Acetaminophen

Acetaminophen is to be administered by intravenous infusion. It is usually dissolved in 100 ml Sodium Chloride 0.9% Sterile Solution (or alternative solutions) or according to doctor’s decision. The 100 ml produced solution is administered by intravenous infusion, in a time interval of 15 min.

Before administration, Acetaminophen should be visually inspected for any particulate matter and discoloration. Acetaminophen is intended for single use only. Any unused solution or waste material should be discarded.

Acetaminophen 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.

Acetaminophen reduces fever within 30 minutes after the start of administration with duration of the antipyretic effect of at least 6 hours.

 Adolescents and adults who weigh more than 50 kg:

1 g of Acetaminophen per dose up to four times a day. The ampoule content is dissolved in Sodium Chloride 0.9% Sterile Solution (or alternative solutions), usually in a 100 ml vial, and is administered immediately.

The minimum interval between each administration must be at least 4 hours.

The maximum daily dose must not exceed 4 g.

Serious renal insufficiency:

When Acetaminophen is administered in patients with severe renal insufficiency (creatinine clearance ≤30 ml/min), the minimum interval between each administration must be at least 6 hours and a reduced total daily dose of Acetaminophen may be warranted.

In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione) and dehydration: The maximum daily dose must not exceed 3 g.

Children, adolescents and adults weighing 33 to 50 kg and Children weighing 10 to 33 kg (approx 1-11 years old):

 15 mg/kg up to four times a day.

The minimum interval between each administration must be at least 4 hours.

0.1 ml of Acetaminophen dissolved in 1.5 ml of Sodium Chloride 0.9% Sterile Solution (or alternative solutions) per Kg of body weight.

Another way is to dissolve the ampoule content into a 100 ml of Sodium Chloride 0.9% Sterile Solution (or alternative solutions) and administer 1.5 ml of the resulting solution per Kg of body weight.

Maximum daily dose :60 mg/Kg of body weight. Maximum 3 g.

 Alternative solutions: 0.9% sodium chloride, Lactated Ringer’s, 3.33% Dextrose/0.3% NaCl, 5.0% Dextrose.

Acetaminophen is stable for 4 hours in intravenous admixtures with these alternative solutions.

Incompatibilities

Acetaminophen should not be mixed with other medicinal products, diazepam and chlorpromazine are physically incompatible with acetaminophen.

Contraindications:

Acetaminophen is contraindicated in patients with:

-Hypersensitivity to Acetaminophen or to one of the product’s excipients.

-Cases of severe hepatocellular insufficiency or severe active liver disease.

Interactions:

Alcohol, Phenobarbital, Carbamazepine, Busulfan, Warfarin, Lamotrigine, Prilocaine, Cholestyramine resin

Pregnancy and Lactation:

Pregnancy: Clinical experience of intravenous administration of Acetaminophen is limited. Reproductive studies with the intravenous form of Acetaminophen have not been performed in animals.

Acetaminophen should only be used during pregnancy after a careful benefit-risk assessment. In this case, the recommended posology and duration must be strictly observed.

Lactation: Low amounts of acetaminophen is exerted into breast milk. No undesirable effects on nursing infants have been reported. Consequently, may be used in breast-feeding women.

Warning and Precaution:

-In order to avoid the risk of overdose, one should check that other medicinal products administered along with, do not contain Acetaminophen.

-Doses higher than the recommended ones entails risk for hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Acetaminophen. Clinical symptoms and signs of liver damage are usually first seen after two days of drug administration, with a peak seen usually after 4 to 6 days.

-Treatment with antidote should be given as soon as possible 

– Acetaminophen has been associated with a risk of rare but serious skin reactions.

Anyone who develops a skin rash or reaction while using Acetaminophen l should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with Acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers.

Acetaminophen l should be used with caution in the following cases:

– Hepatocellular insufficiency, or active hepatic disease,

-Severe renal insufficiency (creatinine clearance ≤ 30 ml/min)

-Chronic alcoholism

– Chronic malnutrition (low levels of hepatic glutathione),

-Severe hypovolemia (e.g., due to dehydration or blood loss)

Adverse Reactions:

Rare: Malaise, Hypotension, Increased levels of hepatic transaminases

Very rare: Cases of hypersensitivity reactions ranging from dyspnea, hypotension and skin rash or urticaria to anaphylactic shock have been reported. Clinical signs include swelling of the face, mouth and throat, respiratory distress, urticaria, rash and pruritis.

Discontinue immediately if symptoms associated with allergy or hypersensitivity occur.

Cases of erythema, flushing, pruritus and tachycardia have been reported.

Storage:

Store below 30 and protect from light and moisture.