Bismuth subsalicylate

362.09

361.999176

238-953-1

759117

DTXSID6024622

MICROSCOPIC PRISMS|WHITE, BULKY CRYSTALLINE POWDER

2918215100

36.5

0.97400

White Powder

>350 °C(lit.)

336.3ºC at 760mmHg

144.5ºC

Practically insoluble in water, alcoholsoluble in acid and alkali. Insoluble in cold water, ethanol, diethyl ether and n-octanol.

ODORLESS

TASTELESS

DECOMP BY BOILING WATER, ALKALIES INTO MORE BASIC SALT

Insoluble in water.

Salts, Basic

BISMUTH SUBSALICYLATE is stable in air but is sensitive to light. It is unstable in alkaline solutions. This compound decomposes in boiling water and alkalis into a more basic salt. (NTP, 1992)

NONH for all modes of transport

3

EB2985000

STABLE IN AIR BUT AFFECTED BY LIGHT

P261, P264, P271, P280, P302+P352, P304+P340, P305+P351+P338, P312, P321, P332+P313, P337+P313, P362, P403+P233, P405, P501

H315

Bierer, DW. Bismuth subsalicylate: history, chemistry and safety. Rev. Infect. Dis. 12 Suppl 1: S3-S8 (1990).

Flash point data for this chemical are not available, but it is probably combustible. (NTP, 1992)

|Warning|H400 (93.55%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard]|P273, P391, and P501|Aggregated GHS information provided by 140 companies from 4 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

Fires involving this compound should be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992)

SMALL SPILLS AND LEAKAGE: If you spill this chemical, FIRST REMOVE ALL SOURCES OF IGNITION, then dampen the solid spill material with toluene, then transfer the dampened material to a suitable container. Use absorbent paper dampened with toluene to pick up any remaining material. Your contaminated clothing and absorbent paper should be sealed in a vapor-tight plastic bag for eventual disposal. Solvent-wash all contaminated surfaces with toluene followed by washing with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should protect this material from exposure to light, and store it in a refrigerator. (NTP, 1992)

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)

BIOAVAILABILITY OF DOXYCYCLINE WAS SIGNIFICANTLY REDUCED BY 37% & 51%, RESPECTIVELY, WHEN SUBSALICYLATE BISMUTH WAS GIVEN SIMULTANEOUSLY & AS A MULTIPLE-DOSE REGIMEN BEFORE DOXYCYCLINE. SUBSALICYLATE BISMUTH SHOULD NOT BE TAKEN WHEN DOXYCYCLINE IS USED FOR THERAPEUTIC PURPOSES.

Used to treat nausea, heartburn, indigestion, upset stomach, diarrhea, and other temporary discomforts of the stomach and gastrointestinal tract.

USED MEDICINALLY AS INTESTINAL ABSORBENT.|MEDICATION (VET): ANTIDIARRHEAL. WEAK INTESTINAL ANTISEPTIC DUE TO LIBERATION OF SALICYLIC ACID. USUALLY COMBINED WITH CARBONATES TO MINIMIZE IRRITANT EFFECTS OF FREE ACID WHILE UTILIZING PROTECTIVE EFFECT OF BISMUTH.|THE CMPD IS SOMETIMES USED ORALLY TO ALLAY DIARRHEA OR TO SOOTHE GASTRITIS OR PEPTIC ULCER. ... BEFORE THE ADVENT OF PENICILLIN, BISMUTH SUBSALICYLATE WAS MUCH USED IN THE TREATMENT OF SYPHILIS...|/SRP: FORMER/ TREATMENT OF VINCENT'S ANGINA, SYPHILIS|For more Therapeutic Uses (Complete) data for BISMUTH SUBSALICYLATE (7 total), please visit the HSDB record page.

EVEN WHEN ITS USE WAS EXTENSIVE, THE GRADUAL IM INJECTION USED AGAINST SYPHILIS RARELY LED TO SERIOUS POISONING. IT WAS CUSTOMARY TO STOP TREATMENT IF GINGIVITIS, ALBUMINURIA, CUTANEOUS ERUPTIONS, OR MARKED DIARRHEA APPEARED.|BIOAVAILABILITY OF DOXYCYCLINE WAS SIGNIFICANTLY REDUCED BY 37% & 51%, RESPECTIVELY, WHEN SUBSALICYLATE BISMUTH WAS GIVEN SIMULTANEOUSLY & AS A MULTIPLE-DOSE REGIMEN BEFORE DOXYCYCLINE. SUBSALICYLATE BISMUTH SHOULD NOT BE TAKEN WHEN DOXYCYCLINE IS USED FOR THERAPEUTIC PURPOSES. AUTHORS SUGGEST TRAVELERS SHOULD NOT TAKE THE AGENTS TOGETHER IN AN EFFORT TO PREVENT DIARRHEA.|The excretion of large amounts of bismuth obtained from bismuth subsalicylate into breast milk is not expected because of the poor absorption of bismuth into the systemic circulation. Salicylates, however, are excreted in milk and are eliminated more slowly from milk than from plasma with milk:plasma ratios, rising from 0.03-0.08 at 3 hours to 0.34 at 12 hours. Due to the potential for adverse effects in the nursing infant, the American Academy of Pediatrics recommends that salicylates should be used cautiously during breast feeding. A recent review also states that bismuth subsalicylate should be avoided during lactation because of systemic salicylate absorption.|Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses.

