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Drug Details

Quinoric 200mg Film-Coated Tablets

• Presentation
  Film coated tablet White, circular, biconvex film coated tablets embossed with 'BL' on one face and '200' on the other.
• Description
  Each film-coated tablet contains 200 mg Hydroxychloroquine Sulphate B.P.
• Indications
  Treatment of rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.
• Adult Dosage
  

  Adults (including the elderly)

  The minimum effective dose should be employed. This dose should not exceed 6.5 mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200 mg or 400 mg per day.

  In patients able to receive 400mg daily:

  Initially 400 mg daily in divided doses. The dose can be reduced to 200 mg when no further improvement is evident. The maintenance dose should be increased to 400 mg daily if the response lessens.

  Children

  The minimum effective dose should be employed and should not exceed 6.5 mg/kg/day based on ideal body weight. The 200 mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg.

  Each dose should be taken with a meal or glass of milk.

  Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light.

  The tablets are for oral administration.

• Contra Indications
  

  - known hypersensitivity to 4-aminoquinoline compounds

  - pre-existing maculopathy of the eye

  - pregnancy

• Special Precautions
  

  General

  • The occurrence of retinopathy is very uncommon if the recommended daily dose is not exceeded. The administration of doses in excess of the recommended maximum is likely to increase the risk of retinopathy, and accelerate its onset.

  • All patients should have an ophthalmological examination before initiating treatment with Hydroxychloroquine. Thereafter, ophthalmological examinations must be repeated at least every 12 months.

  The examination should include testing visual acuity, careful ophthalmoscopy, fundoscopy and central visual field testing with a red target.

  This examination should be more frequent and adapted to the patient in the following situations:

  - daily dosage exceeds 6.5mg/kg lean body weight. Absolute body weight used

  - as a guide to dosage could result in an overdosage in the obese.

  - renal insufficiency

  - visual acuity below 6/8

  - age above 65 years

  - cumulative dose more than 200 g.

  Hydroxychloroquine should be discontinued immediately in any patient who develops a pigmentary abnormality, visual field defect, or any other abnormality not explainable by difficulty in accommodation or presence of corneal opacities. Patients should continue to be observed for possible progression of the changes.

  Patients should be advised to stop taking the drug immediately and seek the advice of their prescribing doctor if any disturbances of vision are noted.

  Hydroxychloroquine should be used with caution in patients taking medicines which may cause adverse ocular or skin reactions. Caution should also be applied when it is used in the following:

  • patients with hepatic or renal disease, and in those taking drugs known to affect those organs. Estimation of plasma hydroxychloroquine levels should be undertaken in patients with severely compromised renal or hepatic function and dosage adjusted accordingly.

  • patients with severe gastrointestinal, neurological or blood disorders.

  Although the risk of bone marrow depression is low, periodic blood counts are advisable and Hydroxychloroquine should be discontinued if abnormalities develop.

  Caution is also advised in patients with sensitivity to quinine, those with glucose-6-phosphate dehydrogenase deficiency, those with porphyria cutanea tarda which can be exacerbated by hydroxychloroquine and in patients with psoriasis since it appears to increase the risk of skin reactions.

  Small children are particularly sensitive to the toxic effects of 4-aminoquinolines; therefore patients should be warned to keep Hydroxychloroquine out of the reach of children.

  All patients on long-term therapy should undergo periodic examination of skeletal muscle function and tendon reflexes. If weakness occurs, the drug should be withdrawn.

• Interactions
  

  Hydroxychloroquine sulphate has been reported to increase plasma digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy. Hydroxychloroquine sulphate may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared. These include: potentiation of its direct blocking action at the neuromuscular junction by aminoglycoside antibiotics; inhibition of its metabolism by cimetidine which may increase plasma concentration of the antimalarial; antagonism of effect of neostigmine and pyridostigmine; reduction of the antibody response to primary immunisation with intradermal human diploid-cell rabies vaccine.

  As with chloroquine, antacids may reduce absorption of hydroxychloroquine so it is advised that a 4 hour interval be observed between Hydroxychloroquine and antacid dosaging.

  As hydroxychloroquine may enhance the effects of a hypoglycaemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required.

• Adverse Drug Reactions
  

  Adverse events observed with Hydroxychloroquine, from spontaneous reports, are classified in body systems however are not listed according to the MedDRA frequency convention, as the frequencies are unknown:

   

  MedDRA system organ class	Adverse Reaction*
  Blood and lymphatic system disorders:	Bone-marrow depression; porphyria.
  Nervous system disorders:	Dizziness; vertigo; tinnitus; hearing loss; headache; nervousness; emotional lability; toxic psychosis and convulsions.
  Eye disorders:	Retinopathy, with pigmentation and visual field defects; scomatous vision with paracentral, pericentral ring types; temporal scotomas. Corneal changes including oedoema and opacities; visual disturbances: haloes, blurring of vision, photophobia.
  Cardiac disorders:	Cardiomyopathy; chronic toxicity; biventricular hypertrophy.
  Gastrointestinal disorders:	Nausea; diarrhea, anorexia, abdominal pain, vomiting.
  Hepato-biliary disorders:	Abnormal liver function; fulminant hepatic failure.
  Skin and subcutaneous disorders:	Skin rashes; pruritis; pigmentary changes in skin and mucous membranes. Hair bleaching; alopecia. Bullous eruptions; erythema multiforme; Stevens-Johnson syndrome, photosensitivity; exfoliative dermatitis; acute generalized exanthematous pustulosis (AGEP); psoriasis associated with fever hyperleukocytosis.
  Musculoskeletal, connective tissue and bone disorders:	Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups. Mild sensory changes; depression of tendon reflexes; abnormal nerve conduction.

   

  * Frequency not known.