Drug Interaction:
Antihistamines Include: First Generation ( Non-selective )
Ethanolamine- Carbinoxamine. Clemastine, Diphenhydramine. Ethylenediamines- Pyrilamine, Triplennamine Akylamines- Brompheneramine, Chlorpheniramine, Dexchlor pheniramine,Pheniramine,Triprolidine
Phenothiazines- Methidilazine, Promethizine, trimeprazine Piperidines- Azatadine, Cyproheptadine, Phenindamine Miscellaneous- Astemazole, Loratadine, Terfenadine Second Generation ( Peripherally selective ) Phthalazinone - Azelastine Piperazine - Cetrizine
Refer - Chlorpheniramine maleate
Fexofenadine +
Ketoconazole/ Erythromycin-
Co-administration of fexofenadine with ketoconazole and erythromycin lead to an increase in plasma levels of fexofenadine, while fexofenadine had no effect on the pharmacokinetics of erythromycin and ketoconazole
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 3
Name of the Drug- Fexofenadine suspension(30mg/5ml)
Pharmacological Classification- Seasonal allergic rhinitis & chronic
idiopathic urticaria
Date of Approval- 19-01-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Allergic conditions
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Fexofenadine Hcl Antihistamine Agent 16-09-1998
2. Fexofenadrine 120mg + Montelukast 10mg 07-07-2011
For the treatment of allergic rhinitis in adults only
3.Fexofenadrine 120mg + Montelukast 10mg 07-07-2011
Chewable tablet
Addiional dosaage form
4. Fexofenadrine suspension (30mg/5ml) 19-01-2007
Seasonal allergic rhinitis & chronic iodopathic urticaria
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Fexofenadine 120mg + 31-08-2010
Montelekast 10mg chewable tablet
For the treatment of allergic fhinitis in adults only
2.Fexofenadine 120mg + 07-07-2011
Montelukast 10mg chewable tablet
Addl.dosage form
For the treatment of allergic rhinitis in adults only
3.Fexofenadine 120mg + 17-09-1999
Pseudoephedrine sulphate USP in ER form
180mg tablet
Allergic and seasonal rhinitis only
4.Fexofenadine 60mg + 17-12-2003
Pseudoephedrine 120mg CR capsules
Allergic and seasonal rhinitis only
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Fexofenadine Respiratory Aventis 17-02-2001
Antihistaminesde Include: First Generation ( Non-selective ) ]
Ethanolamine- Carbinoxamine. Clemastine, Diphenhydramine. Ethylenediamines- Pyrilamine, Triplennamine Akylamines- Brompheneramine, Chlorpheniramine, Dexchlor pheniramine,Pheniramine,Triprolidine
Phenothiazines- Methidilazine, Promethizine, trimeprazine Piperidines- Azatadine, Cyproheptadine, Phenindamine Miscellaneous- Astemazole, Loratadine, Terfenadine Second Generation ( Peripherally selective ) Phthalazinone - Azelastine Piperazine - Cetrizine
Refer - Chlorpheniramine maleate
Adverse Reaction:
Viral infections,cold, flu, nausea, dysmenorrhea, dyspepsia, fatigue, headache, throat irritation.
Contra-Indications:
Hypersensity Special precautions: Use with caution during pregnancy and lactation. Not recommended for children below 12 years Patients with renal impairment
Dosages/ Overdosage Etc:
Allergic conditions
Dosage-
Adults and children over 12 years: 60mg b.i.d. in patients with decreased renal function 60mg once daily
Patient Information:
Antihistamines Include: First Generation ( Non-selective )
Ethanolamine- Carbinoxamine. Clemastine, Diphenhydramine. Ethylenediamines- Pyrilamine, Triplennamine Akylamines- Brompheneramine, Chlorpheniramine, Dexchlor pheniramine,Pheniramine,Triprolidine
Phenothiazines- Methidilazine, Promethizine, trimeprazine Piperidines- Azatadine, Cyproheptadine, Phenindamine Miscellaneous- Astemazole, Loratadine, Terfenadine Second Generation ( Peripherally selective ) Phthalazinone - Azelastine Piperazine - Cetrizine
Refer - Chlorpheniramine maleate
Pharmacology/ Pharmacokinetics:
Pharmacology:
Fexofenadine is a metabolite of terfenadine, showing selective H-receptor antogonist activity. It inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats.
Pharmacokinetics:
The mean plasma concentration was reportedly 209ng/ml. The pharmacokinetics of fexofenadine was found to be linear for oral doses up to 120mg twice daily
Pregnancy and lactation:
Not recommended for use during pregnancy and lactation
Manufacturer Details