Betavert 16 Mg Tablet (15 Tab)

BETAVERT 16 MG TABLET (15 TAB) by SUN PHARMA LABORATORIES LTD.

Name

• Brand Name: Betavert 16 MG Tablet
• Common Name: Betahistine (as Betahistine dihydrochloride)

Composition

Each tablet contains 16 mg of Betahistine dihydrochloride, which is the active ingredient.

Uses

Betavert 16 MG Tablet is primarily used for the treatment of Ménière's disease. This inner ear disorder is characterized by a triad of symptoms:

• Vertigo (dizziness or a spinning sensation)
• Tinnitus (ringing or buzzing in the ears)
• Hearing loss It works by improving blood flow in the inner ear, which helps to alleviate the pressure caused by excess fluid buildup in that area, and by affecting the histaminergic system.

Dosage and Administration

For adults, the usual initial oral treatment is 8 to 16 mg three times daily, preferably taken with meals to avoid stomach problems. Maintenance doses generally range from 24 to 48 mg daily, given in 2 or 3 divided doses throughout the day. The daily dose should not exceed 48 mg. Dosage can be adjusted to suit individual patient needs. It is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.

Side Effects

Common side effects include:

• Feeling sick (nausea)
• Indigestion (acid reflux)
• Bloating or mild stomach ache
• Headache Rare or more serious side effects can include hypersensitivity reactions such as skin rash, itching, urticaria, or swelling of the face, lips, tongue, or neck.

Precautions

• Allergies: Do not use if allergic to betahistine or any other ingredients in the medication.
• Medical Conditions: Use with caution in patients with bronchial asthma, peptic ulcer or a history of peptic ulceration, and severe hypotension (low blood pressure).
• Pheochromocytoma: Contraindicated in patients with a rare tumor of the adrenal gland called pheochromocytoma.
• Pregnancy and Breastfeeding: It is best not to use this medicine during pregnancy and breastfeeding; consult a doctor if necessary.
• Drug Interactions: Betahistine may interact with certain antihistamines and monoamine oxidase inhibitors (MAOIs).
• Food: Taking Betahistine with food can help reduce stomach problems.

Storage

Store at room temperature, away from moisture and direct sunlight, typically below 25°C or between 15-30°C. Keep the medicine out of reach of children and pets.

What is BETAVERT 16 MG TABLET used for?

BETAVERT 16 MG TABLET, containing betahistine, is primarily used to treat Ménière's disease and its associated symptoms. These symptoms include dizziness (vertigo), ringing in the ears (tinnitus), a feeling of sickness (nausea), and difficulty in hearing. It can also be used for other balance disorders and vestibular conditions.

How does BETAVERT 16 MG TABLET work?

Betahistine, the active ingredient in BETAVERT 16 MG TABLET, works by improving blood flow to the inner ear and reducing the amount of fluid buildup there. This action helps alleviate the pressure in the inner ear, which is thought to cause the symptoms of Ménière's disease. It also acts as a partial histamine H1-receptor agonist and a histamine H3-receptor antagonist in neuronal tissue, affecting the histaminergic system and helping to rebalance nerve activity in the vestibular system.

What is the usual dosage of BETAVERT 16 MG TABLET?

The usual starting dose for adults is 16 mg, taken three times a day, preferably with meals. Your doctor may adjust the dose based on your response, and maintenance doses generally range from 24-48 mg daily, given in 2 or 3 divided doses. It's important to swallow the tablet whole with water and take it at the same time each day for consistent results. Do not exceed the prescribed dose.

What are the possible side effects of BETAVERT 16 MG TABLET?

Common side effects can include headache, nausea, indigestion (acid reflux or dyspepsia), bloating or mild stomach ache, vomiting, abdominal pain, diarrhea, and skin reactions like rash or itching. Taking the medicine with food can help reduce stomach problems. If side effects worsen or persist, consult your doctor.

Is BETAVERT 16 MG TABLET safe during pregnancy or breastfeeding?

BETAVERT 16 MG TABLET is generally not recommended during pregnancy due to limited information on its effects on a developing baby. If you are pregnant or planning to become pregnant, consult your doctor, who may prescribe it only if the potential benefits outweigh the risks. Similarly, it is likely that betahistine gets into breast milk, so it's usually recommended to avoid it while breastfeeding. Discuss with your doctor if you are breastfeeding, as they can advise on alternative treatments or if the benefits of taking the medicine outweigh the potential risks to the child.

Can BETAVERT 16 MG TABLET be taken with other medications?

BETAVERT 16 MG TABLET can interact with certain medications. It is advisable to inform your doctor about all prescription, non-prescription, and herbal medicines you are currently taking.

• Antihistamines: Concurrent use with antihistamines (e.g., diphenhydramine, meclizine, cimetidine, ranitidine, loratadine, cetirizine) may reduce the effectiveness of betahistine.
• Monoamine Oxidase Inhibitors (MAOIs): Medications like selegiline and phenelzine (used for depression or Parkinson's disease) can interact with BETAVERT 16 MG TABLET, potentially altering its effect or causing side effects, and caution is recommended.

What precautions should be taken with BETAVERT 16 MG TABLET?

Inform your doctor if you have:

• Allergies: To betahistine or any other ingredients.
• Pheochromocytoma: A rare tumor of the adrenal gland, as this medicine is contraindicated in such cases.
• Stomach Ulcers (Peptic Ulcer Disease): Betahistine may worsen stomach ulcers.
• Asthma: Use with caution as it may exacerbate symptoms or cause bronchospasm.
• Low Blood Pressure: Betahistine may affect blood pressure levels.
• Liver or Kidney Disease: Caution is advised, and your doctor may need to adjust the dose.
• Alcohol Consumption: Limit or avoid alcohol as it may increase the risk of side effects.
• Driving or Operating Machinery: If you experience dizziness or drowsiness, avoid these activities until you feel better.

What happens if a dose is missed?

If you forget to take a dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten one. If you often miss doses, consider setting an alarm or asking your pharmacist for advice on remembering your medication.

How should BETAVERT 16 MG TABLET be stored?

Store BETAVERT 16 MG TABLET in a cool, dry place where the temperature stays below 25°C, away from moisture and direct sunlight. Keep it in its original packaging until it's time to take it. Ensure the medicine is kept out of reach of children and pets.