MINT-HYDROXYCHLOROQUINE 200 MG — DIN 02424991

What is MINT-HYDROXYCHLOROQUINE?

MINT-HYDROXYCHLOROQUINE 200 MG contains HYDROXYCHLOROQUINE SULFATE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02424991, held by MINT PHARMACEUTICALS INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 10-Jun-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MINT-HYDROXYCHLOROQUINE used for?

MINT-HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets) is indicated for: • the treatment of rheumatoid arthritis, and discoid and systemic lupus erythematosus, in adult patients who have not responded satisfactorily to drugs with less potential for serious side effects. • the suppressive treatment and treatment of acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. MINT-HYDROXYCHLOROQUINE is not active against the exo-erythrocytic forms of P. vivax, P. malariae and P. ovale, and therefore will neither prevent infection due to these organisms when given prophylactically, nor prevent relapse of infection due to these organisms. MINT-HYDROXYCHLOROQUINE is highly effective as a suppressive agent in patients with vivax or malariae malaria in terminating acute attacks and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria, MINT-HYDROXYCHLOROQUINE abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Rheumatoid Arthritis: Initial dosage – In adults, from 400 to 600 mg daily. In a few patients, the side effects may require temporary reduction of the initial dosage. Generally, after five to ten days the dose may be gradually increased to the optimum response level, frequently, without return of side effects. Maintenance dosage – When a good response is obtained (usually in four to twelve weeks), the dosage is reduced by 50 percent and continued at an acceptable maintenance level of 200 to 400 mg daily. The incidence of retinopathy has been reported to be higher when the maintenance dose is exceeded. Lupus Erythematosus: Initially, the average adult dose is 400 mg once or twice daily. This may be continued for several weeks or months, depending upon the response of the patient. For prolonged maintenance therapy, a smaller dose, from 200 to 400 mg daily will suffice. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Malaria: Suppression – In adults, 400 mg on exactly the same day of each week. In children (6 years of age and older), the weekly suppressive dose is 5 mg base/kg, but should not exceed the adult dose regardless of body weight. Suppressive therapy should begin two weeks before exposure. When not administered before exposure, give an initial loading dose of 800 mg to adults, or 10 mg base/kg to children in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area. Treatment of the acute attack – In adults, an initial loading dose of 800 mg followed by 400 mg in six to eight hours. This is followed by 400 mg on each of the next two days for a total of 2 g of hydroxychloroquine sulfate or 1.55 g base. Alternatively, the administration of a single dose of 800 mg has also proved effective. The dosage for adults may also be calculated by body weight. For children (6 years of age and older) – dosage calculated by body weight is preferred. A total dose representing 25 mg of base/kg is administered over three days as follows: First dose: 10 mg base/kg (not to exceed 620 mg base); Second dose: 5 mg base/kg 6 hours after the first dose (not to exceed 310 mg base); Third dose: 5 mg base/kg 18 hours after the second dose; Fourth dose: 5 mg base/kg 24 hours after the third dose. For radical cure of vivax and malariae malaria - concomitant therapy with an 8-aminoquinoline compound is necessary. Missed Dose: If a dose is missed, it should be taken as soon as possible. If the missed dose is within twelve hours of the next dose, the missed dose should be skipped, and the regular dosing schedule should be resumed. The patient should be advised never to take a double dose.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

MINT-HYDROXYCHLOROQUINE is contraindicated in: • Patients with pre-existing retinopathy of the eye. • Patients with known hypersensitivity to 4-aminoquinoline compounds. • Patients who are hypersensitive to hydroxychloroquine sulfate or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • Children below 6 years of age (200 mg tablets not adapted for weight <35 kg).

Warnings and precautions

Cardiovascular: MINT-HYDROXYCHLOROQUINE can prolong the PR, QRS and QTc intervals, especially in patients with underlying risk factors. Serious adverse events, including fatal outcomes, have been reported including ventricular arrhythmias, heart blocks, ventricular fibrillation and torsade de pointes. Permanently discontinue MINT-HYDROXYCHLOROQUINE in patients who develop torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia. Not recommended for use in patients with baseline QTc prolongation (e.g., congenital or acquired Long QT Syndrome), second-or third-degree atrioventricular block. Electrolyte imbalances must be corrected prior to use. Concomitant use with other QTc, PR or QRS interval prolonging drugs should be avoided or undertaken with particular caution. Increased risk of cardiovascular events and mortality with azithromycin or other macrolide antibiotics. Ophthalmologic: Irreversible retinal damage has been observed in some patients. Before starting long-term treatment, both eyes should be examined. Examination should be repeated at least annually. Retinal toxicity is largely dose-related. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. Discontinue immediately if abnormality in visual acuity, visual field, or retinal macular areas, or any visual symptoms are observed. Hypoglycemia: Can cause severe hypoglycemia including loss of consciousness. Patients should be warned about the risk and associated clinical signs and symptoms. Discontinue in cases of severe hypoglycemia. Hematologic: Periodic blood counts should be obtained in patients requiring prolonged therapy due to the risk of bone marrow depression. Discontinue if any severe blood disorder appears not attributable to the disease. Hemolysis has been reported in patients with glucose-6-phosphate dehydrogenase deficiency. Hepatic/Biliary/Pancreatic: Use with caution in patients with hepatic disease or alcoholism, or in conjunction with known hepatotoxic drugs. Serious cases of drug-induced liver injury (DILI) including fatal cases have been reported. Discontinue if active liver diseases or unexplained transaminases elevations develop. Skin: Severe cutaneous adverse reactions (SCARs), including DRESS, AGEP, SJS, and TEN, have been reported. These conditions may be life-threatening and fatal. Discontinue immediately if signs and symptoms suggestive of severe skin reactions appear. May cause acute generalized exanthematous pustulosis (AGEP) and exacerbate psoriasis or porphyria. Neurologic: Extrapyramidal reactions have been reported. Symptoms may persist after discontinuation. Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy has been reported. Discontinue if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. Aggravation of myasthenia gravis symptoms has been reported. Reactivation of Infections: Reactivation of hepatitis B virus, herpes zoster virus and tuberculosis has been reported. Consider the risk of reactivation prior to use. Driving and Operating Machinery: Can impair accommodation and cause blurring of vision. Patients should be warned about driving and operating machinery.