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

Excipients: sodium hydrogen carbonate - 828.0 mg, sodium carbonate - 112.0 mg, citric acid - 1300.0 mg, povidone - 2.8 mg, polysorbate 80 - 0.2 mg, silicon dioxide colloid - 0.5 mg, lactose monohydrate -186.5 mg, macrogol-6000 - 60.0 mg.

Description:

Round tablets of flat-cylindrical form from white to almost white, with a bevel.

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 1 hour. The maximum concentration in elderly people increases by 50%, with alcoholic liver damage - with increasing severity of the disease.

The connection with plasma proteins is 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 to loratadine and / or any component of the drug; pregnancy, lactation; children under 6 years of age and / or body weight less than 30 kg (for this dosage form); deficiency of lactase, lactose intolerance, glucose-galactose malabsorption (the preparation contains lactose).

Carefully:

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

Dosing and Administration:

Inside. The effervescent tablet is previously dissolved in a glass of water (200 ml). Tablets should not be swallowed, chewed and sucked in the mouth.

Children older than 6 years (with a body weight of more than 30 kg) and adults: 10 mg (1 tablet effervescent) 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.

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.

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 a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets effervescent 10 mg.

Packaging:

For 10 tablets in a plastic tube, ukuporennuyu plastic cover with silica gel and control the first dissection. 1 or 2 tubes together with instructions for use in a cardboard pack.

Storage conditions:

In original packaging in a dry place.

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:P N 016086/02

Date of registration:27.12.2011

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)