The Ahmedabad-based Lincoln Pharma is planning to launch a unique fixed dose combination for cold in the market shortly. The combination, which contains nimesulide, citrizine and pseudoephedrine, is claimed to be a novel combination drug for cold.
Indicated for relief of symptoms of allergic rhinitis such as sneezing, rhinorrhoea, nasal congestion, itching and lacrimation, the new combination should be administered when both the antihistamine properties of cetirizine and the nasal decongestant activity of pseudoephedrine are desired, says Dr Sanjay Agrawal, general manager (Medical Services), Lincoln Pharma.
Branded as NAM COLD, the FDC is also indicated for the symptomatic relief of the common cold, vasomotor rhinitis, sinusitis and otitis, he adds. Commenting on the medical appreciation of the new combination, Dr Agrawal said that though nimesulide has anti-inflammatory, analgesic and antipyretic activities its exerts on anti-inflammatory, analgesic and antipyretic effect is not fully elucidated.
However, it has been shown that nimesulide might act at different stages of the inflammatory reaction. The other effects of nimesulide is selective inhibition of prostaglandin synthesis at the site of inflammation. The signs and symptoms of allergic rhinitis such as sneezing, rhinorrhoea and edema are primarily mediated by histamine. They are produced as a result of the direct and indirect action of histamine acting largely on the H1 receptors in target tissues. Along with histamine, a range of other vasoactive mediators such as kinins causes vasodilation, resulting in congestion. Antihistamines, which are pharmacologic antagonists of histamine on the H1 receptor, are effective in suppressing sneezing, itching, and nasal discharge. However, they are less effective in relieving nasal congestion. Decongestant have a vasoconstructive action on the blood vessels in the mucous membranes of the upper respiratory tract and hence are effective in tackling nasal congestion. Hence, combination antihistamine and decongestant therapy is frequently prescribed to provide relief of these symptoms.
Cetirizine is a highly potent long acting peripheral H1 receptor antagonist with negligible anticholinergic & antiserotonin effects and hence a low potential for drowsiness at pharmacological active doses. It inhibits both the histamine-mediated 'early' allergic phase and the 'late' allergic response. While, pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa, with substantially less chronotropic, hypertensive and CNS stimulation effects than ephedrine.
The tablet, which would be available in strip of 10, is prescribed for twice a day dosage. The recommended dosage should not be exceeded. The tablets should be swallowed whole and not crushed or chewed, the company sources informed. The combination has already received DCGI approval as a prescription drug, and the company expects that the drug can be sold as over the counter once the post marketing trials are successfully completed.