Lorid® (Tablets) Instructions for Use
Marketing Authorization Holder
Unique Pharmaceutical Laboratories (India)
Company Division
J. B. Chemicals & Pharmaceuticals, Ltd. (India)
ATC Code
R06AX13 (Loratadine)
Active Substance
Loratadine (Rec.INN registered by WHO)
Dosage Forms
 |
Lorid® | Tablets 10 mg: 10 pcs. |
| Syrup 5 mg/5 ml: 100 ml bottle with a measuring spoon |
Dosage Form, Packaging, and Composition
Tablets are round, flat, white or almost white, with a score line on one side.
| 1 tab. | |
| Loratadine | 10 mg |
Excipients: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.
10 pcs. – blister strips (1) – cardboard packs.
Syrup is orange in color.
| 5 ml | |
| Loratadine | 5 mg |
Excipients: propylene glycol, sodium benzoate, sucrose, citric acid monohydrate, sodium saccharin, glycerol, Sunset Yellow color, sweet orange flavor, purified water.
100 ml – bottles (1) with a 5 ml measuring spoon – cardboard packs.
Clinical-Pharmacological Group
Histamine H1-receptor blocker. Antiallergic drug
Pharmacotherapeutic Group
H1 histamine receptor blocker
Pharmacological Action
Lorid® (Loratadine) is a long-acting histamine H1-receptor blocker.
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 antiallergic, antipruritic, and anti-exudative effects. It reduces capillary permeability, prevents the development of tissue edema, and relieves smooth muscle spasms.
The antiallergic effect develops within 30 minutes, reaches its maximum in 8-12 hours, and lasts for 24 hours. It does not affect the CNS and does not cause addiction (as it does not cross the blood-brain barrier).
Pharmacokinetics
It is rapidly and completely absorbed from the gastrointestinal tract. Tmax is 1.3-2.5 hours; food intake delays it by 1 hour. Cmax in elderly people increases by 50%, and in alcoholic liver disease – with increasing severity of the disease. Plasma protein binding is 97%.
It is metabolized in the liver to form an active metabolite, descarboethoxyloratadine, with the participation of the CYP3A4 isoenzyme and, to a lesser extent, CYP2D6.
Steady-state plasma concentrations of loratadine and its metabolite are achieved on the 5th day of administration. It does not cross the blood-brain barrier.
The T1/2 of loratadine is 3-20 hours (average 8.4), and of the active metabolite – 8.8-92 hours (average 28 hours); in elderly patients, it is 6.7-37 hours (average 18.2) and 11-38 hours (17.5 hours), respectively. In alcoholic liver disease, T1/2 increases with 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 do not change.
Indications
- Seasonal and perennial allergic rhinitis;
- Allergic conjunctivitis;
- Hay fever;
- Urticaria (including chronic idiopathic);
- Angioedema;
- Allergic pruritic dermatoses; pseudoallergic reactions;
- Allergic reactions to insect bites;
- Pruritus of various etiologies.
ICD codes
| ICD-10 code | Indication |
| H10.1 | Acute atopic (allergic) conjunctivitis |
| J30.1 | Allergic rhinitis due to pollen |
| J30.3 | Other allergic rhinitis (perennial allergic rhinitis) |
| L20.8 | Other atopic dermatitis (neurodermatitis, eczema) |
| L23 | Allergic contact dermatitis |
| L24 | Irritant contact dermatitis |
| L28.0 | Lichen simplex chronicus (circumscribed neurodermatitis) |
| L29 | Pruritus |
| L50 | Urticaria |
| T78.3 | Angioneurotic edema (Quincke's edema) |
| ICD-11 code | Indication |
| 9A06.70 | Atopic eczema of the eyelids |
| 9A60.01 | Acute atopic conjunctivitis |
| 9A60.02 | Allergic conjunctivitis |
| 9A60.0Y | Other specified papillary conjunctivitis |
| 9A60.0Z | Papillary conjunctivitis, unspecified |
| CA08.00 | Allergic rhinitis due to pollen |
| CA08.03 | Other allergic rhinitis |
| EA80.0 | Infantile atopic eczema |
| EA80.1 | Childhood atopic eczema |
| EA80.2 | Adult atopic eczema |
| EA80.Z | Atopic eczema, unspecified |
| EA83.00 | Lichen simplex of vulva |
| EA83.01 | Lichen simplex of male genital organs |
| EA83.02 | Lichen simplex of perianal area |
| EA83.0Z | Lichen simplex of unspecified location |
| EA85.20 | Atopic hand eczema |
| EB04 | Idiopathic angioedema |
| EC90.Z | Itching, unspecified |
| EK00.Z | Allergic contact dermatitis, unspecified |
| EK02.Z | Irritant contact dermatitis, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
For oral administration. Adults and children over 12 years: 10 mg (1 tablet or 2 measuring spoons of syrup) once a day. The daily dose is 10 mg. Children from 2 to 12 years – 5 mg (1/2 tablet or 1 measuring spoon of syrup) once a day. The daily dose is 5 mg. Children with body weight over 30 kg – 10 mg (1 tablet or 2 measuring spoons of syrup) once a day. The daily dose is 10 mg.
Adverse Reactions
Possible blepharospasm, dysphonia, hyperkinesia, paresthesia, tremor, amnesia, depression, dermatitis, change in urine color, painful urge to urinate; dysmenorrhea, menorrhagia, vaginitis.
Metabolism and nutrition disorders: weight gain, sweating, thirst.
Musculoskeletal and connective tissue disorders: calf muscle cramps, arthralgia, myalgia.
Gastrointestinal disorders dry mouth, taste perversion, anorexia, constipation or diarrhea, dyspepsia, gastritis, flatulence, increased appetite, stomatitis.
Respiratory, thoracic and mediastinal disorders: cough, bronchospasm, dryness of the nasal mucosa, sinusitis.
Eye and ear disorders: visual disturbance, conjunctivitis, pain in the eyes and ears.
Cardiac disorders: decrease and increase in blood pressure, palpitations.
Other photosensitivity, back pain, chest pain, fever, chills, breast pain.
Contraindications
- Pregnancy;
- Lactation period;
- Hypersensitivity to any component of the drug.
With caution – hepatic insufficiency
Use in Pregnancy and Lactation
Contraindicated.
Use in Hepatic Impairment
With caution – hepatic insufficiency.
Pediatric Use
Children from 2 to 12 years – 5 mg (1/2 tablet or 1 measuring spoon of syrup) once a day. The daily dose is 5 mg. Children with body weight over 30 kg – 10 mg (1 tablet or 2 measuring spoons of syrup) once a day. The daily dose is 10 mg.
Special Precautions
During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
Symptoms: drowsiness, tachycardia, headache.
Treatment: in case of overdose, consult a doctor and take measures to remove the drug from the gastrointestinal tract and reduce absorption.
Drug Interactions
No interaction with alcohol was detected when loratadine was used at therapeutic doses.
Erythromycin, cimetidine, ketoconazole, when used concomitantly with loratadine, increase the plasma concentration of loratadine without causing clinical manifestations or affecting the ECG.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine.
Storage Conditions
Store at a temperature not exceeding 30°C (86°F) in a light-protected place, out of the reach of children.
Shelf Life
The shelf life of the tablets is 3 years, the syrup is 2 years.
Dispensing Status
The drug is dispensed by prescription.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical Disclaimer![Lorid® [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Lorid® [Tablets] 2")