Immard (Immard)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydroxychloroquineHydroxychloroquine
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    • Dosage form: & nbspfilm-coated tablets
    Composition:

    Each film-coated tablet contains:

    Active substance: hydroxychloroquine sulfate 200 mg.

    Excipients: corn starch, calcium hydrophosphate, talc, silicon dioxide colloid, polysorbate-80, magnesium stearate.

    The shell contains: titanium dioxide, macrogol, hypromellose, talc.

    Description:Tablets of white or almost white color, film-coated, round, biconvex, engraved on one side of the "HCQS".
    Pharmacotherapeutic group:Anti-malarial drug
    ATX: & nbsp

    P.01.B.A.02   Hydroxychloroquine

    Pharmacodynamics:

    Antimalarial drug, actively suppresses erythrocyte forms (hematoschotropic drug). It compacts lysosomal membranes and prevents the release of lysosomal enzymes, disrupts DNA reduplication, RNA synthesis and Hb utilization by erythrocyte forms of plasmodium.

    It also has an immunosuppressive and anti-inflammatory effect, suppresses free-radical processes,weakens the activity of proteolytic enzymes (protease and collagenase), leukocytes, chemotaxis of lymphocytes.

    Pharmacokinetics:Absorption is variable. The half-absorption period is 3.6 h (1.9-5.5 h). Bioavailability - 74%. Connection with plasma proteins - 45%. The time to reach the maximum concentration of the drug in the blood (Tcmax) is 3.2 h (2-4.5 h), the maximum concentration is (Cmax) after ingestion of 155 mg to 948 ng / ml, after ingestion of 310 mg to 1895 ng / ml. Accumulates in tissues with a high level of metabolism (liver, kidneys, lungs, spleen - in these organs the concentration exceeds the plasma concentration by 200-700 times, in the central nervous system, erythrocytes, leukocytes) and in tissues rich in melanin. In very low concentrations found in the walls of the gastrointestinal tract. Penetrates through the placental barrier, in small amounts is determined in breast milk. The volume of distribution: measured in blood - 5.522 liters, in plasma - 44.257 liters. It is partially metabolized in the liver with the formation of active de-ethylated metabolites. Half-life of blood (T1/2) - 50 days, from the plasma - 32 days. It is excreted by the kidneys (23-25% unchanged) and with bile (less than 10%). Excretion is very slow and can be determined for a long time in the urine after discontinuation of treatment.
    Indications:
    Malaria: treatment of acute seizures and suppressive therapy for malaria caused by Plasmodium vivax, Plasmodium ovale and Plasmodium malariae (excluding hydroxychloroquine-resistant cases) and sensitive strains of Plasmodium falciparum; radical treatment of malaria caused by sensitive strains of Plasmodium falciparum; rheumatoid arthritis; lupus erythematosus (systemic and discoid); photodermatitis.
    Contraindications:

    - Hypersensitivity to hydroxychloroquine, a derivative of 4-aminoquinoline or any other component of the drug;

    - retinopathy (including maculopathy in the anamnesis);

    - pregnancy, the period of breastfeeding (see "Application during pregnancy and during breastfeeding");

    - Children under 6 years of age (tablets of 200 mg are not suitable for use in children weighing less than 31 kg);

    - as well as long-term therapy in childhood.

    Carefully:

    - Visual disorders (reduced visual acuity, impaired color vision, narrowing of visual fields), simultaneous use of drugs that can cause adverse ophthalmic reactions (danger of progression of retinopathy and visual disorders);

    - hepatic and / or renal failure, hepatitis, simultaneous administration of drugs adversely affecting liver and / or kidney function;

    - severe gastrointestinal diseases;

    - violation of bone marrow hematopoiesis;

    - diseases of the central nervous system and cardiovascular system;

    - psychosis (including in the anamnesis);

    - porphyria;

    - psoriasis;

    - skin reactions;

    - deficiency of glucose-6-phosphate dehydrogenase;

    hypersensitivity to quinine.

    Pregnancy and lactation:

    The use of hydroxychloroquine in pregnancy should be avoided, except when the potential benefit to the mother exceeds the risk to the fetus.

    The use of the drug in pregnancy and breast-feeding is possible only for "vital" indications (in therapeutic doses it can cause damage to the central nervous system in the fetus or baby, including ototoxicity, auditory and vestibular, down to deafness), retinal bleeding and pathological pigmentation retinas (infants are particularly sensitive to the toxic effects of 4-aminoquinolines, whose presence in minor amounts in human milk may be due to drug intake).

    Dosing and Administration:

    Inside, during a meal or with a glass of milk. 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg of hydroxychloroquine base.

    Rheumatoid arthritis: the initial dose in adults is 400-600 mg / day, the maintenance dose is 200-400 mg / day.

    Juvenile arthritis: the dose should not exceed 6.5 mg / kg or 400 mg / day (the lowest dose is chosen).

    Discoid and systemic lupus erythematosus: the initial dose for adults is 400-800 mg / day, the maintenance dose is 200-400 mg / day.

    Photodermatosis: up to 400 mg / day. Treatment should be limited to periods of maximum solar exposure.

