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| Combination of | |
|---|---|
| Propyphenazone | Analgesic |
| Paracetamol | Analgesic |
| Caffeine | Stimulant |
| Clinical data | |
| Trade names | Saridon, Caffetin light, Bodrex Migra |
| AHFS/Drugs.com | International Drug Names |
| Routes of administration | By mouth |
| ATC code | |
| Identifiers | |
| CAS Number | |
| ChemSpider |
|
Propyphenazone/paracetamol/caffeine (trade nameSaridon) is ananalgesic combination indicated for the management ofheadache. It contains the analgesicspropyphenazone andparacetamol and the stimulantcaffeine.[1][2]
Saridon was first launched byRoche in 1933, initially containingpyrithyldione andphenacetin, widely used remedies forfever andpain. It often contained aspirin, phenacetin and caffeine, but was reformulated in 1981, replacing the original ingredient phenacetin with paracetamol, before phenacetin was banned by the USFDA in 1983. It was available in more than 80 countries across Europe, Latin America, Asia and Africa, but has been discontinued in many of them.[citation needed]
This combination is used for the relief of pain such as headache, toothache,menstrual discomfort, pain and fever associated with colds and flu,[2] and for postoperative and rheumatic pain.
Paracetamol, an analgesic and antipyretic substance, has slow onset but has a longer duration of action and is lackinganti-inflammatory properties.[3] On the other hand, propyphenazone, anon-steroidal anti-inflammatory drug (NSAID), is proven to have a faster onset but shorter duration of action.[4] The combination of paracetamol and propyphenazone increases and prolongs the therapeutic activity of propyphenazone: peakblood plasma concentrations increase by about 40%, and theelimination half-life is prolonged to about 77 minutes.[citation needed] Caffeine, with a stimulating effect, is a drug that wards off drowsiness and restores alertness. It also enhances the analgesic potency of paracetamol, although aCochrane review concluded that a dose of 100 mg is needed for an effect – double the amount contained in Saridon.[5]
Adverse effects are uncommon and include skin rashes,pruritus (itching),erythema,angioedema, breathing problems such asdyspnea and asthma,anaphylaxis (serious allergic reactions), and decrease in the number of blood cells such asthrombocytopenia,leucopenia,agranulocytosis, andpancytopenia.[2] The latter type of side effect can be severe.[6]
Based on a 2004 report from Lareb, a Dutchpharmacovigilance center, it was noted that twenty adverse reactions to Saridon had been reported with no mention of fatal to near fatal cases. The report 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.[7]
Known interactions are mostly related to the paracetamol component.Barbiturates,phenytoin,carbamazepine andrifampicin increase the formation of toxic paracetamolmetabolites in the liver.Alcohol also increases paracetamol's liver toxicity. The combination ofzidovudine with paracetamol can increase the risk of neutropenia. Elimination ofchloramphenicol is prolonged five-fold by paracetamol.[2][8]
Contraindications are hypersensitivity tophenazone, propyphenazone,aminophenazone,metamizol,phenylbutazone, paracetamol,acetylsalicylic acid, or caffeine;bone marrow deficiencies;glucose-6-phosphate dehydrogenase deficiency; acutehepatic porphyria; alcoholism;gastrointestinal ulcers or bleeding; pregnancy and lactation; infants and children under 6 to 12 years (varying by country).[2]
WHO comment: "Propyphenazone, apyrazolone derivative withanti-inflammatory,analgesic andantipyretic activity, was introduced in 1951 for the treatment ofrheumatic disorders. As it is structurally related to aminophenazone it has been associated with severe blood dyscrasias. However, it cannot be transformed into potentially carcinogenic nitrosamines and has therefore been widely used as a replacement drug foraminophenazone. In certain countries, products containing propyphenazone have now been restricted in their indications, whereas in others they are still available, sometimes as over-the-counter preparations."[9]
Available without prescription as of 2025.
In September 2018, Saridon, along with 327 otherFDCs, was banned by theCentral Drugs Standard Control Organisation.[11].Later, in the same month, based on extensive safety data submitted by Piramal, the Supreme Court of India stayed the centre's decision and allowed the sale of Saridon.[12]
Saridon was made available byPiramal Enterprises Ltd.[13] Commonly used to get relief from a headache, Saridon was available at ₹ 46.50 (As of 2023[update]) per a strip which contained 10 tablets, marketed byBayer pharmaceuticals pvt ltd India. The formulation in India consisted of 150mg ofpropyphenazone, 250 mg ofparacetamol and 50 mg ofcaffeine. Another medicine Dart commonly available also consists similar combination with 150mg ofpropyphenazone, 300 mg ofparacetamol and 50 mg ofcaffeine.
Saridon is available in thePhilippines and is being sold at a suggested retail price of PhP4.35 per tablet. Initially available in the Visayas-Mindanao region only, it was rolled out in Luzon in 2011 with the goal of replicating its success in Visayas and Mindanao in a national scope.
Saridon is the only pain medication in the country that has three active ingredients, and the only one listing caffeine as one of its ingredients.
Saridon is not found in the Singapore market anymore (valid 2016, 2019).[14] In an old copy of DIMS, it was listed that it contained propyphenazone 150 mg,ethoxybenzamide[clarification needed] 250 mg,pyrithyldione 50 mg, and caffeine 50 mg.[15] Please look for an old reference to verify.
| pyrazolones / pyrazolidines | |
|---|---|
| salicylates | |
| acetic acid derivatives and related substances | |
| oxicams | |
| propionic acid derivatives (profens) |
|
| n-arylanthranilic acids (fenamates) | |
| COX-2 inhibitors (coxibs) | |
| other | |
| NSAID combinations | |
Key:underline indicates initially developed first-in-class compound of specific group;#WHO-Essential Medicines;†withdrawn drugs;‡veterinary use. | |
