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Roemmers S.A.I.C.F. - Argentina

DORIXINA
DORIXINA RELAX
FRENALER CORT
INDUCTAL
PLENICA

Forms and presentation
Tablets: Boxes of 20 and 50.

Composition
Each tablet contains : Lysine clonixinate : 125 mg. Excipients: microcrystalline cellulose, corn starch, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, triacetine, polyethylene glycol 6000.

Properties
Dorixina is an analgesic NSAI drug, with mainly analgesic action. It exerts its effect by inhibiting prostaglandin synthesis. It was recently shown that it acts principally on the enzyme that catalyzes the production of prostaglandins responsible for inflammation (cyclooxygenase-2 or COX-2) with less activity on the enzyme that catalyzes the synthesis of prostaglandins of the gastrointestinal mucosa and the kidneys (cyclooxygenase-1 or COX-1), where these substances have a protecting role.

Pharmacokinetics
Lysine clonixinate is rapidly absorbed reaching its peak plasma level about 40-60 minutes following administration. Its bioavailability is of about 56%, with some individual variability. The plasma half-life of Lysine clonixinate in humans is of about 1.75±0.10 hrs (mean ± SD). It is excreted in the form of metabolites, principally in the urine (60%). Its concentration in milk is of about 7-10% of the plasma concentration.

Indications
Dorixina is indicated for the treatment of somatic or visceral pain.

Contraindications
Known hypersensitivity to Lysine clonixinate. Active peptic ulcer or gastroduodenal hemorrhage. Pregnancy. Children under 12 years of age. Patients with a history of bronchospasms, nasal polyps, angioedema or urticaria caused by the administration of acetylsalicylic acid (aspirin) or other NSAIDs.

Precautions
In cases of allergic skin and/or mucosal reactions or symptoms of peptic ulcer or gastrointestinal hemorrhage discontinue treatment with Dorixina.
Caution should be used when administering to patients with history of digestive diseases like gastrointestinal peptic ulcer or gastritis and in patients treated with anticoagulants.
Although no case with the administration of Lysine clonixinate has been reported, it is known that NSAIDs inhibit the synthesis of prostaglandins which have a supportive role in the maintenance of renal perfusion. In patients with impaired renal blood-flow administration of NSAIDs may precipitate overt renal decompensation, usually reversible with the discontinuation of the product. Patients at greatest risk of this reaction are dehydrated patients, patients with congestive heart failure, hepatic cirrhosis, nephritic syndrome or other overt renal diseases, patients taking diuretics or those who underwent major surgeries with subsequent hypovolemia. Control the amount of diuresis and renal function in these patients before treatment.
Although also not observed during treatment with Lysine clonixinate, administration of NSAIDs may increase transaminase plasma levels or other liver parameters. In most cases these elevations over normal limits are small and transient.
Pediatric use: there are no clinical studies available with Lysine clonixinate administered to children under 12 years of age, therefore its use is contraindicated in patients of this age group.
Geriatric use: like with other anti-inflammatories, Lysine clonixinate should be administered with caution to elderly patients, as they may have impairment of their cardiac, hepatic or renal functions.

Drug interactions
Other NSAIDs (including high doses of acetylsalicylic acid): increase of the risk of gastrointestinal ulcer and hemorrhages due to their synergistic action.
Oral anticoagulants, ticlopidine, heparin (systemic administration), thrombolytics: major risk of hemorrhage. If concomitant administration is unavoidable, strict controls of blood coagulation must be performed accordingly adjusting the dosage of those medicines which modify coagulation parameters.
Lithium: usually NSAIDs increase lithium plasma levels. Closely monitor lithium plasma levels when starting, modifying or discontinuing treatment with Dorixina.
Methotrexate: concomitant treatment with methotrexate and NSAIDs may increase the hematological toxicity of methotrexate. In these cases, strict hematological controls must be performed.
Diuretics: in patients with dehydration, treatment with NSDAIDs increases the potential risk of acute renal failure. In cases of concomitant treatment with Lysine clonixinate and diuretics patients must be properly hydrated and their renal function controlled before initiating treatment.
Antihypertensives (for example, beta-adrenergic receptor blocking agents, ACE-inhibitors, vasodilators, diuretics): during concomitant treatment with antihypertensive agents and NSAIDs a decrease in antihypertensive effect has been reported due to the inhibition of vasodilating prostaglandins.

Pregnancy and lactation
Pregnancy: Although preclinical toxicological studies did not show teratogenic effects, there is no sufficient experience available with the administration of Lysine clonixinate to pregnant women. Therefore Dorixina should not be administered during pregnancy.
Lactation: Studies carried out in humans showed that the excretion of Lysine clonixinate in human milk is very low. Notwithstanding this, before administering Lysine clonixinate to nursing mother the risk/benefit ratio should be evaluated.

Side effects
At therapeutic doses Dorixina is well tolerated. In rare cases, specially when administered to sensitive, nausea, vomiting, gastritis and somnolence may occur.

Dosage and administration
Swallow the tablets whole, without chewing them and with abundant liquid.
Adults and children over 12 years of age: Administer 1 tablet 3 or 4 times per day at regular intervals, according to pain intensity.
Maximum daily dosage: 6 tablets.

Overdosage
No cases of overdosage with Dorixina were informed. After a thorough evaluation of the patient, considering the time lapsed from administration, the amount of drug taken and discarding the contraindication of certain procedures, the physician will decide upon carrying out the general rescue treatment: Gastric evacuation (vomiting or gastric lavage), strict clinical control (specially gastroduodenal and renal function) and symptomatic supportive care. There exists no specific antidote.

Storage conditions
Keep in dry place at temperature below 30 °C.

Origin: Argentina
Laboratories: Roemmers S.A.I.C.F.
Distributor: Droguerie Phenicia
Registration Number
Box of 20: 24995/2007
Box of 50: 24996/2007