Chemical formula: C₈H₁₂N₂ Molecular mass: 136.194 g/mol PubChem compound: 2366
Betahistine interacts in the following cases:
In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamino-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
Betahistine dihydrochloride should not be used concurrently with antihistamines. As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs.
Betahistine dihydrochloride should be administered with caution to patients with a history of peptic ulcer.
Betahistine dihydrochloride should be administered with caution to patients with bronchial asthma (due to clinical intolerance).
Betahistine dihydrochloride is considered to be unsafe in patients with porphyria.
There are no adequate data from 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 is unknown. As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy.
It is not known whether betahistine is excreted in human milk. Betahistine is excreted in rat milk. Effects post-partum in animal studies were limited to very high doses. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
Animal studies did not show effects on fertility in rats.
Vertigo, tinnitus and hearing loss associated with Ménière’s syndrome can negatively affect the ability to drive and use machines. In clinical studies specifically designed to investigate the ability to drive and use machines betahistine had no or negligible effects.
The following undesirable effects have been experienced with the below indicated frequencies in betahistine dihydrochloride-treated patients in placebo-controlled clinical trials (very common (≥1/10); very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000))
Common: nausea and dyspepsia
Common: Headache
In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.
Hypersensitivity reactions, e.g. anaphylaxis have been reported
Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Cutaneous and subcutaneous hypersensitivity reactions have been reported in particular angioneurotic oedema, urticaria, rash and pruritus
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