3(?). 3= MODERATELY TOXIC: PROBABLE ORAL LETHAL DOSE (HUMAN) 0.5-5 G/KG, BETWEEN 1 OZ & 1 PINT FOR 70 KG PERSON (150 LB).

Bismuth subsalicylate displays anti-inflammatory action (due to salicylic acid) and also acts as an antacid and mild antibiotic. It can also cause a black tongue and black stools in some users of the drug, when it combines with trace amounts of sulfur in their saliva and gastrointestinal tract. This discoloration is temporary and harmless.

Miscellaneous agents found useful in the symptomatic treatment of diarrhea. They have no effect on the agent(s) that cause diarrhea, but merely alleviate the condition. (See all compounds classified as Antidiarrheals.)

Following oral administration, absorption of the salicylate component from the small intestine is generally rapid and complete (>90%).|THE AUTOPSY DISTRIBUTION OF BISMUTH IN 22 PATIENTS WHO RECEIVED THERAPEUTIC IM INJECTIONS (MAINLY BISMUTH SALICYLATE) WAS AS FOLLOWS (MEDIAN VALUES, MG/KG, WET WEIGHT): KIDNEY 33.3; LIVER 6.8; SPLEEN 1.6; COLON 1.2; LUNG 0.9; BRAIN 0.6 & BLOOD 0.5.|In the gastrointestinal tract, bismuth subsalicylate is converted to salicylic acid and insoluble bismuth salts. The salicylate portion of bismuth subsalicylate is extensively absorbed (greater than 90%) and excreted in urine.|Bismuth subsalicylate (bismuth salicylate) is hydrolyzed in the gastrointestinal tract to bismuth salts and sodium salicylate. Two tablets or 30 ml suspension of the compound yields 204 mg and 258 mg, respectively, of salicylate. Inorganic bismuth salts, in contrast to organic complexes of bismuth, are relatively water-insoluble and poorly absorbed systemically, but significant absorption of salicylate does occur. A brief 1992 study found minimal absorption of bismuth (exact serum concentrations not specified) from bismuth subsalicylate in 12 healthy subjects, as opposed to a peak serum level of 0.050 ug/ml after a dose of 216 mg of colloidal bismuth subcitrate in a single patient. Some bismuth absorption was documented across the normal gastric mucosa, but the primary absorption occurred from the duodenum.

Based on in vitro dissociation data and in vivo animal data, bismuth subsalicylate is believed to be largely hydrolyzed in the stomach to bismuth oxychloride and salicylic acid. In the small intestine, nondissociated bismuth subsalicylate reacts with other anions (bicarbonate and phosphate) to form insoluble bismuth salts. In the colon, nondissociated bismuth subsalicylate and other bismuth salts react with hydrogen sulfide to produce bismuth sulfide, a highly insoluble black salt responsible for the darkening of the stools.

As an antidiarrheal, the exact mechanism has not been determined. Bismuth subsalicylate may exert its antidiarrheal action not only by stimulating absorption of fluid and electrolytes across the intestinal wall (antisecretory action) but also, when hydrolyzed to salicylic acid, by inhibiting synthesis of a prostaglandin responsible for intestinal inflammation and hypermotility. In addition, bismuth subsalicylate binds toxins produced by Escherichia coli. Both bismuth subsalicylate and the intestinal reaction products, bismuth oxychloride and bismuth hydroxide, are believed to have bactericidal action. As an antacid, bismuth has weak antacid properties.|IN THE Y-1 ADRENAL CELL TISSUE CULTURE SYSTEM, A PREPN CONTAINING BISMUTH SUBSALICYLATE REDUCED THE ACTIVITY OF CRUDE TOXIN FROM VIBRIO CHOLERAE BY 104-FOLD AS COMPARED WITH THE ACTIVITY OF CONTROLS. SIMILAR RESULTS WERE OBTAINED USING THE ADULT RABBIT LIGATED INTESTINAL LOOP MODEL. THE PREPN FAILED TO AFFECT CRUDE ESCHERICHIA COLI OR CHOLERA TOXIN ACTIVITY ONCE THESE TOXINS HAD BECOME BOUND TO INTESTINAL MUCOSA.|ATTAPULGITE & PEPTO-BISMOL WERE EFFECTIVE IN REDUCING FLUID ACCUMULATION IN LIGATED SEGMENTS OF PIG INTESTINE INFECTED WITH ENTEROPATHOGENIC ESCHERICHIA COLI. FOR PEPTO-BISMOL THIS EFFECT WAS ASSOCIATED WITH AN ANTIBACTERIAL AS WELL AS AN ANTITOXIC EFFECT, PROBABLY DUE TO ITS ABSORBENT PROPERTIES. AN ASPIRIN-LIKE EFFECT IN THE GUT DUE TO THE ACTIVE INGREDIENT BISMUTH SUBSALICYLATE MAY HAVE CONTRIBUTED TO THE EFFECTIVENESS OF PEPTO-BISMOL.

