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Traduzido de Sodium Bicarbonate - Medical Countermeasures Database ↗ (CHEMM, HHS/ASPR — domínio público), fonte capturada em 2026-08-25. Em caso de dúvida, vale o original.

Sodium Bicarbonate (bicarbonato de sódio) — banco de contramedidas médicas

Name of Chemical Defense therapeutic agent/deviceno original (inglês)
Chemical Defense therapeutic areano original (inglês)
Evidence-based medicine for Chemical Defenseno original (inglês)
Pharmacokinetic and toxicokinetics datano original (inglês)
Indication/dosingno original (inglês)
Formulation/shelf lifeno original (inglês)
Off-label use & dosingno original (inglês)
Route of administrating/monitoringno original (inglês)
Adverse effectsno original (inglês)
Contraindicationsno original (inglês)
Clinical studies in progressno original (inglês)
Non-clinical studies in progressno original (inglês)
Needed studies for Chemical Defenseno original (inglês)
Needed studies for non-Chemical Defenseno original (inglês)
Study-related ethical concernsno original (inglês)
Global regulatory statusno original (inglês)
Other potentially useful informationno original (inglês)
Publicationsno original (inglês)
Web sitesno original (inglês)

1. Nome do agente terapêutico/dispositivo de defesa química

Sodium Bicarbonatedose/fármaco conforme a fonte ↗

2. Área(s) terapêutica(s) de defesa química

O sodium bicarbonate é um antídoto inespecífico, eficaz no tratamento de várias intoxicações por mecanismos distintos. O sodium bicarbonate nebulizado é adjuvante útil no tratamento de pacientes com lesão pulmonar decorrente da inalação de fosgênio e de gás cloro. O sodium bicarbonate inalado neutraliza o ácido clorídrico formado quando o fosgênio ou o gás cloro reagem com a água da árvore respiratória.dose/fármaco conforme a fonte ↗

3. Medicina baseada em evidência para defesa química

A. Resumo

Estrutura

HSDB. Sodium Bicarbonatedose/fármaco conforme a fonte ↗no original (inglês)

Mecanismo de ação

A terapia intravenosa com sodium bicarbonate aumenta o bicarbonato plasmático, tampona o excesso de íon hidrogênio, eleva o pH sanguíneo e reverte as manifestações clínicas da acidose. Em água, o sodium bicarbonate se dissocia em íons sódio (Na + ) e bicarbonato (HCO 3 -). O sódio (Na + ) é o principal cátion do líquido extracelular e tem papel importante na terapia dos distúrbios hidroeletrolíticos. O bicarbonato (HCO 3 -) é constituinte normal dos líquidos corporais e o nível plasmático normal varia de 24 to 31 mEq/liter (24 a 31 mEq/litro). A concentração plasmática é regulada pelo rim, por acidificação da urina quando há déficit ou por alcalinização da urina quando há excesso. O ânion bicarbonato é considerado "lábil", pois, na concentração adequada de íon hidrogênio (H + ), pode ser convertido em ácido carbônico (H 2 CO 3 ) e daí à sua forma volátil, o dióxido de carbono (CO 2 ), excretado pelo pulmão.dose/fármaco conforme a fonte ↗

Product label Sodium Bicarbonate injection, solution [Hospira, Inc.] Last revised: August 2012 [DailyMed]dose/fármaco conforme a fonte ↗no original (inglês)

O sodium bicarbonate nebulizado pode ser outro tratamento adjuvante das exposições pulmonares ao cloro. Teoricamente, o bicarbonato inalado neutraliza os ácidos hipocloroso e clorídrico, reduzindo a gravidade da lesão pulmonar.dose/fármaco conforme a fonte ↗

Jones R, Wills B, Kang C. Chlorine gas: an evolving hazardous material threat and unconventional weapon. West J Emerg Med 2010; 11 (2):151-6. [PubMed Citation]no original (inglês)

Resumo dos estudos clínicos e não clínicos

Chlorine gas, a toxic pulmonary irritant, has been used as a chemical warfare agent by the Germans during World War I, and most recently, by insurgents during the Iraq War. Chlorine gas is more commonly released in industrial or residential settings, such as through swimming pool or home-cleaning preparations (Bosse, 1994). Symptoms of chlorine gas inhalation can occur very rapidly and range from dyspnea and nonproductive cough to pulmonary edema and acute respiratory distress syndrome (ARDS) (Chisholm et al., 1989; Vinsel, 1990). Although there is no specific antidote for treatment of chlorine gas exposure, nebulized sodium bicarbonate (NSB) has demonstrated efficacy and safety as an adjunctive treatment for chlorine gas-related pulmonary injuries. NSB neutralizes the hypochlorous and hydrochloric acids that form when chlorine gas comes into contact with water in the airways (Vinsel, 1990; Jones et al., 2010). In a sheep model, 4% inhaled NSB improved arterial blood gas values after chlorine gas inhalation without altering microscopic pathology (Chisholm et al., 1989). After brief exposure to chlorine, three patients who presented to the emergency department (ED) with mild symptoms were given 4 ml of a 3.75% NSB solution (Vinsel, 1990). The effects of NSB treatment were immediate and long-lasting, with complete relief of symptoms within 24 hours. No clinical deterioration to sodium bicarbonate therapy was observed. In a larger retrospective study (n=86) on the treatment of chlorine gas inhalation with 5% NSB, the clinical condition of 53 patients clearly improved upon release from the ED (Bosse, 1994). A small number of patients (n=17) were admitted to the hospital, receiving either a one-time dose of NSB or concomitant NSB therapy with inhaled beta-agonists and intravenous steroids. Gradual improvement occurred in all admitted patients with no observation of adverse effects. Similar therapeutic benefits from NSB administration have been observed in other studies (Douidar, 1997; Aslan et al., 2006; Howard et al., 2007; Cevik, 2009). Whether chlorine gas is released accidentally as a byproduct of a chemical reaction or intentionally as an unconventional weapon, adjunctive NSB therapy appears to be safe and effective for the treatment of potential pulmonary injuries.dose/fármaco conforme a fonte ↗no original (inglês)

B. Link para os estudos clínicos

Estudos com múltiplas populações

...Although controlled clinical trials are lacking, in several published anecdotal case reports and case series, nebulized sodium bicarbonate solution has demonstrated safety and efficacy when administered for chlorine gas inhalation. Some patients were observed to experience rapid and dramatic relief of signs and symptoms. Treatment is based on the assumption that clinical benefit and cessation of tissue damage will occur with neutralization of the acidic byproducts created by inhaled chlorine gas. ... In one anecdotal case report, a markedly symptomatic 7-year-old exposed to chlorine gas experience dramatic relief from administration of nebulized sodium bicarbonate (Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

Howard C, Ducre B, Burda AM, Kubic A. Management of chlorine gas exposure. J Emerg Nurs. 2007 Aug; 33 (4): 402-4. [PubMed Citation]no original (inglês)

