Propacetamol Hydrochloride

(BANM, rINNM)
Propacetamol Hydrochloride Chemical formula
Synonyms: Hidrocloruro de propacetamol; Propacétamol, chlorhydrate de; Propacetamol-hidroklorid; Propacetamol-hydrochlorid; Propacetamolhydroklorid; Propacetamoli hydrochloridum; Propacetamolio hidrochloridas; Propasetamolihydrokloridi. The hydrochloride of N,N-diethylglycine ester with paracetamol; 4-Acetamidophenyl diethylaminoacetate hydrochloride.
Cyrillic synonym: Пропацетамола Гидрохлорид.

💊 Chemical information

Chemical formula: C14H20N2O3,HCl = 300.8.
CAS — 66532-85-2 (propacetamol).
ATC — N02BE05.
ATC Vet — QN02BE05.

Pharmacopoeias.

In Eur..

Ph. Eur. 6.2

(Propacetamol Hydrochloride). A white or almost white crystalline powder. Freely soluble in water; slightly soluble in dehydrated alcohol; practically insoluble in acetone. Protect from moisture.

💊 Profile

Propacetamol hydrochloride, a para-aminophenol derivative, is hydrolysed to paracetamol in the plasma. It has been given intramuscularly or intravenously in usual doses of 1 to 2 g every 4 hours up to 4 times daily if necessary, to a maximum dose of 8 g daily, for the treatment of pain and fever. For doses in children, see below.

Administration in children.

In some countries propacetamol is used intravenously in the treatment of pain and fever in neonates and children.1,2 Doses range from 20 to 30 mg/kg given over 15 minutes up to 4 times daily, not exceeding a maximum daily dose of 120 mg/kg propacetamol (equivalent to a daily dose of 60 mg/kg of paracetamol).
1. Allegaert K, et al. Pharmacokinetics of single dose intravenous propacetamol in neonates: effect of gestational age. Arch Dis Child Fetal Neonatal Ed 2004; 89: F25–F28
2. Walson PD, et al. Antipyretic efficacy and tolerability of a single intravenous dose of the acetaminophen prodrug propacetamol in children: a randomized, double-blind, placebo-controlled trial. Clin Ther 2006; 28: 762–9.

Adverse effects.

Occupational contact dermatitis has been reported in healthcare professionals after preparing injections of propacetamol.1-3 Propacetamol is the hydrochloride of N,N-diethylglycine ester with paracetamol and the results of a study4 have suggested that allergic reactions to propacetamol are related to sensitisation to the activated ester rather than to paracetamol itself.
1. Barbaud A, et al. Occupational allergy to propacetamol. Lancet 1995; 346: 902
2. Szczurko C, et al. Occupational contact dermatitis from propacetamol. Contact Dermatitis 1996; 35: 299–301
3. Gielen K, et al. Occupational allergic contact dermatitis from drugs in healthcare workers Contact Dermatitis 2001; 45: 273–9
4. Berl V, et al. Mechanism of allergic contact dermatitis from propacetamol: sensitization to activated N,N-diethylglycine. Contact Dermatitis 1998; 38: 185–8.

💊 Preparations

Proprietary Preparations

Belg.: Pro-Dafalgan†; Denm.: Pro-Dafalgan†; Fin.: Pro-Dafalgan†; Gr.: Pro-Dafalgan; Pro-depon†; Israel: Pro-Dafalgan†; Ital.: Pro-Efferalgan†; Mex.: Te m pr a† ; Norw.: Pro-Dafalgan; Port.: Pro-Dafalgan†; Spain: ProEfferalgan†; Swed.: Pro-Dafalgan†; Switz.: Pro-Dafalgan†.
Published March 12, 2019.