US20080185313A1 - Medicament regimen for treating bronchitis or lower respiratory tract condition - Google Patents

Medicament regimen for treating bronchitis or lower respiratory tract condition Download PDF

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US20080185313A1
US20080185313A1 US11/671,155 US67115507A US2008185313A1 US 20080185313 A1 US20080185313 A1 US 20080185313A1 US 67115507 A US67115507 A US 67115507A US 2008185313 A1 US2008185313 A1 US 2008185313A1
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oral
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comprises
adjunct medication
antibiotic
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Donna F. White
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Cornerstone BioPharma Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers

Abstract

A therapeutic treatment regimen for a bronchitic condition or lower respiratory tract infection and method of treating same a subject in need thereof are described. The regimen comprises at least one dosage of an oral antibiotic, at least one therapeutically effective dosage of an oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof and a prepackaged dosage dispenser comprising the oral antibiotic and the oral adjunct medication. The method comprises providing a prepackaged dosage dispenser comprising an oral antibiotic and an oral adjunct medication, providing administering indicia integrated into the prepackaged dosage dispenser for administration of the oral antibiotic and oral adjunct medication.

Description

    TECHNICAL FIELD
  • The present invention relates to a treatment for a bronchitic condition and a lower respiratory tract infection and to a treatment regimen for bronchitic condition and lower respiratory tract infection.
  • BACKGROUND
  • Bronchitis is an obstructive pulmonary disease characterized by inflammation of the bronchi of the lungs. Bronchitis can be acute or chronic. Acute bronchitis may follow a cold or infection and may be of viral or bacterial origin.
  • Acute infectious bronchitis, most prevalent in winter, generally lasts approximately 10 or 11 days. It may accompany or immediately follow a cold or the flu, or it may arrive unaccompanied by any other condition. It may start out with a dry cough, and after a few days, progress to a wetter, productive cough, which may be accompanied by a low grade fever, fatigue, and headache. The fever, fatigue, and malaise may last only a few days, but the wet cough may last up to a few weeks, and for some people, the cough may last a few months.
  • Hyperemia of the mucous membranes is the earliest symptom of acute bronchitis, followed by desquamation, edema, leukocytic infiltration of the submucosa, and production of sticky or mucopurulent exudate. The protective functions of bronchial cilia, phagocytes, and lymphatics are disturbed, which may cause bacteria to invade the normally sterile bronchi, with consequent accumulation of cellular debris and mucopurulent exudate. Cough is essential to eliminate bronchial exudate secretions. Airway obstruction may result from edema of the bronchial walls, retained secretions, and, in some cases, spasm of bronchial muscles.
  • Acute infectious bronchitis may be preceded by symptoms of an upper respiratory infection (URI): coryza, malaise, chilliness, slight fever, back and muscle pain, and sore throat. Onset of a distressing cough usually signals onset of bronchitis. The cough may be initially dry and nonproductive, but small amounts of viscid sputum may be raised after a few hours or days; later, sputum may be more abundant and mucoid or mucopurulent. Purulent sputum may suggest superimposed bacterial infection.
  • Chronic bronchitis is generally a condition that lasts at least three months or longer. This long term problem may be due to environmental irritation of the bronchial tubes. The initiating event in developing chronic bronchitis may be chronic irritation due to inhalation of certain substances, for example, cigarette smoke.
  • Symptoms of chronic bronchitis may include an expectorating cough, dyspnea, fatigue and/or malaise, mild fever, and/or mild chest pains. The presence of a persistent dry or wet cough may be evidence of bronchitis. A variety of lab test results may suggest chronic bronchitis, for example, a chest x-ray revealing hyperinflation and increased bronchovascular markings, a pulmonary function test showing increase in a lung's residual volume and a decreased vital capacity, arterial blood gases showing a decreased level of oxygen in the blood and an increased level of carbon dioxide, and/or a sputum culture indicating pathogenic microorganisms and/or neutrophils.
  • The multiplicity of medications and/or the difference in dosage duration necessary for effective bronchitis treatment makes it especially susceptible to non-compliance. In the United States, it is conservatively estimated that half of the prescription medications dispensed yearly are not taken as prescribed. Because of its potentially negative consequences, many consider lack of compliance with treatment regimens to be one of the most serious problems facing health care today. Non-compliance with antibiotic treatments, for example, is believed to contribute to the spread of resistant strains of bacteria.
  • Therefore, it remains desirous to provide efficacious treatment regimens for bronchitis and lower respiratory tract infection conditions that address variability in condition and allow greater flexibility of healthcare providers to administer therapies that enable patient compliance.
  • SUMMARY
  • In embodiments, a method of providing a treatment regimen for treating a bronchitic condition in a subject in need thereof is provided. The method comprises providing a prepackaged dosage dispenser comprising an oral antibiotic effective for treating the bronchitic condition and an oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof. The method further comprises providing administering indicia for administering the oral antibiotic and the oral adjunct medication for treating the bronchitis condition, the indicia being integrated with the prepackaged dosage dispenser.
