Loratadine 10 mg 30 tablets

Indications

Seasonal and perennial allergic rhinitis, conjunctivitis, hay fever, urticaria (including chronic idiopathic), angioedema, allergic itchy dermatoses, pseudoallergic reactions, allergic reactions to insect bites, itching of various etiologies.

Loratadine is taken orally. Adults, including the elderly, and adolescents aged 12 years and older are recommended to take Loratadine at a dose of 10 mg (1 tablet) once a day. For children aged 3 to 12 years, the dose of Loratadine is prescribed based on body weight:

• for body weight less than 30 kg - 5 mg (1/2 tablet) once a day,

• for body weight 30 kg and more - 10 mg (1 tablet) once a day. For patients with liver dysfunction or renal insufficiency, the initial dose should be 10 mg (1 tablet) every other day.

Section: Composition

1 tablet contains:
Active ingredient: loratadine 10 mg.
Excipients: Ludipress granulate (lactose monohydrate, povidone, crospovidone), magnesium stearate or lactose monohydrate (milk sugar), povidone, crospovidone, magnesium stearate.

Description of the dosage form

Tablets of white or almost white color, flat-cylindrical with a facet and a score line. A slight unevenness of the surface is acceptable.

Contraindications

Hypersensitivity, age under 3 years.

With caution:

Liver failure.

Use during pregnancy and breastfeeding:

The drug is contraindicated during pregnancy and breastfeeding.

Special Instructions

The use of Loratadine during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
The drug is excreted in breast milk, so when prescribing Loratadine during lactation, the issue of discontinuing breastfeeding should be addressed.

Effect on the ability to drive vehicles and operate machinery:
During treatment, one should refrain from engaging in potentially dangerous activities that require increased attention and quick psychomotor reactions.

Section: Side Effects

From the cardiovascular system: decrease or increase in blood pressure, palpitations.
From the nervous system: anxiety, agitation (in children), asthenia, drowsiness, blepharospasm, dysphonia, hyperkinesia, paresthesias, tremor, amnesia, depression, increased fatigue.
From the sensory organs: vision impairment, conjunctivitis, pain in the eyes and ears.
From the digestive tract: dry mouth, altered taste, anorexia, constipation or diarrhea, dyspepsia, gastritis, flatulence, increased appetite, stomatitis, nausea, vomiting.
From the respiratory system: cough, bronchospasm, dryness of the nasal mucosa, sinusitis.
Allergic reactions: dermatitis.
From the urinary system: change in urine color, painful urges to urinate; dysmenorrhea, menorrhagia, vaginitis.
From metabolism: weight gain, sweating, thirst.
From the musculoskeletal system: calf muscle cramps, arthralgia, myalgia.
Others: photosensitization, back pain, chest pain, fever, chills, breast pain.

Section: Overdose

Symptoms: drowsiness, tachycardia, headache.
In case of overdose, consult a doctor.
Treatment: induction of vomiting, gastric lavage, administration of activated charcoal.
There is no specific antidote. Treatment is symptomatic. It should be noted that loratadine is not removed by hemodialysis.

Interaction

Ethanol reduces the effectiveness of loratadine.
Food intake does not affect the action of the drug.
When loratadine is taken together with ketoconazole, erythromycin, or cimetidine, an increase in the concentration of loratadine and its metabolite in plasma has been observed, without causing clinical manifestations and not affecting the ECG.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine.

Pharmacodynamics

Loratadine is an H1-histamine receptor antagonist (long-acting). It inhibits the release of histamine and leukotriene C4 from mast cells. It prevents the development and alleviates the course of allergic reactions. It has anti-allergic, anti-itching, and anti-exudative effects. It reduces capillary permeability, prevents tissue swelling, and relieves smooth muscle spasms. The anti-allergic effect develops within 30 minutes, reaches its peak in 8 to 12 hours, and lasts for 24 hours. It does not affect the central nervous system and does not cause dependence (as it does not cross the blood-brain barrier).

Section: Pharmacokinetics

Rapidly and completely absorbed in the gastrointestinal tract. Time to reach maximum concentration is 1.3 - 2.5 hours; food intake delays it by 1 hour. Maximum concentration in elderly individuals increases by 50%, and in cases of alcoholic liver damage, it increases with the severity of the disease. Binding to plasma proteins is 97%. Metabolized in the liver to form the active metabolite descarboethoxyloratadine with the involvement of cytochrome P450 isoenzymes CYP3A4 and, to a lesser extent, CYP2D6. Steady-state concentration of loratadine and its metabolite is achieved on the 5th day of administration. Does not cross the blood-brain barrier.
The half-life of loratadine is 3 - 20 hours (on average 8.4 hours), and for the active metabolite, it is 8.8 - 92 hours (on average 28 hours); in elderly patients, it is 6.7 - 37 hours (on average 18.2 hours) and 11 - 38 hours (17.5 hours). In cases of alcoholic liver damage, the half-life increases with the severity of the disease. Excreted by the kidneys and in bile. In patients with chronic renal failure and during hemodialysis, pharmacokinetics remain virtually unchanged.

Loratadine 10 mg is a medicinal product containing the active substance loratadine, which has anti-allergic, anti-itching, and anti-exudative effects. The anti-allergic effect develops within 30 minutes, reaches its peak in 8-12 hours, and lasts for 24 hours. It does not affect the central nervous system and does not cause dependence. It is used for the treatment of allergic rhinitis (seasonal and perennial), conjunctivitis, hay fever, urticaria (including chronic idiopathic), Quincke's edema, and itchy dermatoses. It can be taken by adults and children from 3 years old as prescribed by a doctor. There are contraindications; please read the instructions before use.