indometacin Suppositories 100 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #33752

Manufacturer usually replies in nan days

Indometacin

Indometacin is a nonsteroidal anti-inflammatory drug, that has analgesic, anti-inflammatory, and antipyretic properties. It is also called indomethacin. It is used to reduce fever, pain, stiffness, and swelling caused by inflammation. Its actions inhibit the production of prostaglandins, endogenous signaling molecules associated with the symptoms. Indometacin inhibits cyclooxygenase, the enzyme responsible for catalyzing the production of prostaglandins. As such it is used to treat Joint diseases like rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, acute painful shoulder bursitis or tendinitis, Headaches, Trigeminal autonomic cephalgias, Paroxysmal hemicranias, Chronic paroxysmal hemicrania, Episodic paroxysmal hemicrania, Hemicrania continua, Valsalva-induced headaches, Primary cough, headache, Primary exertional headache, Primary headache associated with preorgasmic and orgasmic Primary stabbing headache, Hypnic headache and some others. Indometacin is sold under the brand names Indocin, Indocin SR, Tivorbex among others. Union Carbide Corp patented it in 1961 and was approved for sales in 1963. However, after the expiry of initial patent protection, it is now marketed under more than twelve different brands. In 2017 alone, it was prescribed to 1 million US citizens.

Dosage and administration

Indometacin is available as immediate-release tablets of 25-50 mg, which can be administered orally or rectally, as an Extended release of 75-150 mg a day, orally in a single daily dose or every 12 hours. The daily dose cannot exceed 150 mg a day. In the treatment of Bursitis or Tendinitis, the dose if using Immediate-release tablet, is 75-150 mg per day administered given every 6 to 8 hours or if taking Extended-release tablet, the dose is 75-150 mg a day, taken orally in single daily dose or every 12 hours. In the treatment of Acute Gouty Arthritis, the dose is 50 mg, taken orally or inserted rectally for 3-5 days, and reduced once pain control has been achieved. In the treatment of Nephrogenic Diabetes Insipidus, the dose is 2 mg per kilo per day, taken orally every 8 hours. For mild-to-moderate acute pain, the dose is 20 mg taken orally three times a day or 40 mg taken orally, 2 or 3 times a day.

The Price of Indometacin

In the USA, the average retail price of 30 capsules of 50mg cost around $15.30. Indometacin is much cheaper in developing parts of the world, where it is made and sold by generic drug makers. In India, the price of a 25mg tablet is USD 0.28

How does it work?

Indometacin, as a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. Its actions inhibit the production of prostaglandins, endogenous signaling molecules that causes these symptoms.

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