In this two year retrospective review, 86 cases of chlorine gas inhalation from 49 medical facilities were treated with nebulized sodium bicarbonate on the recommendation of the Kentucky Regional Poison Center. Typical manifestations included cough, chest discomfort, shortness of breath, and wheezing. No patients developed pulmonary edema or respiratory insufficiency requiring ventilatory support. Sixty-three cases (73.3%) were exposures to chlorine producing acid/hypochlorite mixtures. Six (7.0%) were exposed to chlorine gas in industrial settings. Twelve (14.0%) were exposed to chlorine gas in swimming pool settings. Sixty-nine (80.2%) were treated and released from the emergency department. In 53 patients, clinical condition was clearly improved on emergency department discharge. Seventeen (19.8%) were admitted to the hospital. All admitted patients gradually improved and had a mean hospital stay of 1.4 days (range 1 to 3 days). No patients in this study deteriorated clinically after nebulized sodium bicarbonate use. Nebulized sodium bicarbonate appears safe and merits prospective evaluation in the therapy of chlorine gas inhalation (Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

Bosse GM. Nebulized sodium bicarbonate in the treatment of chlorine gas inhalation. J Toxicol Clin Toxicol. 1994;32(3):233-41. [PubMed Citation]dose/fármaco conforme a fonte ↗no original (inglês)

Adulto

Chlorine gas is a potent pulmonary irritant that affects the mucous membranes and induces severe disturbances of pulmonary gas exchange within minutes of inhalation. The present study evaluated an extraordinary type of mass inhalational exposure. Clinical reports of 25 soldiers who were admitted to the emergency department of Maresal Cakmak Military Hospital, Erzurum were retrospectively evaluated. All patients were exposed to chlorine gas as a result of mixing sodium hypochlorite with hydrochloric acid during cleaning activities. All patients were male and the mean age of patients was 22.04+/-2.98 years. The main symptoms were coughing and dyspnea in 18 patients (72%). Forced expiratory volume in 1 second (FEV1) and FEV1/forced volume capacity (FVC) ratio were found to be normal in all patients but FVC and peak expiratory flow (PEF) were below the normal range (80%) in 9 patients (36%). All patients received warmed humidified oxygen combined with nebulized salbutamol. Inhaled budesonide and nebulized sodium bicarbonate were ordered additionally for 19 patients (76%). Thirteen patients (52%) were discharged from the emergency department and 12 patients (48%) were hospitalized. No mortality was observed. Chlorine gas is a potent pulmonary irritant that causes acute damage in both the upper and lower respiratory tract. We suggest that inhaled steroids combined with nebulized sodium bicarbonate could be a safe and effective alternative for the treatment of symptomatic patients. Education of the public about the dangers of mixing of hypochlorite bleach with acidic cleaning agents is also very important (Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

Cevik Y, Onay M, Akmaz I, Sezigen S. Mass casualties from acute inhalation of chlorine gas. South Med J. 2009 Dec; 102 (12): 1209-13. [PubMed Citation]no original (inglês)

Chlorine is one of the most common substances involved in toxic inhalation. As with all irritant gases, the airway injuries caused by chlorine gas may result in clinical manifestations similar to those of asthma. In this study, we investigated the effect of nebulized sodium bicarbonate (NSB) on the treatment and quality of life (QoL) of victims exposed to chlorine gas. Forty-four consecutive patients with reactive airways dysfunction syndrome (RADS) due to chlorine inhalation (40 females and 4 males, age range 17-56 yr) were included in this study. Patients were placed in control and treatment groups in a sequential odd-even fashion based on their order of presentation. Treatment of all patients included corticosteroids and nebulized short-acting beta2-agonists. Then the control group (n = 22) received nebulized placebo (NP), and the NSB group (n = 22) received NSB treatment (4 cm3 of 4.20% sodium bicarbonate solution). A quality of life (QoL) questionnaire and pulmonary function tests (PFTs) were performed before and after treatments in both groups. The most common symptoms were dyspnea (82%) and chest tightness (82%). Baseline characteristics of both groups were similar. Compared to the placebo group, the NSB group had significantly higher FEV1 values at 120 and 240 min (p < .05). Significantly more improvement in QoL questionnaire scores occurred in the NSB group compared to the NP group (p < .001). Thus, NSB is a clinically useful treatment, as tested by PFTs and QoL questionnaire, for patients with RADS caused by exposure to chlorine gas (Class III).dose/fármaco conforme a fonte ↗no original (inglês)

Aslan S, Kandiş H, Akgun M, Cakir Z, Inandi T, Gorquner M. The effect of nebulized NaHCO3 treatment on "RADS" due to chlorine gas inhalation. Inhal Toxicol. 2006 Oct; 18 (11): 895-900. [PubMed Citation]no original (inglês)

Three male patients, 19 to 20 years old, were exposed to chlorine gas secondary to a leak in the chlorination system of an indoor pool. All of the patients were symptomatic with cough, chest pain, and shortness of breath. Physical examinations, arterial blood gases, and chest radiographs were normal. All patients were given a nebulized solution of 3.75% sodium bicarbonate which resulted in prompt relief of their symptoms. None of the patients suffered from prolonged symptomatology. This therapy appears to be useful in treating chlorine gas inhalation; however, it cannot be routinely recommended without prospective clinical studies evaluating its efficacy and safety (Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

Vinsel PJ; Treatment of acute chlorine gas inhalation with nebulized sodium bicarbonate. J Emerg Med. 1990 May-Jun; 8 (3): 327-9. [PubMed Citation]dose/fármaco conforme a fonte ↗no original (inglês)

Mass exposure to chloramine gas has not been reported. We report two groups of 36 patients (72 total) suffering from acute inhalation of chloramine gas. Chloramine gas is produced from mixing common household cleaning agents containing sodium hypochlorite (bleach) and ammonia. The first mass casualty event occurred when 36 male soldiers were exposed during a "cleaning party" in their barracks. Ten days later, 36 female soldiers were exposed in a similar manner and presented to our emergency department. In each event, commonly available cleaning agents--liquid bleach and ammonia--were mixed together, liberating toxic chloramine gas. Nebulized sodium bicarbonate solution has been suggested for treatment of chlorine gas inhalation, but no report of nebulized sodium bicarbonate for treatment of chloramine gas inhalation injury exists. In our series, 22 patients exposed to chloramine gas were treated with a nebulized solution of 3.75% sodium bicarbonate. This treatment made no significant statistical or clinical difference in outcome. We present the largest case series of patients presenting to an emergency department for treatment of acute inhalation of chloramine gas (Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

Pascuzzi TA, Storrow AB; Mass casualties from acute inhalation of chloramine gas. Mil Med. 1998 Feb; 163 (2):102-4. [PubMed Citation]no original (inglês)

