Brand Name :Malidens®IV
Generic name : Paracetamol Infusion I.P. (1.0% w/v)
Strength : 1000 mg/ 100 ml
Pack Size : 100 ml

For short term treatment of moderate pain, especially following surgery and for the short term treatment of fever, when administration by i.v route is clinically justified

General Dosing Information: For the treatment of acute pain or fever, paracetamol may be given as a single or repeated dose. Dose adjustment is not required when converting between oral paracetamol and paracetamol injection dosing in adults and adolescents who weigh 50 kg and above.

Hepatic injury, including the risk of liver failure and death may result by exceeding the maximum mg/kg daily dose of paracetamol. Ensure that the total amount of paracetamol from all routes and from all sources does not exceed the maximum recommended dose to avoid the risk of overdose.
Recommended Dosage : Adults and Adolescents Adults and adolescents weighing 50 kg and over administer paracetamoliv. 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of paracetamolof 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of paracetamolof 4000 mg per day (includes all routes of administration and all paracetamol-containing products including combination products) isthe recommended dosage of paracetamol.
Adults and adolescents weighing under 50 kg: administer paracetamol15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of paracetamolof 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of paracetamolof 75 mg/kg per day (includes all routes of administration and all acetaminophen-containing products including combination products).

Age Group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of paracetamol(by all routes)
Adults and adolescents (13 years and older) weighing ≥ 50 kg 650 mg 1000 mg 1000 mg 4000 mgin 24 hours
Adults and adolescents (13 years and older) weighing < 50 kg 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3750 mg)

Recommended Dosage: Children
Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of paracetamolof 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of paracetamolof 75 mg/kg per dayisthe recommended dosage of paracetamol.

Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of paracetamol(by all routes)
Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3750 mg)

DO NOT USE if particulate matter or discoloration is observed. Examine the vial contents before dose preparation or administering. Administer the contents of the vial intravenously over 15-minutes.
Administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial for adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of paracetamol.

Paracetamol can be administered without further dilution. When preparing paracetamolfor intravenous infusionuse aseptic technique. Do not add other medications to the infusion device or paracetamol vial. The appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration for doses less than 1000 mg. Use aseptic technique to withdraw the appropriate dose (650 mg or weight-based) from an intact sealed paracetamolvial, and place the measured dose in a separate empty, sterile container (e.g. glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL vial of paracetamolis not required for use in patients weighing <50 kg. The unused portion must be discarded . Paracetamol is a single use vial. Place small volume pediatric doses up to 60 mL in volume in a syringe and using a syringe pumpadminister over 15 minutes. In order to prevent the possibility of an air embolism, especially in cases where the paracetamolinfusion is the primary infusion monitor the end of the infusion. Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container administer the dose of paracetamol within 6 hours. Do not add other medications to the paracetamolsolution. As Diazepam and chlorpromazine hydrochloride are physically incompatible withparacetamoldo not administer simultaneously.

Contraindicated in patients with
Known hypersensitivity toparacetamol or to any excipients of product
Severe active liver disease or severe hepatic impairment

Hepatic Injury: Hepatic injury, including the risk of liver failure and death results due to administration of paracetamol in doses higher than recommended. The maximum recommended daily dose ofparacetamol should not be exceeded.

The maximum recommended daily dose of paracetamol includes all paracetamol-containing products administered, including combination products and all routes of paracetamoladministration. Cautious use is recommended when administeringparacetamol in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min) .
Serious Skin Reactions: Rarely, paracetamol may cause serious skin reactions such as Stevens-Johnson Syndrome (SJS), acute generalized exanthematouspustulosis (AGEP), and toxic epidermal necrolysis (TEN), which may be fatal. Immediate discontinuation of the drug at the first appearance of skin rash or any other sign of hypersensitivity is recommended. The , patients should be informed about the signs of serious skin reactions .
Risk of Medication Errors: When prescribing, preparing, and administering paracetamolinjection,take care in order to avoid dosing errors which could result in accidental overdose and death. Be careful to ensure that:

