Universal reference book for medicines
Product name: CETHIRIZIN HEXAL (CETIRIZIN HEXAL)

Active substance: cetirizine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: HEXAL (Germany) manufactured by SALUTAS PHARMA (Germany)
Composition, form of production and packaging
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The tablets covered with a cover of white or almost white color, oblong, with a notch on one side.
1 tab.

cetirizine dihydrochloride 10 mg

Excipients: lactose monohydrate - 80 mg, microcrystalline cellulose - 23.8 mg, silicon colloidal dioxide - 600 μg, magnesium stearate - 600 μg.

The composition of the shell: dye opiate white (lactose monohydrate - 1.8 mg, titanium dioxide - 1.3 mg, hypromellose - 1.4 mg, macrogol 4000 - 500 μg) - 5 mg.

7 pcs.
- packings of cellular contour (1) - packs cardboard.
7 pcs.
- packings cellular planimetric (2) - packs cardboard.
7 pcs.
- packings cellular planimetric (3) - packs cardboard.
7 pcs.
- packings cellular planimetric (5) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (5) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
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Drops for oral administration in the form of a clear, colorless solution without foreign particles.
1 ml

cetirizine dihydrochloride 10 mg

Excipients: benzoic acid - 2 mg, glycerol 85% - 125 mg, propylene glycol - 125 mg, distilled water - 763.6 μg, sodium acetate trihydrate - 15 mg.

10 ml - a bottle of a dropper of dark glass (1) - cardboard boxes.

20 ml - a bottle of a dropper of dark glass (1) - cardboard boxes.

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The syrup is transparent, colorless, without foreign particles, with the smell of a banana.
1 ml

cetirizine dihydrochloride 1 mg

Excipients: sorbitol 70%, glycerol 85%, propylene glycol, sodium acetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, acetic acid 20%, flavoring banana.

75 ml - bottles of dark glass (1) complete with a measuring spoon (5 ml) - packs of cardboard.

150 ml - bottles of dark glass (1) complete with a measuring spoon (5 ml) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the print edition of 2007.

PHARMACHOLOGIC EFFECT

The blocker of histamine H 1 -receptors.
Has anti-allergic effect. Virtually does not have a sedative effect when used in recommended doses and has almost no anticholinergic and antiserotonin action, it prevents development and facilitates the course of allergic reactions. Has antipruritic and antiexsudative effect.
Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells;
oppresses the selection of mediators involved in a late allergic reaction. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasm of smooth muscles. Eliminates the skin reaction to the administration of histamine, specific allergens, and also to cooling (with cold urticaria). Cetirizine significantly reduces the hyperreactivity of the bronchial tree, arising in response to the release of histamine in patients with bronchial asthma.
The therapeutic effect of the drug appears on average 60 minutes after admission.
Against the background of the course, tolerance does not develop.
PHARMACOKINETICS

Suction

After ingestion, cetirizine is quickly and completely absorbed from the digestive tract.
C max is achieved in 40-60 minutes.
Eating does not have a significant effect on the amount of absorption, but in this case, the rate of absorption is slightly reduced.

Distribution

Binding to plasma proteins is approximately 93%.
V d is low and is 0.5 l / kg. Cetirizine does not penetrate the GEB and into the cells.
Metabolism

Cetirizine is metabolized to an insignificant degree in the liver with the formation of an inactive metabolite.
When applied at a dose of 10 mg / day for 10 days, cumulation is not observed.
Excretion

It is excreted mostly by the kidneys (70%) mainly unchanged.
Systemic clearance is about 54 ml / min. After a single dose of 10 mg T 1/2 is about 10 hours.
Pharmacokinetics in special clinical cases

In children aged 2 to 12 years, T 1/2 decreases to 5-6 hours.

If there is a marked violation of the kidney function (KK 11-31 ml / min) and in patients on hemodialysis (CC less than 7 ml / min), T 1/2 increases by 3 times, systemic clearance decreases by 70%.

Against the backdrop of chronic diseases and in the elderly, there is an increase in T 1/2 by 50% and a decrease in systemic clearance by 40%.

INDICATIONS

- All-the-year-round and seasonal allergic rhinitis (as symptomatic therapy);

- urticaria (including chronic idiopathic);

- dermatoses, flowing with itching (including atopic dermatitis, neurodermatitis);

allergic conjunctivitis.

DOSING MODE

Pills

Adults and adolescents over 12 years of age are recommended to take 10 mg (1 tab.) Cetirizine, preferably in the evening.