Clinical experience with five patients exposed to phosgene is described. The treatment of phosgene poisoning was focused upon the presenting problem, pulmonary edema. Arterial hypoxemia was treated with a face mask with 10 cm CPAP with the FiO2 adjusted as needed or with a volume ventilator with controlled ventilation. Ventilation was controlled to reduce the work of breathing. Metabolic acidosis was treated with NaCHO3 to produce a normal pH. A vigorous program of diuresis was used to treat the pulmonary edema. Lasix was administered to produce a negative fluid balance while maintaining a good urinary output. The negative fluid balance correlated well with reduced oxygen requirements (Class IV).no original (inglês)

Wells BA; Phosgene: a practitioner's viewpoint. Toxicol Ind Health. 1985 Oct; 1 (2): 81-92. [PubMed Citation]no original (inglês)

Estudos pediátricos

Nebulized sodium bicarbonate 3.75% overcame the symptoms caused by inhalation of chlorine gas by a 7-year-old girl. Fumes from a can of chlorine tablets used for a swimming pool caused coughing, vomiting, and respiratory distress with nasal flaring and intercostal and subcostal retraction. Her oxygen saturation was 85% on room air. With oxygen treatment, her oxygen saturation remained below 90% and her symptoms did not improve. She was then given 4.25 milliliters of sodium bicarbonate 3.75% by a hand-held nebulizer over 20 minutes. Her symptoms improved dramatically, and she was discharged from the hospital without symptoms or complications. It is thought that the sodium bicarbonate neutralizes the hydrochloric acid formed when chlorine gas comes into contact with water at the target tissues. The possibility of a harmful exothermic reaction with administration of sodium bicarbonate has prevented its widespread use for this purpose. There was no harmful exothermic reaction in this case, possibly because of the low concentration used (Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

Douidar SM; Nebulized sodium bicarbonate in acute chlorine inhalation. Pediatr Emerg Care. 1997 Dec; 13 (6): 406-7. [PubMed Citation]dose/fármaco conforme a fonte ↗no original (inglês)

Revisões clínicas

For the treatment of phosgene poisoning, glucocorticoids and positive pressure ventilation can be recommended as well as supporting measures such as physical rest, antitussives, buffers, sedatives, antibiotics, antispasmodics and possibly diuretics. Roentgenological evaluation of the lungs is advisable. A therapeutic strategy is presented which is based on the phosgene exposure intensity (Class IV).no original (inglês)

Diller WF; Therapeutic strategy in phosgene poisoning. Toxicol Ind Health. 1985 Oct; 1 (2):93-9. [PubMed Citation]no original (inglês)

Terrorism poses a clear and present danger to civilian populations. Although terrorist cells may gain access to traditional chemical weapons, there are literally thousands of other industrial chemicals to choose from. Common chemicals used on a daily basis in an industrialized society can be readily obtained from the local shopping center, rail yard, or from nearby industrial parks, and terrorists may choose to use these agents in an attack. The medical implications of a major incident involving the accidental or intentional release of a dangerous chemical are significant, and all healthcare facilities should have a plan in place to manage the casualties of such an event. This plan should include event recognition, crowd control, primary triage, emergency treatment, decontamination of injured and uninjured patients, and secondary triage. Emergency health care providers should be prepared to respond to classic chemical agents such as mustard, chlorine, and phosgene and must also work carefully with law enforcement and public health agencies to keep abreast of new threats. The ability to recognize an event promptly, triage patients, decontaminate casualties, administer antidotes when available, and provide best supportive care will minimize the adverse outcomes (Class IV).no original (inglês)

Parrish JS, Bradshaw DA; Toxic inhalational injury: gas, vapor and vesicant exposure. Respir Care Clin N Am. 2004 Mar; 10 (1): 43-58. [PubMed Citation]no original (inglês)

A literature search designed to collect information on therapy for phosgene poisoning has been conducted for the period 1920-1982. To achieve this goal, literature services were consulted, cross references were carefully followed and, whenever possible, unpublished reports (e.g., from Edgewood Arsenal and Porton Research Station) were evaluated. The various therapeutic agents and measures described in the literature are presented in alphabetical order. When available, detailed data are given for the phosgene dose, interval of time between exposure and institution of therapy, therapeutic effect and parameters used to assess efficacy. A final summary presents general recommendations for therapy and for further research (Class IV).no original (inglês)

Diller WF, Zante R; A literature review: therapy for phosgene poisoning. Toxicol Ind Health. 1985 Oct; 1 (2): 117-28. [PubMed Citation]no original (inglês)

Humans can come into contact with chlorine gas during short-term, high-level exposures due to traffic or rail accidents, spills, or other disasters. By contrast, workplace and public (swimming pools, etc.) exposures are more frequently long-term, low-level exposures, occasionally punctuated by unintentional transient increases. Acute exposures can result in symptoms of acute airway obstruction including wheezing, cough, chest tightness, and/or dyspnea. These findings are fairly nonspecific, and might be present after exposures to a number of inhaled chemical irritants. Clinical signs, including hypoxemia, wheezes, rales, and/or abnormal chest radiographs may be present. More severely affected individuals may suffer acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS). Up to 1% of exposed individuals die. Humidified oxygen and inhaled beta-adrenergic agents are appropriate therapies for victims with respiratory symptoms while assessments are underway. Inhaled bicarbonate and systemic or inhaled glucocorticoids also have been reported anecdotally to be beneficial. Chronic sequelae may include increased airways reactivity, which tends to diminish over time. Airways hyperreactivity may be more of a problem among those survivors that are older, have smoked, and/or have pre-existing chronic lung disease. Individuals suffering from irritant-induced asthma (IIA) due to workplace exposures to chlorine also tend to have similar characteristics, such as airways hyperresponsiveness to methacholine, and to be older and to have smoked. Other workplace studies, however, have indicated that workers exposed to chlorine dioxide/sulfur dioxide have tended to have increased risk for chronic bronchitis and/or recurrent wheezing attacks (one or more episodes) but not asthma, while those exposed to ozone have a greater incidence of asthma. Specific biomarkers for acute and chronic exposures to chlorine gas are currently lacking...(Class IV).dose/fármaco conforme a fonte ↗no original (inglês)

White CW, Martin JG; Chlorine gas inhalation: human clinical evidence of toxicity and experience in animal models. Proc Am Thorac Soc. 2010 Jul; 7 (4): 257-63. [PubMed Citation]no original (inglês)

