Universal reference book for medicines
Product name: LOMILAN ® (LOMILAN ® )

Active substance: loratadine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: SANDOZ (Slovenia) produced by LEK dd (Slovenia)
Composition, form of production and packaging
?
Tablets white or almost white, round, flat, with a facet and a notch on one side.
1 tab.

loratadine 10 mg

Excipients: lactose - 71.3 mg, corn starch - 15 mg, gelatinized starch - 3 mg, magnesium stearate - 0.7 mg.

7 pcs.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
?
Suspension for oral administration is homogeneous, from white to almost white.
5 ml

loratadine 5 mg

Auxiliary substances: polysorbate 80-1 mg, citric acid monohydrate 1.55 mg, sodium citrate dihydrate 0.6 mg, sodium benzoate 2 mg, avicel RC 591 FMC 16 mg, white crystalline sugar 300 mg, wild cherry flavor 2.5 mg , glycerol (conc.) - 70 mg, propylene glycol - 50 mg, purified water - 690.313 mg.

120 ml - bottles of dark glass (1) complete with a dosage spoon - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

The blocker of histamine H 1 -receptors for systemic use.
Has anti-allergic, antipruritic and antiexudative action.
Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles.

Has no effect on the central nervous system and is not addictive.

The effect of the drug begins 30 minutes after admission, reaches a maximum after 8-12 hours and persists for 24 hours.

PHARMACOKINETICS

Suction and distribution

Once ingested, loratadine is quickly and completely absorbed from the digestive tract.
C max is achieved after 1 hour (after a single dose of 10 mg). The presence of food slows down absorption.
Binding to plasma proteins is more than 95%.
Does not penetrate the BBB.
Metabolism

Metabolized in the liver with the formation of an active metabolite of descabroxetoxyloratadine.

Excretion

T 1/2 is about 8 hours for loratadine. It is excreted with bile and kidneys.

Pharmacokinetics in special clinical cases

T 1/2 increases in the elderly and in chronic alcoholism.

With chronic renal failure and hemodialysis, the pharmacokinetics of loratadine remains virtually unchanged.

INDICATIONS

Prophylaxis and treatment of the following diseases and conditions:

- seasonal and year-round allergic rhinitis;

- allergic conjunctivitis;

- treatment of skin diseases of allergic genesis (including chronic idiopathic urticaria);

- pseudoallergic reactions;

- Allergic reactions to insect bites.

DOSING MODE

Suspension for oral administration

Inside.
Possible reception with food. Wash down with water, milk.
Children under the age of 12 are advised to take Lomilan ® as a suspension.

Adults and children over 12 years of age -
2 dosage spoons (10 ml) 1 time / day; children from 2 to 12 years with a body weight of more than 30 kg - 2 dosage spoons (10 ml) 1 time / day; with a body weight of less than 30 kg - 1 dosage spoon (5 ml) 1 time / day.
Pills

Inside.
Possible reception with food. Wash down with water, milk. If necessary, the tablet can be chewed.
Adults and children over 12 years - 10 mg (1 tab.) 1 time / day;
children from 3 to 12 years with a body weight of more than 30 kg - 10 mg (1 tab.) 1 time / day;with a body weight of less than 30 kg - 5 mg (1/2 tab.) 1 time / day.
Patients with violations of liver function should be prescribed a reduced daily dose of Lomilan ® : adults and children with a body weight of more than 30 kg - 2 dosage spoons (10 ml) or 1 tab.
(10 mg) every other 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 is not effective.
Elderly patients or patients with renal insufficiency do not need dose adjustment.

Patients with severe renal failure (CC less than 30 ml / min): adults and children from 6 years - the starting dose is 10 mg (2 dosage tablespoons or 1 tab.) Every other day;
children from 3 years - the starting dose is 5 mg (1 dosage spoon or 1/2 tablets) every other day.
SIDE EFFECT

According to WHO, unwanted reactions are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10 000, <1/1000) and very rarely (<1/10 000);
frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.
From the side of the immune system: very rarely - anaphylactic reactions.

From the nervous system: often - headache, drowsiness, increased nervous excitability, increased fatigue;
infrequently - insomnia; very rarely - dizziness.
From the cardiovascular system: very rarely - tachycardia, palpitations, syncope, arrhythmia.

From the digestive tract: infrequent - increased appetite;
very rarely - nausea, dry mouth, gastritis.
From the liver and bile ducts: very rarely - a violation of the liver.

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

In addition to the above reactions, children may develop a sedative effect.
The undesirable side effects of the CNS (headache, drowsiness, and increased fatigue) occurred approximately at the same frequency as with placebo.
CONTRAINDICATIONS

- Pregnancy;

- lactation period;

- Children under 2 years of age (for suspension for oral administration);

- Children under 3 years old (for tablets);

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption (for suspension for oral administration);

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption (for tablets);

- Hypersensitivity to any of the components of the drug.

With caution should be used for liver failure, severe renal failure (CK <30 ml / min).

PREGNANCY AND LACTATION

The safety of Lomilan ® during pregnancy is not established, so the use of the drug during this period is contraindicated.

Lomilan ® is excreted in breast milk, therefore, if it is necessary to use the drug during lactation, the question of stopping breastfeeding should be solved.

APPLICATION FOR FUNCTIONS OF THE LIVER

For patients with renal insufficiency, the initial dose of the drug is 10 mg (1 table or 2 dosage slurry) every other day.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

For patients with impaired hepatic function, the initial dose of the drug is 10 mg (1 table or 2 dosage spoons of the suspension) every other day.

APPLICATION FOR CHILDREN

There are no data on the safety and efficacy of Lomilan in children under 2 years of age.

Children aged 2 to 12 years with a body weight of more than 30 kg are prescribed 10 mg / day (1 tablet or 2 dosage spoons / 10 ml /);
children from 2 to 12 years with a body weight of less than 30 kg - 5 mg / day (1 dosage spoon / 5 ml / or 1/2 tab.). The drug is taken 1 time / day.
SPECIAL INSTRUCTIONS

The drug should be discontinued no less than 2 days before the skin allergic tests are performed, tk.
Lomilan ® can influence their results.
Impact on the ability to drive vehicles and manage mechanisms

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: headache, drowsiness, palpitation, which can last a long time.
There is no specific antidote.
Treatment: with an overdose of the drug recommended gastric lavage and intake of adsorbents (activated charcoal).
Lomilan ® is not excreted by hemodialysis. To date, it is also not known whether Lomilan ® is excreted by peritoneal dialysis. After conducting emergency therapy, it is necessary to conduct medical supervision of the patient.
DRUG INTERACTION

Simultaneous use of inducers of microsomal liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, tricyclic antidepressants) decreases the effectiveness of loratadine.

Possible interaction of the drug with inhibitors of cytochrome isoenzymes, such as CYP3A4 or CYP2D6 (ketoconazole, quinidine, itraconazole, erythromycin, fluoxetine), increases the concentration of Lomilan ® in the blood plasma, which can lead to increased side effects of the drug.

TERMS OF RELEASE FROM PHARMACY

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

TERMS AND CONDITIONS OF STORAGE

The drug in the form of tablets should be stored in a dry, protected from light and out of reach of children at a temperature of up to 25 ° C.

The drug in the form of a suspension should be stored out of reach of children at a temperature of up to 25 ° C.
Shelf life - 4 years.
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