Cesera

The drug Cesera belongs to antiallergic agents, in particular to H¹-histamine receptor blockers.

Indications Cesera

• Symptomatic therapy of persistent or periodic allergic rhinitis or conjunctivitis, which are accompanied by itching, nasal discharge, and redness of the mucous membranes.
• Treatment of hay fever, or seasonal allergic rhinoconjunctivitis.
• Allergic rashes such as urticaria.
• Other allergic manifestations.

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Release form

Cesera is produced in tablet form, each tablet has a film coating. Tablet weight is 5 mg.

The composition of the tablet is represented by the active ingredient levocetirizine hydrochloride, as well as additional substances: lactose, microcrystalline cellulose, silicon dioxide, magnesium stearate. The film coating consists of hypromellose, titanium dioxide, lactose, triacetin and macrogol.

The blister pack contains 10 tablets. The cardboard pack may contain 10 tablets, 30 tablets, 60 tablets or 90 tablets. Each cardboard pack contains instructions for use of Cezer.

The drug is produced in Slovenia, Novo Mesto.

Pharmacodynamics

The drug Cesera has an effect opposite to histamine, blocking distal H¹-histamine receptors. The similarity in the main properties of the receptors and levocetirizine is higher than that of cetirizine.

The drug affects the histamine-dependent stage of the allergic process, reduces the degree of cellular movement of eosinophils, prevents the release of the liquid part of the blood into the surrounding tissues, and inhibits the release of mediators of the inflammatory reaction.

The active component of Cesera can prevent the onset and smooth out the symptoms of an allergic process, exhibits anti-edematous and calming effects. The drug does not block the action of cholinergic receptors and serotonin receptors.

Standard dosages of the drug have virtually no sedative effect.

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Pharmacokinetics

The active substance of the drug is perfectly absorbed when taken orally. The peak level in plasma is observed 50-55 minutes after taking Ceser. A stable level is established after two days. The maximum concentration can be 270 ng / ml after a single use of the drug, or 308 ng / ml with regular intake of 5 mg once a day. The degree of absorption depends only on the dosage of the drug, but cannot change depending on the time of food intake. However, the peak level may be somewhat lower and is detected later.

Plasma protein binding is up to 90%. Bioavailability of the drug is up to 100%.

Less than 14% of the obtained amount of the drug undergoes stages of metabolism in the liver by the aromatase oxidation process, N- and O-dealkylation and taurine conjugation.

The biological half-life can be about 8 hours (error 2 hours). The rate of blood plasma clearance can average 0.63 ml per minute per kilogram. The active component and its metabolites leave the body mostly through renal filtration (more than 85% of the consumed amount of the drug). Excretion with feces can reach 12-13%.

There have been cases of the drug penetrating into breast milk.

Patients with kidney pathologies should reduce the dosage of the drug, taking into account creatinine clearance. In case of problems with urination (urinary retention), the rate of blood plasma purification decreases by approximately 80%. Up to 10% of the active component is eliminated during a standard four-hour hemodialysis session.

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Dosing and administration

Cesera is intended for oral use, regardless of meal time. The drug should be washed down with water. Chewing and crushing the tablet is unacceptable.

Adult patients and children over 6 years of age are prescribed an average daily dosage of 1 tablet (5 mg).

For elderly patients with satisfactory renal function, the daily dose of the drug remains the same.

In case of renal dysfunction, the dosage and frequency of administration of the drug are selected individually, taking into account creatinine clearance:

• 30-49 ml per minute – 1 tablet once every 48 hours;
• 10-29 mo per minute – 1 tablet once every 96 hours;
• less than 10 ml per minute – Cezer treatment is contraindicated.

Creatinine clearance is calculated according to the following scheme: 140 minus the number of years of the patient multiplied by the number of kilograms of body weight and divided by 72. The resulting figure should be multiplied by serum creatinine (multiplying by 0.85 for female patients).

In case of isolated liver dysfunction, there is no need to adjust the dosage.

The duration of treatment for hay fever is 7-42 days. Chronic pathologies (chronic allergic rhinitis, atopic dermatitis) require longer treatment – up to one and a half years.

Use Cesera during pregnancy

The drug Cesera is not used by pregnant or lactating women.

Proven facts of the drug penetration into breast milk do not allow the use of the drug during breastfeeding. If there is an urgent need for the use of the drug by a nursing woman, then breastfeeding should be temporarily suspended, with the possibility of its resumption after the course of treatment with Cezer.

Contraindications

Contraindications to the use of Cesera

• Tendency to develop an allergic reaction to any of the components of the drug.
• Severe or complicated course of functional renal failure (with creatinine clearance less than 10 ml per minute).
• Patients who use hemodialysis.
• Children under 6 years of age.
• The period of bearing and breastfeeding a child.
• Galactose metabolism disorder, lactase deficiency (glucose-galactose malabsorption).

The drug should be taken under the supervision of a specialist, especially in cases of moderate renal insufficiency (creatinine clearance less than 60 ml per minute) and in old age (there is a high probability of decreased renal filtration).

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Side effects Cesera

The following side effects of Cesera are noted:

• Headaches, sleep disturbances, general and muscle weakness.
• Dryness of the oral mucosa, thirst, epigastric pain, dyspeptic symptoms, bouts of nausea.
• Tachycardia.
• Change in visual acuity.
• Difficulty breathing.
• Allergic process: itchy skin rashes, redness, Quincke's edema.
• Transient activation of liver enzymes.
• Obesity.

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Overdose

Signs of an overdose of Cesera: adult patients may experience drowsiness, while children, on the contrary, may experience overexcitement, capriciousness and restless behavior, which then progresses to a sleepy state.

Measures in case of overdose: elimination of symptoms and strengthening of the body, cleansing of the stomach (you can induce vomiting and take sorbent drugs, such as activated carbon or sorbex).

There is no special remedy that can stop or weaken the effect of the drug Cesera on the body.

The hemodialysis procedure does not show any effect.

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Interactions with other drugs

Clinical trials of interactions between Cesera and drugs such as diazepam, erythromycin, pseudoephedrine, glipizide, cimetidine, azithromycin and cimetidine have not been conducted.

A decrease in the overall rate of clearance of the active component from blood plasma can be observed with regular administration of theophylline (0.4 g once a day), while the pharmacokinetic properties of theophylline were not affected when used in combination with Cesera.

Food intake does not reduce the degree of absorption of the active substance, but reduces the rate of absorption.

In sensitive patients, the combined use of Cesera with ethyl alcohol and depressants may affect the function of the central nervous system. The effect of alcohol is not enhanced.

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Storage conditions

Cesera is stored at a stable temperature of no more than 30° C. Children should be kept away from the storage areas of the drug.

Shelf life

The shelf life is up to 3 years, after which the drug is not recommended for use.

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