| Generic Name: |
Fexofenadine HCl
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| Therapeutic Category: |
Respiratory Agent
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| Composition: |
Welfex 120
Each film coated tablet contains Fexofenadine HCl USP 120 mg
Welfex 180
Each film coated tablet contains Fexofenadine HCl USP 180 mg
Welfex Suspension
Each 5 ml contains Fexofenadine HCl USP 30 mg
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| Pregnancy Category: |
C
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| Presentation: |
Welfex Tablets
Available in the pack size as 10 tablets X 10 blisters
Welfex Suspension
Available in 60 ml bottle with a measuring cap
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| Mechanism of Action: |
Fexofenadine selectively blocks the H1- receptors. This blockage prevents the activation of the H1 receptors by histamine. Prevents the symptoms associated with allergies brought by histamine. Fexofenadine exhibits no anticholinergic, antidopaminergic, alpha1-adrenergic or beta-adrenergic-receptor blocking effects.
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| Indications: |
- Seasonal allergic rhinitis
- Chronic idiopathic urticaria
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| Dosage: |
Route of administration: Oral
Adults and Children 12 Years and Older: 120 and 180 mg Welfex tablet once daily.
Children 2 to 11 Years: 30 mg (5ml) Welfex Suspension twice daily.
Pediatric 6 months to less than 2 years: 15 mg (2.5 mL) Welfex Suspension twice daily.
Better efficacy if taken in empty stomach.
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| Pharmacokinetics: |
Absorption: Bioavailability 33%
Protein binding: Approximately 60-70%
Metabolism: Hepatic
Route of elimination: Feces (80%) and Urine (10%)
Half-life: 14.4 hours
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| Adverse Effects: |
Most common side effect demonstrated in adults are:
- Headache
- Some also experienced back and muscle pain, miosis* or pinpoint pupils*, nausea, drowsiness, and menstrual cramps.
- Rare effects are anxiety and insomnia.
The most common side effects in children aged 6-11 years:
- Cough, upper respiratory tract infection, fever, and otitis media
For children aged 6 months to 5 years:
- Fatigue
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| Contraindications: |
WELFEX is contraindicated in the following populations and situations:
- Hypersensitivity to histamine or any component of the formulation
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| Precautions: |
- People with Bronchial asthma and peptic ulcer disease
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| Interactions: |
- Antacids containing aluminum or magnesium should not be taken within 15 minutes of fexofenadine as they reduce the absorption of fexofenadine by almost 50%
- Taking erythromycin or ketoconazole while taking fexofenadine does increase the plasma levels of fexofenadine, but this increase does not influence the QT interval.
- Fexofenadine is not to be taken with apple, orange, or grapefruit juice because it could decrease absorption of the drug and should therefore be taken with water
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| Terminologies: |
Miosis: Excessive constriction of the pupil of the eye
Pinpoint pupils: Pupils that are abnormally small under normal lighting conditions
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