Paracetamol 150mg Injection

Category:- Antibiotics-arv | Type:- Injection

COMPOSITION 
Each ml contains: 
Paracet.amol BP 150 mg 
 

PHARMACOLOGICAL CLASSIFICATION: 
Analgesics&Antipyret:ics 
 

PHARMACOLOGICAL ACTION 
PHARMACODYNAMICS 
The precise mechanism of the analgesic and antipyretic properties of paracetamol has yet to be established; it may involve central and peripheral actions. 
Cetamol Injection Solution for Infusion provides onset of pain relief within 5 to 10 minutes after the start of administration. The peak.analgesic effect is obtained in 1 hour and the duration of this effect is usually 4 to 6 hours. CETAMOL Injection Solution for Infusion reduces fever within 30 minutes after the st.art of administration with duration of the ant:ipyretic effect of at least 6 hours. 
 

PHARMACOKINETICS 
 

Absorption 
Paracetamol pharmacokinet:ics is linear up to 2 g after single administration and after repeated administration during 24 hours. 
The bioavailability of paracetamol following infusion of 500mg and 1 g of CETAMOLinjection Solution for Infusion is similar to that observed following infusion of lg and 2 g propacetamol (containing 500mg and 1 g paracetamol respectively). The maximal plasma concentration (Cmax) of paracetamol observed at the end of 15-minutes intravenous infusion of 500mg and 1 g ofCETAMOLinjection Solution for Infusion is about 15µg/ml and 30 µg/ml respectively. Distribution 
The volume of distribution of paracetamol is approximately 1 L/kg. 
Paracetamol is not extensively bound to plasma proteins. 
Following infusion oft g paracetamol, significant concentrations of paracetamol (about 1.5 µg/mL) were observed in the cerebrospinal fluid at and after the 20th minute following infusion. 
 

Biotransformation 
Paracetamol is metabolized mainly in the liver following two major hepatic pathways: glucuronic acid conjugation and sulfuric acid conjugation. The latter route is rapidly saturable at doses that exceed the therapeutic doses. A small fraction (less than 4%) is metabolized by cytochrome P450 to a reactive intermediate (N-acetyl benzoquinone imine) which, under normal conditions of use, is rapidly detoxified by reduced glutathione and eliminated in the urine after conjugation with cysteine and mercapturic acid. However, during massive overdosing, the quantity of this toxic metabolite is increased. 
 

Elimination 
The metabolites of paracetamol are mainly excreted in the urine. 90% of the dose administered is excreted within 24 hours, mainly as glucuronide (60-80%) and sulfate (20-30%) conjugates. Less than 5% is eliminated unchanged. Plasma half-life is 2.7 hours and total body clearance is 18 Lib.. 
 

INDICATIONS: 
CETAMOL Injection Solution for Infusion is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.