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Country of origin : Italy

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varenicline

Tablets 0.5 mg, 1 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Portugal
Manufacturer #17047
A pharmaceutical manufacturer based in the EU that sells its products in Europe, the Middle East, CIS, LATAM, and Asia. Key production lines are pharmaceuticals, bio and nanopharmaceuticals, medical devices, and nutraceuticals. The main therapeutic area is oncology.

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Varenicline

Varenicline used to treat nicotine addiction. Varenicline reduces the craving while reducing the effects of cigarettes and tobacco products that the brain associates with pleasure. It helps people stop smoking tobacco. Research showed that less than 20% of people treated remain abstinent from smoking at one year and more effective than bupropion and nicotine replacement therapies. Varenicline is traded under the brand names Chantix and Champix among others. US FDA approved the use of Varenicline for up to twelve weeks only. Those who can able to reduce smoking, as allowed to take medicine for another 12 weeks. Pfizer first used Cytisus plants to extract Cytisine analogs led to Varenicline. Cytisus plants were already being used as smoking substitutes during World War II which led to using as a cessation aid in eastern Europe. Varenicline In 2006, Varenicline started selling in the United States and the European Union.

Dosage and administration

Varenicline is sold as a tablet to take orally. The initial dose starts with a dose, once a day, followed by a maintenance dose, taken twice a day in the morning and evening. Each dose is taken with a full glass of water or 8 ounces after eating. The low initial dose is gradually increased over the first week of treatment. The 3 ways of administration include, First by setting a quit date and start taking medication one week before the stop date. The user is still allowed to smoke during the medication, but to quit smoking after one week of taking Varenicline. After starting the dose, the user should quit smoking between 8 and 35 days. For no set quit dates or immediate cessation, Varenicline dosage is started slowly over 12 weeks of treatment after quitting smoking. Smoking should be reduced to half of the regularly smoked cigarettes and from weeks 5–8, the user should smoke only a quarter of the normally smoked cigarettes in a day. Between weeks 9–12, this should be reduced to smoking all little as possible. It may take 12 weeks to quit smoking. Doctors can advise a further 12-week treatment even after cessation so that the smoking habit does not return.

The cost of Varenicline

In the USA, The cost is around $471 for a supply of 53 tablets of 0.5 mg-1 mg. the cost of this medicine is much lower in the developing countries, wherein in India, it costs only USD for 28 tablets. How does Varenicline Work? Varenicline has a higher-affinity and partial agonism for the α4β2 nicotinic acetylcholine receptor subtype. When activated, it releases dopamine in the nucleus accumbens. Therefore, it reduces withdrawal caused by smoking cessation. The partial agonism on the α4β2 receptors produces less effect of dopamine release than nicotine's deemed better than nicotine's full agonism. By competitively binding to α4β2, Varenicline decreases the ability of nicotine to bind and stimulate the mesolimbic dopamine system. It works like buprenorphine in the treatment of opioid addiction.

Finding Varenicline Manufacturers and Suppliers:

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