Zodak (cetirizine digidrochloride) coated tablets 10 mg. №30

Description

Zodak (cetirizine digidrochloride) coated tablets 10 mg. №30

Composition

active substance: cetirizine dihydrochloride;

1 tablet contains cetirizine dihydrochloride 10 mg;

Excipients: lactose monohydrate, corn starch, povidone 30, magnesium stearate, hypromellose (2910/5), polyethylene glycol (macrogol 6000), talc, titanium dioxide (E 171), simethicone emulsion (SE 4).

Dosage form

Coated tablets.

Main physical and chemical properties: coated, oblong, white or almost white tablets with a score line on one side.

Pharmacotherapeutic group

Antihistamines for systemic use. Piperazine derivatives. ATX code R06A E07.

Pharmacological properties

Cetirizine, a metabolite of hydroxyzine produced in the human body, is a potent selective antagonist of peripheral H1 receptors. In vitro receptor binding studies have not shown significant affinity for receptors other than H1 receptors.

In addition to this anti-H1 effect, cetirizine has been shown to have antiallergic effects: at 10 mg 1 or 2 times a day, it inhibits the late stage of eosinophil mobilization in the skin and conjunctiva of patients with atopic dermatitis who have been tested for allergies.

Indication

The drug Zodak is indicated for the relief of nasal and ocular symptoms of seasonal and persistent allergic rhinitis and chronic idiopathic urticaria in adults and children over 6 years of age.

Contraindication:

• hypersensitivity to the active substance or to any of the excipients in the medicinal product, to hydroxyzine or to any of the piperazine derivatives;
• severe renal impairment with creatinine clearance less than 10 ml / min;
• rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Method of application and dosage

• Children aged 6 to 12 years: 5 mg 2 times a day (½ tablets 2 times a day).
• Adults and children over 12 years of age: 10 mg once daily (1 tablet once daily).

The tablets should be swallowed with a glass of water.

Children

The drug Zodak should be prescribed to children over 6 years of age. The drug in the form of coated tablets is not recommended for use in children under 6 years of age, as this dosage form does not allow you to choose the right dose.

Overdose

• Symptoms. Symptoms of cetirizine overdose are mainly related to its effects on the central nervous system or to manifestations that may resemble an anticholinergic effect.
  Adverse events observed after taking a dose at least 5 times the recommended daily dose include: confusion, diarrhea, vertigo, fatigue, headache, malaise, mydriasis, itching, restlessness, sedation, drowsiness, stupor, tachycardia, tremor and urinary retention.
• Treatment. The specific antidote for cetirizine is unknown. In case of overdose, symptomatic or supportive therapy is recommended. Gastric lavage should be performed as soon as possible after taking the drug. Removal of cetirizine by dialysis is ineffective.

Side effects

Clinical studies have shown that the use of cetirizine in the recommended doses may lead to minor adverse effects on the central nervous system, including drowsiness, fatigue, vertigo and headache. In some cases, there have been reports of paradoxical stimulation of the central nervous system.

Although cetirizine is a selective antagonist of peripheral H1 receptors without relative anticholinergic activity, there have been isolated reports of difficulty urinating, eye accommodation disorders, and dry mouth.

Cases of hepatic impairment with elevated liver enzymes in combination with bilirubin are known. In most cases, these symptoms disappeared after cessation of cetirizine dihydrochloride treatment.