Each tablet contains: Loratadine 10 mg.
Loratadine is a potent, new generation long acting antihistamine with a high degree of specificity for histamine H1-receptors. It has very limited penetration into the CNS. The result is virtual freedom from unwanted sedative side effects.
Loratadine is chemically related to azatadine.
Loratadine Tablets disintegrate in the mouth within seconds after placement on the tongue, allowing its contents to be subsequently swallowed with or without water, thereby greatly enhancing patient compliance.
Pharmacology: Loratadine is a competitive blocker of peripheral histamine H1-receptors. It has a weak anticholinergic & alpha adrenoceptor blocking action. Onset of antihistaminic action with Loratadine, as measured by wheal and flare suppression, is apparent within first hour of administration, and is sustained up to 24 hours. Loratadine 10 to 20 mg exhibits a protective effect on airways in response to inhaled histamine challenge in patient with asthma. The anti-allergic activity of loratadine has been demonstrated in humans, using cutaneous, nasal challenge and conjunctival provocation tests.
Loratadine is well absorbed after oral administration with peak concentrations of 24.3 and 30.5 mcg/L occurring 1 and 1.5 hours after ingestion of 40 mg drug. Loratadine is 97 to 99% plasma protein bound and has large volume of distribution (119 L/kg). Loratadine is rapidly metabolized and an active metabolite descarboethoxyloratadine (DCL) is formed in vivo. Plasma elimination half life of Loratadine and DCL range from 7.8 to 11 hours and 17 to 24 hours respectively. While loratadine is excreted into breast milk, the amount of administered drug appearing in the milk is minimal. The dosage adjustments are not required in patients with renal dysfunction and elderly.
Pharmacokinetic studies have showed that Loridin MD tablets provide plasma concentrations of loratadine and descarboethoxyloratadine similar to those achieved with plain Loratadine tablets.
Loridin MD is indicated in the treatment of seasonal allergic rhinitis, perennial rhinitis, urticaria and allergic dermatologic disorders.
The recommended dose of Loridin MD is 10 mg daily for adults and for children weighing more than 30 kg.
Children aged 2 to 12 years and weighing less than 30 kg should receive 5 mg once daily.
Loratadine is contraindicated in patients with history of hypersensitivity to drug.
1. Loratadine may be caused to sedative effects in some case. Patients should be cautioned about their ability to undertake potentially hazardous tasks such as driving or operating machinery.
2. Loratadine should not be administered with alcohol or the others content with alcohol.
3. Caution should be exercised when Loratadine is administered to children aged less than 2 years, during the first 3 months of pregnancy and nursing women.
4. If arrhythmia occurred, discontinue the administration and medical consultation is required.
5. Caution should be exercised in patients with liver impairment.
6. Loratadine is concomitant with Macrolides antibiotics (such as erythromycin, clarithromycin) or Imidazole anti-fungicides (such as ketoconazole, itraconazole, fluconazole) or HIV protease inhibitors including the other drugs that inhibit the CYP450 enzyme function (such as cimetidine, metronidazole, zafirlukast and SSRIs) are causes the plasma concentration will be raised into 2.3 times and QT interval prolongation has been reported.
7. Loratadine should not be concomitant with the drugs that caused to prolong the QT interval including calcium channel blockers (bepridil, verapamil), tricyclic antidepressants, cisapride and quinidine.
Dosage adjustment may be necessary in patients with hepatic dysfunction.
Loratadine is generally well tolerated at therapeutic doses in adults, elderly patients and children. Commonly reported events are somnolence, fatigue and headache, while dry mouth and gut upset occur less frequently.
No clinically significant drug interactions are reported with ketoconazole, erythromycin and cimetidine.
STORE BELOW 25°C, PROTECT FROM LIGHT & MOISTURE.
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Loridin MD dispersible tab 10 mg
10 × 10's
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