the package insert of the medicine Reuquinol.
rheumatic and dermatological:
juvenile rheumatoid Arthritis.
systemic Lupus erythematosus.
discoid Lupus erythematosus.
Conditions of skin caused or aggravated by sunlight.
Treatment of acute attacks and treatment suppressive of malaria by Plasmodium vivax, P. ovale, P. malariae, and strains sensitive P. falciparum.
Treatment radical of malaria caused by strains sensitive P. falciparum.
When should I not use?
Maculopatias (retinopatias) pre-existing conditions. Patients with hypersensitivity to derivatives of 4-aminoquinolina and in long-term therapy in children.
How to use?
REUQUINOL should be administered during a meal or with a glass of milk.
The dosages mentioned below refer to the sulphate, and not to the substance of the base. Doses rheumatic action of the REUQUINOL is cumulative and will require several weeks to exert its therapeutic effects beneficial, while that side effects of low severity may occur relatively early. A few months of therapy may be required before maximum effects can be obtained. If an objective improvement (reduction of the edema of the joint, increased mobility) does not occur in 6 months, REUQUINOL should be discontinued.
Warnings and Precautions
what should I know before using?
The risk-benefit should be considered when there are symptoms such as the following.
REUQUINOL can increase the levels of digoxin in plasma.
REUQUINOL may also be subject to many of the interactions described for chloroquine, although reports specific have not been disclosed. Included are:
Pharmaceutical form and presentations
Tablets of 400 mg. boxes of 30 coated tablets
Disorder Blood Severe: Hydroxychloroquine May Cause Dyscrasia Blood, Including Agranuloci
– Deficiency of glucose-6-phosphate dehydrogenase(G6PD): hydroxychloroquine may cause hemolytic anemia in patients with deficiency of G6PD, although it is not likely when hydroxychloroquine is administered in therapeutic doses.
– liver Dysfunction: due to hydroxychloroquine be metabolized in the liver, liver dysfunction can cause the increase of the concentration of blood hydroxychloroquine, increasing the risk of adverse reactions.
– neurological Disorders: hydroxychloroquine can cause neuromiopatia, ototoxicity, polineurites and seizures.
– Porphyria: hydroxychloroquine may cause exacerbation of porphyria.
– Psoriasis: hydroxychloroquine may precipitate crises severe psoriasis.
– the Presence of changes in the visual field or the retina: hydroxychloroquine may cause opacity of the cornea, ceratopatia or retinopathy.
– Hypersensitivity to hydroxychloroquine or chloroquine.
Potentiation of Its Action Blocking Direct At the Neuromuscular Junction By Antibiotics Aminoglico
– The concurrent use of penicillamine with hydroxychloroquine may increase the plasma concentration of penicillamine, increasing the potential for adverse reactions renal and/or hematologic serious, as well as the possibility of skin reactions severe.
– Inhibition of its metabolism by cimetidine which may increase the plasma concentration of the substance; – Antagonism of effect of neostigmine and pyridostigmine;
– Reduction of the humoral (mediated by antibodies) immunization with primary vaccine human diploid anti-rabies intradermal;
– as with chloroquine, antacids may reduce the absorption of REUQUINOL, it is advisable to observe an interval of 4 hours between the administration of the REUQUINOL and antacids.
Adverse Reactions Changes in Laboratory Tests
Adverse reactions to hydroxychloroquine are usually dose-related. When hydroxychloroquine is used in the treatment in the short-term of malaria or other parasitic diseases, the adverse reactions are usually mild and reversible. However, prolonged treatment and/or therapy with high doses, such as in the treatment of rheumatoid arthritis, systemic lupus erythematosus, or rashes polimorfas, the adverse reactions can be serious and sometimes irreversible.
Damage to the retina irreversible may be more likely to happen when the daily dose is equal to or exceeds the equivalent of 310 mg (base), 5 mg (base) per kg daily, of hydroxychloroquine.
The following adverse reactions have been selected on the basis of their meanings for potential clinical:
Reactions that require medical attention:
Incidence less frequent
Toxicity eye specifically opacity of the cornea (blurred vision, or any change in vision); ceratopatia; or retinopathy.
Dyscrasia blood, specifically agranulocytosis (pharyngitis and fever; aplastic anemia (fatigue and weakness); neutropenia or thrombocytopenia; emotional changes or psychosis; neuromiopatia; ototoxicity; convulsions; depression of the bone marrow, cardiomyopathy.
Reactions that require medical attention only if they persist or are bothering you:
Incidence more frequent
Dysfunction of muscles, ciliary (difficulty in reading); gastrointestinal irritation (diarrhea, loss of appetite, nausea, spasm of the stomach or pain, vomiting); headache; rash.
Incidence less frequent Discoloration of the hair or alopecia; discoloration of the skin, fingernails or inside the mouth; dizziness; nervousness; restlessness; “rash” cutaneous or pruritus.
blurred Vision or any change in vision can occur after discontinuation of treatment.
THE REUQUINOL can also exacerbate the porphyria and precipitate crises severe psoriasis.
Lupus Erythematosus, and Discoid lupus
the initial Dose for adults: 400 to 800 mg daily.
maintenance Dose: 200 to 400 mg daily.
– rheumatoid Arthritis:
The initial Dose for adults: 400 to 600 mg daily.
maintenance Dose: 200 to 400 mg daily.
– chronic Arthritis juvenile:
The dosage should not exceed 6,5 mg/kg/day, up to a maximal daily dose of 400 mg.
Apsen Farmacêutica S. A.
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