C. Link para os estudos não clínicos (por exemplo, em animais)

Estudos em animais adultos

Chlorine gas may cause inhalation injuries through exposures from industrial sources, home swimming pools, or admixtures of bleach and acidic cleaning solutions. Victims may rapidly present to the emergency department with dyspnea, chest pain, nonproductive cough, bronchospasm, tachypnea, and even pulmonary edema. Until recently, the Poisindex5 recommended 5% nebulized NaHCO3 as a treatment modality based on anecdotal reports, although the most recent edition states that "it cannot be routinely recommended." Our study was designed to examine the role of nebulized NaHCO3 in the treatment of chlorine gas inhalation injury using a sheep model. Twenty-one sheep had internal jugular and carotid artery catheters placed by direct visualization. After being anesthetized with pentobarbital and succinylcholine, each sheep was endotracheally intubated and exposed to chlorine gas (500 ppm) for four mintes by a closed system. The animals then were placed on a Bird Mark 7 ventilator on room air. At 30 minutes after exposure, the animals were divided into two groups to receive a five-minute nebulized treatment (8 mL of normal saline (Group A, ten) or 4% NaHCO3 (Group B, 11). Arterial blood gases were sampled serially at 5, 15, 30, 60, and 90 minutes and 24 hours after treatment. The animals then were euthanized and the organs taken for gross and microscopic examination. One-way ANOVA revealed no differences over time within groups with the exception of the GRA p02 (f = 6.57). t test for unequal groups revealed differences between groups with higher pCO2 (P < 0.001) and lower p02 (P < 0.05) values for the control group. There was no difference in mortality rates before 24 hours for either group (three) or in microscopic pathology in blinded comparisons. The use of a single inhalation treatment of bicarbonate does not appear to worsen arterial blood gases or alter pathology in this sheep model and may actually improve arterial blood gas values.dose/fármaco conforme a fonte ↗no original (inglês)

Chisholm CD, Singletary EM et al.; Inhaled Sodium Bicarbonate Therapy for Chlorine Inhalation Injuries. Ann Emerg Med 1989; 18 (4): 466.dose/fármaco conforme a fonte ↗no original (inglês)

We exposed 22 mongrel dogs to 94 ppm phosgene for 20 min from a non-rebreathing system. We expressed exposure to phosgene as ppm X VI X min X kg 1, i.e., the amount of gas containing a known phosgene concentration that was actually inhaled per min standardized to body weight, the "exposure index" (EI). In contrast, the conventional expression of exposure, i.e., ppm X min, fails to take volume inhaled (VI) and body weight into account. Five dogs received no intervention and served as controls. Fourteen dogs received basic therapy of oral cortisone (40 mg/kg) and NaHCO3 (3 mEq/kg) plus 100% O2 (FiO2 = 1.0) for 30 min after the exposure period. These animals were further divided according to the following selected additional therapies, which were started 30 min after exposure: Theophylline, 5 mg/kg iv for 20 min followed by 1 mg/kg/hr for 70 min (n = 5). Three dogs of this group were given a trial of 5 cm H2O expiratory resistance during the period of basic therapy. Because of the untoward response, expiratory resistance was discontinued and not used in other experiments. PGE2-hi, [1 microgram/kg/min] iv for 90 min (n = 3). PGE1-lo, [0.04 microgram/kg/min] iv for 90 min (n = 3). Atropine, 0.5 mg/kg iv at 30 and 50 min after exposure (n = 3). Three dogs [group 5] received oral cortisone and NaHCO3 plus inhaled supplementary surfactant, 2.7 mg/min ultrasonically nebulized (FiO2 = 0.5; phosphate buffer), for 30 min after exposure. All treated dogs, groups [1] through [4] and the surfactant group [5], received cortisone (40 mg/kg/hr iv), NaHCO3 to correct base deficit, and O2 to correct hypoxemia from 30 min to 120 min after exposure. Because of its clearly beneficial effect in group [1], theophylline was also given to all other treatment groups during this period. At the end of the study, all lungs were excised, examined and prepared for light microscopy. We found that EI, which varied among subjects because of spontaneous variations of VI during exposure, correlated significantly with the changes in base deficit induced by phosgene inhalation. We also found that the change in minute ventilation, delta VI X kg-1, correlated significantly with changes in lung compliance, peak flow and base deficit. Evaluation of the various therapeutic modalities revealed the following: Immediate therapy with O2 is vital and FiO2 of 0.4 to 0.5 is sufficient.dose/fármaco conforme a fonte ↗no original (inglês)

Mautone AJ, Katz Z, Scarpelli EM; Acute responses to phosgene inhalation and selected corrective measures (including surfactant). Toxicol Ind Health. 1985 Oct; 1 (2): 37-57. [PubMed Citation]dose/fármaco conforme a fonte ↗no original (inglês)

Revisões não clínicas

The inhalation of reactive gases and vapors can lead to severe damage of the airways and lung, compromising the function of the respiratory system. Exposures to oxidizing, electrophilic, acidic, or basic gases frequently occur in occupational and ambient environments. Corrosive gases and vapors such as chlorine, phosgene, and chloropicrin were used as warfare agents and in terrorist acts. Chemical airway exposures are detected by the olfactory, gustatory, and nociceptive sensory systems that initiate protective physiological and behavioral responses. This review focuses on the role of airway nociceptive sensory neurons in chemical sensing and discusses the recent discovery of neuronal receptors for reactive chemicals. Using physiological, imaging, and genetic approaches, Transient Receptor Potential (TRP) ion channels in sensory neurons were shown to respond to a wide range of noxious chemical stimuli, initiating pain, respiratory depression, cough, glandular secretions, and other protective responses. TRPA1, a TRP ion channel expressed in chemosensory C-fibers, is activated by almost all oxidizing and electrophilic chemicals, including chlorine, acrolein, tear gas agents, and methyl isocyanate, the highly noxious chemical released in the Bhopal disaster. Chemicals likely activate TRPA1 through covalent protein modification. Animal studies using TRPA1 antagonists or TRPA1-deficient mice confirmed the role of TRPA1 in chemically induced respiratory reflexes, pain, and inflammation in vivo. New research shows that sensory neurons are not merely passive sensors of chemical exposures. Sensory channels such as TRPA1 are essential for maintenance of airway inflammation in asthma and may contribute to the progression of airway injury following high-level chemical exposures.no original (inglês)

Bessac BF, Jordt SE; Sensory detection and responses to toxic gases: mechanisms, health effects, and countermeasures. Proc Am Thorac Soc. 2010 Jul; 7 (4): 269-77. [PubMed Citation]no original (inglês)

...Animal models for chlorine gas inhalation have demonstrated evidence of oxidative injury and inflammation. Early epithelial injury, airways hyperresponsiveness, and airway remodeling, likely diminishing over time, have been shown. As in humans, acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) can occur, becoming more likely when the upper airways are bypassed. Inhalation models of chlorine toxicity provide unique opportunities for testing potential pharmacologic rescue agents.no original (inglês)

White CW, Martin JG; Chlorine gas inhalation: human clinical evidence of toxicity and experience in animal models. Proc Am Thorac Soc. 2010 Jul; 7 (4): 257-63. [PubMed Citation]no original (inglês)

4. Dados farmacocinéticos e toxicocinéticos

Adulto

Por via oral, os bicarbonatos, como o sodium bicarbonate, neutralizam o ácido gástrico com produção de dióxido de carbono. O bicarbonato não envolvido nessa reação é absorvido e, na ausência de déficit de bicarbonato no plasma, os íons bicarbonato são excretados na urina, que se torna alcalina, com diurese acompanhante.dose/fármaco conforme a fonte ↗