The dose in milliliters (mL) and milligrams (mg) is not confused
For patients under 50 kg weight ,the dosing is based on weight
Properly programmed infusion pumps and
Thetotal daily dose of paracetamolfrom all sources does not exceed maximum daily limits.
Allergy and Hypersensitivity: There are reports of anaphylaxis and hypersensitivity andinfrequent life-threatening anaphylaxis reports associated with the use ofparacetamol. Clinical signs included swelling of the mouth, face, and throat, rash, respiratory distress, urticaria, and pruritus. In thse patients immediate discontinuation of paracetamolis recommended. Avoid paracetamol in patients with paracetamolallergy.
Pregnancy: Pregnancy Category C.
Studies of intravenous paracetamol in pregnant women have not been conducted; There are no reproduction studies of iv paracetamol in animals . Whether paracetamol can cause fetal harm when administered to a pregnant woman is not known. Only if clearly required, paracetamol should be given to a pregnant woman.
Labor and Delivery: Paracetamol should be used in such settings only after a careful benefit-risk assessment as there are no adequate and well-controlled studies with paracetamol during labor and delivery.
Nursing Mothers: Paracetamol is secreted in human milk in small quantities. The calculated infant daily dose of paracetamol is approximately 1 – 2% of the maternal dosebased on data from more than 15 nursing mothers. Caution must be exercised if paracetamol is administered to a nursing woman.
Pediatric Use: The treatment of acute pain and fever with paracetamol in pediatric patients aged 2 years and older the safety and effectiveness of paracetamol is supported by evidence from adequate and well-controlled studies of paracetamol in adults. Paracetamol has not been studied in pediatric patients < 2 years of age. Geriatric Use: Overall differences in safety or effectiveness were not observed between elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Hepatic Impairment In patients with severe hepatic impairment or severe active liver disease, paracetamol is contraindicated and in patients with hepatic impairment or active liver disease ,paracetamol must be used with caution. A reduced total daily dose of paracetamol may be warranted. Patients with Renal Impairment: Longer dosing intervals and a reduced total daily dose of paracetamol may be warranted in cases of severe renal impairment (creatinine clearance ≤ 30 mL/min).

No. Drug Drug Interaction Remarks
Drugs that regulate or induce hepatic cytochrome enzyme CYP2E1 Metabolism of paracetamol can be altered by drugs that regulate or induce hepatic cytochrome enzyme CYP2E1 and increase its hepatotoxic potential. Clinical consequences of these effects have not been established.
Anticoagulants warfarin Chronic oral paracetamol use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio. Since studies have not been performed evaluating the short-term use of paracetamol in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.
Ethanol Ethanol effects are complex, hepatic cytochromes can be induced because of excessive alcohol usage, but ethanol also acts as a competitive inhibitor of the metabolism of paracetamol.

 

  • Common adverse events in adult patients: nausea, headache, vomiting, and insomnia.
  • Other Adverse Reactions Observed during Clinical Studies of paracetemol in Adults
    Blood and lymphatic system disorders: anemia
    General disorders and administration site conditions: edema, peripheral fatigue, site pain, infusion
    Investigations: breath sounds abnormal, aspartate aminotransferase increased
    Metabolism and nutrition disorders: hypokalemia
    Musculoskeletal and connective tissue disorders: trismus, muscle spasms
    Psychiatric disorders: anxiety
    Respiratory, thoracic and mediastinal disorders: dyspnea
    Vascular disorders: hypotension, hypertension
  • Other Adverse Reactions Observed during Clinical Studies of paracetemol in Pediatrics
    Blood and lymphatic system disorders: anemia
    Cardiac disorders: tachycardia
    Gastrointestinal disorders: diarrhea, abdominal pain
    General disorders and administration site conditions: pyrexia, injection site pain, edema peripheral
    Investigations: hepatic enzyme increase
    Metabolism and nutrition disorders: hypervolemia, hypoalbuminemia, hypophosphatemia, hypokalemia, hypomagnesemia,
    Musculoskeletal and connective tissue disorders: pain in extremity, muscle spasm
    Nervous system disorders: headache
    Psychiatric disorders: insomnia
    Renal and urinary disorders: oliguria
    Respiratory, thoracic and mediastinal disorders: wheezing, pulmonary edema, stridor, hypoxia, pleural effusion,
    Skin and subcutaneous tissue disorders: rash, periorbitaledema
    Vascular disorders: hypotension, hypertension

Signs and Symptoms: In acute paracetamol overdosage, potentially fatal, dose-dependent, hepatic necrosis is the most serious adverse reaction. Hypoglycemic coma, Renal tubular necrosis and thrombocytopenia have been reported to occur.

