Saridon

Saridon is an analgesic combination indicated for the management of headache. The currently global base formulation contains 135 mg of propyphenazone, 260 mg of paracetamol and 55 mg of caffeine.^[1] The combination is designed and said to produce effective analgesia with fast onset of action in 15 minutes, as compared to paracetamol, ibuprofen, or aspirin alone.

It was first launched by Roche in 1933, containing initially pyrithyldione and phenacetin, widely used remedies for fever and pain. It often took on the form “A.P.C” (aspirin-phenacetin-caffeine) but Saridon was reformulated in 1981; replacing the original ingredient phenacetin with paracetamol before the US FDA recall in 1983. It is available in more than 80 countries across Europe, Latin America, Asia and Africa.

Efficacy

Paracetamol, an analgesic and antipyretic substance, has slow onset but has a longer duration of action and is said to be lacking in anti-inflammatory properties. On the other hand, propyphenazone, a non-steroidal anti-inflammatory drug (NSAID), is proven to have a faster onset but shorter duration of action. Therefore, the paracetamol-propyphenazone combination further increases and prolongs the therapeutic activity of propyphenazone: peak plasma concentration increases by about 40% and the elimination half-life is prolonged to about 77 minutes. Caffeine, with a stimulating effect, is a drug that wards off drowsiness and restores alertness. Caffeine, a common additive to analgesic drugs, enhances the analgesic potency of paracetamol-containing analgesics by 41%. In a 1996 Boitel study^[2] wherein subjects suffering from dental pain were given Saridon as needed for seven days.

The mentioned subjects were then asked to assess the efficacy, tolerability and safety of Saridon. Listed below were some conclusions made of Saridon.

• There is a statistically significant decrease in pain severity by 15 minutes and a further significant decrease during the following 45 minutes.
• There is a decreasing need to continue taking medication. Most patients discontinued treatment by day 4 due to complete pain relief.
• Saridon was adjudged “very good” or “good” in efficacy by 89.5% of patients.
• Saridon was adjudged “good” or “moderate” in tolerability by 89.5% of patients.

In order to further establish that Saridon is a well-tolerated analgesic with a faster onset and higher analgesic efficacy than paracetamol, ibuprofen, aspirin, and placebo, a study^[3] in 2002 was then conducted. 500 subjects suffering from dental pain were given Saridon 1,000 mg, paracetamol 1,000 mg, ibuprofen 400 mg, aspirin 1,000 mg, or placebo. All were given as 2 tablets. Listed below were conclusions made of Saridon.

• Saridon was assessed as more efficacious than ibuprofen, paracetamol, aspirin, and placebo. More Saridon patients reported “pain gone” and “pain partly gone” 30 to 240 minutes after administration against paracetamol, ibuprofen, aspirin, and placebo.
• Total pain relief was higher for Saridon 60 to 240 minutes after administration versus other treatments.
• More than 98% of the patients assessed Saridon's tolerability as good, better than ibuprofen and paracetamol.
• Adverse effects were noted in 3% of the Saridon patients, the most common being gastrointestinal disorders.

Safety

Based on a report from Lareb, a Dutch pharmacovigilance center, it was noted that twenty adverse reactions to Saridon had been reported with no mention of fatal to near fatal cases. There was only mention of one acute life threatening case of stridor with urticaria - which was caused by a non-Saridon product. The report was concluded by saying that there was no information available of the incidence of anaphylactic reactions to propyphenazone, and that the Summary of Product Characteristics (SPC) states an incidence of less than 0.01%. The Lareb report suggests the actual incidence to be higher.

References