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.

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.

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]

“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]

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 ₹ 22.00 (as of February 2016) 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.

Singapore

Saridon is discontinued from the Singapore market.[13] In an old copy of DIMS, it was listed that it contained propyphenazone 150 mg, ethoxybenzamide 250 mg, prithyldione 50 mg, and caffeine 50 mg.[14]

References

  1. ↑ Voelker, Michael & Petersen, Birte. (2009). “Saridon Summary of Clinical Overview”. 1-3.
  2. ↑ "Saridon | The Filipino Doctor | Find Doctors, Clinics, Hospitals and Drug Information in the Philippines". Saridon.thefilipinodoctor.com. Retrieved 2012-07-24.
  3. ↑ "Saridon – Saridon headache | saridon.thefilipinodoctor.com". Saridon.org. 2012-02-17. Retrieved 2012-07-24.
  4. ↑ http://www.mims.com/Indonesia/drug/info/Saridon/Saridon%20tab
  5. ↑ Boitel, N. (1996). “European Journal of Clinical Research”. 211-217.
  6. ↑ Kiersch, Theodore & Minic, Milos. (2002). “The Onset of Action and the Analgesic Efficacy of Saridon”. 18-25.
  7. ↑ "Saridon – headache specialist". Saridon.net. Retrieved 2012-07-24.
  8. ↑ "Access". Medscape. Retrieved 2012-07-24.
  9. 1 2 Consolidated List of Products Whose Consumption And/Or Sale Have Been Banned Withdrawn Severely Restricted Or Not Approved By Governments Twelfth Issue, Published by the Department of Economic and Social Affairs of the United Nations Secretariat Copyright 2005 New York Page 232 Retrieved on 28 October 2012
  10. 1 2 3 4 Multi-Country Survey On Banned And Restricted Pharmaceuticals, Health Action International Asia Pacific August 2008 Page 7, Retrieved on 28 October 2012
  11. ↑ Bayer’s Saridon-A Among 28 Painkillers Banned To Those Under 15 In Korea, PharmAsia News March 12, 2009; Retrieved on 28 October 2012
  12. ↑ "Saridon tvc.". YouTube. 2011-07-06. Retrieved 2012-07-24.
  13. ↑ HSA website checked on 6/5/2016.
  14. ↑ Singapore DIMS Annual 1990 page 669.
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