  • In embodiments, a method of providing a treatment regimen for a lower respiratory tract infection condition in a subject in need thereof is provided. The method comprises providing a prepackaged dosage dispenser comprising an oral antibiotic effective for treating a bacterial infection related to a lower respiratory tract infection condition and an oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof. The method further comprises providing administering indicia for administering the oral antibiotic and the oral adjunct medication for treating a lower respiratory tract infection condition, the indicia being integrated with the prepackaged dosage dispenser.
  • Other embodiments of the present invention will become apparent in light of the following drawings and detailed description of the invention.
  • BRIEF DESCRIPTION OF THE DRAWING
  • The FIGURE is a topside view of a configuration of an embodiment of the present invention.
  • DETAILED DESCRIPTION
  • Infection is believed to be a trigger for acute bronchitis. However, the particular pathogens are generally not identified but may include typical bacteria (for example, Streptococcus pneumoniae, Haemophilus influenza, and, Moraxella catarrhalis) and atypical bacteria (for example, Mycobacterium pneumoniae, chlamydia pneumoniea, Bordetella pertussis). Although the role of infection in the pathogenesis of chronic bronchitis is secondary, as is not responsible for initiating bronchitis, it may nonetheless have an important role in its duration and treatment. By way of example, acute exacerbations of a long-standing bronchitis may result from infections.
  • In addition to possible bacterial infection associated with acute or chronic bronchitis, cough treatment may be indicated. Coughing is an essential mechanism to help clear the mucus present in the irritated bronchial tubes. Expectorant cough medicine may help make such coughs more productive by thinning the mucus; suppressant cough medicine may help the patient sleep by suppressing the dry coughs prevalent in the early stages of the illness. It may be that 23-50% of all antibiotic prescriptions written for bronchitis are co-prescribed a cough medication. Although acute bronchitis is generally assumed viral, it may actually be bacterial, and therefore many patients suffering from symptoms of bronchitis of bacterial origin may only receive advice for rest, lots of liquids, and aspirin for fever instead of antibiotic treatment. Therefore, in both acute and chronic bronchitis, management of both the infection and the cough may be indicated, and such dual management may provide the most effective overall treatment regimen.
  • Thus, there may be a perceived benefit from providing a combination therapeutic regimen of antibiotics and an adjunct medication such as an antitussive, expectorant, antihistamine, decongestant, anticholinergic, mucolytic and combinations thereof for the treatment of acute and chronic bronchitis that are provided herein.
  • Combining an antibiotic with an antitussive, an expectorant, a combination antitussive/expectorant, an antihistamine, a decongestant, an anticholinergic or a mucolytic provides for a therapeutic regimen for treating acute bacterial exacerbations of chronic bronchitis, secondary bacterial infections of acute bronchitis and lower respiratory tract infections. Thus, the methods herein described may provide for an improved treatment regimen for treating bronchitis and lower respiratory tract infection (LTRI) conditions and increasing compliance with such medication regimens. The methods herein described may provide a patient with a unified, understandable, and organized treatment regimen for bronchitis and LRTI. The methods may minimize complexity and facilitate ease of use of a bronchitis or lower respiratory infection (LRTI) treatment regimen. The methods may comprise a multiplicity of medications for bronchitis or LRTI physically arranged to simplify their use, functional indicia and instructions for coordinating the medications together as a regimen, and unification of these elements within a pharmaceutical dispensing dosage dispenser.
  • A method of providing a treatment regimen for treating a bronchitic condition in a subject in need thereof is described. The methods comprises providing a prepackaged dosage dispenser comprising an oral antibiotic effective for treating the bronchitis condition and an oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof. The method further comprises providing administering indicia for administering the oral antibiotic and the oral adjunct medication for treating the bronchitic condition, the indicia being integrated with the prepackaged dosage dispenser.
  • A method of providing a treatment regimen for a lower respiratory tract infection condition in a subject in need thereof is also described. The method comprises providing a prepackaged dosage dispenser comprising an oral antibiotic effective for treating a bacterial infection related to a lower respiratory tract infection and an oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof. The method further comprises providing administering indicia for administering the oral antibiotic and the oral adjunct medication for treating a lower respiratory tract infection condition, the indicia being integrated with the prepackaged dosage dispenser.
  • The term “bronchitic condition” refers generally to symptomology and etiology of bronchitis. The bronchitic condition may include an acute bacterial exacerbation related to chronic bronchitis. The bronchitic condition may include a secondary bacterial exacerbation related to acute bronchitis.
