Bismatrol Chewable Tablets

Bismuth subsalicylate exerts its antidiarrheal and anti-secretory effects through multiple mechanisms. The bismuth component has direct antimicrobial activity against various gastrointestinal pathogens (e.g., H. pylori, E. coli, Salmonella, Shigella) and binds to toxins. It also has anti-secretory effects by inhibiting prostaglandin synthesis and chloride secretion. The salicylate component, once absorbed, acts as an anti-inflammatory agent and also inhibits prostaglandin synthesis, reducing intestinal inflammation and hypermotility. It also has anti-secretory effects.

Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
- Signs of an allergic reaction, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Ringing in the ears, hearing loss, or any other changes in your hearing

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- Constipation
- Dark tongue and stool (this is a normal and harmless side effect)

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
* If you have a history of bleeding problems, ulcers, or have experienced black, tarry, or bloody stools.

Additionally, if you are taking a salicylate drug, such as aspirin, inform your doctor.

For Children and Teenagers:
If your child or teenager is currently experiencing or recovering from flu symptoms, chickenpox, or other viral infections, it is crucial to discuss this with your doctor. There is a risk of developing a severe condition called Reye's syndrome, and this medication should not be given to a child or teenager with a viral infection.

This list is not exhaustive, and it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have phenylketonuria (PKU), consult with your doctor, as some formulations of this drug may contain phenylalanine. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.

• Methotrexate (increased methotrexate levels and toxicity due to salicylate competition for renal tubular secretion)
• Valproic acid (increased valproic acid levels and toxicity due to salicylate displacement from protein binding and inhibition of metabolism)

• Anticoagulants (e.g., Warfarin, Heparin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban) - increased risk of bleeding due to antiplatelet effects of salicylate and potential displacement of warfarin from protein binding.
• NSAIDs (e.g., Ibuprofen, Naproxen, Aspirin) - increased risk of GI bleeding and salicylate toxicity.
• Probenecid, Sulfinpyrazone (uricosurics) - decreased uricosuric effect due to salicylate.
• Tetracyclines (e.g., Doxycycline, Minocycline) - bismuth can chelate tetracyclines, reducing their absorption. Separate administration by at least 2 hours.
• Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin) - bismuth can chelate fluoroquinolones, reducing their absorption. Separate administration by at least 2 hours.

• Oral Hypoglycemics (e.g., Sulfonylureas, Insulin) - salicylate may enhance hypoglycemic effect.
• Thiazide Diuretics, Loop Diuretics - salicylate may reduce diuretic effect.
• Corticosteroids - increased risk of GI ulceration and bleeding.
• Thyroid hormones - salicylate may displace thyroid hormones from protein binding.

• Other antacids - may alter absorption of other medications.

• Resolution of diarrhea or upset stomach symptoms
• Occurrence of black or dark stools (expected due to bismuth sulfide formation, but differentiate from melena)
• Occurrence of black tongue (expected)
• Signs of salicylate toxicity (tinnitus, hearing loss, dizziness, nausea, vomiting, rapid breathing, confusion)
• Signs of Reye's syndrome in children/adolescents (persistent vomiting, lethargy, confusion, seizures - especially after viral illness)

Generally not recommended during pregnancy, especially in the third trimester. The salicylate component is an NSAID and can cause premature closure of the fetal ductus arteriosus, fetal renal dysfunction, and increased maternal/fetal bleeding risk. Category C.

Use with caution. Salicylate is excreted into breast milk. While the amount is generally small with typical doses, there is a theoretical risk of adverse effects in the infant, particularly if the infant has a viral illness (Reye's syndrome risk). Monitor infant for signs of salicylate toxicity (e.g., irritability, rash). L3.

Contraindicated in children and teenagers (under 12 years old, or 12-18 years old if recovering from viral infections like flu or chickenpox) due to the risk of Reye's syndrome, a rare but serious condition affecting the brain and liver. For children 12 years and older, use with caution and only as directed.

Use with caution. Elderly patients may be more susceptible to salicylate toxicity due to age-related decline in renal function and potential for polypharmacy. Start with lower doses and monitor closely for adverse effects, especially tinnitus, hearing loss, and GI bleeding.

• Bismuth subsalicylate can cause temporary, harmless darkening of the tongue and/or stool (black color) due to the formation of bismuth sulfide. This is a normal side effect and should not be confused with melena (black, tarry stools from GI bleeding), although patients should be advised to report any concerning symptoms.
• Crucial to warn patients about the risk of Reye's syndrome in children and teenagers with viral infections (flu, chickenpox). This drug should not be given to this population.
• Patients on anticoagulants (e.g., warfarin) or other NSAIDs should avoid bismuth subsalicylate due to increased bleeding risk.
• Advise patients to separate administration from tetracycline and fluoroquinolone antibiotics by at least 2 hours to prevent reduced antibiotic absorption.
• Overuse or chronic use, especially in patients with renal impairment, can lead to salicylate toxicity (salicylism), characterized by tinnitus, dizziness, and hearing loss.

• Loperamide (Imodium) for diarrhea
• Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide) for heartburn/upset stomach
• H2-receptor antagonists (e.g., Famotidine) for heartburn
• Proton pump inhibitors (e.g., Omeprazole) for heartburn
• Oral rehydration solutions for dehydration associated with diarrhea

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.