LORA

LORA
29 May

LORA

Anti-allergic Drugs

-Loratadine, a piperidine derivative related to azatadine, is a 
 potent long acting tricyclic antihistamine with selective 
 peripheral H1- receptor antagonistic activity. It is no sedating 
 antihistamine with no significant sedative or antimuscarinic 
 activity.  
- Loratadine is rapidly absorbed from gastrointestinal tract 
 after oral administration, peak plasma concentrations being 
 attained in about one hour. 
- Bioavailability of Loratadine is increased & time to peak 
 plasma concentration is delayed when administered with food
- Loratadine undergoes extensive metabolism. The major 
 metabolite,  descarboethoxyloratadine (desloratadine) has a 
 potent antihistamine activity.
- Loratadine is about 98% bound to plasma proteins,  
 descarboethoxyloratadine is less extensively bound .
- Loratadine & it’s metabolites have been detected in breast 
 milk,  but don’t appear to cross the blood brain barrier to a 
 significant extent .
- Most of dose of Loratadine is excreted equally in the urine & 
 faces, mainly in the form of metabolites .
- The elimination half life for Loratadine & it’s metabolites            
 (desloratadine)  are 8.4 & 28 hour respectively.
 

Indecation

- LORA®  is used for relief of nasal & non nasal symptoms of 
 seasonal allergic rhinitis, such as sneezing, nasal discharge  
 and itching as well as ocular itching & burning. 
-LORA®  is used for relief of symptoms and signs of chronic 
 urticaria & other allergic dermatologic disorders.    

Dosage & Administration

 - Adult  and children 12 years of age and over :
 LORA®  :  one  tablet once daily .
 - Children 2 to 12 years of age :
 Body weight > 30 kg :- one tablet of  LORA®  once daily
 Body weight <30 kg  :-  ½  tablet of LORA® once daily

- Each tablet of  LORA® 10 contains :
  Micronized Loratadine (USP )         10 mg 
 

 LORA®  is contraindicated in patients who have shown 
 hypersensitivity or idiosyncrasy to Loratadine 

- Concomitantly administration with  Alcohol, Loratadine 
  has no potentiating effects as measured by psychomotor 
  performance studies.
- Concomitantly administration with Cimetidine, Erythromycin 
 or Ketoconazol lead to increases plasma concentration of 
 Loratadine in controlled clinically trials but without clinically  
 significant changes.
- Other drugs known to inhibit hepatic metabolism should be 
 coadministered with caution until definitive studies can be 
 completed.     
 

-Safe use of LORA®  during pregnancy has not been established 
 therefore use only if potential benefit justifies potential risk to 
 fetus. 
-Loratadine and its major metabolite are excreted in breast milk  
 and because of the increased risk of antihistamines for infants,  
 particularly  newborns and premature infants, a decision should 
 be made wether to discontinue nursing or discontinue the drug.
 

 LORA®  has no clinically significant sedative properties of the  
 daily recommended dose of 10 mg.
- Most commonly reported side effects include fatigue, headache 
 somnolence, dry mouth, gastrointestinal disorders such as 
 nausea, gastritis , & also allergic symptoms like rash .
- Anaphylaxis, abnormal hepatic functions & allopecia have 
 been reported rarely.

-Patients with sever liver impairment or renal insufficiency
 ( GFR<30 ml/ min ) should be given a lower initial dose of  
 5mg daily or 10 mg every other days. 
-Safety & efficacy of LORA® product in children younger 
 than two years of age  have not been yet established.
 

 (Blister of 10 tablets, pack of one blister).
 Hospital packs of different sizes.

 Store in a dry place  at a temperature below  30oC.