Propyphenazone/paracetamol/caffeine

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Propyphenazone/paracetamol/caffeine
Combination of
PropyphenazoneAnalgesic
ParacetamolAnalgesic
CaffeineStimulant
Clinical data
Trade namesSaridon
AHFS/Drugs.comInternational Drug Names
Routes of
administration		By mouth
ATC code
Identifiers
CAS Number
ChemSpider
  • None

Propyphenazone/paracetamol/caffeine (trade name Saridon) is an analgesic combination indicated for the management of headache. It contains the analgesics propyphenazone and paracetamol and the stimulant caffeine.[1][2]

Saridon was first launched by

FDA 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
]

Medical uses

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.

Efficacy

Paracetamol, an analgesic and antipyretic substance, has slow onset but has a longer duration of action and is lacking

Cochrane review concluded that a dose of 100 mg is needed for an effect – double the amount contained in Saridon.[5]

Adverse effects

Adverse effects are uncommon and include skin rashes,

leucopenia, agranulocytosis, and pancytopenia.[2] The latter type of side effect can be severe.[6]

Based on a 2004 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. 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]

Interactions

Known interactions are mostly related to the paracetamol component. Barbiturates, phenytoin, carbamazepine and rifampicin increase the formation of toxic paracetamol metabolites in the liver. Alcohol also increases paracetamol's liver toxicity. The combination of zidovudine with paracetamol can increase the risk of neutropenia. Elimination of chloramphenicol is prolonged five-fold by paracetamol.[2][8]

Contraindications

Contraindications are hypersensitivity to

gastrointestinal ulcers or bleeding; pregnancy and lactation; infants and children under 6 to 12 years (varying by country).[2]

Society and culture

Restrictions

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]

India

In September 2018, Saridon, along with 327 other

FDCs, was banned by the Central 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 by

mg of propyphenazone, 300 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 not found in the Singapore market anymore (valid 2016, 2019).

ethoxybenzamide[clarification needed] 250 mg, pyrithyldione 50 mg, and caffeine 50 mg.[15]
Please look for an old reference to verify.

References

  1. ^ Voelker M, Petersen B (2009). Saridon Summary of Clinical Overview (Report). pp. 1–3.
  2. ^ a b c d e Jentzsch A, ed. (1998). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
  3. ISBN 978-1-118-34489-7
    .
  4. ^ "Saridon - Concise Prescribing Information". MIMS Pte Ltd. Archived from the original on 7 January 2012.
  5. PMID 25502052
    .
  6. ^ Consolidated List of Products whose Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or not Approved by Governments, Twelfth Issue (PDF). New York: Department of Economic and Social Affairs of the United Nations Secretariat. 2005. p. 232.
  7. ^ "Anaphylactic reactions on the combination of paracetamol, propyphenazone and caffeine (Saridon)" (PDF). Lareb. 2004.
  8. ^ "Interaction check". Mediq.ch. Archived from the original on 9 March 2021. Retrieved 16 February 2017.
  9. ^ a b "Consolidated List of Products Whose Consumption And/Or Sale Have Been Banned Withdrawn Severely Restricted Or Not Approved By Governments Twelfth Issue" (PDF). Department of Economic and Social Affairs of the United Nations Secretariat. New York. 2005. p. 232. Retrieved 28 October 2012.
  10. ^ a b c Multi-Country Survey On Banned And Restricted Pharmaceuticals, Health Action International Asia Pacific August 2008, page 7, Retrieved on 28 October 2012
  11. ^ "Govt bans Saridon, 327 other combination drugs - Times of India". The Times of India. Retrieved 2018-09-13.
  12. ^ Sinha B (17 September 2018). "Supreme Court lifts ban on sale of painkiller Saridon". Hindustan Times. New Delhi.
  13. ^ "Saridon tvc". YouTube. 2011-07-06. Archived from the original on 2014-06-09. Retrieved 2012-07-24.
  14. ^ Singapore HSA checked on 07/09/2016.
  15. ^ Singapore DIMS Annual 1990 page 669.
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