Dioxaflex Duo (Diclofenac, Pridinol)
Active Ingredient: Diclofenac, Pridinol
Dosage: 50 mg/4 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 15 tablets per pack
Dioxaflex Duo is indicated in painful inflammatory processes with muscle contracture component, articular and extra-articular rheumatic complaints, fibrositis, myalgias, lumbalgias, ciatalgias, torticollis, traumatisms, sprains, muscle tears. The drug contains diclofenac and pridinol.
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Dioxaflex Duo is an analgesic, anti-inflammatory and muscle relaxant indicated in: painful inflammatory processes with myocontracting component, rheumatic joint and extra-articular conditions, fibrositis, myalgia, low back pain, sciatica, stiff neck., trauma, sprains.
Dosage and administration
The dose should be established individually according to the patient’s medical criteria and clinical picture.
As a guideline, the following doses are recommended:
Adults: Usual dose: 1 tablet of Dioxaflex Duo every 12 hours. Maximum dose: 3 tablets per day, divided into 3 doses (every 8 hours). The tablets can be taken before, during or after light meals, preferably with 1 full glass of water or another non-alcoholic beverage.
Administration together with large meals may decrease the rate of absorption of active substances. The duration of treatment will be determined according to medical criteria according to the type and evolution of the condition. In patients weighing less than 60 kg the maximum total daily dose should be reduced.
Pediatric Use: This pharmaceutical form is not suitable for children.
- Patients with hypersensitivity to any of the components of the formulation;
- Children under 12 years;
- Patients with a history of asthma attacks, hives or other allergic reactions with the administration of aspirin or other NSAIDs;
- Gastroduodenal ulcer;
- Severe liver or kidney insufficiency.
Due to possible anticholinergic effects, the administration of this drug is not recommended in cases of narrow-angle glaucoma, urodynamic disorders with voiding residue, mechanical occlusion of the gastrointestinal tract, tachyarrhythmias, megacolon and acute lung edema.
- Therapeutic doses of Dioxaflex Duo are generally well tolerated. The following adverse reactions have been described:
- General: Abdominal pain, headache, hydrosaline retention, abdominal distention, general malaise, lip and tongue edema, photosensitivity, anaphylactoid reactions, isolated cases of anaphylaxis;
- Gastrointestinal: Diarrhea, dyspepsia, nausea, constipation, flatulence, impaired liver tests, peptic ulcer with or without perforation and / or bleeding, vomiting, jaundice, mane, stomatitis, dry mucous membranes, diarrhea, hepatitis, pancreatitis, esophageal lesions, liver necrosis, cirrhosis, hepatorenal syndrome, colitis;
- Nervous system: Vertigo, insomnia/drowsiness, depression, anxiety, diplopia, irritability, aseptic meningitis and seizures;
- Skin: Eruptions, pruritus, alopecia, hives, dermatitis, angioedema, Stevens-Johnson syndrome, erythema multiforme, blister dermatitis;
- Senses: Tinnitus.
- Cardiovascular: Hypertension, congestive heart failure;
- Hematologic: Decreased hemoglobin, leukopenia, thrombocytopenia, purpura, eosinophilia, anemia, agranulocytosis;
- Respiratory: Epistaxis, asthma, laryngeal edema;
- Senses: Blurred vision, scotoma, hearing loss, dysgeusia;
- Urogenital: Proteinuria, nephrotic syndrome, oliguria, papillary necrosis, acute renal failure, interstitial nephritis.
No cases of untreated overdose with Diclofenac + Pridinol have been reported so far. Overdose may cause an increase in the incidence or severity of any of the known adverse reactions. In case of overdose, the usual measures of gastric emptying and general support should be applied. The dose of diclofenac should always be individualized and used at the lowest effective dose to minimize the possible adverse effects. In case of acute overdose, forced diuresis can theoretically be beneficial since the drug is excreted in the urine.
Diclofenac has the following interactions: Aspirin: Concomitant administration is not recommended due to the additive effect of nephropathy and gastric irritation of aspirin. Anticoagulants: Although studies have not shown significant interaction with warfarin-like anticoagulants, caution is recommended since such interaction has been proven with other NSAIDs. Digoxin, Methotrexate, Cyclosporine: Diclofenac, like other NSAIDs, can affect renal prostaglandins and increase the adverse reactions of certain drugs. The administration of diclofenac or the increase in the administered dose may increase the serum concentrations of digoxin and methotrexate and increase the renal adverse effects of cyclosporine, particularly if renal function is impaired. It may be necessary to control serum levels. Lithium: Diclofenac can decrease the renal clearance of lithium and raise plasma levels with the consequent increased risk of adverse effects. Oral hypoglycemic agents: Diclofenac does not alter glucose metabolism in normal subjects or alter the effects of oral hypoglycemic agents. Diuretics: Diclofenac, as well as other NSAIDs, can reduce its prostaglandin-dependent natriuretic action and inhibit the increase in renin plasma activity after administration, and may be associated with increased serum potassium levels. Other drugs: In small groups of patients, co-administration of azathioprine, gold salts, chloroquine, d-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect the maximum levels or values of the area under the curve (ABC) of diclofenac. Protein binding: In vitro studies do not reveal significant interference of diclofenac with various drugs, including salicylic acid, tolbutamide, prednisolone or warfarin; benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin and sulfamethoxazole.
Pridinol has the following interactions: Amantadine, quinidine, tricyclic or neuroleptic antidepressants: Possible anticholinergic effects may be evident or intensified by concomitant administration. Alcohol, psychotropic: Additive effects may occur.