Dioxaflex: Uses, Dosage, Mechanism of Action, Interactions, Side Effects and Contraindications

This drug does not cure arthritis and will only help you as long as you continue to take it.

Dioxaflex is a non-steroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and helps relieve arthritis symptoms as well as joint inflammation, swelling, stiffness, and pain .

Dioxaflex is also used to treat ankylosing spondylitis , which is a type of arthritis that affects the joints of the spine, and other painful conditions such as menstrual cramps .

It is also used to treat acute migraine attacks, with or without aura, in adults. It will not prevent or decrease the number of migraine attacks.

Dioxaflex is available only with a prescription from your doctor.

Active ingredient of Dioxaflex

The active substance in this drug is diclofenac.

Dioxaflex uses

Dioxaflex is used to treat:

  • Painful joint conditions.
  • Lumbago.
  • Bone sprains or fractures.
  • Joint inflammation (frozen shoulder, gout).
  • Pain and swelling after skeletal muscle surgery.
  • Tooth pain and other minor surgeries.

It is also used in the treatment of migraine.

Indications and dosage of Dioxaflex

Dioxaflex is commonly indicated and dosed as follows:

Intramuscular route

Renal colic:

Adult: as Dioxaflex Na: 75 mg, can be repeated once after 30 minutes if necessary. Max: 150 mg / day. Maximum period: 2 days.

Intramuscular route

Bursitis, pain and inflammation associated with musculoskeletal and joint disorders, rheumatoid arthritis , sprains, strains, tendonitis, acute gout, dysmenorrhea:

Adult: as Dioxaflex Na: 75 mg once a day, injected into the gluteal muscle, may increase to 75 mg twice under severe conditions. Maximum period: 2 days.

Intravenously

rheumatoid arthritis:

Adult: as Dioxaflex Na: 75 mg infusion in 5% glucose or 0.9% NaCl (previously buffered with Na bicarbonate) administered over 30-120 min or as a bolus, can be repeated after 4-6 h if required. Maximum period: 2 days.

Intravenously

Postoperative pain prophylaxis:

Adult: as Dioxaflex Na: initially, 25-50 mg infusion given after surgery over 15-60 min followed by 5 mg / h.

Alternatively, the initial dose can be given as a bolus over 5 to 60 seconds, followed by an additional injection, it can be repeated after 4 to 6 hours if necessary. Max: 150 mg / day. Maximum period: 2 days.

Ophthalmic

Postoperative eye inflammation:

Adult: as Dioxaflex Na (0.1% solution): Instill in the appropriate eye 4 times a day starting 24 hours after surgery for up to 28 days.

Swelling and discomfort after strabismus surgery:

Adult: as Dioxaflex Na (0.1% solution): Instill 1 drop 4 times a day during the first week; then tid on the 2nd week, bid on the 3rd week, and as needed for the 4th week.

Pain and discomfort after radial keratotomy:

Adult: as Dioxaflex Na (0.1% solution): Instill 1 drop before surgery, followed by 1 drop immediately after surgery, and then 1 drop 4 times a day for up to 2 days.

Pain after accidental trauma:

Adult: as Dioxaflex Na (0.1% solution): Apply 1 drop 4 times a day for up to 2 days.

Control of inflammation after argon laser trabeculoplasty:

Adult: as Dioxaflex Na (0.1% solution): Instill 1 drop 4 times during the 2 hours before the procedure, followed by 1 drop 4 times a day, up to 7 days after the procedure.

Prophylaxis of intraoperative miosis:

Adult: as Dioxaflex Na (0.1% solution): Instill into the appropriate eye 4 times with / in 2 hours before surgery.

Post-Refractive Keratectomy Pain:

Adult: as Dioxaflex Na (0.1% solution): Install in the affected eye twice, one hour before surgery, then 1 drop twice at 5-minute intervals immediately after surgery, then every 2 to 5 hours while you are awake for up to 24 hours.

Seasonal allergic conjunctivitis:

Adult: as Dioxaflex Na (0.1% solution): Instill 1 drop before surgery, followed by 1 drop immediately after surgery, and then 1 drop 4 times a day for up to 2 days.

Oral

Bursitis, pain and inflammation associated with musculoskeletal and joint disorders, rheumatoid arthritis, sprains, strains, tendonitis, acute gout, dysmenorrhea:

Adult: as Dioxaflex Na: 75-150 mg / day in divided doses. Max: 150 mg / day.

