Aurochem Lab


Endure Medical
Full Prescribing Info
Levocetirizine hydrochloride.
Each film-coated tablet contains: Levocetirizine hydrochloride 5 mg. Each film-coated tablet contains: Levocetirizine hydrochloride 10 mg.
Pharmacology: Pharmacokinetics: Levocetirizine is rapidly absorbed from the gastrointestinal tract after oral doses, peak plasma concentrations being attained within about an hour. Food delays the time to peak plasma concentrations but does not decrease the amount of drug absorbed. Levocetirizine is highly bound to plasma proteins and has an elimination half-life of about 10 hours. It has been detected in breast milk. Levocetirizine is excreted primarily in the urine mainly as unchanged drug. It does not appear to cross the blood-brain barrier to a significant extent.
For the symptomatic relief of allergic conditions including rhinitis and chronic urticaria.
Dosage/Direction for Use
In adults and children aged 6 years and over: Levocetirizine hydrochloride is given by mouth-in a dose of 10 mg once daily or 5 mg twice daily.
Children aged 2 to 5 years: May be given Levocetirizine 5 mg once daily or 2.5 mg twice daily.
In the USA, children aged 6 months to 2 years may be given a dose of 2.5 mg once daily, increased to a maximum of 2.5 mg twice daily in those aged 12 months and over, for the treatment of perennial allergic rhinitis and chronic urticaria.
It is also used with a decongestant such as pseudoephedrine hydrochloride.
Administration in Renal Impairment: Dosage of Levocetirizine should be reduced in patients with hepatic or renal impairment according to creatinine clearance (CC): CC 30 to 49 mL/minute: 5 mg every other day; CC 10 to 29 mL/minute: 5 mg every 3days; CC less than 10 mL/minute: contra-indicated.
Special Precautions
Drowsiness is a major problem with the sedating antihistamines and those affected should not drive or operate machinery; alcohol should be avoided. In the case of non-sedating antihistamines, although drowsiness is rare, it can occur and may affect the performance of skilled tasks.
Because of their antimuscarinic actions the sedating antihistamines should be used with care in conditions such as angle-closure glaucoma, urinary retention, prostatic hyperplasia, or pyloroduodenal obstruction; antimuscarinic adverse effects are not a significant problem with the non-sedating antihistamines. Occasional reports of convulsions in patients taking antihistamines suggest a need for caution in patients with epilepsy.
Many antihistamines are excreted in the urine in the form of active metabolites so that dosage reduction may be necessary in renal impairment. Caution is also needed in hepatic impairment, notably with phenothiazine antihistamines and, above all, with the non-sedating antihistamines, astemizole and terfenadine (hazardous ventricular arrhythmias may occur in the presence of excessive blood concentrations).
Other important cautions for astemizole and terfenadine include avoidance of use with drugs liable to interfere with their hepatic metabolism or otherwise increase the risk of arrhythmias, and contra-indication in patients with cardiac disease, known or suspected prolongation of the QT interval, or hypokalaemia or other electrolyte imbalances.
Antihistamines should not be given to neonates because the latter are more susceptible to antimuscarinic effects. It has also been recommended that antihistamines, in particular phenothiazines, should be avoided in young children.
Elderly patients are also more susceptible to many of the adverse effects of antihistamines and, in particular, their inappropriate use for postural giddiness should be avoided. Topical preparations containing antihistamines should not be used on broken or eczematous skin.
A number of large studies have failed to find any strong associations between fetal abnormalities and antihistamines taken during pregnancy.
Adverse Reactions
The most common adverse effect of the sedating antihistamines is CNS depression, with effects varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and incoordination (although paradoxical stimulation may occasionally occur, especially at high doses and in children or the elderly). These sedative effects, when they occur, may diminish after a few days of treatment. A major advantage of the non-sedating antihistamines is that they generally cause little or no drowsiness.
Other adverse effects that are more common with the sedating antihistamines include headache, psychomotor impairment, and antimuscarinic effects, such as dry mouth, thickened respiratory-tract secretions, blurred vision, urinary difficulty or retention, constipation, and increased gastric reflux. Another major advantage of the non-sedating antihistamines is that most have little or no antimuscarinic effect.
Occasional gastrointestinal adverse effects of antihistamines include nausea, vomiting, diarrhea, or epigastric pain. Those with antiserotonin actions, such as cyproheptadine, may cause LEVOCETIRIZINE an increase in appetite with resultant weight gain, whereas anorexia has been reported with some other antihistamines. Palpitations and arrhythmias have been reported occasionally with most antihistamines, but a major disadvantage of the non-sedating antihistamines astemizole and terfenadine is the rare occurrence of hazardous ventricular arrhythmias which has led to important restrictions on their use. Antihistamines sometimes cause rashes and hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis) and cross sensitivity to related drugs may occur. Photosensitivity can be a problem, particularly with the phenothiazine antihistamines.
Blood disorders, including agranulocytosis, leucopenia, haemolytic anemia, and thrombocytopenia, although rare, have been reported. Jaundice has also been observed, particularly with the phenothiazine antihistamines.
Other adverse effects that have been reported with the antihistamines include convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, tremor, sleep disturbances, depression, confusion, tinnitus, hypotension, and hair loss. Despite reports suggesting a possibility of human fetal abnormalities resulting from the use of some antihistamines, especially the piperazine derivatives, a causal relationship has largely been rejected. Some antihistamines have been abused for their mental effects.
Drug Interactions
Sedating antihistamines may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics. Sedative interactions apply to a lesser extent with the non-sedating antihistamines; they do not appear to potentiate the effects of alcohol, but it should be avoided in excess. Sedating antihistamines have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs). Potentially hazardous ventricular arrhythmias have occurred when the non-sedating antihistamines astemizole and terfenadine have been given with drugs liable to interfere with their hepatic metabolism, with other potentially arrhythmogenic drugs including those that prolong the QT interval, or with those likely to cause electrolyte imbalance. It has been suggested that some sedating antihistamines could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics. Antihistamines may suppress the cutaneous histamine response to allergen extracts and should be stopped several days before skin testing.
Store at temperatures not exceeding 30°C.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Levocer FC tab 10 mg
Levocer FC tab 5 mg
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