Pharmacology: Pharmacodynamics: Ibuprofen is an analgesic-anti-inflammatory drug, also endowed with antipyretic properties. It is a phenylpropionic acid derivative and its analgesic action is not of narcotic type. Its pharmacological activity is based on the prostaglandin synthesis inhibition at peripheral level.
Pharmacokinetics: Spedifen allows a high and prompt ibuprofen absorption, due to the presence of the amino acid L-arginine, that favors its solubilization and improves its bioavailability, thus reaching plasma concentration peaks 20 min after administration. Spedifen administration did not show evidence of accumulation phenomena, both for ibuprofen arginine and its metabolites. Its plasma half-life is 2 hrs and the drug excretion is practically complete 24 hrs after last administration.
Toxicology: Preclinical Safety Data: In some reproduction studies on animals, an increase in dystocia and labor delay were observed, which are related to prostaglandin synthesis inhibition induced by nonsteroidal anti-inflammatory drugs.