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Medical Foods Classification Pulmona™ is a Medical Food formulated to be used by practicing physicians to be used for the management of pulmonary artery pressure in the presence of pulmonary hypertension and to reduce bronchospasm in the presence of asthma. Pulmona™ helps to promote nitric oxide in the bronchi and the pulmonary arteries. Under the regulations of the Food and Drug Administration, Medical Foods may only be used when a patient is under the ongoing care of a physician or other healthcare provider. Medical Foods are used for the dietary management of disease states with known nutritional deficiencies. Medical Foods must contain ingredients from the human diet. Medical Foods cannot be sold directly to patients without medical supervision. Distinctive Nutritional Requirements Patients with pulmonary hypertension and asthma may have nutritional deficiencies of arginine, choline, and certain antioxidants. Patients with pulmonary hypertension and asthma frequently exhibit reduced plasma levels of arginine. Patients with pulmonary hypertension and asthma respond to oral administration of arginine. Arginine reduced diets result in a fall of circulating arginine. Patients with pulmonary hypertension and asthma have activation of the arginase pathway that diverts arginine from production of nitric oxide to production of deleterious nitrogen molecules such as peroxynitrite leading to a reduced level of production of nitric oxide for a given arginine blood level. Supplementation with antioxidants and arginine can restore the production of beneficial nitric oxide production Indications for Use
Neurotransmitter Production in the Human Body
Targeted Cellular Technology This unique five-component process allows milligram quantities of neurotransmitter precursors to produce therapeutic effects of neurotransmitters. This process includes a neurotransmitter precursor, an uptake stimulator, a neuron activator, an adenosine brake inhibitor, and attenuation releaser. Previous attempts to use neurotransmitter precursors have required much larger quantities of the precursors to elicit a therapeutic effect, making it functionally impossible for a patient to ingest large, gram quantities of a precursor agent on a daily basis. The use of the Targeted Cellular Technology process also prevents the development of tolerance. Unlike pharmaceutical agents that lose their effectiveness in a relatively short period, Pulmona™ maintains its effectiveness and does not attenuate. Pulmona™ Ingredients: Targeted Cellular Technology and Pulmona™ Pulmona™ is designed to produce the neurotransmitters nitric oxide and acetylcholine. Nitric oxide is the neurotransmitter that initiates dilatation of the pulmonary arteries in the presence of pulmonary hypertension and dilates the bronchi in the presence of bronchoconstriction. Acetylcholine is the neurotransmitter that facilitates the action of nitric oxide on the pulmonary arteries and bronchi. Pulmona™ is designed to provide the nitric oxide precursor arginine and the acetylcholine precursor choline to enhance the production of the nitric oxide and acetylcholine neurotransmitters in the lung. Pulmona™ and Clinical Testing Physiologic testing of nitric oxide function has been performed on individuals taking Pulmona™. Patients with pulmonary hypertension have increased pulmonary artery pressures. Patients with asthma have decreased pulmonary flow rates as measured by FEV1. Pulmona™ has been shown to reduce pulmonary artery pressures as measured by right heart catheterization in patients with pulmonary hypertension. Pulmona™ increases FEV1 as measured by spirometry in patients with asthma. Pulmona™ reduces the incidence of cough in patients with exercise-induced asthma and patients with environmentally induced bronchospasm. Pulmona™ Dosage Pulmona™ should be taken as a dose of two (2) capsules three times per day. An additional dose of Pulmona™ may be used if shortness of breath continues. As with all Medical Food products, the best dosing protocol is established by the healthcare provider in coordination with the requirements of each individual patient. Pulmona™ and Prescription Drugs In patients taking pharmaceutical agents to treat pulmonary hypertension or asthma, it is suggested that the medication dosage should be maintained. Pulmona™ should be added and clinical state monitored by the healthcare provider. Patients with pulmonary hypertension and shortness of breath should be clinically monitored. Patients with asthma should be clinically monitored and have intermittent FEV1 testing. Side Effects The side effect profile of Pulmona™ is comparable to the rate of food intolerance in the community. The ingredients of Pulmona™ are derived from nutrient based compounds found in the normal food chain. Food intolerance is an adverse reaction to food that does not involve the body's immune system. When first starting any amino acid therapy, some people complain of mild headaches, stomach upset, and nausea or mouth dryness. These symptoms are mild and temporary and can be managed by drinking plenty of fluids and carefully titrating the dose. Rarely, some individuals feel jittery or over-stimulated. These side effects are relieved by lowering the dose. L-Arginine Contraindications, Precautions, Adverse Reactions, Contraindications Precautions Because of absence of long-term safety studies, and because of the possibility of growth hormone stimulation, pregnant women and nursing mothers should avoid L-arginine supplementation. Individuals with renal or hepatic failure should exercise caution in the use of supplemental L-arginine. Proteins of the herpes simplex virus are rich in L-arginine, and there are a few reports (mainly anecdotal) of those taking supplemental L-arginine who have had recurrences of oral herpes lesions. Although it is unlikely that those with a history of herpes simplex virus infection will have recurrences if they use L-arginine supplements, they should nevertheless be aware of this possibility. Adverse Reactions Oral supplementation with L-arginine at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some may experience these symptoms at lower doses. Drugs Interactions Cyclosporine: L-arginine may counteract the antinaturetic effect of cyclosporin. Herbs Yohimbe: L-Arginine, if used concomitantly, may enhance the effect of yohimbe Pulmona™ contains a formula blend of selected GRAS (generally regarded