SYMPTOMS: Symptoms of exposure to this compound may include headache, nausea, foul breath, blue-black line on the gums and stomatitis. (NTP, 1992)

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. (NTP, 1992)

SIX EXAMPLES OF POISONING BY BISMUTH SUBSALICYLATE WERE REPORTED...ARISING FROM TREATMENT OF SYPHILIS.../INVOLVING/ THE SIMULTANEOUS OCCURRENCE OF STOMATITIS & ALBUMINURIA. /AUTHOR/...NOTED THAT BISMUTH...TENDED TO BE MOBILIZED DURING ACIDOSIS, &...ADVISED CAUTION IN ADMIN BISMUTH TO PATIENTS SUBJECT TO ACIDOSIS.|...GRADUAL IM INJECTION USED AGAINST SYPHILIS RARELY LED TO SERIOUS POISONING. IT WAS CUSTOMARY TO STOP TREATMENT IF GINGIVITIS, ALBUMINURIA, CUTANEOUS ERUPTIONS, OR MARKED DIARRHEA APPEARED. IF...DOSING CONTINUED, SERIOUS ULCERATIVE STOMATITIS WITH SALIVATION WAS LIKELY TO APPEAR & SOON BE FOLLOWED BY ONE OR MORE OF THE FOLLOWING: MALAISE, HEADACHE, INSOMNIA, DEPRESSION, ASTHENIA, JOINT PAINS, NAUSEA, LOSS OF APPETITE, DIARRHEA, LOSS OF WEIGHT, ALBUMINURIA, & SKIN REACTIONS (SUCH AS PURITIS, HERPES ZOSTER, PURPURA, & SOMETIMES SERIOUS EXFOLIATIVE DERMATITIS). JAUNDICE & CONJUNCTIVAL HEMORRHAGE WERE RARE... A LINE OF BISMUTH SULFIDE /SRP: BLACK IN COLOR/ OFTEN APPEARED AT GINGIVAL MARGIN ALONG WITH SIMILAR BLOTCHES ON MUCOSA OF MOUTH, TONGUE, THROAT, COLON, RECTUM, CECUM, & APPENDIX. THE BISMUTH LINE WAS NOT A CONTRAINDICATION TO TREATMENT.|A CASE WAS DESCRIBED IN WHICH ENCEPHALOPATHY OCCURRED IN A 60-YR-OLD MAN & WAS ATTRIBUTED TO USE OF BISMUTH SUBSALICYLATE FOR DIARRHEA. THE DIAGNOSIS WAS SUPPORTED BY AN ELECTROENCEPHALOGRAM & A BLOOD BISMUTH LEVEL OF 72 UG/L. THE PATIENT RECOVERED COMPLETELY WITHIN ONE MONTH AFTER THE DRUG WAS DISCONTINUED.|... Inorganic bismuth salts, formed from metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the fetus from normal therapeutic doses, but the data available for bismuth in pregnancy are poor, and the actual fetal risk cannot be determined. On the other hand, the potential actions of salicylate on the fetus are complex. Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses.

bismuth subsalicylate

100% IS USED IN OVER-THE-COUNTER PHARMACEUTICALS FOR THE TREATMENT OF UPSET STOMACH (1975)

Paint and coating manufacturing|4H-1,3,2-Benzodioxabismin-4-one, 2-hydroxy-: ACTIVE|PMN - indicates a commenced PMN (Pre-Manufacture Notices) substance.|USED AT RATE OF 1-1/2 LB/100 GAL PLUS SPREADER STICKER, THIS MATERIAL HAS GIVEN EFFECTIVE CONTROL OF DOWNY MILDEW (BLUE MOLD) OF TOBACCO.

Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients