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Country of origin : Mexico

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betahistine

Tablets 24 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Mexico
GMP approvals
FDA
Manufacturer #8698
It has a multi-purpose chemical and pharmaceutical plant with over 17 years of experience producing Active Pharmaceutical Ingredients (APIs). The company aims to be a leader in the creation of active pharmaceutical ingredients for human health care, with the quality, service, and pricing that enable it to compete internationally and improves the quality of life for the patients of the company.

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Betahistine

Betahistine is an anti-vertigo medication. It is prescribed in the treatment of balance disorders or to alleviate vertigo symptoms, those associated with Ménière's disease. Symptoms of Ménière's disease include dizziness expressed as vertigo, ringing in the ears called tinnitus, loss of hearing, feeling sick like nausea. Patients with Ménière’s disease develop excess fluid buildup in the inner ear structures. This Excess fluid interferes with the nerve signals sent by inner ear structures to the brain helping a person balance, movement, and position. It is also under clinical trials for the treatment of Attention Deficit Hyperactivity Disorder. Its actions can dilate the blood vessels in the inner ear, which relieves pressure from excess fluid, and act on the smooth muscle. It is also hypothesized that it can increase the level of serotonin in the brainstem, thus inhibiting the activity of vestibular nuclei. Betahistine is sold under the brand name Serc among others. Betahistine was first registered in Europe in 1970 for the treatment of Ménière's disease. But, Betahistine did not get approved for marketing in the United States in the past few decades.

Forms and dosage

Betahistine comes in a tablet as well as an oral solution and is taken orally. It is rapidly and completely absorbed in the body. Betahistine is sold as 8mg or 16mg tablets. It is for adults use only. The patient normally takes tablets 3 times a day, with 6 to 8 hours between doses. The common side effects include headache, feeling sick, or indigestion. It is best taken with or after food, as this way it is least likely to upset stomach.

The cost of Betahistine

In the USA and Canada, The lowest price consumers pay for Betahistine 16 mg is $0.37 per pill or unit for 90 pills. Whereas the branded version sells for USD49 in the UK for a 120 pill supply of 8mg. The same supply costs USD58 for a supply for 90 pills. The price for the same is USD81 in Canada and higher still in European countries.

How does Betahistine work?

Betahistine is a strong antagonist of the histamine H3 receptor, at the same time a weak agonist of the histamine H1 receptor. Betahistine primarily has two mechanisms of action; it is a weak agonist on the H1 receptors located on blood vessels in the inner ear, which gives rise to local vasodilation and increased permeability. This eventually helps in reversing the underlying problem of endolymphatic hydrops. Critically, it also has powerful antagonistic effects at H3 receptors, so it can aid in increasing the levels of neurotransmitters histamine, acetylcholine, norepinephrine, serotonin, and GABA released from the nerve endings of patients. The increase in histamine release from histaminergic nerve endings stimulates the receptors resulting in potent vasodilatory affects the inner ear.

Finding Betahistine Manufacturers and Betahistine Suppliers

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