Loratadin-Hemofarm - instructions for use, dose, side effects, contraindications

Excipients: glycerol 500 mg, propylene glycol 500 mg, sucrose 2750 mg, sodium benzoate 5 mg, citric acid monohydrate 42.5 mg, cherry flavor 7.5 mg, disodium edetate 1.25 mg, water up to 5 mg ml.

Description:Transparent solution from colorless to slightly yellow, with a fruity odor.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

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

R.06.A.X.13 Loratadin

Pharmacodynamics:

H1-histamine receptor blocker (long-acting). Inhibits the release of histamine and leukotriene C4 from mast cells. Prevents development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative action. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles. The antiallergic effect develops within 30 minutes, reaches a maximum after 8-12 hours and lasts for 24 hours. The duration of action is greatly enhanced by the active metabolite desloratadine. Does not affect the central nervous system and is not addictive (because it does not penetrate the blood-brain barrier).

Pharmacokinetics:

Quickly and completely absorbed in the gastrointestinal tract. The maximum concentration in blood plasma is achieved after 1.3 - 2.5 hours; eating slows it down for 1 hour.The maximum concentration in the elderly is increased by 50%, at alcoholic damage to the liver - with increasing severity of the disease.

Connection with plasma proteins - 97%.

Metabolized in the liver with the formation of an active metabolite of descarbon ethoxyloratadine with the participation of cytochrome P450 isoenzymes CYP3A4 and to a lesser extent CYP2D6.

The equilibrium concentration of loratadine and metabolite in plasma is reached on the 5th day of administration.

Does not penetrate the blood-brain barrier.

The half-life of loratadine is 3-20 hours (an average of 8.4), the active metabolite is 8.8-92 hours (an average of 28 hours); in elderly patients, respectively, 6.7-37 hours (an average of 18 hours) and 11-38 hours (17.5 hours). In alcoholic liver damage, the half-life increases with increasing severity of the disease.

It is excreted by the kidneys and through the intestines.

In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

Indications:Allergic rhinitis (seasonal and year-round), conjunctivitis, hay fever, urticaria (including chronic idiopathic), Quincke's edema, itching dermatoses; pseudoallergic reactions, allergic reactions to insect bites.

Contraindications:

Hypersensitivity, pregnancy, lactation, children under 2 years, sugar / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (the preparation contains sucrose).

Carefully:

Hepatic and / or renal failure (creatinine clearance <30 mL / min).

Dosing and Administration:

Inside.

Children from 2 to 6 years (with a body weight of less than 30 kg): 1 measuring spoon (5 ml) of syrup 1 time per day.

Children over 6 years old (weighing more than 30 kg) and adults: 2 measuring spoons (10 ml) of syrup 1 time per day.

In patients with hepatic and / or renal insufficiency (creatinine clearance <30 ml / min), the drug is used every other day.

Older people do not need a dose reduction.

Side effects:

From the digestive system: dry mouth, taste change, anorexia, constipation or diarrhea, dyspepsia, gastritis, flatulence, increased appetite, stomatitis, nausea, vomiting, transient liver dysfunction.

From the nervous system: anxiety, agitation (in children), asthenia, drowsiness, blepharospasm, dysphonia, hyperkinesia, paresthesia, tremor, amnesia, depression, increased fatigue.

From the skin: dermatitis, alopecia.

From the genitourinary system: a change in the color of urine, painful urge to urinate; dysmenorrhea, menorrhagia, vaginitis.

From the side of metabolism: weight gain, sweating, thirst.

From the side of the musculoskeletal system: spasms of gastrocnemius muscles, arthralgia, myalgia.

From the respiratory system: cough, bronchospasm, dry nasal mucosa, sinusitis.

From the sense organs: visual impairment, conjunctivitis, pain in the eyes and ears.

From the side of the cardiovascular system: decrease or increase in blood pressure, palpitations.

Allergic reactions: angioedema, anaphylaxis, urticaria, pruritus, rash. Other: photosensitivity, back pain, chest pain, fever, chills, pain in the mammary glands, headache (in children).

Overdose:

Symptoms: drowsiness, tachycardia, headache.

Treatment: induction of vomiting, gastric lavage, reception of activated charcoal.

Interaction:Erythromycin, cimetidine, ketoconazole increase the concentration of loratadine in the blood plasma, without causing clinical manifestations and without affecting the ECG. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine.

Special instructions:

Patients with diabetes should take into account that in 1 measuring spoon of syrup (5 ml) contains 2.75 g of sucrose (0.23 bread units).

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

During the treatment period it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed psychomotor reactions due to the risk of drowsiness.

Form release / dosage:

Syrup 5 mg / 5 ml.

Packaging:

To 120 ml of syrup in the bottle of dark glass III hydrolytic group, sealed with a screwed plastic cover with the control of the first opening, equipped with a system to protect against accidental opening by children. On the top side of the lid is a scheme for opening the vial. 1 bottle complete with a measuring spoon (volume 5 ml, with a risk for a volume of 2.5 ml) and instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N016086 / 03

Date of registration:28.04.2011

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp19.03.2018

Illustrated instructions

Instructions

Loratadin-Hemofarm (Loratadine-Hemofarm)