as safe) ingredients that are found in the normal human food chain. The primary ingredients are key amino acids, the building blocks of proteins. The Pulmona™ formula is designed to increase the function of the neurotransmitters nitric oxide and acetylcholine. The Pulmona™ is designed to produce two neurotransmitters including nitric oxide and acetylcholine. These two neurotransmitters are involved in pulmonary hypertension(1-35) (36-63)and asthma(64-107). Normal pulmonary arteries do not significantly respond to nitric oxide while constricted pulmonary arteries in pulmonary hypertension dilate in response to nitric oxide. Nitric oxide production is increased by the inflammation associated with asthma. Importantly, however, certain sites of nitric oxide production are reduced in asthma inducing bronchoconstriction. Inhalation or nitric oxide or production of iNOS induced nitric oxide induces bronchodilatation in diseased lungs. Acetylcholine potentiates the activity of nitric oxide in the lung(108-131). Pulmona™ is designed to produce neurotransmitters that initiate vasodilatation in pulmonary hypertension and bronchodilation in asthma. In the Pulmona™ formulation, arginine is used as the precursor to nitric acid and choline is used as a precursor to acetylcholine. In the Pulmona™ formula, both Ginkgo Biloba and cinnamon are used as uptake stimulators(132-137). Glutamine is used to produce glutamate to stimulate neurotransmitter release (138-169). Cocoa and caffeine are used to disinhibit the adenosine brake(170-180) (181-184). Hawthorn Berry, containing polyphenols(185-188), is used to prevent the attenuation usually associated with neurotransmitter precursor administration. Nitric oxide is an important mediator of pulmonary artery pressure in the presence of pulmonary hypertension(11;189-233). Nitric oxide has little effect on pulmonary arteries when pulmonary artery pressure is in the normal range. In the presence of increased pulmonary artery pressure, nitric oxide serves to provide pulmonary artery vasodilation. Nitric oxide is a selective pulmonary artery dilator in the presence of pulmonary hypertension. Nitric oxide in exhaled air (eNO) is elevated in allergic asthma compared with healthy subjects and has been proposed as a marker of bronchial inflammation(87;94;234-269). Nitric oxide is endogenously released in the airways after synthesis from arginine induced by the enzyme nitric oxide synthase (NOS). Functionally, three isoforms of this enzyme exist: neuronal, constitutive, and inducible. The nitric oxide produced from neuronal and constitutive NOS appear to protect airways from excessive bronchoconstriction. The inducible form of NOS has a modulatory role in inflammatory disorders of the airways such as asthma, and is a marker for the inflammation process. Thus, the role of lung-produced nitric oxide is complex and reflects both the bronchodilation of constricted bronchi and the role of nitric oxide as a marker for inflammation. Nitric oxide has little role in modulating basal airway tone in either normal subjects or patients with asthma. Nitric oxide opposes the bronchoconstriction induced by a variety of bronchial spasmogens. The bronchodilatory effects of nitric oxide are potentiated by endogenous histamine. In severe asthma there is a reduction in cNOS produced nitric oxide, indicating a reduced supply of the bronchomodulatory effects of nitric oxide. An early response to an allergen challenge induces nitric oxide production. Blocking the early nitric oxide response results in an augmented vasoconstriction response to the allergen. Early release of nitric oxide in response to an allergen challenge protects the bronchi from severe bronchoconstriction. The ability of the bronchi to produce the favorable nitric oxide response is lost as the asthma worsens. The bronchoconstriction in severe asthma is related to a reduced availability of arginine and a shunt of the arginine from nitric oxide production to peroxynitrite production from arginase activity. Nitric oxide reduces the inflammation associated with asthma, and directly reduces histamine release by mast cells. Nitric oxide also inhibits arginase activity leading to reduced peroxynitrite production. Thus nitric oxide has multiple beneficial effects in both early and late asthma. Arginine alone, without inhibition of the arginase activity may prolong the late allergic response. Accordingly, it is important to augment cNOS while inhibiting iNOS in treating asthma. When nitric oxide is increased by direct production of cNOS, asthma in both animal and human models is improved. The Pulmona™ formula contains precise proprietary proportions of arginine, cocoa powder, caffeine, cinnamon, Hawthorn Berry, glutamine, histidine, and choline. Several open label trials have been conducted using the Pulmona™ formula in patients with either pulmonary hypertension or asthma. In patients with documented pulmonary hypertension, these trials have shown a reduction of pulmonary artery pressures as measured by right heart catheterization. In patients with documented asthma, reduction of FEV1 as measured by spirometry was shown. Pulmona™ has been shown to increase nitric oxide production by the lung. Nutritional Deficiency Associated with Pulmonary Hypertension and Asthma Patients with pulmonary hypertension and asthma may have nutritional deficiencies of arginine, choline and certain antioxidants (270-302). Patients with pulmonary hypertension and asthma have reduced plasma levels of arginine. Patients with pulmonary hypertension and asthma respond to oral administration of arginine. Arginine reduced diets result in a fall of circulating arginine. Patients with pulmonary hypertension and asthma have activation of the arginase pathway that diverts arginine from production of nitric oxide to production of deleterious nitrogen molecules such as peroxynitrite thus leading to a reduced production of nitric oxide for a given arginine blood level(303-325). Supplementation with antioxidants and arginine can restore the production of beneficial nitric oxide production. The use of Pulmona™ may produce reduced pulmonary artery pressure and reduced FEV1 in patients with pulmonary hypertension and asthma. Thus, Pulmona™ may result in reduced shortness of breath and improved exercise tolerance in these patients.
© 2006 Physician Therapeutics LLC & Nationwide Medical Foods
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Pulmona™ Product Information
