Propyphenazone/paracetamol/caffeine

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Propyphenazone/paracetamol/caffeine (trade name Saridon ) is an analgesic combination indicated for headache management. It contains analgesics of propyphenazone and paracetamol and caffeine stimulants.

Saridon was first launched by Roche in 1933, initially containing pyrithyldione and phenacetin, a drug widely used for fever and pain. It often contains aspirin, phenacetin and caffeine, but was formulated in 1981, replacing the original ingredient phenacetin with paracetamol, before phenacetin was banned by the US FDA in 1983. It is available in more than 80 countries across Europe, Latin America, Asia and Africa, but has been discontinued in many of them.

Video Propyphenazone/paracetamol/caffeine

Medical use

This combination is used to relieve pain such as headache, toothache, menstrual discomfort, pain and fever associated with colds and flu, and for postoperative and rheumatic pain.

Benefits

Paracetamol, an analgesic and antipyretic substance, has a slow onset but has a longer duration of action and has less anti-inflammatory properties. On the other hand, propyphenazone, a non-steroidal anti-inflammatory drug (NSAID), is shown to have a faster onset but shorter duration of action. The combination of paracetamol and propifenezone increased and prolonged the therapeutic activity of propifenzone: the blood plasma concentration increased by about 40%, and the elimination half-life was extended to about 77 min. Caffeine, with its stimulating effect, is a drug that prevents drowsiness and restores alertness. This also increases the potential for paracetamol analgesics, although Cochrane's review concludes that a dose of 100 mg is required for the effect - twice the amount contained in Saridon.

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Adverse effects

Side effects are rare and include skin rashes, pruritus (itching), erythema, angioedema, respiratory problems such as dyspnea and asthma, anaphylaxis (serious allergic reactions), and decreased blood cell counts such as thrombocytopenia, leukopenia, agranulocytosis, and pancytopenia. The last kind of side effects can be severe.

Based on a report from Lareb, a Dutch pharmacovigilance center, it was noted that twenty adverse reactions to Saridon have been reported with no mention of fatal cases to nearly fatal. The report concludes by saying that no information is available about the incidence of anaphylactic reactions to propyphenazone, and that the product character summary (SPC) states the incidence is less than 0.01%. The Lareb report shows the actual incidence to be higher.

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Interactions

Known interactions are mostly related to the paracetamol component. Barbiturates, phenytoin, carbamazepine and rifampicin promote the formation of toxic paracetamol metabolites in the liver. Alcohol also increases the liver toxicity of paracetamol. Combination of zidovudine with paracetamol may increase the risk of neutropenia. Elimination of chloramphenicol prolonged fivefold by paracetamol.

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Contraindications

Contraindications are hypersensitivity to phenazone, propyphenazone, aminophenezone, metamizol, phenylbutazone, paracetamol, acetylsalicylic acid, or caffeine; bone marrow deficiency; lack of glucose-6-phosphate dehydrogenase; acute liver porphyria; alcoholism; gastrointestinal ulcers or bleeding; pregnancy and breastfeeding; infants and children under 6 to 12 years (varies by country).

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Society and culture

Banned

WHO commentary: "Propyphenazone, a pyrazolone derivative with anti-inflammatory, analgesic and antipyretic activity, was introduced in 1951 for the treatment of rheumatic disorders because structurally associated with aminophenzone has been associated with severe blood dyscrasias, but can not be converted to potentially carcinogenic nitrosamines and therefore has been widely used as a substitute for aminophenols. 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. "

• Sri Lanka
• Malaysia
• Thailand
• Turkey: Banned for production and sale in January 1986 due to severe adverse reactions.

India

In India, Saridon is provided by Piramal Enterprises Ltd. Mostly used by ordinary people to get help from headaches. Saridon is available at INR 24.10 (as of November 2016) per strip with 10 tablets.

Formulations in India consist of 150 mg of propifenzone, 250 mg of paracetamol and 50 mg of caffeine.

Another commonly available Dart drug also consists of a combination similar to 150 mg of propyphenazone, 300 mg of paracetamol and 50 mg of caffeine.

Philippines

Saridon is available in Philippines and sold at suggested retail price of PhP4.35 per tablet. Originally available only in the Visayas-Mindanao region, it was launched in Luzon in 2011 with the aim of replicating its success in Visayas and Mindanao within the national scope.

Saridon is the only pain medication in a country that has three active ingredients, and the only one that registers caffeine as one of its ingredients.

Singapore

Saridon is not found in the Singapore market anymore. In old copies of DIM, it is noted that it contains propifenzone 150 mg, ethoxybenzamide 250 mg, pyrithyldione 50 mg, and caffeine 50 mg. Please look for old references to verify.

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References

Source of the article : Wikipedia