  • The term “lower respiratory tract infection condition” refers generally to symptomology and etiology of a lower respiratory tract infection (LRTI). The LRTI condition may include an acute bacterial exacerbation and/or a secondary bacterial exacerbation related to the LRTI. The LRTI may include pneumonia.
  • As used herein, “medication” refers to a compound or composition of matter that when administered to a subject (human or animal) causes a desired pharmacologic and/or physiologic effect by local and/or systemic action.
  • As used herein, “pharmaceutical dosage form” refers to a dosage form of a medication (e.g., sublingual, chewable, buccal and extended delivery dosages (EDT) forms, dosages, capsules, lozenges, gelcaps, powders and oral care strips/film) which is generally safe, non-toxic and not biologically or otherwise undesirable. A pharmaceutical dosage form includes that which is acceptable for veterinary and/or human pharmaceutical use, and which possesses the necessary and desirable characteristics of a dosage form acceptable for administration to a subject (e.g., a dosage of acceptable hardness, dissolution, stability, and a size and weight practical for oral administration).
  • As used herein, the term “antitussive” refers to a medication that suppresses cough. Antitussives may act centrally (on the brain, and specifically the vagus nerve) or locally (on the respiratory tract) to suppress the cough reflex. The terms “antitussive” and “cough suppressant” are used herein interchangeably. Examples of antitussives include hydromorphone, dextromethorphan, hydrocodone, codeine, carbetapentane and benzonatate.
  • As used herein, the term “expectorant” refers to a medication that facilitates the removal of secretions of the bronchopulmonary mucous membrane and/or increases expulsion of tracheal or bronchial mucus through expectoration or coughing. The terms “expectorant” and “protussive” are used herein interchangeably. An example of an expectorants includes guaifenesin.
  • As used herein, the term “antihistamine” refers to a medication that inhibits or reduces effects mediated by histamine. By way of example, moieties having negative modulation of histamine receptors as their main therapeutic effect are antihistamines. For example, chlorpheniramine, which may also have anticholinergic activity, is considered an antihistamine. Antihistamine includes, for example, first, second and third generation antihistamines such as ethylenediamines, ethanolamines, alkylamines, piperazines, tricyclics, acrivastine, astemizole, carbinoxamine, cetirizine, loratadine, mizolastine, desloratidine, brompheniramine, chlorpheniramine, dexbrompheniramine, diphenhydramine, pheniramine, phenyltoloxamine, promethazine, pyrilamine, triprolidine and fexofenadine.
  • As used herein, “decongestant” refers generally to a medication that reduces swelling of the mucous membranes in the nasal passages of a subject. Decongestants include, for example, phenylephrine, phenylpropanolamine and pseudoephedrine.
  • As used herein, the term “anticholinergic” refers to a medication that reduces or inhibits effects of acetylcholine on the central nervous system or peripheral nervous system. For example, moieties having as their main therapeutic effect reversible inhibition of muscarinic acetylcholine receptors or nicotinic acetylcholine receptors are considered anticholinergics. Anticholinergics with limited capacity to cross the blood-brain barrier are preferred, for example, methscopolamine salts and glycopyrrolate.
  • As used herein, the term “mucolytic” refers to a medication that dissolves thick mucus in the bronchial passageways to provide relief of respiratory difficulties. For example, a mucolytic provides for hydrolyzing glycosaminoglycans, breaking down or lowering the viscosity of mucin-containing body secretions. Examples of mucolytics include serratiopeptidase, Radix Gentianae, Flores Primulae cum Calycibus, Herba Rumicis, Flores Sambuci and/or Herba Verbenae.
  • As used herein, the term “pharmacological effect” encompasses pharmacokinetic and pharmacodynamic effects produced in a subject that achieve the intended purpose of a therapy or regimen. By way of example, a pharmacological effect means that infection or cough symptoms of the subject being treated are prevented, alleviated, or reduced.
  • The oral antibiotic of the method herein described may be from the class of antibiotics such as penicillins, cephalosporins and macrolides. In embodiments, the oral antibiotic may be selected from amoxicillin, azithromycin, cefdinir, cefditoren, cefprozil, cefuroxime and clarithromycin. In embodiments, the oral antibiotic may be amoxicillin, azithromycin, cefdinir, cefditoren, cefprozil, cefuroxime and clarithromycin.
  • The oral adjunct medication may be an antitussive, an expectorant, an antihistamine, a decongestant, an anticholinergic, a mucolytic and combinations thereof. In embodiments, the oral adjunct medications include antitussives and/or expectorants. The oral adjunct medication may include benzonatate, carbetapentane, chlorpheniramine, dextromethorphan, guaifenesin, hydrocodone, methscopolamine, phenylephrine and pseudoephedrine. In embdodiments, oral adjunct medication includes benzonatate, carbetapentane, chlorpheniramine, dextromethorphan, guaifenesin, hydrocodone, methscopolamine, phenylephrine and/or pseudoephedrine.
