Spedifen Mechanism of Action

ATC code: M01AE01.
Pharmacology: Pharmacodynamics: Spedifen contains the active ingredient Ibuprofen in the form of arginine salt.
Ibuprofen is a non-steroidal anti-inflammatory drug with analgesic, antirheumatic and antipyretic properties. Its action is based primarily on a synthesis inhibition of prostaglandins, which play a role in inflammatory and painful processes. Ibuprofen arginine has the same pharmacological properties as ibuprofen but is characterized by higher water solubility.
It is effective after approximately 30 minutes.
Pharmacokinetics: Absorption: The active substance peak concentrations of 24 and 40 μg/ml ibuprofen are achieved in serum 28-42 minutes after oral administration of ibuprofen 200 mg and respectively 400 mg (as ibuprofen arginine).
If Spedifen is taken after meals, the absorption will be slower and the maximum plasma concentrations will be lower.
Distribution: Serum half-life is 1.5-2 hours. Protein binding is approx. 99 %.
Metabolism: After hepatic metabolism, ibuprofen is eliminated rapidly, predominantly in the form of pharmacologically inactive metabolites and especially through the kidneys.
Elimination: Ibuprofen does not accumulate even during long-term therapy, with ibuprofen and its metabolites being almost completely eliminated 24 hours after the last dose.
Toxicology: Preclinical Safety Data: Mutagenicity: In vitro and in vivo studies (bacteria, human lymphocytes) for mutagenicity revealed no evidence of any mutagenic effects of ibuprofen. In studies on the tumorigenic potential of ibuprofen in rats and mice, no evidence of carcinogenic effects of ibuprofen was found.
Reproductive toxicity: Experimental studies in two animal species have shown that ibuprofen crosses the placenta; however, there was no indication of any teratogenic effects.