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.

General information

Caffeine, paracetamol, propyphenazone^[2]

Medical uses

For the relief of mild to severe headaches, relief of pain such as headache, toothache, menstrual discomfort, postoperative and rheumatic pain, and for pain and fever associated with colds and flu.

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.^[3] On the other hand, propyphenazone, a non-steroidal anti-inflammatory drug (NSAID), is proven to have a faster onset but shorter duration of action.^[4] 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^[5] 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^[6] 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. ^[7]
• 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.^[8]
• Adverse effects were noted in 3% of the Saridon patients, the most common being gastrointestinal disorders, such as diarrhea.

Adverse effects

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.

Precaution

Impaired hepatic and renal function. Gilbert's syndrome. Hematopoetic dysfunction. Should not be taken regularly for a prolonged period since it may lead to analgesic nephropathy, irreversible renal insufficiency, chronic headaches. Asthma, chronic rhinitis or chronic urticaria.

Drug Interaction

Hypnotics, phenobarbital, phenytoin, carbamazepine, rifampicin, propanthelin, metoclopramide, chloramphenicol, zidovudine, barbiturates, antihistaminics, benzodiazepines, oral contraceptives, cimetidine, disulfiram, theophylline, ephedrine, smoking, alcohol.

Side effect

Skin rash, urticaria, pruritus, erythema, angioedema, dyspnea, asthma, anaphylactoid reactions, thrombocytopenia, leucopenia, agranulocytosis, pancytopenia.

Contraindication

Hypersensitivity to phenazone, propyphenazone, aminophenazone, metamizol-containing compounds, phenylbutazone-containing products, paracetamol, acetylsalicylic acid. Known allergy to caffeine. Glucose-6-phosphate dehydrogenase deficiency. Acute hepatic porphyria. Pregnancy, lactation. Infants or children under 12 years.

Society and culture

Banned

“WHO Comment : Propyphenazone, a pyrazolone derivative with anti-inflammatory, analgesic and antipyretic activity, was introduced in 1951 for the treatment of rheumatic 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 for aminophenazone. 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]

• Sri Lanka ^[10]
• Korea ^[10]

“SEOUL - Amid rising claims that it isn't moving fast enough to counter public concern over the safety of OTC painkillers, Korea FDA has banned Bayer Korea's painkiller Saridon-A, Samjin Pharm's Geworin and 26 other products from being prescribed or sold over the counter to those under 15 years of age”^[11]

• Malaysia ^[10]
• Thailand ^[10]
• Turkey: Banned for Production and sale Jan. 1986 having regard to severe adverse reaction. ^[9]

India

In India, Saridon is made available by Piramal Enterprises Ltd. ^[12] Mostly used by common man to get relief from headache. Saridon is available at INR 19.95 (as of October 2014) per a strip which contains 10 tablets. It is widely regarded in India as an efficient medicine to counter headaches.

The formulation in India consists of 150 mg of propyphenazone, 250 mg of paracetamol and 50 mg of caffeine.

Philippines

Saridon is available in the Philippines 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.

Advertising

Right before its launch in the Luzon region, Saridon launched its 15-seconder TVC material entitled “Building” in January 24, 2011.^[13] The brand’s personality is “emphatic, with a quirk; highly credible, but non-alienating; dependable and reassuring.” Bayer Philippines, Inc. aims to launch Saridon on a nationwide scale as a strong player in the analgesics market. The brand also launched its campaign jingle in order to promote top of mind recall and encourage users to switch from competition.

Above-the-line campaigns, supported by strong below-the-line efforts, are being implemented to induce trial among its target market. The brand has collaborated with radio stations in promoting its jingle and launched its 3-month television campaign in order to promote brand awareness. The brand also conducts “sampling fares” during town fiestas and distributes its products for free in public markets, grocery stores, and supermarkets all over the country.

References