INDOXEN ® Indomethacin

INDOXEN ® is a drug based on Indomethacin

THERAPEUTIC GROUP: Non-steroidal anti-inflammatory and antirheumatic drugs

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications INDOXEN ® Indomethacin

INDOXEN ® is indicated in the treatment of painful states on an inflammatory basis of rheumatic and extrareumatic origin of the musculoskeletal system.

Mechanism of action INDOXEN ® Indomethacin

Indomethacin, the active ingredient of INDOXEN ®, is a molecule belonging to the category of non-steroidal anti-inflammatory drugs, known for its marked anti-inflammatory, analgesic and antipyretic activities.

Like other NSAIDs, Indomethacin is also able to perform its therapeutic action by inhibiting the activity of cyclooxygenases, enzymes expressed during harmful events and involved in the conversion of membrane phospholipids such as arachidonic acid, into chemical mediators equipped with edemigenic, vasopermeabilizing, chemotactic and algic activity known as prostaglandins.

All the aforementioned biological activities result in the reduction of classic signs of inflammation such as pain, swelling and when present also fever.

The therapeutic action of Indomethacin is also optimized by good pharmacokinetic properties, which guarantee rapid intestinal absorption and maximum plasma concentrations in just 3 hours after intake, following oral drug intake.

Following a rapid half-life and hepatic metabolism, Indomethacin and its catabolites are excreted predominantly via the kidneys.

Studies carried out and clinical efficacy

1.INDOMETHACIN IN OPERATIVE PAIN

J Am Assoc Lab Anim Sci. 2008 Jul; 47 (4): 8-19.

Experimental study demonstrating the greater efficacy of pre and perioperative treatment with Indomethacin compared to that of other commonly used analgesics in reducing post-operative pain.

2. THE PREVENTION OF MUCOSAL DAMAGE INDUCED BY INDOMETHACIN

J Clin Biochem Nutr. 2008 Jul; 43 (1): 34-40.

Interesting work that demonstrates how the association between Indomethacin and H2 receptor antagonists can preserve the gastric mucosa from inflammatory damage that is commonly induced by therapy with non-steroidal anti-inflammatory drugs in particularly predisposed patients.

3 INDOMETHACIN IN THE TREATMENT OF THE GOTHER ATTACK

Eur J Emerg Med. 2009 Oct; 16 (5): 261-6.

An interesting clinical trial that demonstrates how Indomethacin may be more advantageous in terms of cost-benefits than prednisone in the treatment of acute gout joint pain.

Method of use and dosage

INDOXEN ®

25 - 50 mg hard capsules of Indomethacin;

Suppositories of 50 - 100 mg of Indomethacin.

Regardless of the pharmaceutical form used, the dosage scheme for the treatment of painful states based on inflammation of the musculoskeletal system involves dosages of Indomethacin ranging from 100-200 mg per day to be divided into several assumptions.

In order to reduce the incidence and severity of possible side effects it would be preferable to start therapy with the minimum possible dose, limiting the intake of the drug for the shortest time necessary to guarantee a remission of symptoms.

All treatment should be supervised by your doctor.

Warnings INDOXEN ® Indomethacin

The use of INDOXEN ® should always be under strict medical supervision in order to reduce the incidence and severity of the various side effects commonly associated with NSAID therapy, while maximizing the therapeutic efficacy of the treatment.

Particular attention should be paid to patients suffering from gastrointestinal, cardiovascular, hepatic and renal diseases, in which the therapy with non-steroidal anti-inflammatory drugs is more frequently associated with the onset of side effects or the exacerbation of the already present symptomatology.

The onset of unexpected side effects should therefore alarm the patient, who, after consulting his doctor, should consider suspending the treatment.

INDOXEN ® contains lactose, therefore its use is not recommended in patients with lactase enzyme deficiency, lactose intolerance or glucose-galactose malabsorption syndrome.

PREGNANCY AND BREASTFEEDING

Given the presence of studies in the literature that demonstrate the different toxic effects of anti-inflammatory drugs on the fetus, with the appearance of serious cardiovascular and pulmonary malformations as well as repeated abortions, the use of INDOXEN ® during the pregnancy and the following is strongly discouraged breastfeeding period.

To the mutagenic effects directed at the fetus, those associated with the mother are associated, subjected to an increased risk of bleeding during childbirth.

Interactions

Oral administration of non-steroidal anti-inflammatory drugs could expose the patient to possible drug interactions, capable of altering both the efficacy and the safety profile of Indomethacin.

Particularly at risk are the contextual assumptions between Indomethacin and:

Oral anticoagulants and serotonin reuptake inhibitors, responsible for the increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and ciclosporin, associated with an increase in the toxic effects of Indomethacin especially affecting the kidney and liver;
Non-steroidal anti-inflammatory drugs and corticosteroids, responsible for significant damage to the gastric mucosa;
Antibiotics, whose intake is often linked to a significant variation in the therapeutic profile of both drugs;
Sulfonylureas, potentially dangerous for alterations affecting glucose homeostasis.

INDOXEN ® Indomethacin Contraindications

The use of INDOM COLLIRIO ® is contraindicated in patients who are hypersensitive to the active ingredient or to structurally and chemically related products and to the various excipients present in the product.

We do not recommend the use of INDOM COLLIRIO ® even in patients with contact lenses.

Undesirable effects - Side effects

Treatment with non-steroidal anti-inflammatory drugs such as Indomethacin is often related to the onset of numerous side effects from the different clinical course.

The most interesting organs and devices are:

The gastrointestinal tract exposed to the risk of nausea, vomiting, diarrhea, constipation, gastritis, and in severe cases ulcers with possible erosions and bleeding;
The nervous system with the appearance of headache, dizziness and rarely drowsiness;
The integumentary apparatus with the appearance of dermatological reactions such as itching, skin rash, eczema, urticaria and even severe bullous reactions;
The kidney and the liver, subject to the increased risk of cytotoxicity and functional deterioration;
The cardiovascular system with hypotension, hypertension and increased cardio and cerebrovascular accidents.