Lorahexal - instructions for use, dose, side effects, contraindications

active substance: loratadine - 10,000 mg;
Excipients: lactose monohydrate - 69.175 mg, corn starch - 18,000 mg, silicon dioxide colloidal anhydrous - 1,825 mg, magnesium stearate - 1,000 mg.

Description:White oval tablets with risk and engraving LT I 10 on one side.

Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker

ATX: & nbsp

R.06.A.X Other antihistamines for systemic use

R.06.A.X.13 Loratadin

Pharmacodynamics:

Loragexal (loratadine) - blocker of H1-histamine receptors (long action), which does not possess central and anticholinergic action.

Suppresses the release of histamine and leukotriene C₄ from mast cells.

Prevents development and facilitates the course of allergic reactions. Possesses antiallergic, antipruritic, anti-exsudative action.

Reduces the permeability of capillaries, prevents the development of edema of tissues, removes spasms of smooth muscles. The antiallergic effect develops after 30 minutes, reaches a maximum after 8 to 12 hours and lasts for 24 hours. It does not affect the central nervous system, and does not cause addiction (because it does not penetrate the blood-brain barrier).

Pharmacokinetics:

When ingested, the drug is quickly and completely absorbed in the gastrointestinal tract.

Absorption of the drug is not dependent on food intake. Time to reach the maximum concentration - 1,3 - 2,5 h; eating slows it down for 1 hour.The maximum concentration in the elderly is increased by 50%, with alcoholic liver damage - with an increase in the severity of the disease.

Connection with blood plasma proteins - 97%. Metabolized in the liver with the formation of an active metabolite of descarbon ethoxyloratadine with the participation of cytochrome isoenzymes CYP3A4 and to a lesser extent CYP2D6. The equilibrium concentration of loratadine and metabolite in blood plasma is reached on the 5th day of administration. Does not penetrate the blood-brain barrier. The half-life of loratadine is 3 to 20 hours (an average of 8.4 hours), the active metabolite is 8.8 to 92 hours (an average of 28 hours); in elderly patients, respectively, 6.7-37 hours (an average of 18.2 hours) and 11-38 hours (17.5 hours). In alcoholic liver damage, the half-life period increases in proportion to the severity of the disease. It is excreted by the kidneys and with bile. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

Indications:

- seasonal (pollinosis) and all-the-year-round allergic rhinitis and allergic conjunctivitis - elimination of symptoms associated with these diseases - sneezing, itching of the nasal mucosa, rhinorrhea, burning sensation and itching in the eyes, lacrimation;

- chronic idiopathic urticaria;

- skin diseases of allergic origin.

Contraindications:

- hypersensitivity to loratadine or any other component of the drug;

- pregnancy;

- lactation period;

- children up to 3 years;

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Carefully should take the drug in patients with severe hepatic insufficiency.

Pregnancy and lactation:

The safety of LoraGEXAL® during pregnancy is not established, therefore, the use of the drug during this period is not recommended. LoraGEXAL® is excreted into breast milk, so if you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Inside.

Adults and children over 12 years of age: 10 mg (1 tablet) once a day.

Children from 3 to 12 years old:

with a body weight of more than 30 kg - 10 mg (1 tablet) once a day; with a body weight of less than 30 kg - 5 mg (1/2 tablets) once a day.

The duration of treatment depends on the duration of the manifestation of the symptoms of the disease.If the patient's condition does not improve within 3 days of starting treatment, then loratadine not effective.

Patients with severe hepatic insufficiency should be prescribed a reduced daily dose of the drug:

adults and children weighing more than 30 kg: 10 mg (1 tablet) every other day.

children with a body weight of less than 30 kg: 5 mg (1/2 tablet) every other day.

Older patients do not need a dose adjustment.

Patients with severe renal failure (CC <30 mL / min): 5 mg once a day daily or 10 mg once a day every other day. The maximum daily dose is 10 mg.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their developmental frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, < 1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the immune system rarely: reactions hypersensitivity (including angioedema and anaphylactic reactions).

From the nervous system often: headache, drowsiness, increased nervous excitability, increased fatigue; infrequently: insomnia; rarely: dizziness, convulsions.

From the side of the cardiovascular system rarely: tachycardia, heart palpitations, syncope, arrhythmia.

From the gastrointestinal tract infrequently: increased appetite; rarely: nausea, dry mouth, gastritis.

Co hand liver and bile ducts rarely: function violation liver.

From the skin rarely: allergic reactions (rash), alopecia.

In addition to the above reactions children can develop sedative effect. Such unwanted effects like headache (2.7%), nervousness (2.3%) and fatigue (1%) were detected more often than when taking placebo.

Overdose:

Symptoms: headache, drowsiness, palpitation, which can continue for a long time. There is no specific antidote.

Treatment: when the drug is overdosed, it is recommended to wash the stomach and take adsorbents (Activated carbon). Loratadin is not excreted by hemodialysis. To date, it is also not known whether loratadine with peritoneal dialysis. After conducting emergency therapy, it is necessary to conduct medical supervision of the patient.

Interaction:

When using loratadine in therapeutic doses, its interaction with alcohol was not revealed.

Possible interaction of the drug with inhibitors of cytochrome isoenzymes, such as CYP3A4 or CYP2D6 (cimetidine, ketoconazole, quinidine, itraconazole, erythromycin, fluoxetine), increases the concentration of loratadine in the blood plasma, without causing clinical manifestations and without affecting the ECG; however, this combination may lead to an increase in the side effects of loratadine.

Inductors of microsomal oxidation (phenytoin, barbiturates, flumecinol, rafampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine.

Special instructions:

The drug should be stopped at least two days before the skin allergic tests, because loratadine can influence their results.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of LoraHEXAL® in recommended doses on the ability to drive or work with mechanisms are not present. At the same time, patients who have exceeded the dose of the drug or who mark non-standard effects when taking LoraHEXAL®,caution should be exercised when engaging in potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Some patients experience drowsiness when taking loratadine, which can affect their ability to drive vehicles and work with mechanisms.

Form release / dosage:

Tablets 10 mg.

Packaging:

Primary packaging

For 7 or 10 tablets in PVC / Al. blister.

Secondary packaging

For 1, 2, 3 or 5 blisters together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014516 / 01

Date of registration:17.11.2008 / 25.12.2014

The owner of the registration certificate:Sandoz S.A.Sandoz S.A. Argentina

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp23.06.2016

Illustrated instructions

Instructions

Lorahexal® (Lorahexal®)