Audited Supplier
ANTI-010-06
No
Customized
GMP, Copp
Elderly, Adult
Solid
>99%
Serumpharm
Level 3
10'S× 10/BOX
China
2901231000
Product Description
INDOMETHACIN CAPSULE 25mg
Specification: 10'S×10/BOX
Trademark: Serumpharm
Support OEM/ODM: Yes
Mini. Order: 10000 Boxes
Delivery Time: 30~60 Days
Trade Term: FOB,CIF
Payment Term: T/T,L/C
Standard Available: BP
Documents: GMP,COPP,CTD
INDOMETHACIN CAPSULE 25mg
Indications:
The treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute musculoskeletal disorders and acute gout.
Contra-indications:
Active peptic ulcer or a history of recurrent gastro-intestinal lesions. Sensitivity to aspirin, indometacin or other non-steroidal anti-inflammatory agents.
Pregnancy or lactation.
Patients operating machinery.
Patients with epilepsy, parkinsonism, psychiatric disturbances or porphyria.
Children, since conditions for safe use have not been established.
Severe heart failure.
Adverse Effects:
Most adverse effects are dose related
Gastro-intestinal adverse effects are common and include anorexia, nausea (with or without vomiting) dyspepsia, abdominal pain and diarrhoea. Infrequently, ulceration of the upper GI tract, sometimes with perforation and haemorrhage, has occurred. Acute pancreatitis has been reported. Hepatic involvement is rare, though fatal cases of hepatitis and jaundice have been reported.
CNS effects are also common. Severe frontal headache may occur in 25 - 50% of patients who take the drug chronically. Dizziness, light-headedness, vertigo and mental confusion are also frequent. Depression and psychosis have also been reported but the incidence is less than 1%.
Haemopoietic reactions, including neutropenia, thrombocytopenia and, rarely, aplastic anaemia have been reported.
Hypersensitivity reactions, manifested as rashes, itching, urticaria or rarely acute asthma, may occur.
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Drug Interactions:
1.Probenecid. The plasma concentration of Indometacin is increased.
2.Frusemide. The natriuretic and anti-hypersensitivity effects are antagonised by Indometacin.
3.Thiazide diuretics and beta-blocking agents. Indometacin reduces the anti-hypertensive effects of these compounds.
4.Antacids. The bioavailability of Indometacin may be reduced by concomitant antacid therapy.
5.Triamterene. Acute renal failure has been reported with concomitant Indometacin therapy.
Precautions & Warning:
Indometacin should be used with great care in elderly patients. Indometacin should be used with caution in patients with impaired renal function. Indometacin inhibits platelet aggregation and prolongs bleeding time. It should be used with caution therefore in patients with bleeding disorders, and concurrent administration of anti-coagulant agent may be hazardous because of increased risk of gastrointestinal bleeding.
Peptic ulcer has been reported in a small proportion of patients. If G.I. bleeding occurs, indometacin should be discontinued immediately. Indometacin may mask the signs and symptoms of infection. If clinical signs of hepatic disease develop, or if liver function tests become abnormal, indometacin should be withdrawn. Indometacin should be given with or immediately after food in order to lessen the incidence and severity of gastrointestinal side-effects.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
Use in Pregnancy and Nursing Mothers:
Indometacin is contraindicated during pregnancy and lactation.
Treatment/antidote in The Event of Overdose:
Gastric lavage should be performed if ingestion is recent. Otherwise, supportive measures and observation.
Storage instructions:
Store below 25ºC. Protect from moisture. Keep out of reach of children.
Jiangxi Serum Pharma Industries Co.,Ltd. is a professional medical and pharmaceutical products supplier in China. We have been focused on exporting Biological products,Vaccines,Western medicines, APIs, Intermediates and medical products over 10 years, accumulating a wealth of experience. Our products have been exported to more than 30 countries, mainly in Asia, Africa, South America, Middle East and Europe, such as Philippines, Bangladesh,Laos,Cambodia, Kyrghyzstan, Cameroon, Guinea, Nigeria, Liberia, Mali, Yemen, Turkey, Chile, Australia and so on.Our finished products have won great popularity with reliable quality and competitive price,we have numerous end-users and good market reputation.
We have developed advanced into the leading enterprise in pharmaceutical overseas exporting industry after years of efforts.Our products, including API and finished formulation, have been accredited with various certificates, such as Chinese GMP certificate, ISO9001 quality certificate.
The company has established close cooperation relations with domestic manufacturers of biological products, vaccines, raw material medicines and auxiliary materials, and has shared resources and complementary advantages. we are committed to the development and penetration of the international market and provide customers with quality assurance. We provide various pharmaceutical APIs and finished products with top quality at reasonable price and better after-sales service.
Our company has established a perfect quality assurance system in strict accordance with China's GMP requirements. The entire process from raw material procurement to finished product shipment is controlled by the quality assurance department.All raw materials are provided by selected reliable suppliers and carefully inspected by the Quality Assurance Department before use.
Excellence, Professionalism, and integrity are our cultures. We will offer good quality products with competitive prices and fast delivery for our customers. We are looking forward to setting up long-term cooperation relationship with you.