  • The multiplicity of medications necessary for bronchitis or LRTI treatment may increase the complexity of the regimen as patients may not fully understand the benefit of each component, or the multiple containers and separate instructions for each component may make complying with a regimen more difficult. The multiplicity of medications for bronchitic conditions or LRTI may be physically arranged to simplify their use, functional indicia and instructions for coordinating the medications together as a regimen, and unification of these elements within a pharmaceutical dispensing dosage dispenser.
  • Thus, in embodiments, a pre-filled, prepackaged dosage dispenser containing an oral antibiotic and an oral adjunct medication for the treatment of bronchitis or a LRTI condition and indicia for distinguishing the dosage forms and signifying their use together is provided. Either single or multiple dispensers of each dosage form may be contained as is desired. The dosage forms may be in the form of dosages, capsules, lozenges or gelcaps, some of which may require reconstituting, or any generally recognized oral form of medication.
  • A unitary prepackaged dosage dispenser may be designed so that the treatment regimen is immediately comprehended by visual inspection. The medication may be arranged in such a prepackaged dosage dispenser so that each dosage of the treatment regimen is presented in a logical sequence. The basic sequence may take the form of events associated with particular daily events, such as activities and/or times of day. Indicia associated with the event may lead the patient through the treatment regimen over its full time period, leading to a greater degree of compliance with the regimen and a greater probability that the treatment will be successfully completed. The indicia may represent events and medications. One set of indicia may indicate the time of day or the activity with which the dosages of each event module is to be taken. A second set of indicia may identify each of the medications by visual appearance in the event such that detailed knowledge of the exact medications should become necessary.
  • All of the medications for the treatment regimen may be prepackaged into a single prescription package for the patient. The medication may be organized to correspond with daily events at which the medication may be taken. By way of example, the event may be a time of day or an activity that is performed during the day. Indicia representing the events associated with the event may assist the patient through the treatment regimen over its full time period, leading to a greater degree of compliance with the regimen and a greater probability that the treatment will be successfully completed.
  • The medication dosages may be assembled in any manner such as a blister packs or pouches. The blister pack may include a clear plastic sheet with compartments for the dosages and a rupturable or otherwise enterable cover for retaining the dosages in their compartments until manually removed. The pouch may be a container that is composed of thin sheets of plastic or foil which is typically opened by tearing. The present invention can be used with many physical forms of medication, but the preferred forms are those that are most easily taken, such as dosages, capsules, and liquid-gels.
  • The dosage dispenser may include an instruction area that contains any information deemed necessary to the safe use of the medications. Such information includes, but is not limited to, a graphical depiction of an event, a graphical medication legend, and instructions for use.
  • The choice of medications for treatment of bronchitis or LRTI conditions and an accompanying cough by way of an adjunct medication and their use together are dependent on numerous considerations besides the mechanism of action and risks of the individual medications. These considerations include pre-existing conditions, absorption, time of onset after dosing, rate of elimination, duration of action after dosing, therapeutic effect by virtue of combination, and side effects by virtue of combination. Medication error and misuse due to a multiplicity of medications and modalities pose an additional risk. Medical and pharmaceutical expertise may be required to formulate a treatment regimen utilizing medications and appropriate instructions for use by a lay individuals affected by bronchitis or LRTI.
  • In embodiments, the dosage dispenser may contain combinations of medications, which include an antibiotic and an oral adjunct medication that comprise a regimen for treating a bronchitis or LRTI condition in combination with a cough treatment. For example, the dosage dispenser may be comprised of at least two or more oral adjunct medications, one for administration of an antibiotic to treat an acute bacterial exacerbation related to chronic bronchitis or a secondary bacterial exacerbation related to acute bronchitis, and an adjunct medication to treat a cough associated with the bronchitis or LRTI.
  • In embodiments, the dosage dispenser may contain combinations of medications, which include an antibiotic and an oral adjunct medication that comprise a regimen for treating a bronchitis or LRTI condition in combination with a decongestant treatment. For example, the dosage dispenser may be comprised of at least two or more oral adjunct medications, one for administration of an antibiotic to treat an acute bacterial exacerbation related to chronic bronchitis or a secondary bacterial exacerbation related to acute bronchitis, and an adjunct medication to treat congestion associated with the bronchitis or LRTI.
  • In embodiments, the dosage dispenser may contain an oral antibiotic and a combination of adjunct medications. The combinations of adjunct medications may be configured to avoid or minimize undesirable side-effects, or may be configured to compliment any such effects. For example, the dosage dispenser may be comprised of an oral antibiotic and at least two oral adjunct medications, one for administration when sedation is not desired, as, for example, during the day, and one for administration when sedation is desired, as, for example, at night. The regimen is devised utilizing a combination of oral adjunct medications that are favorable for use with each other, particularly with regard to pharmacokinetic and therapeutic characteristics. It is possible to formulate these regimens with presently available pharmaceutical dosage forms or medications as well as with newly formulated oral adjunct medications. Further examples of such regimens related to oral adjunct medication combinations are found in co-assigned U.S. application Ser. No. 11/485,931, filed Jul. 13, 2006, and incorporated herein by reference in its entirety.
