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Diphenhydramine hydrochloride manufacturers

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Country of origin : Poland

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diphenhydramine hydrochloride + lidocaine hydrochloride

Gel 20 mg + 10 mg/g - 5 g, 30 g

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
OTC Indication: Symptomatic treatment of inflammatory and allergic skin lesions associated with itching following insect bites and contact with plants, e.g. nettle Classification WEU
Manufacturer #279
This company is a leading manufacturer of drugs, dietary supplements, cosmetics, and medical devices with nearly 40 years of experience. They produce high-quality products to meet the health needs of patients, delivering over 48 million packages annually. The company prides itself on its Polish heritage, being one of the few family-owned pharmaceutical companies with entirely local capital. They aim to be a leader in the pharmaceutical industry, focusing on quality, innovation, and customer satisfaction. The company values honesty, responsibility, high standards, flexibility, openness to solutions, and continuous development, employing over 1,500 people in Lower Silesia.

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Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride as the name suggests is the hydrochloride salt form of diphenhydramine. It is a first-generation histamine antagonist and an ethanolamine with anti- allergic activity. Diphenhydramine Hydrochloride relieves symptoms of red, irritated, itchy, watery eyes, sneezing, runny nose caused by hay fever, allergies, or the common cold and cough caused by airway irritation. It has antiemetic, antitussive, hypnotic, and antiparkinson properties. When used to cure allergies, its receptors exist both peripherally and in the CNS and can sedate as an antagonist of histamine H1 receptors in the CNS. Due to its sedative effect, it is not the first choice of medicine for curing allergies. However, it has been used in many non-prescription OTC sleep medicines and cough-and-cold medications sold for nighttime use. Diphenhydramine Hydrochloride is sold under the brand names like Allerdryl, Benadryl, Benhydramin and Benylin to name a few. George Rieveschl, a former professor at the University of Cincinnati discovered it in 1943. It has the distinction of being the first prescription antihistamine approved by the U.S. FDA In 1946. Further research in the 1960s revealed that its effective in inhibiting the reuptake of neurotransmitter serotonin.

Dosage and administration

Diphenhydramine Hydrochloride is sold as tablets and capsules. The recommended dose for adults and children older than 12 years is 25 mg to 50 mg or 1 to 2 capsules. The pediatric dose for children aged 6 to 12 years, is 12.5 mg. and parents should consult for dose in kids younger than 6 years.

The cost of Diphenhydramine Hydrochloride

In the USA, the consumers pay an average retail price of $5 for a generic 30 capsules of 25mg. However, this medicine is significantly cheaper in the developing world. In India, for 20 capsules, the consumers pay an average retail price of USD0.40 or 40 cents.

How does Diphenhydramine Hydrochloride Work?

Diphenhydramine hydrochloride competitively blocks H1receptors. This results in the prevention of histamine actions on bronchial smooth muscle, capillaries, and gastrointestinal smooth muscle. This achieves the desired reduction in histamine-induced bronchoconstriction, vasodilation, increased capillary permeability, and GI smooth muscle spasms. Diphenhydramine hydrochloride has antitussive, hypnotic, antiemetic, and antiparkinson actions. In its actions in curing allergies, its receptors exist both peripherally and in the CNS and can sedate as an antagonist of histamine H1 receptors in the CNS. Due to its sedative effect, it is not the first choice of medicine for curing allergies.

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