Plaquenil (hydroxychloroquine) coated tablets 200 mg. №60

Description

Plaquenil (hydroxychloroquine) coated tablets 200 mg. №60

Composition

active substance: hydroxychloroquine;

1 tablet contains hydroxychloroquine sulfate 200 mg;

Excipients: lactose monohydrate, povidone, corn starch, magnesium stearate; shell: Opadry OY-L-28900 (hypromellose, titanium dioxide (E 171), polyethylene glycol, lactose monohydrate).

Dosage form

Film-coated tablets

Main physical and chemical properties: white biconvex film-coated tablets with flat edges, marked “HCQ” on one side and “200” on the other.

Pharmacotherapeutic group

Antiparasitic drugs. Antimalarial drugs. Aminoquinolines. Hydroxychloroquine. ATX code P01B A02.

Pharmacological properties

Antimalarial drugs, such as chloroquine and hydroxychloroquine, have several pharmacological actions that determine their therapeutic effect in the treatment of rheumatic diseases, although the role of each of these mechanisms remains unknown. These effects include interaction with sulfhydryl groups, alteration of enzyme activity (including phospholipases, NADH-cytochrome-C-reductase, cholinesterases, proteases and hydrolases), DNA binding, stabilization of lysosomal membranes, inhibition of prostaglandin production inhibition and inhibition. polymorphonuclear cells, a possible effect on monocyte production of interleukin-1 and inhibition of superoxide neutrophil release.

Indication

Adults

A drug such as Plaquenil is indicated for treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, as well as dermatological diseases that cause or worsen the course of which is the action of sunlight.

Pediatric population

Treatment of juvenile idiopathic arthritis (in combination with other drugs), discoid and systemic lupus erythematosus.

Contraindication:

• hypersensitivity to 4-aminoquinoline compounds is known;
• maculopathy diagnosed before treatment with Plaquenil;
• age less than 6 years (200 mg tablets are not suitable for use in patients weighing <35 kg) or ideal body weight <31 kg.

Method of application and dosage

Plaquenil  is intended for oral use. Each dose should be taken with food or with a glass of milk.

The effect of Plaquenil is cumulative, so it takes several weeks to achieve a therapeutic effect, while minor side effects may occur relatively early. If the patient’s condition does not improve within 6 months in the treatment of rheumatic disease, the drug should be discontinued.

In diseases associated with hypersensitivity to light, treatment should be carried out only during periods of maximum insolation.

Adults and elderly patients

The minimum effective dose should be used. This dose should not exceed 6.5 mg / kg / day (based on the patient’s ideal, not actual body weight) and should be either 200 mg or 400 mg per day.

Children

The minimum effective dose should not exceed 6.5 mg / kg / day for ideal body weight. Therefore, 200 mg tablets are not suitable for use in children with an ideal body weight of less than 31 kg.

Side effects:

• Metabolic and nutritional disorders: lack of appetite.
• Mental disorders: affective lability.
• Nervous system disorders: headache.
• Visual disorders: blurred vision due to impaired accommodation, which is a dose-dependent and reversible phenomenon.