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Allora 5/Allora Syrup

Allora 5/Allora Syrup

desloratadine

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma
Full Prescribing Info
Contents
Desloratadine.
Description
Allora Syrup: Each 1 ml of syrup contains Desloratadine 0.5 mg.
Action
Allora Syrup: Pharmacology: Pharmacodynamics: Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cell in vitro.
Pharmacokinetics: Absorption: There was no effect of food on the absorption of desloratadine.
Distribution: Vd of children is 686 to 1565 L.
Metabolism: Desloratadine is extensively metabolized in liver via CYP2C8-mediated hydroxylation. 3-Hydroxydesloratadine is active metabolite. Desloratadine is a substrate of CYP2C8.
Excretion: 46.5% of drug was excreted in feces as metabolites. 40.6% of drug was excreted by kidney, primarily as metabolites.
Elimination half-life: Half-life in children is 16 to 19 hours.
Indications/Uses
Allora 5: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR); chronic idiopathic urticaria (CIU).
Allora Syrup: For the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing.
For the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives.
Dosage/Direction for Use
Allora 5: For adult and children ≥12 years of age: 5 mg once daily.
Allora Syrup: Perennial allergic rhinitis and Seasonal allergic rhinitis/Intermittent allergic rhinitis and Persistent allergic rhinitis and urticaria: 12 years or older: 10 ml (5 mg) orally once daily.
6 years to 11 years of age: 5 ml (2.5 mg) orally once daily.
12 months to 5 years of age: 2.5 ml (1.25 mg) orally once daily.
6 to 11 months of age: 2 ml (1 mg) orally once daily.
Dosage adjustment in renal/hepatic impairment: Be careful in patients with renal disease. In the case of severe renal insufficiency (GFR <30 mL/min), ALLORA syrup should be used as alternate day dosage until the physicians can determine the individual patient's response.
Overdosage
Allora Syrup: Mild to moderate: Adult: Somnolence, tachycardia, and headache have been reported in overdose (range 40 to 180 mg).
Children: Extrapyramidal signs and palpitations have been reported in children following doses of greater than 10 mg.
Severe: Prolonged QT interval and Torsades de pointes (TDP) and/or ventricular tachycardia (VT) have been reported after therapeutic use, and might occur after overdose. Most of these patients had other risk factor for TDP or VT.
Treatment: Treatment is symptomatic and supportive. Prehospital gastrointestinal decontamination is not routinely required. Consider activated charcoal if the overdose is very large, recent, the patient is not vomiting, and is able to maintain airway.
Contraindications
Hypersensitivity to desloratadine or loratadine or to any of the excipients.
Warnings
Allora Syrup: Warnings (based on the notification of the Ministry of Public Health): 1. This medicine may cause drowsiness in some patients. Individual response should be determined that it does not cause drowsiness before driving, operating machines or working in areas with risk of falling.
2. This medicine should not be used in first trimester pregnancy, breast-feeding and children below 6 months.
3. This medicine should be used with caution in patients with renal disease.
4. Concomitant use of this medicine and macrolides antibiotics such as erythromycin or imidazole antifungal such as ketoconazole result in increased blood level of this medication.
Special Precautions
Allora 5: Renal or hepatic impairment.
Allora Syrup: Liver dysfunction (desloratadine is metabolized in liver; potential for enhanced toxicity and need for dose adjustment).
Dose adjustment recommended in renal impairment.
Desloratadine should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
Use in Children: Allora Syrup: Safety and efficacy have not been established in children less than 6 months of age.
Use In Pregnancy & Lactation
Allora Syrup: Pregnancy Risk Factor C.
There are no adequate and well-controlled studies in pregnant women.
Weigh the potential benefits of treatment against potential risks before prescribing desloratadine during breast-feeding.
Adverse Reactions
Allora 5: Dry mouth, headache, somnolence.
Allora Syrup: Gastrointestinal: Xerostomia.
Musculoskeletal: Myalgia.
Neurologic: Headache, somnolence.
Reproductive: Dysmenorrhea.
Respiratory: Pharyngitis.
Other: Fatigue.
Drug Interactions
Allora Syrup: Not found.
Storage
Allora Syrup: Store below 30°C.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
Form
Allora 5 FC tab 5 mg
Packing/Price
10 × 10's;10's
Form
Allora Syrup syr 0.5 mg/mL
Packing/Price
60 mL x 1's
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