Sweetman SC (ed.): Martindale: The Complete Drug Reference Thirty-sixth Edition. Royal Pharmaceutical Society of Great Britain, Pharmaceutical Press, London, UK , 2009 p. 1673-1674no original (inglês)

5. Indicações e posologia atualmente aprovadas pela FDA/EUA

Adultos (FDA)

Ressuscitação cardiopulmonar: as diretrizes de ressuscitação cardiopulmonar (RCP) e de atendimento cardiovascular de emergência (ECC) afirmam que o sodium bicarbonate IV não é recomendado para uso de rotina no suporte avançado de vida cardiovascular (ACLS) durante a RCP e não é considerado agente de primeira linha no tratamento da parada cardíaca; contudo, se o fármaco for usado, uma dose IV de 1 mEq/kg pode ser dada inicialmente a adultos em parada cardíaca.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Acidose metabólica: uma dose de 2-5 mEq/kg de sodium bicarbonate pode ser administrada a adultos em infusão IV de 4- to 8-hour (4 a 8 horas). As doses subsequentes devem ser determinadas pela resposta do paciente e por exames laboratoriais apropriados. A terapia com sodium bicarbonate deve ser planejada de forma escalonada, pois o grau de resposta a uma dada dose nem sempre é previsível. Em geral, a dose e a frequência de administração devem ser reduzidas depois que os sintomas graves melhorarem.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Arritmias e hipotensão associadas a emergências cardiovasculares induzidas por fármacos (toxicidade por antidepressivo tricíclico ou por bloqueador de canal de sódio [por exemplo, procainamide, flecainide]): em adultos, 1-2 mEq/kg de sodium bicarbonate têm sido administrados por injeções IV diretas (isto é, em bolus) repetidas, para manter pH arterial de 7.45-7.55; contudo, o pH-alvo ideal da terapia com sodium bicarbonate não está estabelecido. Alguns especialistas recomendam infusão de manutenção de 150 mEq/L de sodium bicarbonate mais 30 mEq de cloreto de potássio por litro em injeção de glicose a 5%. Esses especialistas afirmam também que injeções IV diretas (isto é, em bolus) de sodium bicarbonate podem ser usadas sem determinação prévia do pH sérico na descompensação aguda, se o intervalo QRS exceder 100 msec ou se houver hipotensão.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Hipercalemia associada a elevação moderada do potássio (6-7 mEq/L) ou a elevação grave (acima de 7 mEq/L com alterações tóxicas no ECG): em adultos, 50 mEq de sodium bicarbonate têm sido administrados IV ao longo de 5 minutes (5 minutos).dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Cetoacidose diabética: embora o papel específico da terapia com sodium bicarbonate no tratamento da cetoacidose diabética não esteja estabelecido, quando o sodium bicarbonate IV é administrado a acidose deve ser corrigida apenas parcialmente, em geral até pH arterial de cerca de 7.2, para evitar alcalose de rebote.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Alcalinização da urina: a dose oral usual de sodium bicarbonate para alcalinização da urina em adultos é de 48 mEq (4 g) inicialmente, seguida de 12-24 mEq (1-2 g) a cada 4 hours (4 horas). Doses de 30-48 mEq (2.5-4 g) a cada 4 hours, até o máximo de 192 mEq (16 g) por dia, podem ser necessárias em alguns pacientes. A dose deve ser titulada individualmente para manter o pH urinário desejado.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Crianças (FDA)

Suporte avançado de vida em pediatria: se o sodium bicarbonate for usado em crianças e lactentes, as diretrizes de suporte avançado de vida em pediatria (PALS) afirmam que a dose pediátrica inicial do fármaco é de 1 mEq/kg (1 mL/kg de uma solução de sodium bicarbonate a 8.4%), administrada lentamente por injeção IV ou intraóssea. Pela possível associação entre hemorragia intracraniana e infusão de sodium bicarbonate em prematuros, os neonatos devem receber diluição 1:1 da injeção de sodium bicarbonate a 7.5 ou 8.4% com injeção de glicose a 5%, para evitar hipertonicidade; alternativamente, pode-se usar a solução a 4.2% disponível comercialmente.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Acidose metabólica: uma dose de 2-5 mEq/kg de sodium bicarbonate pode ser administrada a crianças maiores em infusão IV de 4- to 8-hour (4 a 8 horas). As doses subsequentes devem ser determinadas pela resposta do paciente e por exames laboratoriais apropriados. A terapia com sodium bicarbonate deve ser planejada de forma escalonada, pois o grau de resposta a uma dada dose nem sempre é previsível. Em geral, a dose e a frequência de administração devem ser reduzidas depois que os sintomas graves melhorarem.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Emergências cardiovasculares induzidas por fármacos (toxicidade por antidepressivo tricíclico ou por outro bloqueador de canal de sódio): em pacientes pediátricos, 1-2 mEq/kg de sodium bicarbonate têm sido administrados por injeção IV direta (isto é, em bolus) até o pH arterial exceder 7.45, seguidos de infusão de 150 mEq/L de sodium bicarbonate em injeção de glicose a 5% para manter a alcalose; na intoxicação grave, o pH foi elevado a 7.50-7.55. Para o tratamento de arritmias ventriculares associadas à toxicidade por cocaína em pacientes pediátricos, 1-2 mEq/kg de sodium bicarbonate IV têm sido administrados.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Alcalinização da urina: em crianças, sugere-se dose oral de 1-10 mEq (84-840 mg) por kg ao dia, ajustada conforme a resposta.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Gravidez (FDA)

Categoria de risco na gravidez da FDA:

C; O RISCO NÃO PODE SER DESCARTADO. Faltam estudos humanos adequados e bem controlados, e os estudos em animais mostraram risco ao feto ou também estão ausentes. Há chance de dano fetal se o fármaco for dado durante a gravidez; mas os benefícios potenciais podem superar o risco potencial.

Product label Sodium Bicarbonate injection, solution [Hospira, Inc.] Last revised: August 2012 [DailyMed]dose/fármaco conforme a fonte ↗no original (inglês)

Lactantes (FDA)

O hidrogenocarbonato de sódio é designado "compatível com a amamentação"; os fármacos são classificados como compatíveis com a amamentação quando não há contraindicações conhecidas ou teóricas ao seu uso, sendo considerado seguro que a mãe tome o fármaco e continue amamentando.