  • Referring now to the FIGURE, a dosage dispenser is depicted in the form of a blister pack dispenser 23 comprising a topside surface 10 with indicia 12 defined thereon having held therein two or more types of discrete pharmaceutical dosage forms 1, 2, 3 and 4; together with optional printed matter 40.
  • The blister pack dispenser shown in the FIGURE is shaped as an elongate rectangle but may be of any acceptable shape. The indicia 12 is defined on the topside surface 10 by the arrangement of printed words or other symbols along two axes, the first axis being alongside one edge of the topside surface 10, the other axis being at right angles to the first. The indicia 12 may be arranged in any fashion as desired. The first axis is defined by the words “Day 1”, “Day 2”, etc., and may be regularly spaced, these words representing, for example, consecutive days or administration periods of the therapy or regimen. The other axis may be defined by the words “AM” and “PM”, or other well recognized equivalent symbols representing daytime and night-time within each day/period of the therapy or regimen.
  • The topside surface 10 has an area 50, in proximity to the indicia 12, on which may be printed administration instructions. Administration instructions may include words or well recognized symbols. The words or well recognized symbols may convey to the user the intended administration therapy or regimen to be followed. Alternatively, the section may be intentionally left blank, for example, to allow a health care provider to write specific instructions.
  • The blister film may be of a conventional blister pack dispenser type, in which blisters may be formed in a regular grid of rows and columns as shown in the FIGURE. A grid of blisters may be so arranged in the blister pack dispenser 23 that a column of blisters is in register with each of “Day 1”, “Day 2”, etc. on the topside surface 10 and a row of blisters are in register with “AM” and with “PM” on the topside surface 10.
  • The two or more types of pharmaceutical dosage forms may be in the form of soft gelatin capsules located in the closed blisters 25 of the blister pack dispenser 23. Pharmaceutical dosage forms 1, 2, 3 and 4 may comprise a combination of an antibiotic and the adjunct medication packed in the rows of blisters 25 in register with the word “AM” in the indicia 12. Pharmaceutical dosage forms 1, 2, 3 and 4 are a combination of oral antibiotic and an oral adjunct medication selected from antitussive, expectorant, antihistamine, decongestant, anticholinergic, mucolytic and combinations thereof. Preferably, pharmaceutical dosage forms 1, 2, 3 and 4 are a combination of an oral antibiotic and an oral antitussive. Alternatively, pharmaceutical dosage forms 1, 2, 3 and 4 are a combination of an oral antibiotic and an oral expectorant.
  • Each pharmaceutical dosage form of the medication may be of a different color to aid in distinguishing the medication or to compliment the administration instructions. Combinations of medications may be provided in a single dosage form. The dosage forms may be provided in time-release formulations. In one embodiment, adjunct medication that may include a sedative medication may be packed in the rank of blisters 25 in register with the word “PM” in the indicia 12.
  • To remove any or all pharmaceutical dosage forms 1, 2, 3 and 4 at a time indicated as appropriate as above the corresponding blister 25 containing it may be accomplished by pressing with a finger to push the pharmaceutical dosage form through the topside surface 10. In addition to indicating and facilitating the taking of the various pharmaceutical dosage forms in accordance with a desired treatment regimen, the dispenser may also show when the necessary pharmaceutical dosage forms have been taken.
  • The base and blister film of the blister pack dispenser 23 may be of any materials suitable for the construction of blister packs, for example, an aluminum foil base and a thermoplastic blister film. Although the administration instructions may be printed on the base, they may also be written or printed on a separate surface such as a sheet of paper, or on a label attached to the pack.
  • Although the illustrated dispenser specifically described is generally useable for up to a ten-day dosage regimen, it is envisaged that the dispenser may be adapted for longer or shorter periods of time, as desired, merely by shortening or lengthening the dispenser and correspondingly decreasing or increasing the number of columns of blisters as appropriate. For example, a dosage dispenser may contain only a five-day dosage regimen or a seven-day dosage regimen or fourteen-day dosage regimen, for example. The dosage dispenser may contain a dosage regimen for the oral antibiotic that is longer, shorter or the same as the oral adjunct medication.
  • Further, although the illustrated dispenser specifically described is for a regimen of pharmaceutical dosage forms for day-time use and for night-time use, it is envisaged that the desired regimen may specify any number of pharmaceutical dosage forms for each aspect of the therapy. Consequently, the dispenser may be adapted in accordance with the requirements of the regimen by narrowing or widening the dispenser and correspondingly decreasing or increasing the number of rows of blisters and the number of rows in register with “AM” and “PM” as appropriate.
