each 5 mI Contains
Desloratadine 2.5 mg
Oesloratadlne is a long-acting lricyclic histamine antagoniSt with selective Ht-receptor histamine antagonist activity, Receptoe binding data indicates that a concentration of 2-3 nanogram/ml . DeslOOl\adioe shows significant intamction with ee human histamine Hl-feceptor. Oesloratadine inhibited histamine release from mast coil in vitro. Results of tissue distribution study showed that des\ofaladine did not readily cross the blood blain barrier ,
– Absorption: neither food nor grapefruit Juice has an effect on the bioavailablllty of desloratadine.
– Distribution: DesJoratadine end J.hydroxydesloraladine are approximately 82% to 87% to 89% bound to plasma proteins, respectively. Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in stJbteds with impaired (erlal function
– Metabolism: deslorBtadlne is exteosivety metaboliZed to 3-hydroxydesloratadine .an active metabdfle.which is subs8quenlly
glucourinated. No overan differences in safety when! observed between poor metabolizer and normal metabolizers.
– Elimination: the mean elimination hatfltfe of deslO/Clladine was zr tcors. the degree of accumulatlon after 14 days of dosing was consistent with half life & dosing lrequency.
– Seasonal Allergic Rhinitis: lORAFAST Is Indicated for the relief of the nasal & rco-neser symptoms of seasonal rhinitis (in patients 2 years of age & older).
– Perennial Allergic Rhinitis: LORAFAST Is Indicated fO( the relief of the nasal & non-nasal symptoms of perennial allergic rhlnitls (in patients 6 months 01 age & older).
– Chronic Idiopathic Urticaria: LORAFAST is Indicated for the symptomatic relief of pruritus. reduction In the number of hives & size of hives in patients with chronic Idiopathic urticaria (6 months of age & older).
Dosage. and Admlnstration :
– Adults & children 12 years of age &over. tile reoommended dose of lORAFAST is 2 Teaspoonfulls ONCE daity.
-Children 6 to 11 years of age: the recommended dose of lORAFAST Is 1 Teaspoonful! ONCE daity.
-Children 12 months to 5 years of age: the recommended dose of LORAFAST is YoleaspoonruJl ONCE daily.
-Children 6 to 11 months of age: the recommended dose of lORAFAST is 2 rnI ONCE dally. should be administered with a commer- cially ava~able measuring dropper or syringe thalls calibrated 10 deliver 2 mI .
LORAFAST Is contraindicated In patienls who are hypersensitive 10 this medication or to any of it’s ingredients Of to loratadine.
The following spontaneous adverse events have been reported during the marKeting of desloratadine: tachycardia .palpitatiOns f3rety hypersensitlvity reactions ( such as rash ,pruritus. urtlcaria . edema. dyspnea and anaphylaxis) and elevated liver enzymes including bilirubin and very rarely hepatitis, allergic rhinitis and chronic idiopathic urticaria.
Drug interaction ::
Oesloratadlne exh!bils an antihistaminlc effect by 1 hour.
Pregnancy & lactation:
– Pregrnmcy cetegory C: desloretedine should not be used during pregnency, end only used If cleerly needed.
– Nursing mothers: Oeslolatadine passes into breast milk. therefore a dedslon should be made whether to discontinue nursing Of to discontinue Desloratadine taking according to the Importance of drug to the mother.
precautlons and warning:
LORAFAST contains Oeslofaladlne
Carclnogenesll, mulageneals,!mpalnnent of fertility:
-rhe studies did not show significant increase in the incldence of any tumor.
-In genotoxiclty studies there was no evidence of genoloxic potential in a reverse mutation assay.
-there was no effect on female fertility in rats a\ Oosloratadlne dose up 10 24 mg/mt , and there was also no effect on male fertillly in rats in dose up to 3 mglmI.
The safety & effectiveness of LORAFAST has not been demonstrated In pedlatric patients less Ihan 6 month of age.
In general. dose selection lor an elderly patient shOuld be cautious. reflecting the greater freQuency of decreased hepatic. renal. or cardiac function. arK! of concomitant disease or other drug therapy.
Not 10 be used for diabetic patients.
Instructions for patients :
lORAFAST may be taken without regard to meals .patients should be advised to increase the dose or dosing frequency as studies have no demonstrated increase effectiveness at h:gher ocses 3. somnolence may occur.
Drug Abuse & Dependence:
There is no information to Indicate that abuse or dependency occur with LORAFAST.
In the event of overdoses. consider standard measures to remove any unabsort>ed drug. Symptomatic & supportive treatment is recommended. Oesloraladine and it’s metabohte are not eliminated by heamodiatysis.
Package and storage:
A bottle contains 100 mI.
Store below 30oc, protoct from light
keep out of Ihe reach of chlldntn.
EGYPHAR Obour City. Egypt