INDICATIONS:
- Ménière's syndrome is defined by the following core symptoms:
- Vertigo (with nausea/vomiting)
- Hearing loss (hardness of hearing)
- Tinnitus (ringing in the ears)
- Symptomatic treatment of vestibular vertigo.
Uses Kert Tablet Betahistine
The active ingredient of Kert is betahistine dihydrochloride. Betahistine is a synthetic and an orally active analogue of histamine. The major application of Kert is in the treatment of Ménière's disease and Ménière like syndrome charactrized by severe attacks of vertigo, tinnitus and progressive loss of hearing, frequently accompanied by nausea and vomiting. Betahistine chemically is 2-[2 (methylamino)ethyllpyridine, and is formulated as the dihydrochloride salt.
Dosage of Kert Tablet Betahistine
- The dosage for adults is 24-48mg divided over the day.
- 8 mg Tablets: 1-2 tablets 3 times per day
- 16 mg Tablets: 12 - 1 tablet 3 times per day
Dosage should be adjusted according to patient's response to the medication. Improvement of symptoms may take up to two weeks and the best results are sometimes obtained only after a few months. There are indications that treatment from the onset of the disease prevents its progression and/or the loss of hearing in later phases of the disease.
Pediatric population:
Betahistine is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.
CONTRAINDICATIONS:
Betahistine is not to be taken if there is hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND SPECIAL PRECAUTION FOR USE
Patients with bronchial asthma and history of peptic ulcer disease need to be carefully monitored during the therapy.
INTERACTIONS WITH OTHER MEDICATIONS
No in vivo interaction studies have been performed. Based on in vitro data, no in vivo inhibition on Cytochrome P450 enzymes is expected. In vitro data includes an inhibition of betahistine metabolism by drugs that inhibits monoamino-oxidase (MAO) including MAO subtypes B (e.g. selegiline).
Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
PREGNANCY & LACTATION
Pregnancy
There is no adequate data for the use of betahistine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans in this regard is unknown. Betahistine shouldn't be used during pregnancy unless is it deemed necessary by doctor.
Lactation
It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of drug to the mother should be weighed against the benefits of nursing and the potential rises for the child.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.