Alaron 10mg

Tablet
Loratadine
ACI Pharmaceuticals

Other Strength:

Alternative:
- Pretin 10mg
- ORIN 10mg
- Encilor 10mg
- Loratin® 10mg
- Aleze 10mg



Alaron
Description
Alaron®is a preparation of Loratadinewhich is long acting non-sedative anti-histamine with selective peripheralH1receptor antagonisticactivity.

Indications
Alaron® is indicated for the relief of Symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge and itching, and ocular itching and burning.Symptoms and signs of chronic urticaria and other allergic dermatological disorders.

Dosage and administration
Tablet:Adults and children over 12 years of age:One Alaron® tablet(10 mg)once daily.Children of 2 to 12 years(body weight more than 30kg):One Alaron® tablet(10 mg)once daily.Children of 2 to 12 years (body weight less than 30kg):HalfAlaron® tablet(5 mg) once daily.

Suspension:
Adults and children over 12 years of age: Two teaspoonfulsof Alaron® suspension (10 ml) once daily.Children of 2 to 12 years (body weight more than 30kg):Two teaspoonfulsof Alaron® suspension (10 ml) once daily.Children of 2 to 12 years (body weight less than 30kg):Oneteaspoonful of Alaron® suspension (5 ml) once daily.

Use in patients with liver impairmentor renal insufficiency (GFR<30 ml/min): Patients with severe liver impairmentor renal insufficiencyshould be administered a lower initial dose. The dose should be-Adults and children ≥ 6 years of age: 10 mg (oneAlaron® tablet) every other day as starting dose.Children 2 to 5 years of age: 5 mg(half of Alaron® tablet) every other day as starting dose.Sudden withdrawal of Loratadine is not hazardous but symptoms may reappear within 24 to 48 hours.

Use in pregnancy and lactation
Loratadine is pregnancy category B.The safe use of Loratadine during pregnancy or lactation has not been established and therefore the compound should only be used if the potential benefit outweighs the potential risk to the fetus or the infant. Since Loratadine is excreted intobreast milk and because of the increased risk of antihistamines for infants, particularly newborns and premature infants, a decision should be made whether to discontinue nursing or discontinue Loratadine use.

Sideeffects
The most common side effects of loratadinewere fatigue, dizziness, dry mouth, headache, sedation, nausea and pruritus. Gastrointestinal side effects reported during paediatric trails may have been slightly more frequent in theyounger patients (less than or equal to 30 kg) butin older children (greater than 30 kg) is similar to placebo. In case of acute overdose the adverse reaction like nausea, vomiting, hypotension, tachycardia, ataxia and drowsinesshave been reported.

Contraindications
Loratadine is contraindicated in patients who have known hypersensitivity or idiosyncrasy to Loratadineor any of its components.

Warnings and precautions
The dose should not exceed the recommended dose. Loratadine is no more likely than placebo to cause sedation. However, individual response should be determined before driving or performing tasks requiring alertness. Patients with severe liver impairment or renal insufficiency (GFR < 30ml/min) should be givena lower initial dose because they may have reduced clearance of Loratadine.

Drug interactions
In contrast to many other histamine H1receptorantagonists, Loratadine has no potentiating effects when administered concomitantlywith alcohol. Concomitanttherapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate the plasma concentration of either drug and this may result in adverse effects. Cimetidine inhibits both enzymes while erythromycin and ketoconazoleinhibit P450 and 3A4. Thesedrugs increase Loratadine serum concentrations but no adverse effects are reported. Quinidine, fluconazole, or fluoxetine are also known to inhibit either P450 34A or 2D6.

Pharmaceutical precautions
Store in a cool and dry place.Protect from light.

Presentation
Alaron®10tablet: Each tablet contains Loratadine USP 10 mg
Alaron®suspension: Each 5 ml contains Loratadine USP 5 mg

Packagingquantities
Alaron®tablet:Carton of 100’s pack in blister.
Alaron®suspension: Bottle of 60 ml.

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