  • The blister pack dispenser described has an indicia defined on it in the form of rows and columns with corresponding positioning of the pharmaceutical dosage form containing blisters. The indicia, and corresponding blisters, may be in any geometric configuration provided that the indicia clearly indicate which pharmaceutical dosage forms are to be taken and when. The indicia may be omitted, but the pharmaceutical dosage forms of the different types must have a visible distinguishing feature, such as a difference in color, to indicate that they relate to different aspects of the dosage regime. The indicia and such the distinguishing feature may both be present.
  • One or more blister packs within the scope of the present invention may be housed in any suitable form for dispensing. The dispenser embodiments described herein are not limited to blister packs. Thus, any conventional pharmaceutical containers are suitable. Examples thereof include bottles, tubes, canisters and packets. Where such containers do not readily permit the housing of the pharmaceutical dosage forms in register with a indicia, for example bottles, the pharmaceutical dosage forms must be mutually distinguished by some visible feature. A distinguishable visible feature includes, for example, a difference in color, form, shape or size, or by marking or printing thereon, to indicate which pharmaceutical dosage forms are to be taken and when.
  • There are a number of possible combinations of oral adjunct medication that may be employed in combination with an oral antibiotic. Other medications, such as analgesics and non-sympathomimics may be incorporated into or separately therefrom.
  • The treatment regimen herein described may provide for improved therapeutic compliance. The treatment regimen herein described may also provide for reduced medication error.
  • Example Treatment Regimens
  • An example of a treatment regimen that continues for ten days includes cefuroxime axetil 500 mg indicated for 1 dosage every 12 hours and Tussionex BID (dose dependent on weight of patient). Another example provides for cefprozil 500 mg indicated for 1 dosage every 12 hours and benzonatate 100 mg 1-2 doses every 8 hours.
  • An example of a treatment regimen that continues for ten days includes amoxicillin/clavulanate 875/125 mg indicated for 1 dosage every 12 hours and pseudoephedrine HCl 120 mg 1 dosage every 12 hours.
  • An example of a treatment regimen that continues for ten days includes amoxicillin/clavulanate 875/125 mg indicated for 1 dosage every 12 hours and phenylephrine HCl 20 mg/guaifenesin 375 mg 1-2 doses every 12 hours.
  • An example of a treatment regimen that continues for ten days includes cefditoren 2000 mg 2 doses every 12 hours to be taken in the AM and to be taken in the PM and 60 mg carbetapentane/600 mg guaifenesin/25 mg phenylephrine 1 dosage to be taken in the AM and 5 mg hydrocodone/600 mg guaifenesin/10 mg phenylephrine 1 dosage to be taken in the PM.
  • An example of a treatment regimen that continues for ten days includes cefdinir 300 mg indicated for 1 dosage every 12 hours to be taken in the AM and to be taken in the PM and 120 mg pseudoephedrine/2.5 mg methscopolamine 1 dosage to be taken in the AM and 8 mg chlorpheniramine/2.5 mg methscopolamine to be taken in the PM.
  • An example of a treatment regimen that continues for ten days includes azithromycin 250 mg 2 doses every 24 hours day 1, azithromycin 250 mg 1 dosage every 24 hours days 2-5, 120 mg pseudoephedrine/1200 mg guaifenesin 1 dosage to be taken in the AM and 40 mg pseudoephedrine/1200 mg guaifenesin/60 mg dextromethorphan 1 dosage to be taken in the PM. These three previously described regimens may maximize the therapeutic effects of each medication and may minimize their side effects. Thus, the decongestant medication is indicated during the daytime hours as it may cause insomnia. The expectorant is indicated both day and night to thin secretions for improving productivity of cough. Somnolence that may be experienced with this adjunct medication may to be counteracted by the stimulation of the decongestant taken during the day. The antibiotic agent may be indicated on a 24-hour basis, which may be effective for microorganisms most commonly infecting the lungs and lower respiratory tract.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for ten days includes cefuroxime axetil 500 mg indicated for 1 dosage every 12 hours and benzonatate 200 mg 1 dosage every 8 hours.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for ten days includes cefuroxime axetil 500 mg 1 dosage every 12 hours and benzonatate 100 mg 1-2 doses every 8 hours.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for ten days includes amoxicillin/clavulanate 875/125 mg indicated for 1 dosage every 12 hours and benzonatate 200 mg 1 dosage every 8 hours.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for ten days includes amoxicillin/clavulanate 875/125 mg indicated for 1 dosage every 12 hours and 30 mg dextromethorphan/600 mg guaifenesin 1-2 doses every 12 hours.
  • An example of a treatment regimen suitable for treating a bronchitis or a LRTI condition that continues for ten days includes cefditoren 200 mg 2 doses every 12 hours and 60 mg Carbetapentane/40 mg pseudoephedrine 1 dosage every 12 hours for ten days cefditoren 200 mg 2 doses every 12 hours and benzonatate 200 mg 1 dosage every 8 hours.