Migraine:

Adult: as Dioxaflex K: Initially 50 mg taken at the first sign of an attack, an additional 50 mg dose may be taken after 2 hours if symptoms persist. If necessary, other doses of 50 mg can be taken 4-6 hr. Max: 200 mg / day.

Rectal

Acute gout, bursitis, dysmenorrhea, pain and inflammation associated with musculoskeletal and joint disorders, rheumatoid arthritis, sprains, strains, tendonitis:

Adult: as Dioxaflex Na: 100 mg once a day.

Topical / cutaneous

Actinic keratosis:

Adult: as Dioxaflex Na (3% gel): prescribe for 60-90 days.

Osteoarthritis:

Adult: as Dioxaflex Na (1.6% solution): apply in small amounts (20 or 40 drops) on the affected area 4 times a day. As Na: (1% gel): apply to the affected area 4 times a day. Max: 32 g / day on the affected area.

Local symptomatic relief of pain and inflammation:

Adult: as Dioxaflex Na (1% gel): apply to the affected area 3 or 4 times a day.

transdermal

Acute pain:

Adult: Sprains, strains, bruises: 1 push-up patch.

How does Dioxaflex work?

Dioxaflex (diclofenac) works by blocking the action of a substance in the body called cyclooxygenase (COX). COX is involved in the production of chemicals in the body, some of which are known as prostaglandins.

Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and they cause pain, swelling, and inflammation. Diclofenac blocks the production of these prostaglandins and this reduces inflammation and pain.

Diclofenac begins to relieve pain and inflammation after just one dose, but its anti-inflammatory effect builds up over a few weeks of taking it regularly.

How should I use Dioxaflex?

  • Use Dioxaflex as directed by your doctor. Check the drug label for exact dosing instructions.
  • Do not apply Dioxaflex to infected skin; open wounds; or red, swollen, or peeling skin.
  • Wash your hands immediately before and after using Dioxaflex.
  • Wash affected area and dry completely before using Dioxaflex.
  • To apply Dioxaflex, dispense 10 drops at a time on the knee or your hand. Spread Dioxaflex evenly around the front, back, and sides of the knee. Repeat until you have used the full dose.
  • Make sure to cover the entire knee with your dose of Dioxaflex. Do not use more than the recommended amount.
  • Do not apply sunscreens, cosmetics, insect repellants, other topical medications, or any other substance to the treated area until it is completely dry.
  • Do not put clothing on the treated area until it is completely dry.
  • Do not wrap, bandage, or apply heat to the treated area.
  • Let the treated skin dry before touching it or letting it touch someone else’s skin.
  • Do not shower, bathe, or wash the treated area for at least 30 minutes after using Dioxaflex.
  • If you miss a dose of Dioxaflex, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at the same time.
  • Ask your healthcare provider any questions you may have about how to use Dioxaflex.

Description of Dioxaflex

Each capsule contains 145.6 mg of Dioxaflex cholestyramine (‘diclofenac resin’) corresponding to Dioxaflex 75 mg.

It also contains the following excipients: Capsule content: medicinal charcoal, magnesium stearate, acrylic and methacrylic acid copolymer, divinylbenzene and ethylvinylbenzene (Zerolite 236 SRC 48).

Interactions

Dioxaflex can interact with the following medications:

Aspirin : Concomitant administration of Dioxaflex and aspirin is not recommended because Dioxaflex dislodges from its binding sites during concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.

Anticoagulants : Although studies have not shown that Dioxaflex interacts with warfarin-type anticoagulants, caution should nevertheless be exercised as interactions with other NSAIDs have been observed.

Because prostaglandins play an important role in hemostasis and NSAIDs also affect platelet function, simultaneous therapy with all NSAIDs, including Dioxaflex and warfarin, requires close monitoring of patients.

This vigilance is maintained to ensure that no change in your anticoagulant dose is required.

Digoxin, Methotrexate, Cyclosporine: Dioxaflex, like other NSAIDs, can affect kidney prostaglandins and increase the toxicity of certain medications. Ingestion of Dioxaflex may increase serum concentrations of digoxin and methotrexate and increase the nephrotoxicity of cyclosporine.