WHO/UNICEF. Breastfeeding and maternal medication: Recommendations for drugs in the eleventh WHO model list of essential drugs (2003)no original (inglês)

Insuficiência renal (FDA)

Acidose associada à insuficiência renal crônica: a terapia oral com sodium bicarbonate é geralmente iniciada quando a concentração plasmática de bicarbonato é menor que 15 mEq/L. Em adultos, a terapia costuma ser iniciada com dose oral de sodium bicarbonate de 20-36 mEq ao dia, em doses divididas. A dose é então titulada para fornecer concentração plasmática de bicarbonato de cerca de 18-20 mEq/L. Pelo teor de sódio do sodium bicarbonate, o equilíbrio hidroeletrolítico do paciente deve ser cuidadosamente monitorado durante a terapia com o fármaco.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Insuficiência renal e osteomalácia em pacientes com acidose tubular renal: são necessárias doses mais altas de sodium bicarbonate. Em adultos com acidose tubular renal distal (tipo 1), sugere-se dose oral inicial de 0.5-2 mEq/kg ao dia, em 4 ou 5 doses divididas. A dose é titulada até controlar a hipercalciúria e a acidose, e conforme a resposta e a tolerância do paciente. Alternativamente, sugere-se dose adulta de 48-72 mEq (cerca de 4-6 g) ao dia. Doses mais altas são geralmente necessárias em pacientes com acidose tubular renal proximal (tipo 2); sugerem-se doses orais de 4-10 mEq/kg ao dia, em doses divididas.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Autorização de uso emergencial (FDA/CDC)

Nenhuma Autorização de Uso Emergencial para o Sodium Bicarbonate foi emitida pela Food and Drug Administration sob a seção 564 do Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), alterado pelo Project Bioshield Act of 2004 (Public Law 108-276).dose/fármaco conforme a fonte ↗

DHHS/FDA; Emergency Preparedness and Response - Counterterrorism and Emerging Threats (01/12/2011)

6. Formulações disponíveis atualmente / prazo de validade

Formulação

Pó oral
Comprimidos orais 325 mg*dose/fármaco conforme a fonte ↗
Comprimidos orais 650 mg*dose/fármaco conforme a fonte ↗
Injeção parenteral 4.2% (0.5 mEq/mL) (2.5 ou 5 mEq)*dose/fármaco conforme a fonte ↗
Injeção parenteral 5% (0.595 mEq/mL) (297.5 mEq)*dose/fármaco conforme a fonte ↗
Injeção parenteral 7.5% (0.892 mEq/mL) (8.92 ou 44.6 mEq)*dose/fármaco conforme a fonte ↗
Injeção parenteral 8.4% (1 mEq/mL) (10 ou 50 mEq)*dose/fármaco conforme a fonte ↗
Injeção parenteral, para preparo de misturas IV, 7.5% (0.892 mEq/mL) (178.4 mEq), embalagem a granel para farmáciadose/fármaco conforme a fonte ↗
Solução parenteral estéril, para ajuste de pH de injetáveis, 4% (0.48 mEq/mL) (2.4 mEq)dose/fármaco conforme a fonte ↗
Solução parenteral estéril, para ajuste de pH de injetáveis, 4.2% (0.5 mEq/mL) (2.5 mEq)*dose/fármaco conforme a fonte ↗

* disponível de um ou mais fabricantes, distribuidores e/ou reembaladores pelo nome genérico (não proprietário)

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Prazo de validade

Prazo de validade: o Sodium Bicarbonate for Injection tem prazo de validade de 18 months (18 meses).dose/fármaco conforme a fonte ↗

Burda AM, Sigg T; Pharmacy preparedness for incidents involving weapons of mass destruction. Am J Health Syst Pharm. 2001; 58 (23):2274-84. [PubMed Citation]no original (inglês)

Estabilidade

O sodium bicarbonate é estável em ar seco, mas se decompõe lentamente em carbonato de sódio, dióxido de carbono e água em ar úmido. Quando aquecido, o sodium bicarbonate perde água e dióxido de carbono e se converte em carbonato de sódio. As soluções de carbonato de sódio são muito mais alcalinas que as de sodium bicarbonate; como o carbonato de sódio pode se formar quando o sal seco ou suas soluções são esterilizados por calor, o pH das soluções esterilizadas por calor, ou das preparadas a partir de pó esterilizado por calor, deve ser determinado antes do uso. Quando o sodium bicarbonate é combinado com ácidos em solução aquosa, ocorre desprendimento vigoroso de gás carbônico; o dióxido de carbono liberado borbulha pela solução, resultando em efervescência. No estado seco, sodium bicarbonate e ácidos não reagem.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Armazenamento

Os comprimidos e os comprimidos efervescentes de sodium bicarbonate devem ser guardados em recipientes bem fechados, a temperatura inferior a 40°C, preferencialmente entre 15-30°C.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

A injeção de sodium bicarbonate deve ser guardada a temperatura inferior a 40°C, preferencialmente entre 15-30°C; o congelamento deve ser evitado.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

7. Utilização e posologia off-label atuais

Adulto

Prevenção da nefrotoxicidade por meio de contraste: sodium bicarbonate (154 mEq/L) foi administrado a 3 mL/kg/h por 1 h antes da administração do meio de contraste, seguido de infusão de 1 mL/kg/h por 6 h após o procedimento.dose/fármaco conforme a fonte ↗

Kastrup EK et al., eds. Drug Facts and Comparisons St Louis, MO: Wolters Kluwer Health, 2012 p.146-7no original (inglês)

BACKGROUND: Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN. METHODS AND RESULTS: Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (n=111), sodium bicarbonate infusion plus NAC (n=108), and 0.9% saline plus ascorbic acid plus NAC (n=107). All enrolled patients had serum creatinine > or = 2.0 mg/dL and/or estimated glomerular filtration rate < 40 mL x min(-1) x 1.73 m(-2). Contrast nephropathy risk score was calculated in each patient. In all cases, iodixanol (an iso-osmolar, nonionic contrast agent) was administered. The primary end point was an increase of > or = 25% in the creatinine concentration 48 hours after the procedure (CIN). The amount of contrast media administered (179+/-102, 169+/-92, and 169+/-94 mL, respectively; P=0.69) and risk scores (9.1+/-3.4, 9.5+/-3.6, and 9.3+/-3.6; P=0.21) were similar in the 3 groups. CIN occurred in 11 of 111 patients (9.9%) in the saline plus NAC group, in 2 of 108 (1.9%) in the bicarbonate plus NAC group (P=0.019 by Fisher exact test versus saline plus NAC group), and in 11 of 107 (10.3%) in the saline plus ascorbic acid plus NAC group (P=1.00 versus saline plus NAC group). CONCLUSIONS: The strategy of volume supplementation by sodium bicarbonate plus NAC seems to be superior to the combination of normal saline with NAC alone or with the addition of ascorbic acid in preventing CIN in patients at medium to high risk.dose/fármaco conforme a fonte ↗no original (inglês)

Briguori C, Airoldi F, D'Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A; Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation. 2007 Mar 13; 115 (10): 1211-7. [PubMed Citation]no original (inglês)