    Malaria: suppressive therapy in adults - 400 mg / day every 7 days; In children, the weekly suppressive dose is 6.5 mg / kg, but regardless of body weight, should not exceed the adult dose (400 mg). If the conditions allow, suppressive therapy is prescribed 2 weeks before the exposure, otherwise an initial double dose can be given: 800 mg for adults and 12.9 mg / kg (but not exceeding 800 mg) for children divided into 2 divided doses with an interval of 6 h. Suppressive therapy should be continued for 8 weeks. After the endemic zone is abandoned.

    Treatment of an acute attack of malaria: the initial dose for adults is 800 mg, then after 6-8 hours - 400 mg and 400 mg on the 2nd and 3rd days of treatment (a total of 2 g of hydroxychloroquine sulphate). As an alternative, an effective dose of 800 mg once can be effective.

    For children, a total dose of 32 mg / kg (but not exceeding 2 g) is given for 3 days: the first dose is 12.9 μg / kg (but not more than a single dose of 800 mg), the second dose is 6.5 mg / kg (but not exceeding 400 mg) at 6 hours after the first, the third dose of 6.5 mg / kg (but not exceeding 400 mg) 18 hours after the second dose, the fourth dose of 6.5 mg / kg (but not exceeding 400 mg) 24 hours after the third dose .

    The dose for adults can be calculated for 1 kg of body weight, as well as for children.

    Side effects:

    From the side of the musculoskeletal and nervous systems: weight loss, myopathy or neuromyopathy, leading to increased myasthenia and atrophy of proximal muscle groups; sensory disorders, decreased tendon reflexes, abnormal nerve conduction; headache, dizziness, nervousness, psychosis, emotional lability, convulsions.

    From the sense organs: noise in the ears, deafness, photophobia, visual acuity, accommodation, edema and opacity of the cornea, scotoma; with prolonged use of large doses - retinopathy (including with a violation of pigmentation and visual field defects), atrophy of the optic nerve, keratopathy, dysfunction of the ciliary muscle.

    From the cardiovascular system: with prolonged therapy with large doses - myocardial dystrophy, cardiomyopathy, atrioventricular blockade, decreased myocardial contractility, myocardial hypertrophy.

    From the digestive system: nausea, vomiting (rarely), decreased appetite, abdominal pain of a spastic nature, diarrhea; hepatotoxicity (a violation of liver function, liver failure).

    From the hematopoiesis: neutropenia, aplastic anemia, agranulocytosis, thrombocytopenia, hemolytic anemia (in patients with deficiency of glucose-6-phosphate dehydrogenase).

    From the skin: skin rash (including bullous and generalized pustular), itching, skin and mucous membrane pigmentation disorder, hair discoloration, alopecia, photosensitivity, Stevens-Johnson syndrome (multifunctional exudative erythema), exacerbation of psoriasis (including with fever and hyperleukocytosis), aggravation of porphyria.

    Overdose:

    Symptoms:

    cardiotoxicity (impaired conduction by the bundle of the Gis, with chronic intoxication - myocardial hypertrophy of both ventricles), lowering of arterial pressure, neurotoxicity (dizziness,headache, increased excitability, convulsions, coma), visual impairment, respiratory and cardiac arrest.

    Overdose is especially dangerous in young children, even taking 1-2 g of the drug can lead to death.

    Treatment: gastric lavage, the appointment of activated charcoal (in a dose 5 times the dose of the drug), forced diuresis and alkalinization of urine (for example, ammonium chloride to urine pH 5.5-6.5) increase excretion of urine with 4-aminoquinoline, symptomatic therapy (including cramping - diazepam, anti-shock therapy). It is necessary to monitor the concentration of sodium in the blood serum and constant medical control for at least 6 hours after the relief of symptoms.

    Interaction:Increases concentration digoxin in plasma, aminoglycosides strengthen the blocking effect on neuromuscular conduction. Enhances the effect hypoglycemic drugs (requires a lower dose of the latter). With simultaneous application antacids the interval between the reception should be at least 4 hours (reduced absorption). Alkaline drinking and alkali accelerate excretion from the body. Increases plasma concentrations penicillamine and the risk of its side effects from the organs of hematopoiesis, urinary system and skin reactions. Enhances side effects glucocorticosteroids, salicylates, antiarrhythmic drugs Ia class, hemato-, hepato- and neurotoxic agents.
    Special instructions:

    Before and during therapy, it is necessary to carry out an ophthalmological examination at least once every 6 months. The examination should be more frequent if:

    - daily dose of the drug more than 6.5 mg / kg "ideal" (not increased) body weight (the actual mass used to set the dose for obese patients may lead to an overdose);

    - patients with renal insufficiency;

    - the total dose exceeds 200 g;

    - elderly patients (over 65 years);

    - decreased visual acuity.

    The use of daily doses of more than 6.5 mg / kg increases the risk of retinopathy and accelerates its appearance. If adverse reactions occur (visual acuity, color perception, etc.), the drug should be immediately discontinued (changes in the retina may progress even after the drug has been discontinued, so patients should be monitored).

    During therapy, continuous monitoring of the cellular composition of the blood, the state of skeletal muscles (including tendon reflexes) is necessary.

    If there is a muscle weakness, a deviation from the norm of hematological parameters, the drug should be discarded.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    The tablets covered with a film membrane on 200 mg.
    Packaging:

    For 10 tablets per blister Al / PVC.

    By 3, 6, 10 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    List B.

    Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:2 years. After the expiration date, the drug can not be used.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001058/09
    Date of registration:12.02.2009 / 21.04.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India
    Information update date: & nbsp24.10.2017
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