Meniere's Disease/Betahistine HCL
Betahistine Hydrocloride
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Betahistine hydrochloride clinical information
Betahistine Hydrochloride
Betahistine hydrochloride is a drug resembling naturally occurring histamine in some of its effects and is used as a treatment for Meniere's disease, a condition caused by the pressure of excess fluid in the inner ear. When taken regularly, betahistine hydrocloride can reduce the frequency and severity of the attacks of nausea and vertigo that characterize this condition and is thought to work by improving blood flow in the small blood vessels of the inner ear. Betahistine hydrochloride as a treatment is not always successful and surgery is sometimes required.
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Possible Side Effects
Like any drug, Betahistine hydrochloride can have side effects. Reported adverse effects are minor. "Occasionally patients have experienced gastric upset, nausea, and headache." For information an possible side effects carefully read Betahistine Hydrochloride Clinical Information.
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Is betahistine hydrochloride a cure for Meniere's Disease?
While betahistine hydrochloride is not a "cure" for Meniere's Disease, some of the research has verified that betahistine hydrochloride can eliminate many of the symptoms associated with Meniere's Disease.
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Betahistine Hydrochloride Clinical Information
Chemistry:
Betahistine hydrochloride's chemical name is 2 (2' meihylaminoethyl) pyridine dihydrochloride. There is some similarity in structure between betahistine and histamine.Action:
Betahistine was found to have a histamine-like action in animals. Since parenteral histamine has been used in the treatment of Meniere's disease, studies were conducted to test the action of betahistine in this condition. Unlike some other anti-vertigo drugs, testing with nystagmus induced by caloric and rotational stimulation has demonstrated that betahistine does not decrease the vestibular response, as recorded by electronystagmography. In addition, the absorption, metabolism and action of betahistine when administered by the oral route are not known. However, clinical studies indicate that betahistine hydrocloride may be useful in reducing the vertigo of Meniere's disease.Indications:
Betahistine hydrochloride may be of value in reducing the episodes of vertigo in Meniere's disease.Clinical Use:
The extremely variable course of Meniere's disease makes it almost impossible to predict. Consequently, assessment of the results of treatment is fraught with difficulties since spontaneous remissions or a placebo effect cannot be excluded, short of conducting prolonged studies extending over a period of years. The implication is that some information must be accepted from controlled trials falling short of an entirely acceptable design. In addition , most trials with betahistine have included a choice of patients with frequent episodes of vertigo that may not be representative of a cross section of patients with Meniere's disease.No studies are available comparing betahistine with other antivertigo agents. Betahistine hydrochloride has not been demonstrated to have any effect on the evolution or progression of Meniere's Disease and it appears not to eliminate the development of incapacitating vertigo and the subsequent need for surgery in some patients.
No claim is made for the effectiveness of betahistine hydrochloride in the symptomatic treatment of any form of vertigo other than that associated with Meniere's Disease. It also has not been established that betahistine has any effect on other manifestations of Meniere's disease.
Meniere's Disease, or idiopathic labyrinthine hydrops, is characterized clinically by recurrent episodes of vertigo accompanied by, usually unilateral, tinnitus and hearing loss. Nausea and vomiting may also occur. The vertigo lasts from a few minutes to several hours. Other forms of aural vertigo may be distinguished only because they tend to last longer. As a rule, between dizzy spells there are no other complaints save for varying levels of hearing and tinnitus. The prognosis in individual patients with Meniere's is difficult to predict. Some patients have mild or major dizzy spells in frequent clusters, possibly once or twice weekly, for a period of several weeks or months, then have remission of episodes which may last for months or years. Others may have vertiginous attacks only once or twice yearly. Virtually none have daily spells, and continuous vertigo in the sense of dizziness without remission for many days or weeks. In general, hearing is poorer and tinnitus loud when vertiginous attacks are frequent. Hearing may return to normal between attacks in early cases, but as time progresses, hearing slowly deteriorates, whether dizzy spells occur or not. In general, early Meniere's is featured by hearing levels which become worse with vertiginous attacks and improve even to normal between the attacks, while in late Meniere's hearing loss is less directly related to dizziness. The pathology of Meniere's disease consists of distention of the membranous labyrinth associated with accumulation due to overproduction or under absorption of endolymph.
Contraindications:
Several patients with a history of peptic ulcer have experienced an exacerbation of symptoms while using betahistine hydrochloride. Although no causal relation has been established betahistine hydrochloride is contraindicated in the presence of peptic ulcer and in patients with a history of this condition.Precautions:
Although clinical intolerance to betahistine hydrochloride by patients with bronchial asthma has not been demonstrated, caution should be exercised if the drug is used in these patients.Betahistine hydrochloride should not be used concurrently with antihistamine agents since no information is available with regard to the possible interaction of these drugs.
The physician should be aware of the possibility of hitherto unreported adverse reactions to betahistine hydrochloride.
Use in Pregnancy:
The safety of betahistine hydrochloride in pregnancy has not been established. Therefore, its use in pregnancy or lactation, or in women of child bearing age requires that its potential benefits be weighed against the possible risks.Adverse Reactions:
Occasionally patients have experienced gastric upset, nausea, and headache.Pharmacology:
In the course of animal studies, the response to betahistine, following intravenous administration, and its action on a variety of isolated and intact tissues, resembled some of the responses to histamine. Intravenous administration of betahistine hydrochloride produced a transient increase in blood flow through the labyrinthine artery in dogs, preceded by a fall in pulse pressure reflecting a systemic response. It is assumed that betahistine hydrochloride could act by decreasing endolymphatic pressure as a result of increased vascularization. However, there is no experimental evidence of an increased perfusion of the stria vascularis or evidence that changes occur in the fluid physiology of the inner ear that would decrease distension of the membranous labyrinth. In addition, information on absorption, metabolism and excretion of betahistine hydrochloride has not yet been obtained.Toxicology:
The lethal dose of betahistine hydrochloride for the albino rat is 3040 mg./kg. by the oral route. By the intravenous route the lethal dose for the rabbit is 5.1 mg./kg. The main signs of toxicity observed were: ataxia, salivation, inactivity, hyperapnea, tremors, and cyanosis. The pathology revealed severe gastroenteritis.A two-litter reproductive study with rats revealed no adverse effects.
Chronic toxicity studies in dogs given doses up to 25 mg./kg./day for eighteen months, revealed no significant abnormalities in the parameters measured.
Clinical Studies:
In the course of clinical trials with betahistine hydrochloride several hundred patients with Meniere's disease were treated with this product. These studies have ranged from clinical experience with this drug during short or long periods of treatment to double-blind, placebo controlled trials. In view of the unpredictable natural history of Meniere's disease, no judgment of efficacy is possible in many studies with faulty designs or other serious defects.One study included approximately 60 patients with Meniere's disease, followed in a longitudinal fashion without a concurrent control group. All patients had evaluation of the vestibular function recorded by electronystagmography. The results of this study favor the efficacy of betahistine hydrochloride in reducing vertigo. In addition, the vestibular function improved in the majority of patients that had a subjective response to the drug.
Three double-blind placebo controlled studies suggest a possible therapeutic effect of the drug. No untoward clinical effects were noted.
Dosage and Administration:
The usual adult dosage has been one to two tablets (4mg. each) administered orally three times a day. The dosage has ranged from two tablets per day to eight tablets per day. No more than eight tablets are recommended to be taken in any one day.Betahistine hydrochloride is not recommended for use in children. As with all drugs, Betahistine hydrochloride should be kept out of reach of children.