Treatment of Specific Conditions

Amino adds find apphcations as ingredients of infiision solutions for parenteral nutrition and individnally for treatment of specific conditions. They are obtained either by fermentation processes similar to those used for antibiotics or in cell-fiee extracts employing enzymes isolated fiom bacteria (Table 25.1). Details of the mar and varied... 

Nutraceuticals are used by the medical profession as part of the treatment of specific conditions. (Many are available in commercial preparations.) They include glutamine, arginine, nucleosides and polyunsaturated fatty acids. The explanation for their benefit is described in Chapter 18. 

Both zolpidem and zaleplon are available in 5- and 10-mg tablets for oral administration. The maximum recommended dose for adults is 10 mg/day and 20 mg/day, respectively, administered at night. The initial dose for elderly persons should not exceed 5 mg. Caution is advised in patients with hepatic dysfunction. In general, hypnotics should be limited to short-term use, with reevaluation for more extended therapy (see below under Treatment of Specific Conditions ). 

Neurodegenerative diseases are generally characterized by the death of specific neuronal populations. Many such neurons are responsive, in vitro at least, to one or more neurotrophic factor. This infers a potential therapeutic role for these molecules in the treatment of such conditions (Table 7.11). Lack of current effective therapies for the treatment of any neurodegenerative disease renders this avenue of investigation even more attractive. Target diseases include amyotrophic lateral sclerosis and peripheral neuropathies, as well as various neurodegenerative diseases of the brain, including Alzheimer s and Parkinson s. 

In the United States, the three MAOIS available for the treatment of psychiatric conditions are phenelzine (Nardil), tranylcypromine (Parnate), and isocarboxazid (Marplan). All three agents have indications for adult major depression (>16 years old) and, more specifically, atypical depression (anergia, hypersomnia, hy-perphagia, somatization, and anxiety symptoms). Although not indicated for anxiety, the MAOIs can also be particularly helpful in treatment of these disorders. Selegiline or L-deprenyl (Eldepryl) is also available in the United States and indicated for symptoms of Parkinson s disease and depression. 

The treatment of major depression in psychiatry is analogous to the treatment of many conditions in general medicine. Thus, patients with these various disorders can benefit from several classes of medications with different mechanisms of action and adverse effects. The development of newer agents with unique spectra of activity requires the parallel development of specific strategies for their optimal use. Later, after a review of the efficacy literature, we suggest such a model to manage the depressed patient. 

Conduct disorder occurs in 2% to 10% of the general pediatric population and represents the largest diagnostic group referred to outpatient psychiatric clinics ( 146). Nevertheless, only a few double-blind, controlled treatment studies have been conducted of this condition. Although no studies show a single treatment to be more effective for conduct disorder, some data exist about the treatment of specific symptoms. 

Although the term pseudoneurotic schizophrenia has been dropped from the nomenclature, Klein ( 219) made an interesting observation regarding the drug treatment of this condition. Specifically, in an investigation comparing the effects of chlorpromazine and imipramine in a wide variety of patients, imipramine was observed to be beneficial. Thus, in this controlled study, imipramine produced a positive outcome in 60% of subjects, in contrast to placebo, which produced only a 25% positive outcome. 

The use of antidepressants outside the treatment of MDD tends to require specific agents. For example, the TCAs and SNRIs appear to be useful in the treatment of pain conditions, but other antidepressant classes appear to be far less effective. SSRIs and the highly serotonergic TCA, clomipramine, are effective in the treatment of OCD, but noradrenergic antidepressants have not proved to be as helpful for this condition. Bupropion and nortriptyline have usefulness in the treatment of smoking cessation, but SSRIs have not been proven useful. Thus, outside the treatment of depression, the choice of antidepressant is primarily dependent on the known benefit of a particular antidepressant or class for a particular indication. 

Fish oil has been one of the hottest topics in general nutrition and health care over the past few years, mainly because it is primarily composed of - fatty acids. The benefits of fish oil have a strong foundation in well-documented scientific studies, the most important ones dealing with the treatment of heart disease. Treatment of any condition associated with essential fatty acid changes inevitably involves the use of fish oil or more specific mixtures of the primary important essential fatty acids [14]. 

This time controlled release tablet with a designated lag time followed by a rapid release may provide an alternative to site-specific delivery of drugs with optimal absorption windows or colonic delivery of drugs that are sensitive to low pH or enzyme action for the treatment of localized conditions such as ulcerative colitis, Crohn s disease, and irritable bowel syndrome (IBS). Also, by controlling a predetermined lag time of drug from dosage form, the release behavior can be matched with the body s circadian rhythm pattern in chronotherapy. 

Antimicrobials that are restricted to certain specific uses, i.e. tuberculosis, urinary tract infections, are described with the treatment of these conditions in Chapter 13. 

The second type of method-of-use claims relates to methods of using the invention. In terms of pharmaceuticals, method-of-use claims typically relate to the use of a particular drug in the treatment of specific diseases or conditions. FDA approval of a new drug is linked to specific therapeutic uses, and therefore these types of method claims provide important protection for the innovator. These claims are important because they provide patent protection that is in addition to any composition-of-matter claims that may be applicable. Method-of-treatment claims are particularly important for compounds that are already subject to composition-of-matter claims or for which composition-of-matter claims are not available. For example, an inventor may discover that a previously known compound possesses unreported and unexpected antiinflammatory properties. The inventor may not obtain composition-of-matter protection for the compound itself because the compound is contained in the literature and therefore does not meet the novelty requirement for patentability. However, the inventor may instead obtain a method-of-use claim based on the unexpected anti-inflammatory properties because a compound s unexpected properties may be enough to support patentability. 

While the evidence from trials with acceptable methodology was considered limited and more trials are called for, both reviews concluded treatment with P. sidoides offered relief from the symptoms of acute respiratory tract infechon, and specifically from acute bronchihs in children. Taking into account additional data from observational studies and post-market surveillance, results support the use of Umckaloabo (EPs 7630) as a possible alternative to antibiotics for the acute treatment of these conditions. Overall safety and a very low incidence of side effects have been confirmed. 

The information that must be included in a PGD for a physiotherapist follows the same general rules that are listed in the podiatric example given earlier in this chapter. Specific examples of drugs that might be included in a physiotherapy PGD are triamcinolone acetonide lOmg/ml and methylprednisolone acetate 40 mg/lidocaine hydrochloride 10 mg/ml, which are administered by intra- or extra-articular injection. Both of these drugs are used for the treatment of inflammatory conditions such as soft tissue injuries and isolated joint inflammation (see Chapter 7). 

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