In 90% of patients plasma paracetamol levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage, if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion, minimal hepatic damage is anticipated. Early symptoms after a potentially hepatotoxic overdose include: vomiting, nausea, general malaise and diaphoresis. No clinical and laboratory evidence of hepatic toxicity may be evident until 48 to 72 hours post-ingestion. Treatment: Obtain a serum paracetamol assay as soon as possible, but no sooner than 4 hours following oral ingestion if an paracetamol overdose is suspected. Test the liver function and repeat at 24-hour intervals.Immediately administer the antidote N-acetylcysteine (NAC). The paracetamollevel can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew) as a guide to treatment of acute ingestion. The lower toxic line on the nomogram is equivalent to 37.5 mcg/mL at 12 hoursand 150 mcg/mL at 4 hours. Administer the entire course of NAC treatment if serum level is above the lower line. If the paracetamol level is below the lower line withholding of NAC therapy is recommended .

PharmacodynamicProperties:
Paracetamol has been shown to have antipyretic and analgesic activities in human and animal studies. Repeated doses of paracetamol 1000 mg every 6 hours for 48 hours has not beenshown to cause a significant effect on platelet aggregation.

Read Less << Paracetamol does not have any delayed or immediate effects on small-vessel hemostasis. Pharmacokinetic Properties

Paracetamol does not have any delayed or immediate effects on small-vessel hemostasis.
Pharmacokinetic Properties

Parameters Paracetamol
Absorption At the end of the 15 minute intravenous infusion of paracetamol the maximum concentration (Cmax) occurs.
Pharmacokinetic parameters (area under the concentration time curve (AUC) and maximum concentration (Cmax) of paracetamol following administration of a single intravenous dose of 15 mg/kg for the pediatric population and 1000 mg in adults are as follows.
In Neonates, Infants, Children, Adolescents and Adults, AUC was 62, 57, 38, 41 µg × h/mL and Cmax was 25, 29, 29, 31, 28 µg/mL respectively.
Distribution Paracetamol is widely distributed throughout most body tissues except fat.
Pharmacokinetic parameters (systemic clearance [CL] and volume of distribution at steady state [Vss]) of paracetamol following administration of a single intravenous dose of 15 mg/kg for the pediatric population and 1000 mg in adults are as follows.In Neonates, Infants, Children, Adolescents and Adults, CL was 0.12, 0.29, 0.34, 0.29 and 0.27 L/h/kg and Vss was 1.1, 1.1, 1.2, 1.1 and 1.8 L/kg respectively.
Protein Binding Binding of paracetamolto plasma proteins is low (ranging from 10% to 25%) at therapeutic levels.
Metabolism Paracetamol is primarily metabolized in the liver by first-order kinetics and involves three separate principal pathways:
Conjugation with sulphate, conjugation with glucuronide, and oxidation via the enzyme pathway cytochrome P450, CYP2E1 primarily, to form a intermediate reactive metabolite (NAPQI or N-acetyl-pbenzoquinone imine).
NAPQI undergoes rapid conjugation with glutathione with therapeutic doses, and is then further metabolized to form mercapturic acid and cysteine conjugates.
Excretion Paracetamol metabolites are excreted mainly in the urine. Less than 5% unconjugated (free) paracetamol is excreted in the urine and Within 24 hours more than 90% of the administered dose is excreted.
Half Life Half life (T 1/2) in Neonates, Infants, Children, Adolescents, Adults were 7.0, 4.2, 3.0, 2.9 and 2.4 hour respectively

Recommended Dosage: Children
Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of paracetamolof 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of paracetamolof 75 mg/kg per dayisthe recommended dosage of paracetamol.

Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of paracetamol(by all routes)
Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3750 mg)

Preclinical data reveal no special hazard for humans beyond the information included in other sections of the SmPC. Studies on local tolerance of Paracetamol 10 mg/ml Solution for Infusion in rats and rabbits showed good tolerability.

Absence of delayed contact hypersensitivity has been tested in guinea pigs.
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available

©2025 Abbott, All Rights Reserved.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.