Betahistine Mesilate Tablet JP 6 mg
Betahistine Mesilate Tablet JP 12 mg
Description
Betahistine mesilate is an alkylamine. A histamine analogue and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.
Composition
a) Betahistine Mesilate Tablet JP 6mg
Each tablet contains:
Betahistine Mesilate JP 6mg
Excipients
q.s.
b) Betahistine Mesilate Tablet JP 12mg
Each tablet contains:
Betahistine Mesilate JP 12mg
Excipients
q.s.
Indications
This generic drug is indicated in the following cases:
- Meniere’s disease
- Prophylactic management of vertigo
Dosage form
Tablet, Oral use.
To be taken with water during meals.
Adults only (> 18 years of age):
-Recommended dose: one to two tablets, three times a day, depending on the individual response.
-Treatment duration: patient to be followed during at least one month, and even longer, if needed, continuously or not.
Children (< 18 years of age): contraindicated.
Administration
The following precautions should be taken when administering this drug:
Administer during meals
Drug interactions
Severity: Precaution
| Orally administered drugs + Cholestyramine | |
| Risks and Mechanisms | Cholestyramine can reduce intestinal absorption, and potentially, the effectiveness of other drugs taken at the same time. This interaction was proved for some substances or therapeutic classes (thyroid hormones, statins, digoxin, oral anticoagulants, hydrochlorothiazide, paracetamol, bile acids) but probably concerns also many other drugs. |
| Course of Action | In general, cholestyramine should be taken sometime after the other drugs (more than two hours, if possible). |
| Orally administered drugs + Topical gastrointestinal agents, antacids and adsorbents | |
| Risks and Mechanisms | Reduced absorption of certain other drugs ingested simultaneously. |
| Course of Action | As a precaution, these topical agents or antacids should be taken some time after any other drug (more than 2 hours, if possible). |
Contraindications
Severity: Absolute contraindication
| Asthma Hypersensitivity to H1 antihistamines Hypersensitivity to H2 antihistamines Hypersensitivity to one of the components Patients under 18 years old Pheochromocytoma Progressive peptic ulcer |
Precautions
Severity: Precaution
| History of peptic ulcer Women of childbearing potential Lactation Pregnancy |
Adverse effects
| System | Medium to high frequency (?1/1 000) | Low frequency (<1/1 000) | Unknown frequency |
| Dermatology | Exanthema Pruritus | ||
| Digestive system | Nausea (Common) Vomiting (Common) | Abdominal pain | |
| Nervous system | Headache (Common) | Sleepiness Vertigo | |
| Other | Fatigue Weakness | ||
| Psychiatry | Insomnia Lethargy |
Warnings
Warnings for special population
Pregnancy
This medicine is not recommended for pregnant women unless absolutely necessary. Discuss with your doctor about the potential benefits and risks of this medicine.
Breast-feeding
This medicine is not recommended for breastfeeding women unless absolutely necessary. Discuss with your doctor about the potential benefits and risks of this medicine.
General warnings
Gastrointestinal disorder
This medicine may increase the risk of stomach ulcers. Inform the doctor if you have a history of peptic ulcer disease or any gastrointestinal disease. Drink adequate amount of water to prevent stomach irritation.
Asthma
This
medicine may increase the risk of breathing problem. Inform the doctor if you
have a history of asthma or any lung diseases.
Impaired liver function
Liver injury may cause accumulation of this medicine in the body. Any history of liver disease should be reported to the doctor and necessary precautions should be taken to prevent further accumulation.
Pediatric use
This medicine is not recommended for the children less than 18 years.
Interactions
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol
Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine
- Monoamine oxidase inhibitors
- antihistamines
- Beta-2 agonists
Disease interactions
- Pheochromocytoma
This medicine is not recommended in patients with a condition called Pheochromocytoma.
Food interactions
Information
not available.
Lab interactions
Information not available.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you?re taking.
Side effects
- Nausea
- Headache
- Indigestion
- Bloating
- Skin rash
- Trouble sleeping
- Fast heartbeat
- Difficulty in breathing
Overdose
If overdose is suspected, contact your local poison control centre or emergency room immediately.
Missed dose
If you miss a dose, take it as soon as you remember. If it is near the time of
the next dose, skip the missed dose and resume your usual dosing schedule. Do
not “double-up” the dose to catch up.
Storage:
Store at room temperature away from light and
moisture. Do not store in the bathroom.
Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)