUSP 100ML
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically , with attention to the water/electrolyte balance. Amoxicillin crystalluria in some cases leading to renal failure, has been observed. New – Clav Extra can be removed from the circulation by haemodialysis. A prospective study of 51 pediatric patients at a position control centre suggested that overdosage of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
CONTRA-INDICATION OF NEWCLAV 642GM SUSP 100ML
New-Clav Extra is contraindicated in patients, with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. New-Clav Extra is contraindicated in patients with a previous history of Amoxicillin-associated jaundice/hepatic dysfunction.
STORAGE OF NEWCLAV 642GM SUSP 100ML
Stored in well sealed container, in a dry place at or below 25 °C. Reconstituated suspensions should be stored in a refrigerator (2-8 °C) and used within 10 days.
PACK OF NEWCLAV 642GM SUSP 100ML
Bottle of 100 ml after reconstitution with sterile water and inner leaflet.
NEWCLAV 642GM SUSP 100ML MANUFACTURED BY
Sigmatec Pharmaceutical Industries for Al Andalous For Pharmaceutical Industries.