Loratadine Sandoz Orodispergeerbare Tablet

Uses

Allergic Rhinitis: Loratadine Sandoz Orodispergeerbare Tablet is used for the relief of the nasal and non-nasal symptoms of allergic rhinitis (Both seasonal and perennial) in patients 2 years of age and older.

Chronic Idiopathic Urticaria: Loratadine Sandoz Orodispergeerbare Tablet is also used for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 2 years of age and older.

Loratadine Sandoz Orodispergeerbare Tablet is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Asthma, Chronic Idiopathic Urticaria, Common Cold, Nasal Congestion, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis, Nasal symptoms, Non-nasal symptoms, Antihistamine

How Loratadine Sandoz Orodispergeerbare Tablet works

Like other H1-blockers, Loratadine Sandoz Orodispergeerbare Tablet competes with free histamine for binding at H₁-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine.

Dosage

Loratadine Sandoz Orodispergeerbare Tablet dosage

Pediatric drops :

• Child 6 -11 months of age: 2 ml drops once daily
• Child 1 -2 years of age: 2.5 ml drops once daily

Syrup:

• Child 6-11 months of age: 2 ml once daily
• Child 1-5 years of age: 2.5 ml once daily
• Child 6-11 years of age: 5 ml once daily
• Adults & > 12 years of age: 10 ml once daily

Tablet:

• Adults and children 12 years of age and over: 5 mg daily

Side Effects

Loratadine Sandoz Orodispergeerbare Tablet is generally well tolerated. However, dry mouth, fatigue, somnolence and myalgia are commonly reported side-effects. Less common side-effects may include dizziness, headache and nausea. Rarely rash, pruritus and urticaria may occur.

Toxicity

Information regarding desloratadine overdose is limited, although somnolence has been reported. In case of overdose, symptomatic and supportive treatment, including removing the unabsorbed drug, is recommended; note, however, that desloratadine and its active metabolite 3-hydroxydesloratadine cannot be eliminated by hemodialysis.

In animal studies, lethality was observed at or above doses of 250 mg/kg in rats and of 353 mg/kg in mice (oral LD₅₀), doses that represent 120 and 290 times the human exposure based on the recommended daily oral dose. In monkey, no deaths occurred at doses up to 250 mg/kg, representing an exposure roughly 810 times that of the recommended dose in humans.

Precaution

Hepatic and renal impairment. Pregnancy and lactation.

Interaction

Concomitant administration of Erythromycin, Ketoconazole, Azithromycin, Fluoxetine, and Cimetidine with Loratadine Sandoz Orodispergeerbare Tablet increased the plasma concentration of Loratadine Sandoz Orodispergeerbare Tablet. But there were no clinically relevant changes in the safety profile of Loratadine Sandoz Orodispergeerbare Tablet.

Food Interaction

• Take with or without food. The absorption is unaffected by food.

Loratadine Sandoz Orodispergeerbare Tablet Disease Interaction

Moderate: asthma, renal/hepatic impairment

Elimination Route

Loratadine Sandoz Orodispergeerbare Tablet administered orally for ten days to healthy volunteers as a 5 mg tablet once daily resulted in a mean T_max of approximately 3 hours, a mean steady-state C_max of 4 ng/ml, and a mean steady-state AUC of 56.9 ng*hr/ml. A similar profile was observed using 10 ml of an oral solution containing 5 mg of desloratadine. Food was found not to affect desloratadine absorption.

Half Life

Loratadine Sandoz Orodispergeerbare Tablet has a mean plasma elimination half-life of approximately 27 hours.

Elimination Route

Approximately 87% of a C-desloratadine dose was equally recovered in urine and feces as metabolic products.

Pregnancy & Breastfeeding use

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Loratadine Sandoz Orodispergeerbare Tablet should be used in pregnancy only if clearly needed.

Lactation: Loratadine Sandoz Orodispergeerbare Tablet passes into breast milk. Therefore, a decision should be made whether to discontinue nursing or to discontinue Loratadine Sandoz Orodispergeerbare Tablet, taking into account the importance of the drug to the mother.

Contraindication

Loratadine Sandoz Orodispergeerbare Tablet is contraindicated in patient having hypersensitivity to this medication or to any of its ingredients or Loratadine.

Special Warning

Paediatric Use: The safety and effectiveness of Loratadine Sandoz Orodispergeerbare Tablet in pediatric patients under 2 years of age have not been established.

Geriatric Use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data.

Acute Overdose

No clinically relevant adverse events have been reported in case of overdosage. However, in the event of overdosage, symptomatic and supportive treatment is recommended.

Storage Condition

Store in a cool and dry place, protected from light.

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