Somaplex 1 Bismuth by Nestmann

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Helicobacter pylori. Clinical research in patients with duodenal ulcers shows that bismuth nitrate 375 mg along with metronidazole 250 mg and tetracycline 500 mg, each taken orally four times daily for two weeks, followed by bismuth nitrate 375 mg orally four times daily for an additional 2 weeks, increases the rate of duodenal ulcer healing and the rate of Helicobacter pylori eradication when compared to treatment with omeprazole plus amoxicillin, with or without tinidazole. However, an intention to treat analysis showed no significant between-group difference in duodenal ulcer healing rate. Also, there was improvement in eradication rate only when compared to treatment with omeprazole plus amoxicillin alone, but not when compared to treatment with omeprazole, amoxicillin, and tinidazole. After one year, there was no significant between-group difference in the rate of symptomatic ulcer relapse (100548). More evidence is needed to rate bismuth nitrate for this use.

(Read more about BISMUTH NITRATE)

There is insufficient reliable information available about the safety of bismuth nitrate when used medicinally.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about BISMUTH NITRATE)

(Read more about BISMUTH NITRATE)

General ...Orally, bismuth nitrate may cause loss of appetite, headache, methemoglobinemia, or kidney damage. Chronic use of bismuth nitrate may cause black spots on the gums, bad breath, salivation, and a "bismuth line." In rare cases, chronic use of bismuth may cause bismuth encephalopathy. Orally or topically, bismuth nitrate may cause mild skin irritation. Occupational exposure to bismuth nitrate may cause eye irritation or respiratory tract irritation (100540,100547,100550,101507,101508).

Dermatologic ...Orally or topically, bismuth nitrate may cause mild skin irritation (100547).

Gastrointestinal ...Orally, bismuth nitrate may cause loss of appetite (100547). Chronic use of bismuth nitrate may cause black spots on the gums, bad breath, salivation, and a "bismuth line," which is a thin, blue-black discoloration along the gum margin. Serious ulcerative stomatitis may occur if bismuth nitrate use is not discontinued when gingivitis appears (100547,101507).

Hematologic ...Orally, bismuth nitrate may be converted to nitrites in the intestines, which may cause methemoglobinemia. Symptoms may include shortness of breath, cyanosis, headache, fatigue, changes in mental status, dizziness, and discoloration of the skin. In severe cases, dysrhythmias, convulsion, coma, or death may occur (100547,101508).

Neurologic/CNS ...Orally, bismuth nitrate may cause headache (100547). Long-term use of bismuth nitrate has been associated with bismuth encephalopathy. One report describes a patient who developed confusion, restlessness, convulsions, hypertonia, hypoventilation, and fever after taking 30-40 grams of bismuth nitrate daily for 10-20 years to treat stomach troubles. The patient was comatose upon admission to the hospital. Treatment with anticonvulsant therapy improved the convulsions, but the patient remained comatose for weeks thereafter. Bismuth encephalopathy was confirmed with laboratory analyses, which showed bismuth concentrations of 575 mcg/L in plasma, 918 mcg/L in urine, and 98 mcg/L in cerebrospinal fluid (100540). Another report describes a patient who developed malaise, nausea, dizziness, night sweats, and dry mouth within two months of taking bismuth nitrate 8 grams orally daily for 3 weeks followed by 4 grams daily thereafter. Depressed mood, insomnia, lack of interest in activities, fatigue, loss of energy, and difficulty concentrating occurred over the next 6 months. Panic attacks, nervousness, and apprehension were also reported. Myoclonic encephalopathy resembling Creutzfeldt-Jakob disease became apparent after 15 months. The patient improved within 4 months of discontinuing bismuth and treatment with steroids by parenteral infusion (100550).

Ocular/Otic ...Occupational exposure to bismuth nitrate may cause mild eye irritation (100547).

Pulmonary/Respiratory ...Inhalation of bismuth nitrate may cause respiratory tract irritation, with symptoms including cough and shortness of breath (100547).

Renal ...Orally, bismuth nitrate may cause kidney damage, although the damage is usually mild (100547,101507).

(Read more about BISMUTH NITRATE)