Betahistine hydrochloride safety data sheet section 2. For this generic application, the mah has submitted one bioequivalence study in which the pharmacokinetic profile of the test product betahistine 2hcl biogened 16 mg biogened s. Betahistine dihydrochloride 8mg tablets summary of. Betahistine hydrochloride 8mg things you didnt know. Synonyms betahistine hcl unii 49k58smz7u cas number 5579840 weight average. Betahistine hydrochloride definition of betahistine. Betahistine, a structural analogue of histamine with weak histamine h1 receptor agonist and more potent h3 receptor antagonist properties. Betahistine dihydrochloride is a histaminelike drug in which pharmacological activity can be attributed to a specific effects andor more direct influences on recovery mechanisms the vestibular nuclei. The chemical name of betahistine is nmethyl2pyridin2ylethanamine. Assay preparation transfer about 38 mg of betahistine hydrochloride, accurately weighed, to a 100ml volumetric flask, dissolve in and dilute with mobile phase to volume, and mix. Each tablet contains 16mg betahistine dihydrochloride.
Articles of betahistine dihydrochloride are included as well. For research use only, not for human or veterinary use. Betahistine dihydrochloride 16 mg tablets summary of. The date of authorisation was on 15 february 2005 in the netherlands. Betahistine increases histamine turnover and release by blocking presynaptic h3receptors and inducing h3receptor downregulation.
Betahistine tablets 24betahistine dihydrochloride 16mg. This medication is used to treat dizziness in those who have menieres disease. The tablets also contain povidone k90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid. All spectrum chemical usp products are manufactured, packaged and stored under current good manufacturing practices cgmp per 21cfr part 211 in fda registered and inspected facilities. Whats the difference between betahistine hydrochloride. Betahistine 16mg tablets are imprinted with b16 on one side. As with certain medications, side effects can generate alternative, or offlabel, uses. Iso kosher gmp licence commercial bulk capacity factory in china transportation. Treatment of menieres disease to decrease episodes of vertigo available dosage from the hospital. Betahistine hydrochloride is a wellknown active substance with established efficacy and tolerability.
Betahistine hydrochloride is a medication commonly prescribed for tinnitus, or ringing in the ears, dizziness and vertigo. Sigmaaldrich offers a number of betahistine dihydrochloride products. Consumer information about the medication betahistine oral, includes side effects, drug interactions, recommended dosages, and storage information. Betahistine, sold under the brand name serc among others, is an antivertigo medication. Betahistine dihydrochloride, methyl22pyridyl ethyl amine dihydrochloride cas number 5579840. Material may be irritating to the mucous membranes and upper respiratory tract. Betahistine hydrochloride united states pharmacopeia usp. Betahistine dihydrochloride 16mg tablets summary of product. You should not use this information on this web site or the information on links from this site to diagnose or treat a health problem or disease without consulting with a qualified healthcare provider. Development and evaluation of sustained release tablet of. Description betahistine is a histamine h3 receptors inhibitor with ic50 of 1. The product is indicated for treatment of menieres syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea. Betahistine hcl definition of betahistine hcl by medical.
It is used generally as the hydrochloride or mesylate salt to reduce the symptoms of vertigo, tinnitus, and hearing loss. Sds of betahistine dihydrochloride, safety data sheets. Such a relief to be finally on vertigo meds, ive had probs with my ear since i was a child am now 17. Betahistine is a histamine analogue, concurrent administration of h1 antagonists may cause a mutual attenuation of effect of the active agents.
Betahistine hydrochloride tablets manufacturer generics. It acts as a histamine agonist and a vasodilator, and is thought to improve the microcirculation of the labyrinth, resulting in reduced endolymphatic pressure. This sustainedrelease phenomenon after the sublingual route is reflected in the mean residence times mrts of propranolol in the body mrtor 5. It serves as a vasodilator and is most commonly used to treat the symptoms of vertigo. Betahistine dihydrochloride16 is available in packs of 84 tablets and containers with 500 or tablets. May cause eye, skin, or respiratory system irritation. Whats the difference between betahistine hydrochloride and. Betahistine mylan works by improving the blood flow of the inner ear and restoring it to normal.
Am currently taking meds of 100 mcg of levothyroxine. Chromatographic system see chromatography 621 the liquid chromatograph is equipped with a 254nm detector and 3. Betahistine is an aminoalkylpyridine that is pyridine substituted by a 2 methylaminoethyl group at position 2. M 1 in vitro betahistine progressively enhances camp formation with a maximal effect, observed up to 10 nm, in choh3r cells incubated with 3. Results showed that betahistine hcl was formulated into a sustained dosage form as an alternative to the conventional tablet. Betahistine dihydrochloride is a histamine h3 receptors inhibitor used as an antivertigo drug. Sds of betahistine dihydrochloride, safety data sheets, cas 5579. What betahistine tablets look like and contents of the pack betahistine tablets are white to almost white tablets. Public assessment report of the medicines evaluation. Betahistine mylan betahistine dihydrochloride drug.
