16, Badaru Street, off Adegoke Street, Surulere, Lagos State, Nigeria.
Tel: 234-1-5454964, 5454974, 5848519, 234-803-301-7170
Shanghai Medicinal Corporation, 9, Yan An Road (E), Shanghai, China
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Capsule (NRN: 04-2622): Indomethacin BP 25 mg.
How to identify the Product: A white to yellow-tan, odourless or almost odourless, crystalline powder.
Pack size: 10 x 10’s (in boxes).
Naxa-25 (Indomethacin) is a non-steroidal anti-inflammatory drug (NSAID) that exhibits antipyretic and analgesic properties. Its mode of action, like that of other anti-inflammatory drugs, is not known. However, its therapeutic action is not due to pituitary-adrenal stimulation.
Naxa-25 (Indomethacin) is a potent inhibitor of prostaglandin synthesis in vitro. Concentrations are reached during therapy which have been demonstrated to have an effect in vivo as well. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Moreover, prostaglandins are known to be among the mediators of inflammation. Since indomethacin is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Naxa-25 (Indomethacin) has been shown to be an effective anti-inflammatory agent, appropriate for long-term use in rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
Indomethacin, an indole acetic acid derivative, is an NSAID. It is used in musculoskeletal and joint disorders including ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, and acute gout, and in peri-articular disorders such as bursitis and tendinitis.
Rectal administration should be avoided in patients with proctitis and haemorrhoids. In addition, Indomethacin should not be given to neonates with untreated infection, with significantly impaired renal function, or with necrotizing enterocolitis.
As for other NSAIDs, Indomethacin should not be given to patients with peptic ulceration and should be used with caution in patients with a history of such disorders. Indomethacin should be used with caution in patients with infections, since symptoms such as fever and inflammation may be masked, and also used with caution in patients with asthma or allergic disorders.
Other general precautions to be observed include administration to patients with haemorrhagic disorders, hypertension, and impaired renal, hepatic or cardiac function. Indomethacin should be administered with caution to patients with epilepsy, parkinsonism, or psychiatric disorders.
Usage in Pregnancy & Lactation:
Indomethacin is not recommended for use in pregnant women, since safety for use has not been established, and because of the known effect of drugs of this class on the human fetal cardiovascular system (closure of the ductus arteriosus) during the third trimester of pregnancy. Indomethacin is excreted in the milk of lactating mothers. It is not recommended for use in nursing mothers.
Indomethacin can adversely affect the fetus and whether the risk is increased the earlier it is used in gestation is not clear.
Some products that may interact with this drug include: aliskiren, ACE Inhibitors (such as lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, cyclosporine, lithium, methotrexate, pemetrexed.
This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Some affected drugs include anti-platelet drugs such as clopidogrel, "blood thinners" such as enoxaparin/warfarin, bisphosphonates such as alendronate, corticosteroids such as prednisone, SSRI antidepressants such as fluoxetine/sertraline, among others.
Adverse effects are more frequent with indomethacin than with many other NSAIDs. The most common being gastro-intestinal disturbances, headache, dizziness, and lightheadedness. Gastro-intestinal perforation, ulceration, and bleeding may also occur; rarely, intestinal strictures have been reported.
Reported adverse effects include: transient constriction of the ductus arteriosus, pulmonary hypertension, bronchopulmonary dysplasia, reduced volume of amniotic fluid (oligohydramnios) and possible renal damage.
Dosage & Administration
The usual initial dose by mouth in chronic musculoskeletal and joint disorders is 25 mg two or three times daily increased, if required, by 25 to 50 mg daily at weekly intervals to 150 to 200 mg daily. The total daily combined dose by mouth and by rectum should not exceed 200 mg.
To alleviate night pain and morning stiffness: 100 mg of the total daily dose may be administered by mouth, or rectally as a suppository, on retiring. Alternatively, the total dose may be administered by rectum as 100 mg in the morning and at night.
In acute gout, the daily dose is 150 to 200 mg in divided doses until all symptoms and signs subside.
In dysmenorrhoea, up to 75 mg daily has been suggested.
Store in a well-closed container, protected from heat and light.