Vertina-D
Generic Name
Betahistine Dihydrochloride + Domperidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| vertina d 10 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Vertina-D 10 mg tablet is a combination medicine used to treat vertigo, nausea, and vomiting associated with Meniere's disease or other vestibular disorders. Betahistine helps to reduce vertigo symptoms by improving blood flow in the inner ear, while Domperidone helps to alleviate nausea and vomiting by blocking dopamine receptors in the brain's trigger zone.
Uses & Indications
Dosage
Adults
Usually one Vertina-D 10 mg tablet two or three times daily, preferably before meals. Dosage may be adjusted by physician based on response.
Elderly
No specific dose adjustment is generally required, but caution is advised due to potential age-related decrease in renal or hepatic function. Use the lowest effective dose.
Renal_impairment
In moderate to severe renal impairment, Domperidone dose should be reduced to once or twice daily depending on severity. Betahistine may require dose adjustment if creatinine clearance is low.
How to Take
Take the tablet orally with water, preferably before meals for optimal absorption of Domperidone. Do not crush or chew the tablet.
Mechanism of Action
Betahistine acts as a weak H1-receptor agonist and H3-receptor antagonist, increasing histamine turnover and improving microcirculation in the inner ear. Domperidone selectively blocks peripheral dopamine D2-receptors in the chemoreceptor trigger zone (CTZ) located outside the blood-brain barrier, thereby exerting antiemetic and prokinetic effects.
Pharmacokinetics
Onset
The onset of action for Betahistine in improving vertigo symptoms is gradual, often taking weeks to show full effect. Domperidone's antiemetic effect typically starts within 30-60 minutes.
Excretion
Betahistine metabolites are primarily excreted in the urine. Domperidone is excreted via urine (approximately 31%) and feces (approximately 66%).
Half life
The elimination half-life of Betahistine is approximately 3-4 hours. The elimination half-life of Domperidone is about 7-9 hours in healthy subjects.
Absorption
Betahistine is rapidly and completely absorbed after oral administration, with peak plasma concentrations reached within 1 hour. Domperidone is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations within 1 hour; however, its bioavailability is reduced by food.
Metabolism
Betahistine is extensively metabolized to 2-pyridylacetic acid (2-PAA) in the liver. Domperidone undergoes extensive first-pass metabolism in the liver and gut via CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Betahistine, Domperidone, or any excipients.
- Patients with pheochromocytoma.
- Patients with prolactinoma.
- Patients with known prolongation of cardiac conduction intervals (e.g., QTc), significant cardiac disease (e.g., congestive heart failure), or moderate to severe hepatic impairment.
- Concurrent use with potent CYP3A4 inhibitors.
- Gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Drug Interactions
Levodopa
Domperidone may antagonize the effects of dopamine agonists like levodopa.
Antihistamines
May antagonize the effect of Betahistine.
Anticholinergics
May decrease the prokinetic effect of Domperidone.
Potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)
Increased plasma levels of Domperidone, increasing the risk of QTc prolongation and cardiac arrhythmias. Concomitant use is contraindicated.
QTc-prolonging drugs (e.g., certain antiarrhythmics, antipsychotics, antidepressants)
Increased risk of cardiac arrhythmias with Domperidone. Concomitant use should be avoided.
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, extrapyramidal reactions, and cardiac arrhythmias (with Domperidone). Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if taken recently.
Pregnancy & Lactation
Pregnancy Category C for Domperidone and Betahistine. Not recommended during pregnancy unless potential benefits outweigh potential risks. Domperidone is excreted in breast milk and may cause adverse effects in the infant; use during lactation should be avoided.
Side Effects
Contraindications
- Hypersensitivity to Betahistine, Domperidone, or any excipients.
- Patients with pheochromocytoma.
- Patients with prolactinoma.
- Patients with known prolongation of cardiac conduction intervals (e.g., QTc), significant cardiac disease (e.g., congestive heart failure), or moderate to severe hepatic impairment.
- Concurrent use with potent CYP3A4 inhibitors.
- Gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Drug Interactions
Levodopa
Domperidone may antagonize the effects of dopamine agonists like levodopa.
Antihistamines
May antagonize the effect of Betahistine.
Anticholinergics
May decrease the prokinetic effect of Domperidone.
Potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)
Increased plasma levels of Domperidone, increasing the risk of QTc prolongation and cardiac arrhythmias. Concomitant use is contraindicated.
QTc-prolonging drugs (e.g., certain antiarrhythmics, antipsychotics, antidepressants)
Increased risk of cardiac arrhythmias with Domperidone. Concomitant use should be avoided.
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, extrapyramidal reactions, and cardiac arrhythmias (with Domperidone). Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if taken recently.
Pregnancy & Lactation
Pregnancy Category C for Domperidone and Betahistine. Not recommended during pregnancy unless potential benefits outweigh potential risks. Domperidone is excreted in breast milk and may cause adverse effects in the infant; use during lactation should be avoided.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies and Hospitals
Approval Status
DGDA Approved
Patent Status
Off-patent
Clinical Trials
Information on clinical trials specific to this fixed-dose combination might be limited, but individual components (Betahistine and Domperidone) have undergone extensive clinical trials for their respective indications.
Lab Monitoring
- No specific routine lab monitoring is required for this combination. However, patients with pre-existing cardiac conditions should have their ECG monitored, especially during initiation or dose changes of Domperidone.
Doctor Notes
- Assess patient's cardiac risk factors before initiating Domperidone, especially for elderly or those with pre-existing heart conditions.
- Prescribe the lowest effective dose for the shortest possible duration to minimize risks.
- Advise patients to report any cardiac symptoms or unusual side effects promptly.
Patient Guidelines
- Take the tablet whole with water, preferably before meals.
- Do not exceed the prescribed dose or duration of treatment.
- If you experience dizziness or drowsiness, avoid driving or operating heavy machinery.
- Report any unusual heart symptoms (e.g., palpitations, fainting) to your doctor immediately.
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or drowsiness in some individuals. Patients should exercise caution when driving or operating machinery until they know how Vertina-D affects them.
Lifestyle Advice
- Avoid sudden movements that might trigger vertigo.
- Maintain a balanced diet and stay hydrated.
- Manage stress, as it can worsen vertigo symptoms.
- Limit consumption of caffeine, alcohol, and high-salt foods.
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