Prosp Pharma
Full Prescribing Info
Fexofenadine hydrochloride.
Each film coated tablet contains Fexofenadine hydrochloride 180 mg.
Pharmacology: Pharmacodynamics: Fexofenadine is an active metabolite of terfenadine and like terfenadine it competes with histamine for H1-receptor site on effector cell in the gastrointestinal tract, blood vessels and respiratory tract it appears that fexofenadine dose not cross the blood brain barrier to any appreciable degree, resulting in a reduced potential for sedation.
Pharmacokinetics: Absorption: Rapid. Time to peak approximately 2.6 hours.
Distribution: Protein binding 60% to 70%, primarily albumin and alpha1-acid glycoprotein.
Metabolism: Hepatic approximately 5%.
Elimination: Half-life elimination is 14.4 hours and longer in renal impairment 31% to 72. Unchanged drugs are mainly excreted via the feces (approximately 80%) with approximately 20% are appeared in urine.
For relief of symptoms associated with allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/ palate/ throat, itchy/ watery/ red eyes.
For relief of symptoms associated with chronic idiopathic urticaria in adults and children 12 years of age and older.
Dosage/Direction for Use
Adult and children 12 years of age and older: 180 mg (1 film-coated tablet) once daily.
Studies in special populations (elderly, renal or hepatic impairment) indicated that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
Mode of administration: Administer with water.
Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established.
Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Hemodialysis does not effectively remove fexofenadine hydrochloride from blood.
Hypersensitivity to fexofenadine or any component of the formulation.
Special Precautions
It may cause drowsiness. Avoid driving a motor vehicle or operating machinery.
Should not be used in 1st trimester pregnancy, breastfeeding mothers and children < 6 months of age.
If you have arrhythmia, you have to stop the medicine and consult the doctor.
Use with caution in patients with renal impairment.
Fexofenadine used with macrolides antibiotics such as erythromycin or imidazole antifungals such as ketoconazole may increase fexofenadine levels.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy category C. The use of antihistamines during pregnancy is considered to be safe at recommended doses.
It should not be used in 1st trimester pregnancy.
Lactation: It is not known if fexofenadine is excreted in breast milk. Use with caution when administering fexofenadine to nursing women.
Adverse Reactions
Nervous system disorders: Common: headache, drowsiness, dizziness.
Gastrointestinal disorders: Common: nausea.
General disorders and administration site conditions: Uncommon: fatigue.
Immune system disorders: hypersensitivity reactions with manifestation such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis.
Psychiatric disorders: insomnia, nervousness, sleep disorders or nightmare/excessive dreaming (paroniria).
Cardiac disorders: tachycardia, palpitations.
Gastrointestinal disorders: Diarrhea.
Skin and subcutaneous tissue disorders: rash, urticaria, pruritus.
Drug Interactions
Administration of fexofenadine within 15 minutes of an aluminium and magnesium containing antacids decreased fexofenadine AUC by 41% and Cmax by 43%. Fexofenadine should not be taken closely in time to these antacids.
Coadministration of fexofenadine with erythromycin or ketoconazole may be increased fexofenadine plasma levels.
Store below 30°C.
ATC Classification
R06AX26 - fexofenadine ; Belongs to the class of other antihistamines for systemic use.
FC tab 180 mg (light orange, oblong, biconvex, and plain on both sides) x 1 x 10's, 5 x 10's, 10 x 10's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in