doxofylline + montelukast Tablets for oral solution 400 mg + 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #19780
This pharmaceutical company, established in South Asia over three decades ago, specializes in manufacturing and marketing affordable, safe, and effective medicines. They are committed to providing global access to healthcare and have a strong presence in the region. The company focuses on producing a variety of Rx and OTC products, including oral antibiotics/antibacterials, analgesics/anti-inflammatories, antacids/anti-ulcer medications, and anti-allergics. Their manufacturing facilities are equipped with state-of-the-art technology and follow rigorous quality control measures, meeting international GMP standards. They produce various dosage forms like oral solids, liquids, and injectables. The company's commitment to quality and its extensive range of products have helped them gain a strong reputation within the industry.

Doxofylline

Doxofylline is a new kind of Bronchodilator that is a Methyl xanthine derivative. It treats COPD, asthma, and bronchospasm, inhibit platelet-activating factor and generation of leukotriene production. Structurally, Doxofylline differs from Theophylline as the dioxolane group in Doxofylline is in position 7. Doxofylline select and then inhibits phosphodiesterase 4. The resulting benefit the relaxing of bronchial smooth muscle. Even though different, it still has low affinities toward adenosine A1 and A2 receptors, giving the drug, a better safety profile. Doxofylline is reported to be marketed under many brand names like Xiva, An Li Nuo Er, An Sai Ma worldwide by several manufacturers. Alistair Pharmaceuticals demonstrated efficacy similar to theophylline but with significantly fewer side effects in 2013. By 2014, it received an orphan drug designation to doxofylline for the treatment of bronchiectasis by the US FDA.

Dosage & Administration

Doxofylline is available as 200 and 400mg tablets and sustained-release tablets. The standard adult dose for the Elderly is 200 mg tablets, taken 2 to 3 times a day. For adults, the dose is set at 400 mg tablet, taken 2 to 3 times, or as directed by the physician. In treating children, the dose for kids younger than 12 years of age is 10 ml syrup or 200 mg tablets, taken 2 to 3 times a day. For kids between 6-12 years of age, the dose is 6-9 mg for every kg of body weight, taken 2 to 3 times a day. For a body weight of 10 kg, a dose of 3 ml or 60 mg is prescribed. When the daily dose needed is 400 mg, the user can take the SR tablet, once a day.

The cost of Doxofylline

In the USA, the consumer pay USD43 for a supply of 60 tablets of 400mg. In India, the retail cost of 60 tablets of 400 mg, the same quantity as in the USA will cost around USD8.

How does Doxofylline Work?

Although its main mechanism of action is unclear, it is thought to inhibit phosphodiesterase activity in turn lifting cAMP levels and promoting smooth muscle relaxation. Doxofylline Interaction with beta-2 adrenoceptors, Serine 169, and serine 173 residues in the receptor critical binding sites. This is where the hydrogen bonds are formed by mediating actions of beta-2 adrenoceptors, Doxofylline stimulates blood vessel relaxation and airway smooth muscle relaxation. It may also have anti-inflammatory actions in decreasing pleurisy induced by the inflammatory mediator platelet-activating factor in animal studies.

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