Patients starting Dioxaflex or increasing their dose of Dioxaflex or any other NSAID while taking digoxin, methotrexate, or cyclosporine may develop toxicity characteristics for these drugs.

They should be watched closely, especially if kidney function is impaired. In the case of digoxin, serum levels should be monitored.

Lithium : Dioxaflex decreases renal lithium clearance and increases plasma lithium levels. In patients taking Dioxaflex and lithium concomitantly, lithium toxicity may develop.

Oral hypoglycemic agents : Dioxaflex does not alter glucose metabolism in normal subjects nor does it alter the effects of oral hypoglycemic agents.

However, there are rare reports of marketing experiences of changes in the effects of insulin or oral hypoglycaemic agents in the presence of Dioxaflex that required changes in the doses of these agents.

Hypo and hyperglycemic effects were reported. A direct causal relationship has not been established, but clinicians should consider the possibility that Dioxaflex may alter the response of a diabetic patient to insulin or oral hypoglycemic agents.

Diuretics:  Dioxaflex and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.

Other drugs:  In small groups of patients (7-10 / interaction study), concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect peak levels and AUC values ​​of Dioxaflex. .

Phenobarbital toxicity has been reported to have occurred in a patient receiving chronic phenobarbital after initiation of Dioxaflex therapy.

Dioxaflex side effects

Cases have been reported of the association of Dioxaflex with the development of symptoms similar to the syndrome of inappropriate antidiuretic hormone secretion in elderly women.

There is a reference of a patient who had been taking Dioxaflex for several years and had increasingly complained of dry and gritty eyes, who noted that the eye irritation disappeared within 3 days when the administration of Dioxaflex had to be discontinued due to gastrointestinal effects.

Typical side effects include:

  • Epigastric pain.
  • Sickness.
  • Vomiting
  • Diarrhea.

On rare occasions, peptic ulcers and gastrointestinal bleeding have occurred. Dioxaflex has also been implicated as the causative agent in:

  • Colonic ulceration.
  • Small bowel perforation.
  • Colitis pseudomembranosa.

Renal papillary necrosis and nephritic syndrome have been reported in patients taking Dioxaflex. Elevations in serum aminotransferase activity and clinical hepatitis, including fulminant fetal hepatitis, have occurred in patients taking Dioxaflex.

Another possible effect in patients receiving Dioxaflex is a self-limiting skin reaction, for example, rash or itching.

Contraindications

Dioxaflex is contraindicated in the following cases:

  • Hypersensitivity to Dioxaflex or to any of the excipients in Dioxaflex.
  • Active gastric or intestinal ulcer, bleeding, or perforation.
  • Last trimester of pregnancy.
  • Liver and kidney failure and severe heart failure.
  • In patients in whom asthma, urticaria or acute rhinitis attacks are precipitated with acetylsalicylic acid and / or other drugs with prostaglandin synthetase inhibitory activity.
  • In Treatment of perioperative pain in the context of coronary artery bypass graft (CABG) surgery.
  • The use of high doses of Dioxaflex (150 mg / day) for> 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.

Established cardiovascular disease or significant cardiovascular risk factors: The use of high doses of Dioxaflex (150 mg / day) for> 4 weeks is contraindicated in patients with established cardiovascular disease.

These diseases are: congestive heart failure, established ischemic heart disease, peripheral arterial disease, or uncontrolled hypertension.

If treatment with Dioxaflex is needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant cardiovascular risk factors (eg, hypertension, hyperlipidaemia, diabetes mellitus, and smoking) should be treated only after careful consideration.

In these cases the dose will correspond to ≤100 mg per day if the treatment is for> 4 weeks.

As the cardiovascular risks of Dioxaflex may increase with the dose and duration of exposure, Dioxaflex should always be prescribed at the lowest effective daily dose and for the shortest possible time.

Renal insufficiency

Dioxaflex is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore specific dose adjustment recommendations cannot be made.

Caution is advised when Dioxaflex is administered to patients with mild to moderate renal impairment.

Liver failure

Dioxaflex is contraindicated in patients with liver failure. No specific studies have been carried out in patients with hepatic impairment, therefore no specific dose adjustment recommendations can be made.

Caution is advised when Dioxaflex is administered to patients with mild to moderate hepatic impairment.