AMOKLAVIN-BID FILM COATED TABLETS 1000 MG [SIN17489P]
Active ingredients: AMOKLAVIN-BID FILM COATED TABLETS 1000 MG
Product Info
AMOKLAVIN-BID FILM COATED TABLETS 1000 MG
[SIN17489P]
Product information
Active Ingredient and Strength | AMOXICILLIN TRIHYDRATE EQV AMOXICILLIN - 875 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | DEVA HOLDING A.Ş. (SITE NO: 32) - TURKEY |
Registration Number | SIN17489P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J01CR02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
AMOKLAVIN-BID is an antibiotic agent with a notably broad-spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.
AMOKLAVIN-BID should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.
AMOKLAVIN-BID oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites:
Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis (AECB), lobar and bronchopneumonia.
Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections e.g. boils, abscesses, cellulitis, wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess, pericoronitis, acute periodontitis.
Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.
Susceptibility to AMOKLAVIN-BID will vary with geography and time (see Pharmacological Properties, Pharmacodynamics for further information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.
Dosing
4.2 Posology and method of administration
Pharmaceutical form: Film-coated tablets.
Dosage depends on the age and renal function of the patient and the severity of the infection.
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of AMOKLAVIN-BID is optimised when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review. Therapy can be started parenterally and continued with an oral preparation.
Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.
AMOKLAVIN-BID tablets are not recommended in children of 12 years and under.
Adults and Children over 12 years
The usual recommended daily dosage is:

Renal Impairment
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min. The AMOKLAVIN-BID 1 g tablet should only be used in patients with a creatinine clearance (CrCl) rate of more than 30 mL/min.

Hepatic Impairment
Administer with caution; monitor hepatic function at regular intervals.
Contraindications
4.3 Contraindications
AMOKLAVIN-BID is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
AMOKLAVIN-BID is contraindicated in patients with a previous history of amoxicillin/clavulanic acid - associated jaundice/hepatic dysfunction.
