Instruction for use: Primalan

Dosage form: Tablets; syrup

Active substance: Mequitazine*

ATX

R06AD07 Mequitazine

Pharmacological group:

Antiallergic agent - H1-histamine receptor blocker [H1-antihistamines]

The nosological classification (ICD-10)

H10.1 Acute atopic conjunctivitis: Allergic conjunctivitis; Allergic eye diseases; Allergic conjunctivitis; Allergic conjunctivitis caused by chemical and physical factors; Allergic rhinoconjunctivitis; Allergic inflammation of the eyes; Spring Qatar; Spring keratitis; Spring conjunctivitis; Conjunctivitis allergic; Year-round allergic conjunctivitis; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic keratoconjunctivitis; Acute allergic conjunctivitis; Superficial bacterial infection of the eyes; Rhinoconjunctivitis; Seasonal allergic conjunctivitis; Seasonal conjunctivitis; SENSORY; Chronic allergic keratoconjunctivitis; Chronic allergic conjunctivitis

J30.1 Allergic rhinitis caused by pollen of plants: Hay fever; Hay fungus; hay fever; Hypersensitivity to pollen of plants; Polyposis allergic rhinosinusitis; Seasonal pollinosis; Seasonal rhinitis

J30.2 Other seasonal allergic rhinitis: Allergic rhinitis seasonal; Seasonal rhinitis of an allergic nature

J30.3 Other allergic rhinitis: Allergic rhinitis year-round; Allergic rhinoconjunctivitis

L20 Atopic dermatitis: Allergic diseases of the skin; Allergic skin disease noninfectious etiology; Allergic skin disease etiology nemikrobnoy; Allergic skin diseases; Allergic skin lesions; Allergic reactions on the skin; atopic dermatitis; Allergic dermatosis; Allergic diathesis; Allergic itching dermatosis; Allergic skin disease; Allergic skin irritation; allergic Dermatitis; atopic Dermatitis; allergic dermatoses; exudative diathesis; Itchy atopic eczema Itchy allergic dermatosis; Allergic skin disease; Cutaneous allergic reaction to drugs and chemicals; Cutaneous reactions to medications; Skin and allergic disease; Acute eczema; common neurodermatitis; Chronic atopic dermatitis; Exudative diathesis

L50 Urticaria: Idiopathic chronic urticarial; Injury Urticaria; Chronic urticarial; Hives of the newborn

Composition and release form

Tablets are divisible 1 table.

Mechitazine 5 mg; 10 mg

Excipients: lactose; starch; Acacia gum; Silicon colloidal; talc; Sodium carmellose; Magnesium stearate

In a planar cell pack of 14 pcs .; In a pack of cardboard 1 package.

Syrup, 30 mg / 60 ml 100 ml

Mechitazine 0.05 g

Auxiliary substances: ascorbic acid; Sucrose; Tangerine essence; water; Methylparahydroxybenzoate; Propyl parahydroxybenzoate

In vials of 60 ml; In a pack of cardboard 1 bottle.

Description of dosage form

Tablet 5 mg: white-cream (almost white), round, with a risk on one side.

Tablet 10 mg: white-cream (almost white) color, oval with a risk on one side.

Syrup: a syrupy liquid from colorless to light yellow with a fruity smell.

Pharmachologic effect

Mode of action - antiallergic, antipruritic, antiexudative.

It blocks histamine H1 receptors. Prevents the release of mast cells from biologically active substances. Has a weak anticholinergic effect.

Pharmacokinetics

Quickly and almost completely absorbed from the digestive tract. Eating reduces the absorption rate, but does not affect its magnitude. Cmax after a single dose of 5 mg is achieved after 3.2 hours and is 3.26 ng / ml. Does not pass through GEB. Metabolised in the liver with the formation of pharmacologically active metabolites. T1 / 2 - 18 hours. It is excreted mainly with feces (in the form of metabolites and unchanged), a small amount - in unchanged form by the kidneys.

The effect manifests itself after 30 minutes and lasts 24 hours.

Indications of the preparation Primalan

Allergic rhinitis (seasonal and year-round) and conjunctivitis, urticaria (acute and chronic relapsing), atopic dermatitis.

Contraindications

Hypersensitivity to the components of the drug and other phenothiazine derivatives, angle-closure glaucoma, benign prostatic hyperplasia, simultaneous administration of MAO inhibitors.

Side effects

From the nervous system and sensory organs: drowsiness, headache, fatigue, emotional lability in elderly patients and children.

From the part of the digestive tract: dry mouth, dyspeptic phenomena.

Interaction

With simultaneous administration with atropine, tricyclic antidepressants (imipramine, etc.), anticholinergic antiparkinsonics, myotropic antispasmodics, disopyramide, antipsychotic drugs, phenothiazine derivatives, there may be an increase in side effects. Strengthens the effect of antihypertensive drugs and drugs that depress the central nervous system (antidepressants with sedative effect, barbiturates, benzodiazepines, clonidine, hypnotics, analgesics, central antitussive and antipsychotic drugs).

Dosing and Administration

Inside, with water, regardless of food intake. Adults and children over 12 years of age - 5 mg 2 times a day (morning and evening) or 10 mg once a night.

Children from 6 to 12 years: with a body weight of less than 30 kg (6-10 years) - 2.5 mg 2 times a day (morning and evening) or 5 mg once a night; From 30 to 40 kg (10-12 years) - 2.5 mg in the morning and 5 mg in the evening or 7.5 mg (1.5 tablets) once in the evening. The course of treatment is set by the doctor.

When taking syrup, it should be borne in mind that 1 scoop of syrup (2.5 ml) contains 1.25 mg of the drug.

Overdose

Symptoms: increased side effects.

Treatment: gastric lavage, symptomatic therapy.

Precautionary measures

It is not recommended to appoint (if necessary, use special caution) in pregnancy, breastfeeding, children under 6 years. With caution - patients with hepatic insufficiency (risk of cumulation) and elderly patients predisposed to constipation, with epilepsy.

With caution apply during work drivers of vehicles and people whose profession is associated with increased concentration of attention.

A comment

The drug is in the process of registration.

Storage conditions of the drug Primalan

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Primalan

Tablets divisible 5 mg - 3 years.

Tablets divisible 10 mg - 3 years.

Syrup 30 mg / 60 ml - 2 years.

Do not use after the expiry date printed on the package.