Clavulanic acid + Amoxycillin-(FDC-List) (Aug 1990)
Drug Name:
Clavulanic acid + Amoxycillin-(FDC-List) (Aug 1990)
List Of Brands:
Indication Type Description:
Drug Interaction:
Potentiates action of ampicillin and ticarcillin. Infact it is commercially available,only in combination with either of them.
Refer amoxycillin.
Indication:
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Clavulanate Antibiotic SmithKline 25-12-2001
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Clavulanic acid as potassium salt 200mg+ 07-08-1990
Amoxycillin as sodium salt 1gm injection
For the treatment of bacterial infection such as sinusitis otitis
modia tonsilitis, acute and chronic bronchitis, skin and soft
tissue infections, pelvic infections, osteomylitis post operative
pain
Upper and lower respiratory tract infection
Genito-urinary tract infection Skin and soft tissue infection
Septicaemia
Post operative infections
Adverse Reaction:
Anaphylaxis produced by amoxycillin component.
GI upset,glositis,black hairy tongue,
pseudomembranous colitis,
hypersensitivity reaction(skin rash,urticaria,arthalgia,myalgia),
Impairment of liver function,anaemia,
Thrombocytopenia,leucopenia,
Rarely agitation,anxiety,
Insomnia,confusion,
Behavioural changes, dizziness.
Contra-Indications:
Hypersens to penicilline or sensitivity to multiple allergens,bacterial resistence.
Special Precautions:
Renal impairment.
Monitoring of renal,hepatic and haemato-logical functions during prolonged therapy,
Lactation and pregnancy.
Dosages/ Overdosage Etc:
Indication-
Upper and lower respiratoryn tract infection
Genito-urinary tract infection
Skin and soft tissue infection
Septicaemia
Post operative infections
Dosage
1 tablet 3 times a day before meals for upto 14 days then review
Severe infections- 2 tabs thrice daily
Pregnancy and lactation:
Observe caution when use during pregnancy or lactation is required