BACKGROUND: The combination of bicarbonate and mannitol (BIC/MAN) is commonly used to prevent renal failure (RF) in patients with rhabdomyolysis despite the absence of sufficient evidence validating its use. The purpose of this study was to determine whether BIC/ MAN is effective in preventing RF in patients with rhabdomyolysis caused by trauma. METHODS: This study was a review of all adult trauma intensive care unit (ICU) admissions over 5 years (January 1997-September 2002). Creatine kinase (CK) levels were checked daily (abnormal,>520 U/L). RF was defined as a creatinine greater than 2.0 mg/dL. Patients received BIC/MAN on the basis of the surgeon's discretion. RESULTS: Among 2,083 trauma ICU admissions, 85% had abnormal CK levels. Overall, RF occurred in 10% of trauma ICU patients. A CK level of 5,000 U/L was the lowest abnormal level associated with RF; 74 of 382 (19%) patients with CK greater than 5,000 U/L developed RF as compared with 143 of 1,701 (8%) patients with CK less than 5,000 U/L (p < 0.0001). Among patients with CK greater than 5,000 U/L, there was no difference in the rates of RF, dialysis, or mortality between those who received BIC/MAN and those who did not. Subanalysis of groups with various levels of CK still failed to show any benefit of BIC/MAN. CONCLUSION: Abnormal CK levels are common among critically injured patients, and a CK level greater than 5,000 U/L is associated with RF. BIC/MAN does not prevent RF, dialysis, or mortality in patients with creatine kinase levels greater than 5,000 U/L. The standard of administering BIC/MAN to patients with post-traumatic rhabdomyolysis should be reevaluated.dose/fármaco conforme a fonte ↗no original (inglês)

Brown CV, Rhee P, Chan L, Evans K, Demetriades D, Velmahos GC; Preventing renal failure in patients with rhabdomyolysis: do bicarbonate and mannitol make a difference? J Trauma. 2004 Jun; 56 (6): 1191-6 [PubMed Citation]no original (inglês)

8. Via de administração / monitorização

Inalação de three mL de sodium bicarbonate a 8.4% misturados com 2 mL de soro fisiológico, para preparar 5 mL de uma solução de sodium bicarbonate a 5%.dose/fármaco conforme a fonte ↗

Bosse GM. Nebulized sodium bicarbonate in the treatment of chlorine gas inhalation. J Toxicol Clin Toxicol. 1994;32(3):233-41. [PubMed Citation]dose/fármaco conforme a fonte ↗no original (inglês)

A dose da injeção de sodium bicarbonate é determinada pela gravidade da acidose, por exames laboratoriais apropriados e pela idade, peso e condição clínica do paciente. Exames laboratoriais frequentes e avaliação clínica do paciente são essenciais durante a terapia com sodium bicarbonate, especialmente na terapia prolongada, para monitorar mudanças no equilíbrio hidroeletrolítico e ácido-base.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Em geral, não se deve tentar a correção total do déficit de bicarbonato nas primeiras 24 hours (24 horas) de terapia com sodium bicarbonate, pois isso pode precipitar alcalose metabólica em razão do atraso dos mecanismos fisiológicos compensatórios. Quando o conteúdo total de dióxido de carbono retorna ao normal, ou o ultrapassa, no primeiro dia de terapia, é provável que ocorram valores substancialmente alcalinos de pH sanguíneo e efeitos adversos subsequentes. Quando a administração inicial rápida do fármaco é considerada necessária, recomenda-se em geral que não mais que 33-50% das necessidades calculadas de bicarbonato sejam administradas inicialmente.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

9. Efeitos adversos

Distensão gástrica e flatulência podem ocorrer quando o sodium bicarbonate é administrado por via oral.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

A extravasação inadvertida de soluções hipertônicas de sodium bicarbonate causou, segundo relatos, celulite química por causa da alcalinidade, resultando em necrose tecidual, ulceração e/ou descolamento no local da injeção. Um fabricante recomenda que a extravasação seja tratada elevando a área afetada, aplicando compressas mornas no local e injetando localmente lidocaine ou hyaluronidase.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

O sodium bicarbonate, quando dado em doses altas ou a pacientes com insuficiência renal, pode causar alcalose metabólica. A alcalose metabólica pode vir acompanhada de hiperirritabilidade ou tetania; a tetania é particularmente provável em pacientes com hipocalcemia, como pode ocorrer na uremia, já que o aumento do pH induzido pelo bicarbonato aumenta a ligação do cálcio à albumina. A alcalose metabólica pode prejudicar a liberação de oxigênio nos tecidos periféricos, podendo resultar em acidose láctica. Os fabricantes recomendam que a alcalose grave induzida por bicarbonato seja tratada com um sal de cálcio parenteral (por exemplo, calcium gluconate) e/ou um agente acidificante (por exemplo, ammonium chloride). Em pacientes com cetoacidose, a alcalinização rápida com sodium bicarbonate pode, segundo relatos, resultar em obnubilação da consciência, disfunção cerebral, torpor, convulsões e hipóxia tecidual periférica com acidose láctica.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

Retenção de sódio e água e edema podem ocorrer durante a terapia com sodium bicarbonate, especialmente quando o fármaco é dado em doses altas ou a pacientes com insuficiência renal, insuficiência cardíaca congestiva, ou predispostos a retenção de sódio e edema. A sobrecarga de sódio e água pode resultar em hipernatremia e hiperosmolalidade. Estados hiperosmolares graves podem se desenvolver durante a ressuscitação cardiopulmonar quando doses excessivas de sodium bicarbonate são administradas. As concentrações séricas de potássio ou de cálcio podem diminuir durante a terapia com sodium bicarbonate.dose/fármaco conforme a fonte ↗

McEvoy GK, ed. Drug Information 2012. Bethesda, MD: American Society of Health-System Pharmacists, 2012 p.2750-2754no original (inglês)

10. Contraindicação(ões)

A Sodium Bicarbonate Injection, USP é contraindicada em pacientes que estão perdendo cloreto por vômito ou por aspiração gastrointestinal contínua, e em pacientes que recebem diuréticos conhecidos por produzir alcalose hipoclorêmica.dose/fármaco conforme a fonte ↗

Product label Sodium Bicarbonate injection, solution [Hospira, Inc.] Last revised: August 2012 [DailyMed]dose/fármaco conforme a fonte ↗no original (inglês)

11. Estudos clínicos em andamento

Nenhum dado disponível no momento.

12. Estudos não clínicos em andamento

Nenhum dado disponível no momento.

13. Estudos necessários para a indicação clínica de defesa química

Nenhum dado disponível no momento.

14. Estudos necessários para indicações clínicas fora da defesa química

Nenhum dado disponível no momento.

15. Questões éticas relacionadas aos estudos

As questões éticas incluem:

Consentimento informado para coleta de dados em situação de desastre/múltiplas vítimas
Comitês de ética em pesquisa centralizados (IRBs)
Como conduzir estudos multicêntricos: centros de intoxicação, Pediatric Emergency Care Applied Research Network, consórcios hospitalares.

