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doxylamine + pyridoxine

Tablets 10 mg + 10 mg

Dossier type
CTD
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Ready to file
Country of origin
Canada
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Canada
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Reference product : Diclectin (Duchesnay)
Manufacturer #278

The company has become a prominent partner of the pharmacy community in North America, with the fastest rising market share among generic leaders. It can provide best-in-class supply reliability thanks to production capacity. In more than 50 countries, it's available locally or through corporate partnerships. R&D expenditures range from $40 million to $50 million per year. They are dedicated to maintaining a customer satisfaction rate of over 95% by continuously enhancing supply chain efficiency.

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Doxylamine

Doxylamine is an antihistamine. It gives relief from symptoms of allergy, hay fever, and the common cold. It medication works by blocking certain histamine & acetylcholine, substances in the body that causes allergic symptoms. This blocking helps to relieve allergy/cold symptoms such as watery eyes, runny nose, and sneezing. Doxylamine is used in the short-term treatment of insomnia, a condition in which the patient feels difficulty falling asleep or staying asleep. It is also used in combination with decongestants and to relieve sneezing, runny nose, and nasal congestion caused by the common cold. It is also used as a short-term sedative and hypnotic with other medicines to provide night-time allergy and cold relief. The preparations containing the analgesics paracetamol and codeine have a claiming effect. Doxylamine is available under the many different brand names including Unisom. S. Merrell Company was first marketed in the U.S. in 1956 as Bendectin. However, Doxylamine with weak hypnotic and calming effects was first reported as early as1949. Doxylamine succinate with pyridoxine got approval from the USFDA for the first-line treatment of nausea and vomiting of pregnancy.

Forms and Dosage

Doxylamine is sold in the tablet form. In the treatment of Insomnia, Adults and Children over 12 years old are given a dose of 25 mg orally every evening as needed, this is done 30 minutes before bedtime. This medicine is not recommended for use in children under 12 years old. In the treatment of Upper Respiratory Tract Allergy, the standard dose for adults is 50 mg orally every 4-6 hours. The body tends to develop tolerance when used as hypnotic.

The cost of Doxylamine

In the USA, The consumer has to pay around $13 for a supply of 32 tablets of doxylamine oral 25 mg, this may vary as depending on the pharmacy. Whereas the supply of 192 tablets costs 21 pounds in the UK for the 25mg oral tablet.

How does it work?

Doxylamine competitively blocks the histamine receptor, whose actions prevent the actions of endogenous histamine as well as the release of pro-inflammatory mediators from basophils and mast cells. It can antagonize the effects of histamine in the large blood vessels, uterus, GI tract, and bronchial muscles. Doxylamine binds both centrally and peripherally, giving the sedative effects in helping patients get effective sleeping aid. Doxylamine’s actions also depress labyrinthine function, block the chemoreceptor trigger zone, and diminishes vestibular stimulation in addition to the reduction of nausea and vomiting by inhibiting histaminergic signaling to the vomiting center in the medulla.

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