Children aged 6 to 12 years and weighing less than 30 kg of 5 mg (1/2 tab.) In the evening;
with a body weight of more than 30 kg - 10 mg (1 tab.) in the evening.It is possible to take 5 mg (1/2 tab.) 2 times / day (morning and evening).
Syrup

Adults and adolescents over 12 years of age are recommended to take 10 mg (10 ml / 2 measuring spoons /) of cetirizine, preferably in the evening.

Children aged 2 to 12 years and with a body weight of less than 30 kg are prescribed 5 ml (1 measuring spoon);
with a body weight of more than 30 kg - 10 ml (2 measuring spoons) in the evening. It is possible to take 5 ml (1 measuring spoon) 2 times / day (morning and evening).
Drops

Adults and adolescents over 12 years of age are recommended to take 10 mg (20 drops) of cetirizine, preferably in the evening.

For children aged 1-2 years, the drug is prescribed 2.5 mg (5 drops) 2 times / day;
at the age of 2-6 years - 2.5 mg (5 drops) 2 times / day (morning and evening) or 5 mg (10 drops) in the evening; at the age of 6-12 years - 5 mg (10 drops) 2 times / day (morning and evening) or 10 mg (20 drops) in the evening.
Patients with renal insufficiency should reduce the recommended dose in 2 times.

If the liver function is disturbed, the dose should be selected individually, especially cautiously - with simultaneous renal failure.

Elderly people with normal renal function are not required to adjust the dose.

With seasonal allergic rhinitis, the duration of therapy for adults is usually from 3 to 6 weeks, and for a short-term exposure to an allergen, it is enough to take within 1 week.
The duration of therapy for children over the age of 6 years is from 2 to 4 weeks, and with a short-term exposure to the allergen, it is enough to take within 1 week.
Tablets are taken orally, regardless of food intake, without chewing and drinking with a sufficient amount of liquid, preferably in the evening.

SIDE EFFECT

On the part of the digestive system: dry mouth, indigestion.

From the side of the central nervous system: headache, drowsiness, fatigue, dizziness, agitation, migraine.

Allergic reactions: skin rash, angioedema, hives, itching.

The drug is usually well tolerated.
Adverse events occur rarely and have a transient nature.
CONTRAINDICATIONS

- severe kidney disease;

- Pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

With caution appoint a drug for chronic pyelonephritis of moderate and severe severity (requires correction of the dosing regimen), the elderly (due to the possible reduction in glomerular filtration in this category of patients).

The drug in the form of drops for oral administration is intended for children over the age of 1 year.

The drug in the form of a syrup is intended for children over the age of 2 years.

The drug in the form of tablets is intended for children over the age of 6 years.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy.
If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be solved.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe kidney disease.

With caution appoint a drug for chronic pyelonephritis of moderate and severe severity (requires correction of the dosing regimen), the elderly (due to the possible reduction in glomerular filtration in this category of patients).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If the liver function is disturbed, the dose should be selected individually, especially cautiously - with simultaneous renal failure.

APPLICATION FOR CHILDREN

The drug in the form of drops for oral administration is intended for children over the age of 1 year.

The drug in the form of a syrup is intended for children over the age of 2 years.

The drug in the form of tablets is intended for children over the age of 6 years.

APPLICATION IN ELDERLY PATIENTS

Use with caution elderly patients.

SPECIAL INSTRUCTIONS

It is not recommended simultaneous use of drugs that depress the central nervous system.

Against the background of the drug should not use ethanol.

When prescribing a patient with diabetes, one should take into account that 1 tablet corresponds to less than 0.01 XE, 10 ml of syrup (2 measuring spoons) contain 3.15 g of sorbitol (800 mg of fructose), which corresponds to 0.026 XE.

In connection with the content of glycerol, propylene glycol, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate in the syrup, headache, gastrointestinal disorders, bronchospasm, urticaria are possible in high doses.

Impact on the ability to drive vehicles and manage mechanisms

During the period of application of the drug, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms : drowsiness, retardation, weakness, headache, tachycardia, increased irritability, urinary retention, fatigue (usually with cetirizine at a daily dose of 50 mg) are possible.

Treatment: conduct symptomatic therapy.
A specific antidote has not been identified. Hemodialysis is ineffective. The stomach is washed, activated charcoal is prescribed.
DRUG INTERACTION

Clinically significant interaction of cetirizine with other drugs has not been established.

Joint use with theophylline (at a dose of 400 mg / day) leads to a decrease in the total clearance of cetirizine (the kinetics of theophylline does not change).

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
After opening the bottle, the drug in the form of drops for oral administration should be used for 6 months, in the form of a syrup - for 3 months.

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