  • An example of a treatment regimen suitable for treating a bronchitis or a LRTI condition that continues for ten days includes cefdinir 300 mg indicated for 1 dosage every 12 hours and Tussionex BID (dose dependent on weight of patient).
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for ten days includes cefdinir 300 mg 2 doses every 24 hours and 30 mg dextromethorphan/1200 mg guaifenesin every 12 hours.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for ten days includes cefprozil 500 mg indicated for 1 dosage every 12 hours and 60 mg carbetapentane/375 mg guaifenesin/25 mg phenyephrine HCl 1 dosage every 12 hours.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for seven days includes clarithromycin 500 mg and 30 mg pseudoephedrine/2.5 mg hydrocodone/100 mg guaifenesin (Duratuss HD, Tussend) as directed PO.
  • An example of a treatment regimen suitable for treating a bronchitic or a LRTI condition that continues for five days includes azithromycin 250 mg 2 doses on day 1, 1 dosage every 24 hours days 2-5 and Tussionex BID (dose dependent on weight of patient).
  • These examples and illustrations are intended only as examples of treatment regimens that may be advantageously used for the treatment of bronchitic or LRTI conditions. They include examples of antibiotics that may be incorporated with other medications deemed salutary for the treatment of bronchitis and LRTI conditions and associated manifestations including: decongestants, analgesics, expectorants, anticholinergics, mucolytics and antitussives to form a bronchitis or LRTI treatment regimen.
  • As used herein, “comprising,” “including,” “containing,” “characterized by,” and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional, unrecited elements or method steps. “Comprising” is to be interpreted as including the more restrictive terms “consisting of” and “consisting essentially of.”
  • As used herein, “consisting of” and grammatical equivalents thereof exclude any element, step, or ingredient not specified in the claim.
  • As used herein, “consisting essentially of” and grammatical equivalents thereof limit the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic or characteristics of the claimed invention.
  • While the invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention.

Claims (48)

1. A method of providing a treatment regimen for treating a bronchitic condition in a subject in need thereof, the method comprising:
(a) providing a prepackaged dosage dispenser comprising an oral antibiotic effective for treating the bronchitic condition and a oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof; and
(b)providing administering indicia for administering the oral antibiotic and the oral adjunct medication for treating the bronchitic condition, the indicia being integrated with the prepackaged dosage dispenser.
2. The method of claim 1, wherein the bronchitic condition is an acute bacterial exacerbation related to chronic bronchitis.
3. The method of claim 1, wherein the bronchitic condition is a secondary bacterial exacerbation related to acute bronchitis.
4. The method of claim 1, wherein the treatment regimen provides for improved therapeutic compliance.
5. The method of claim 1, wherein the treatment regimen provides for reduced medication error.
6. The method of claim 1, wherein the at least one oral antibiotic is selected from the class of antibiotics consisting of penicillins, cephalosporins and macrolides.
7. The method of claim 1, wherein the at least one oral antibiotic is selected from the group consisting of amoxicillin, azithromycin, cefdinir, cefditoren, cefprozil, cefuroxime and clarithromycin.
8. The method of claim 1, wherein the at least one oral adjunct medication is selected from the group consisting of benzonatate, carbetapentane, chlorpheniramine, dextromethorphan, guaifenesin, hydrocodone, methscopolamine, phenylephrine and pseudoephedrine.
9. The method of claim 1, wherein the at least one oral adjunct medication is a decongestant.
10. The method of claim 9, wherein the decongestant is phenylephrine, phenylpropanolamine or pseudoephedrine.
11. The method of claim 1, wherein the at least one oral antibiotic is selected from the group consisting of amoxicillin, azithromycin, cefdinir, cefditoren, cefprozil, cefuroxime and clarithromycin; and the at least one oral adjunct medication is phenylephrine or pseudoephedrine.
12. The method of claim 1, wherein the oral antibiotic comprises amoxicillin/clavulanate and the oral adjunct medication comprises phenylephrine and guaifenesin.
13. The method of claim 1, wherein the oral antibiotic comprises amoxicillin/clavulanate and the oral adjunct medication comprises pseudoephedrine.
14. The method of claim 1, wherein the oral antibiotic comprises azithromycin and the oral adjunct medication comprises pseudoephedrine, guaifenesin and dextromethorphan.
15. The method of claim 1, wherein the oral antibiotic comprises azithromycin and the oral adjunct medication comprises chlorpheniramine and hydrocodone.
16. The method of claim 1, wherein the oral antibiotic comprises cefdinir and the oral adjunct medication comprises pseudoephedrine, methscopolamine and chlorpheniramine.
