It can be harmful for people to take this medication if their doctor has not prescribed it. It may take several weeks before the beneficial effects of hydroxychloroquine for the treatment of rheumatoid arthritis are seen, and several months before maximum effects are achieved. After 5 to 10 days, the dose may be gradually increased.
This dose may be continued for several weeks or months depending on the benefits that occur.
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Children's doses are based on body weight and are calculated as 5 mg of hydroxychloroquine base per kilogram of body weight to a maximum dose of mg. Children's doses are based on body weight as prescribed by the doctor. To help reduce stomach upset, hydroxychloroquine should be taken with a meal or a glass of milk. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications.
If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is within 12 hours of your next dose, skip the missed dose and continue with your regular dosing schedule.
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Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. Store this medication at room temperature and keep this medication out of the reach of children.
Do not dispose of medications in wastewater e. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Nonmedicinal ingredients: black ink, calcium hydrogenophosphate, carnauba wax, corn starch, magnesium stearate, opadry White YS-I, and polyethylene glycol Many medications can cause side effects.
A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Stop taking the medication and seek immediate medical attention if any of the following occur:. Some people may experience side effects other than those listed.
Check with your doctor if you notice any symptom that worries you while you are taking this medication. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication. Blood tests: If you take this medication for a long period of time, your doctor will likely want you to have blood tests to monitor your levels of red and white blood cells.
People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. People without diabetes have also been known to experience low blood sugars while taking hydroxychloroquine.
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If you experience signs of low blood sugar cold sweat, cool pale skin, headache, or weakness , contact your doctor immediately. Blurred vision: While taking this medication, use caution when driving or operating machinery, since hydroxychloroquine can cause blurring of vision. If your vision blurs, call your doctor.
Eye damage: Irreversible damage to the retina of the eye has occurred for some people who take long-term or high-dosage treatment with hydroxychloroquine. Eye damage is more likely to occur if recommended doses are exceeded. Your doctor will want you to have regular eye exams if you take this medication for a period of time. If any severe blood disorder such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia, appears which is not attributable to the disease under treatment, consider discontinuation of Hydroxychloroquine sulfate tablets. Drugs that prolong QT interval and other arrhythmogenic drugs : Hydroxychloroquine sulfate tablets prolong the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias.
Antiepileptics : The activity of antiepileptic drugs might be impaired if co-administered with Hydroxychloroquine sulfate tablets. The following interactions have been observed on treatment with the structurally related substance chloroquine phosphate, and therefore cannot be ruled out for hydroxychloroquine. Praziquantel : Chloroquine has been reported to reduce the bioavailability of praziquantel.
Antacids and kaolin : Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Cimetidine : Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided. Ampicillin : In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin.
Information for Patients: Patients should be informed of the early signs and symptoms of toxicity such as rash or visual changes. Patients must see their physicians promptly in case of the appearance of these or of any unusual effects. Periodic laboratory tests may be recommended in some patients. Patients should be fully informed of the potential risks of the use of Hydroxychloroquine sulfate tablets, especially in pregnancy and in children.
Carcinogenesis, mutagenesis, impairment of fertility: Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of Hydroxychloroquine sulfate tablets. The mutagenic potential of hydroxychloroquine was not evaluated. However, chloroquine has been shown to be a catalytic inhibitor of DNA repair enzymes topoisomerase II and to produce weak genotoxic effects through this mode of action. Teratogenic Effects: Human pregnancies resulting in live births have been reported in the literature and no increase in the rate of birth defects has been demonstrated.
Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine. It has been demonstrated that hydroxychloroquine administered to nursing women is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines. Children are especially sensitive to the 4-aminoquinoline compounds. Most reported fatalities followed the accidental ingestion of chloroquine, sometimes in small doses 0.
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However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia. Hemolysis reported in individuals with glucosephosphate dehydrogenase GPD deficiency. Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness. Gastrointestinal disorders: Nausea, vomiting, diarrhea, and abdominal pain. Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute. Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased.
Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction. Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs. Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia.
Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms DRESS syndrome , photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis AGEP.
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It may be associated with pyrexia and hyperleukocytosis. The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes.
The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Treatment is symptomatic and must be prompt. Immediate gastric lavage until the stomach is completely emptied is indicated. After lavage, activated charcoal is introduced by the stomach tube within 30 minutes of ingestion of the drug may inhibit further intestinal absorption.
To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested. Consideration should be given to administering diazepam parenterally since studies suggest that it may be beneficial in reversing chloroquine and hydroxychloroquine cardiotoxicity. A patient who survives the acute phase and is asymptomatic should be closely observed for at least six hours. Serological studies suggest that H5N1 seroconversion in market poultry is low and that vaccination may have facilitated the selection of the Fujian-like sublineage.
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