The present invention relates generally to novel pharmaceutical compositions of matter comprising aspirin, sodium salicylate, salicylamide or acetaminophen, in combination with a non-sedating antihistamine and optionally one or more other active components selected from a sympathomimetic drug (e.g. nasal decongestant or bronchodilator), cough suppressant and/or expectorant, optionally in combination with suitable pharmaceutically acceptable non-toxic carriers or excipients, and to methods of using said compositions in the treatment, management or mitigation of cough, cold, cold-like and/or flu symptoms and the discomfort, pain, headache, fever and general malaise associated therewith.
Aspirin, salicylamide and acetaminophen have heretofore been included as the pain reliever and fever-reducing component in conventional cough/cold multisymptom alleviating compositions.
Exemplary prior art cough/cold formulations containing aspirin, salicylamide or acetaminophen include Coricidin.RTM., Coricidin D.RTM., Comtrex.RTM., Dristan.RTM., Daycare.RTM., Cotylenol.RTM., Sinubid.RTM. and the like. These formulations generally contain in addition to aspirin, salicylamide or acetaminophen, one or more conventional antihistaminics, decongestants, cough suppressants, antitussives and expectorants.
One of Applicants' earlier applications, U.S. Pat. No. 4,619,934, was directed to one or more of the newer non-steroidal anti-inflammatory (NSAIDs) drugs (specifically excluding aspirin, acetaminophen and the like) in combination with a conventional antihistamine and optionally other cough/cold components. Subsequently, Applicants filed U.S. Ser. No. 042,120 on Apr. 24, 1987 which covers the non-sedating antihistamines, which are pharmacologically and chemically distinct from the conventional antihistamines, in combination with the newer NSAIDs. That combination offers significant advantages in the treatment, management or mitigation of cough, cold, cold-like and/or flu symptoms and the discomfort, pain, headache, fever and general malaise associated therewith.
It is well known that the conventional antihistamines may cause drowsiness or marked drowsiness. While this may be an advantage at bedtime, if taken during the day, the label recommends that a patient use caution when driving a motor vehicle or operating machinery. Therefore, the combination of a non-sedating antihistamine and the newer NSAIDs is therefore particularly advantageous for daytime administration.
However, because of individual variability there are many patients for whom the newer NSAIDs do not perform as effectively or produce more side effects in comparison with aspirin, sodium salicylate, salicylamide or acetaminophen.
It has not heretofore been proposed to use aspirin, sodium salicylate, salicylamide or acetaminophen along with a non-sedating antihistamine in the preparation of advantageous cough/cold pharmaceutical compositions. Such combinations are particularly advantageous for daytime use by patients for whom the newer NSAIDs offer little or no benefit.
USPTO Backgrounds
USPTO Backgrounds