Novelta
Generic Name
Fexofenadine Hydrochloride
Manufacturer
SQUARE Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
novelta 480 mg suspension | ৳ 120.00 | N/A |
novelta 480 mg chewable tablet | ৳ 3.01 | ৳ 30.10 |
Description
Overview of the medicine
Novelta (Fexofenadine Hydrochloride) is a second-generation antihistamine used to relieve symptoms of seasonal allergic rhinitis (hay fever) and chronic idiopathic urticaria (hives). It helps reduce sneezing, runny nose, itchy watery eyes, and itching.
Uses & Indications
Dosage
Adults
For seasonal allergic rhinitis: 60 mg twice daily or 120 mg/180 mg once daily. For chronic idiopathic urticaria: 60 mg twice daily or 180 mg once daily.
Elderly
No dose adjustment is generally required in elderly patients with normal renal function. However, dosage should be adjusted for renal impairment.
Renal_impairment
For adults and children 12 years and older with impaired renal function, the recommended starting dose is 60 mg once daily. Not recommended for children under 6 years with renal impairment.
How to Take
Novelta tablets should be taken orally, with or without food. Avoid taking with fruit juices (e.g., grapefruit, orange, apple) as they may reduce bioavailability.
Mechanism of Action
Fexofenadine is a selective peripheral H1-receptor antagonist. It effectively blocks the histamine H1 receptors on effector cells, thereby inhibiting the actions of histamine, such as vasodilation, increased capillary permeability, and itching, without causing significant sedation.
Pharmacokinetics
Onset
Onset of action is typically within 1 hour.
Excretion
Primarily excreted unchanged, approximately 80% via feces and 11% via urine.
Half life
The elimination half-life is approximately 11-15 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are reached in approximately 1-3 hours.
Metabolism
Undergoes negligible metabolism in the liver.
Side Effects
Contraindications
- Hypersensitivity to fexofenadine hydrochloride or any of the excipients.
- Patients with known allergic reactions to any component of the formulation.
Drug Interactions
Erythromycin and Ketoconazole
These drugs have been shown to increase fexofenadine plasma concentrations. Clinical significance is generally low, but caution is advised.
Antacids (aluminum and magnesium containing)
Coadministration with aluminum and magnesium containing antacids can decrease fexofenadine absorption. Separate administration by about 2 hours.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Reports of fexofenadine overdose have been infrequent. Symptoms such as dizziness, drowsiness, and dry mouth have been reported. Management should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fexofenadine is excreted in breast milk; caution should be exercised when Novelta is administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to fexofenadine hydrochloride or any of the excipients.
- Patients with known allergic reactions to any component of the formulation.
Drug Interactions
Erythromycin and Ketoconazole
These drugs have been shown to increase fexofenadine plasma concentrations. Clinical significance is generally low, but caution is advised.
Antacids (aluminum and magnesium containing)
Coadministration with aluminum and magnesium containing antacids can decrease fexofenadine absorption. Separate administration by about 2 hours.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Reports of fexofenadine overdose have been infrequent. Symptoms such as dizziness, drowsiness, and dry mouth have been reported. Management should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fexofenadine is excreted in breast milk; caution should be exercised when Novelta is administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months, depending on specific formulation and packaging. Refer to product label for exact expiry date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by FDA, DGDA
Patent Status
Generic available, patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of fexofenadine for its approved indications.
Lab Monitoring
- Routine laboratory monitoring is generally not required for patients taking fexofenadine.
- Monitor renal function in patients with known renal impairment.
Doctor Notes
- Fexofenadine is a preferred second-generation antihistamine due to its non-sedating profile and efficacy.
- Advise patients to avoid fruit juices due to potential interaction.
- Consider renal dose adjustment for patients with impaired kidney function.
Patient Guidelines
- Take Novelta exactly as prescribed by your doctor.
- Avoid taking with fruit juices.
- Do not exceed the recommended dose.
- If symptoms persist or worsen, consult your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Although Novelta is generally non-sedating, individual responses may vary. Patients should exercise caution when driving or operating machinery until they know how Novelta affects them.
Lifestyle Advice
- Identify and avoid known allergens that trigger your symptoms.
- Maintain good indoor air quality.
- Stay hydrated.
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