| Product name |
Paracetamol injection/infusion |
| Specification |
1g:100ml |
| Package |
72bottles/carton |
Paracetamol Infusion 1000mg/100ml
Composition:
Each 100ml contains:1000mgParacetamolWater for Injection q.s 100m
PHARMACOLOGICALPROPERTIES:
Pharmacotherapeutic group: Other analgesicsand antipyreticsPharmacodynamic properties:The precise mechanism of the analgesic andantipyretic properties of paracetamol has yet tobe established;it mayinvolve central andperipheral actions.Paracetamol Infusion provides onset of painrelief within 5 to 10 minutes after the start ofadministration.The peak analgesic effect isobtained in 1 hour and the duration of this effect isusually 4 to 6 hours.Paracetamol infusion reduces fever within 30minutes after the start of administration with aduration of the antipyretic effect of at least 6 hours .
Pharmacokinetic properties:Adults:
Absorption:Paracetamol pharmacokinetics is linear up to 2 gafter single administration and after repeatedadministration during 24 hours.The bioavailability of paracetamol followinginfusion of 500 mg and 1 g of ParacetamolInfusion is similar to that observed followinginfusion of1gand 2gpropacetamol(corresponding to 500 mg and 1 g paracetamolrespectively).The maximalplasmaconcentration(Cmax)of paracetamol observedat the end of 15-minutes intravenous infusion of500 mg and 1 g of Paracetamol Infusion is about15 ug/mL and 30 ug/mLrespectively.
Distribution:The volume of distribution of paracetamol isapproximately 1 L/kg.Paracetamol is not extensively bound to plasmaproteins.Following infusion of 1 g paracetamol, significantconcentrations of paracetamol (about 1.5 μg/mL)were observed in the Cerebro Spinal Fluid as andfrom the 20th minute following infusion.Metabolism:Paracetamol is metabolised mainly in the liverfollowing two major hepatic pathways: giucuronicacid conjugation and sulphuric acid conjugation.The latter route is rapidly saturable at doses thatexceed the therapeutic doses.A small fraction(less than 4%)is metabolised by cytochromeP450 to areactive intermediate(N-acetylbenzoquinone imine)which,undernormaconditions ofuse,is rapidly detoxified by reducedglutathione and eliminated in the urine afterconjugation with cysteine and mercapturic acid.However, during massive overdosing,thequantityofthis toxic metabolite isincreased.
Elimination:The metabolites of paracetamol are mainlyexcreted in the urine.90%of the doseadministered is excreted in 24 hours, mainly as(60-80%)andsulfate(20-30%glucuronideconjugates.Less than5%iseliminatedunchanged.Plasmahalf-life is 2.7 hours and totalbody clearance is 18 L/h.
INDICATIONS:Paracetamol infusion is indicated for the short-term treatment of moderate pain, especiallyfollowing surgery and for the short-termtreatment of fever, when administration byintravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/orwhen other routes of administration are not possible.
Precautions:
Paracetamol should be used with caution in casesof:
.hepatocellularinsufficiency,.severe renal insufficiency(creatinine clearance≤ 30 mL/min),
chronic alcoholism,.chronic mainutrition(low reserves of hepaticgluthatione),
dehydration.
Must not be used in series connections.lfvisible solid particles are observed, do not usethe solution.
INTERACTIONS: Probenecid causes an almost 2-fold reduction inclearance ofparacetamol byinhibiting itsconjugation with glucuronic acid. A reduction ofthe paracetamol dose should be considered forconcomitant treatment with probenecid.Salicylamide may prolong the elimination t1/2 ofparacetamol.*Caution should be paid to the concomitant intakeofenzyme-inducing substances..Concomitant use of paracetamol (4 g per day forat least 4 days) with oral anticoagulants may leadto slight variations of lNR values. In this case,increased monitoring of INR values should beconducted during the period of concomitant useas well as for 1 week after paracetamol treatmenthas been discontinued.
Symptomatic treatment:
Hepatic tests must be carried out at the beginningof treatment and repeated every 24 hours.in mostcases hepatic transaminases return to normal inone to two weeks with full restitution of liverfunction.In very severe cases, however, livertransplantation may be necessary
Storage:Do not store above 25°CDo not refrigerate or freeze.
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