17. The method of claim 1, wherein the oral antibiotic comprises cefdinir and the oral adjunct medication comprises chlorpheniramine and hydrocodone.
18. The method of claim 1, wherein the oral antibiotic comprises cefdinir and the oral adjunct medication comprises dextromethorphan and guaifenesin.
19. The method of claim 1, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises carbetapentane and pseudoephedrine.
20. The method of claim 1, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises carbetapentane, guaifenesin, phenylephrine, and hydrocodone.
21. The method of claim 1, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises benzonatate.
22. The method of claim 1, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises carbetapentane, guaifenesin and phenyephrine.
23. The method of claim 1, wherein the oral antibiotic comprises cefprozil and the oral adjunct medication comprises benzonatate.
24. The method of claim 1, wherein the oral antibiotic comprises cefuroxime axetil and the oral adjunct medication comprises chlorpheniramine and hydrocodone.
25. The method of claim 1, wherein the oral antibiotic comprises clarithromycin and the oral adjunct medication comprises pseudoephedrine, hydrocodone and guaifenesin.
26. A method of providing a treatment regimen for a lower respiratory tract infection condition in a subject in need thereof, the method comprising:
(a) providing a prepackaged dosage dispenser comprising an oral antibiotic effective for treating a bacterial infection related to a lower respiratory tract infection condition and a oral adjunct medication selected from antitussives, expectorants, antihistamines, decongestants, anticholinergics, mucolytics and combinations thereof; and
(b) providing administering indicia for administering the oral antibiotic and the oral adjunct medication for treating a lower respiratory tract infection condition, the indicia being integrated with the prepackaged dosage dispenser.
27. The method of treating bronchitis of claim 26, wherein the treatment regimen provides for improved therapeutic compliance.
28. The method of treating bronchitis of claim 26, wherein the treatment regimen provides for reduced medication error.
29. The method of claim 26, wherein the at least one oral antibiotic is selected from the class of antibiotics consisting of penicillins, cephalosporins and macrolides.
30. The method of claim 26, wherein the at least one oral antibiotic is selected from the group consisting of amoxicillin, azithromycin, cefdinir, cefditoren, cefprozil, cefuroxime and clarithromycin.
31. The method of claim 26, wherein the at least one oral adjunct medication is selected from the group consisting of benzonatate, carbetapentane, chlorpheniramine, dextromethorphan, guaifenesin, hydrocodone, methscopolamine, phenylephrine and pseudoephedrine.
32. The method of claim 26, wherein the at least one oral adjunct medication is an decongestant.
33. The method of claim 26, wherein the decongestant is phenylephrine, phenylpropanolamine or pseudoephedrine.
34. The method of claim 26, wherein the at least one oral antibiotic is selected from the group consisting of amoxicillin, azithromycin, cefdinir, cefditoren, cefprozil, cefuroxime and clarithromycin; and the at least one oral adjunct medication is phenylephrine or pseudoephedrine.
35. The method of claim 26, wherein the oral antibiotic comprises amoxicillin/clavulanate and the oral adjunct medication comprises phenylephrine and guaifenesin.
36. The method of claim 26, wherein the oral antibiotic comprises amoxicillin/clavulanate and the oral adjunct medication comprises pseudoephedrine.
37. The method of claim 26, wherein the oral antibiotic comprises azithromycin and the oral adjunct medication comprises pseudoephedrine, guaifenesin and dextromethorphan.
38. The method of claim 26, wherein the oral antibiotic comprises azithromycin and the oral adjunct medication comprises chlorpheniramine and hydrocodone.
39. The method of claim 26, wherein the oral antibiotic comprises cefdinir and the oral adjunct medication comprises pseudoephedrine, methscopolamine and chlorpheniramine.
40. The method of claim 26, wherein the oral antibiotic comprises cefdinir and the oral adjunct medication comprises chlorpheniramine and hydrocodone.
41. The method of claim 26, wherein the oral antibiotic comprises cefdinir and the oral adjunct medication comprises dextromethorphan and guaifenesin.
42. The method of claim 26, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises carbetapentane and pseudoephedrine.
43. The method of claim 26, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises carbetapentane, guaifenesin, phenylephrine, and hydrocodone.
44. The method of claim 26, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises benzonatate.
45. The method of claim 26, wherein the oral antibiotic comprises cefditoren and the oral adjunct medication comprises carbetapentane, guaifenesin and phenyephrine.
46. The method of claim 26, wherein the oral antibiotic comprises cefprozil and the oral adjunct medication comprises benzonatate.
47. The method of claim 26, wherein the oral antibiotic comprises cefuroxime axetil and the oral adjunct medication comprises chlorpheniramine and hydrocodone.
48. The method of claim 26, wherein the oral antibiotic comprises clarithromycin and the oral adjunct medication comprises pseudoephedrine, hydrocodone and guaifenesin.
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