Paracetamol Suppositories

Products

Paracetamol is available in suppository form from several suppliers (e.g., Panadol, Acetalgin, Ben-u-ron, Dafalgan, Tylenol). Available dosages include 80, 125, 250, 300, 350, 500, 600, and 1000 mg. Paracetamol suppositories are used primarily in pediatrics, but they can also be given to adults.

Structure and properties

Paracetamol (C8H9NO2, Mr = 151.2 g/mol) exists as a white crystalline powder that is sparingly soluble in water. It has a slightly bitter taste and is odorless.

Effects

Paracetamol (ATC N02BE01) has analgesic and antipyretic properties, but it has little anti-inflammatory and antiplatelet activity, unlike the nonsteroidal anti-inflammatory drugs (NSAIDs). The effects are based on peripheral and central mechanisms. Maximum plasma concentration is reached after two hours with rectal administration. Onset of action is expected to be more rapid with oral administration.

Indications

For the treatment of mild to moderate pain and for the symptomatic treatment of fever.

Dosage

According to the SmPC. In infants and children under 12 years of age, the single dose and the maximum daily dose depend on body weight. The dosing interval, the time interval between single doses, should be 6 to 8 hours. The instructions in the package leaflet and in the professional information should be followed exactly to avoid dangerous overdose. Other drugs containing acetaminophen should not be administered concomitantly. The duration of therapy is limited to three days for self-medication. Longer lasting pain should be clarified by a doctor. To improve lubrication, the suppository can be warmed in the hand or briefly dipped in warm water. General instructions for the use and administration of suppositories are presented in the article Suppositories.

Contraindications

  • Hypersensitivity
  • Severe liver dysfunction, acute hepatitis, or decompensated active liver disease
  • Hereditary constitutional hyperbilirubinemia (Meulengracht’s disease).

Full details of precautions and interactions can be found in the drug label.

Adverse effects

Possible adverse effects include rarely hypersensitivity reactions, rarely blood count changes, and rarely elevated liver enzyme levels. Overdose can cause severe liver injury and may be fatal in a dose-dependent manner. N-acetylcysteine is given as an antidote.