Betahistine dihydrochloride, methyl22pyridylethylamine dihydrochloride empirical formula hill notation. Betahistine mylan tablets contain the active ingredient betahistine dihydrochloride. Betahistine is an aminoalkylpyridine that is pyridine substituted by a 2methylaminoethyl group at position 2. Betahistine hydrochloride oral solution,physical properties,suppliers,cas, msds,structure,molecular formula, molecular weight,solubility,boiling point, melting point. Betahistine hydrochloride oral solution,physical properties. Betahistine dihydrochloride betahistini dihydrochloridum contd. Betahistine dihydrochloride drug information, uses, side. Animal studies, though insufficient do not indicate direct or indirect harmful. Pdf formulation and performance evaluation of betahistine. Betahistine betahistine 16 mg twice per day for 3 months has a significant effect on the frequency, intensity and duration of vertigo attacks. Page headings overview primary characterstics indications pharmacokinetics contraindications drug interactions side effects dosage high risk groups warning precautions storage conditions interference in pathology brands of betahistine hcl. It is used generally as the hydrochloride or mesylate salt to reduce. Betahistine hydrochloride is an orally administered antihistaminic drug. Betahistine 8mg tablets are imprinted with b8 on one side.
Hi claire yep, i m hypo with the autoimmune type, was diagnosed in march this year. Betahistine has a very strong affinity for histamine h3 receptors and a weak affinity for histamine h1 receptors. The diagnosis was based on paroxysmal attacks of rotational vertigo, with tinnitus, and a fluctuating sensorineural deafness, together with the results of auditory and vestigular tests. White, circular, flat tablets marked with b16 on one side and a breakline on the other side. A doubleblind, placebocontrolled, crossover clinical trial was performed to assess the effect of betahistine hydrochloride serc in menieres disease.
Went to see gp today, have been put on 8mcg betahistine hydrochloride for vertigo, which should be taken three times a day. It is commonly prescribed for balance disorders or to alleviate vertigo symptoms, e. Betahistine hydrochloride is a histamine analog and h1 receptor agonist. Information provided on this web site is neither intended nor implied to be a substitute for professional medical advice. Betahistine also has strong affinity as an antagonist for histamine h3 receptors. Material safety data sheet of betahistine dihydrochloride abmole. The serum concentrationtime curves of propranolol after sublingual administration resembled those of a sustainedrelease preparation. Betahistine hydrochloride united states pharmacopeia usp reference standard synonym. Betahistine hydrochloride tablets, manufacturer india exporter india,tablets,capsules,injections,gelatin betahistine hydrochloride usp 16 mg largest generic manufacturer,composition,drugs,formula,producing betahistine hydrochloride,msds,coa, pdf,doc chemical api method according to the present betahistine hydrochloride invention suppliers. Betahistine oral side effects, medical uses, and drug. The name of your medicine is betahistine dihydrochloride 8mg or 16mg tablets. Tmic is funded by genome alberta, genome british columbia, and genome canada, a notforprofit. For commercial use or customized versions, please contact biobyte solutions gmbh.
Know about technical details of betahistine dihydrochloride like. Material safety data sheet of betahistine dihydrochloride. Read more about the prescription drug betahistine oral. Betahistine dihydrochloride8 is available in packs of 120 tablets and containers with 500 or tablets. Export standard and according to the clients requirement storage. There are insufficient data on the use of betahistine in pregnant women. The active ingredient is a specific histamine agonist with virtually no h 2activity. Betahistine dihydrochloride 5579840 msds report, betahistine dihydrochloride msds safety technical specifications search, betahistine dihydrochloride safety information specifications ect. Betahistine dihydrochloride 5579840 msds report, betahistine. It acts as a histamine agonist and a vasodilator, and is thought to improve the microcirculation of th e labyrinth, resulting in reduced endolymphatic pressure. Betahistine has a very strong affinity as an antagonist for histamine h 3 receptors and a weak affinity as an agonist for histamine h 1 receptors. If you notice other effects not listed above, contact your doctor or pharmacist. Disclaimer the sds samples above are collected from the internet by chemblink and displayed here for the tutorial purpose only. May 30, 2018 the mechanism of action of betahistine is known partially.
Otc medicines oral healthcare pharmaceuticals manx. It is never wise to take someone elses medication no matter how reliably you think you have the same disease. You need to get checkout first, and then if the presciption is given, taking the same medication is ok. Betahistine dihydrochloride 5579840 msds, safety technical. For commercial use or customized versions, please contact biobyte solutions gmbh disclaimer. Doctors give trusted answers on uses, effects, sideeffects, and cautions. As per certificate of analysis and our tds, msds package.
Jun 18, 2012 the release of betahistine hcl from resinate controls the diffusion of drug molecules through the polymeric material into aqueous medium. The tablets were characterized for betahistine dihydrochloride release in both gastric simulated fluid 0. The content of this database of side effects adverse drug reactions is intended for educational and scientific research purposes only. Betahistine dihydrochloride16 is round, bioconvex, scored, white to almost white and with plain on both face of the tablet. Except as otherwise noted, this work is licensed under a creative commons attributionnoncommercialshare alike 4. It is used generally as the hydrochloride or mesylate salt to reduce the symptoms of vertigo, tinnitus, and hearing loss associated with m e ni e res disease. Betahistine dihydrochloride, methyl22pyridyl ethylamine dihydrochloride empirical formula hill notation. Material safety data sheet of betahistine dihydrochloride contains identification of substance and details of the supplier of the safety data sheet. Betahistine hcl 5579840 nl nl nl nl nl nl nl nl nl not listed. See section 8 for information on personal protection equipment. It has weak agonist activity at histamine h 1 receptors and moderate antagonist activity at h 3.
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