Biodefense Meeting. Best Pharmaceuticals for Children Act. Eunice Kennedy Shriver National Institute of Child Health and Human Development , September 8-9, 2008, Rockville, MD (NICHD)no original (inglês)

16. Situação regulatória global

EUA

Sodium Bicarbonate comprimido — alivia: indigestão ácida; azia; estômago ácido; estômago perturbadodose/fármaco conforme a fonte ↗

Product label Sodium Bicarbonate tablet [Mirror Pharmaceuticals LLC] Last revised: April 2011 [DailyMed]dose/fármaco conforme a fonte ↗no original (inglês)

Sodium Bicarbonate solução — a Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution é indicada para acelerar o início da analgesia e reduzir a dor da injeção, ajustando as preparações comerciais de solução anestésica de Lidocaine com Epinephrine a um pH mais fisiológico.dose/fármaco conforme a fonte ↗

Product label Sodium Bicarbonate solution [Onpharma, Inc.] Last revised: June 2012 [DailyMed]dose/fármaco conforme a fonte ↗no original (inglês)

Sodium Bicarbonate Injection — a Sodium Bicarbonate Injection, USP é indicada no tratamento da acidose metabólica que pode ocorrer na doença renal grave, no diabetes descontrolado, na insuficiência circulatória por choque ou desidratação grave, na circulação extracorpórea do sangue, na parada cardíaca e na acidose láctica primária grave. O sodium bicarbonate é ainda indicado no tratamento de certas intoxicações por fármacos, incluindo barbiturates (quando se deseja a dissociação do complexo barbitúrico-proteína), no envenenamento por salicylates ou por álcool metílico e em reações hemolíticas que exijam alcalinização da urina para diminuir a nefrotoxicidade dos pigmentos sanguíneos. O sodium bicarbonate também é indicado na diarreia grave, que costuma vir acompanhada de perda significativa de bicarbonato. O tratamento da acidose metabólica deve, se possível, ser somado a medidas destinadas a controlar a causa básica da acidose, por exemplo, insulina no diabetes não complicado, restauração da volemia no choque. Mas, como pode transcorrer um intervalo de tempo apreciável até que todos os efeitos auxiliares se produzam, a terapia com bicarbonato é indicada para minimizar os riscos inerentes à própria acidose. Terapia vigorosa com bicarbonato é necessária em qualquer forma de acidose metabólica em que o aumento rápido do CO 2 total plasmático seja crucial, por exemplo, parada cardíaca, insuficiência circulatória por choque ou desidratação grave, e acidose láctica primária grave ou acidose diabética grave.dose/fármaco conforme a fonte ↗

Product label Sodium Bicarbonate injection, solution [Hospira, Inc.] Last revised: August 2012 [DailyMed]dose/fármaco conforme a fonte ↗no original (inglês)

Reino Unido

O Sodium Bicarbonate é indicado para o alívio de infecções leves do trato urinário; alcalinização da urina.dose/fármaco conforme a fonte ↗

Martin J, et al., eds. British National Formulary, No. 58. London, UK: BMJ Group, RPS Publishing, 2009 p.460no original (inglês)

O Sodium Bicarbonate é usado para controlar a acidose metabólica grave (pH< 7.1), particularmente a causada por perda de bicarbonato (como na acidose tubular renal ou por perdas gastrointestinais excessivas).dose/fármaco conforme a fonte ↗

Martin J, et al., eds. British National Formulary, No. 58. London, UK: BMJ Group, RPS Publishing, 2009 p.532no original (inglês)

O Sodium Bicarbonate não deve mais ser prescrito isoladamente para o alívio da dispepsia, mas está presente como ingrediente em muitos remédios para indigestão.dose/fármaco conforme a fonte ↗

Martin J, et al., eds. British National Formulary, No. 58. London, UK: BMJ Group, RPS Publishing, 2009 p.38no original (inglês)

As gotas otológicas de Sodium Bicarbonate são eficazes para a remoção de cerume, mas podem causar ressecamento do canal auditivo.dose/fármaco conforme a fonte ↗

Martin J, et al., eds. British National Formulary, No. 58. London, UK: BMJ Group, RPS Publishing, 2009 p.611no original (inglês)

17. Outras informações potencialmente úteis

O sodium bicarbonate é um antídoto inespecífico, eficaz no tratamento de várias intoxicações por mecanismos distintos. O sodium bicarbonate nebulizado é adjuvante útil no tratamento de pacientes com lesão pulmonar decorrente da inalação de gás cloro. O sodium bicarbonate inalado neutraliza o ácido clorídrico formado quando o gás cloro reage com a água da árvore respiratória.dose/fármaco conforme a fonte ↗

Nelson LS, Lewin NA, Howland M, Hoffman RS, Goldfrank LR, Flomenbaum NE, eds. Goldfranks's Toxicologic Emergencies, 9 th Edition. New York, NY: McGraw-Hill Medical, 2011 p. 520-527no original (inglês)

...O sodium bicarbonate deve ser administrado por nebulização separadamente dos tratamentos inalatórios com albuterol sulfate, porque os estudos de compatibilidade mostram que pode ocorrer formação de precipitado quando as soluções são misturadas.dose/fármaco conforme a fonte ↗

Howard C, Ducre B, Burda AM, Kubic A. Management of chlorine gas exposure. J Emerg Nurs. 2007 Aug; 33 (4): 402-4. [PubMed Citation]no original (inglês)

Solubility in water = 6.4, 7.6, 8.7, 10.0, 11.3, 12.7, 14.2, 16.5, and 19.1 g/100g solution at 0, 10, 20, 30, 40, 50, 60, 80, and 100 deg C, respectively; Solubility in water = 6.9, 8.2, 9.6, 11.1, 12.7, 14.5, 16.5, 19.7, and 23.6 g/100g H2O at 0, 10, 20, 30, 40, 50, 60, 80, and 100 deg C, respectively; Solubility is lower in the presence of sodium carbonatedose/fármaco conforme a fonte ↗no original (inglês)

HSDB. Sodium bicarbonatedose/fármaco conforme a fonte ↗no original (inglês)

Coeficiente de partição octanol/água: log P = -4.010 (estimado)

US NLM. ChemIDplus Lite. Sodium bicarbonatedose/fármaco conforme a fonte ↗no original (inglês)

18. Publicações

Bosse GM. Nebulized sodium bicarbonate in the treatment of chlorine gas inhalation. J Toxicol Clin Toxicol. 1994;32(3):233-41. [PubMed Citation]dose/fármaco conforme a fonte ↗no original (inglês)

Burda AM, Sigg T; Pharmacy preparedness for incidents involving weapons of mass destruction. Am J Health Syst Pharm. 2001; 58 (23):2274-84. [PubMed Citation]no original (inglês)

Cevik Y, Onay M, Akmaz I, Sezigen S. Mass casualties from acute inhalation of chlorine gas. South Med J. 2009 Dec; 102 (12): 1209-13. [PubMed Citation]no original (inglês)

Chisholm CD, Singletary EM et al.; Inhaled Sodium Bicarbonate Therapy for Chlorine Inhalation Injuries. Ann Emerg Med 1989; 18 (4): 466.dose/fármaco conforme a fonte ↗no original (inglês)

DHHS/FDA; Emergency Preparedness and Response- Counterterrorism and Emerging Threats (12/01/2011)no original (inglês)