GENERIC NAME: BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE - ORAL (BIZZ-muth sub-sal-ISS-ih-late/meh-troh-NID-uh-zole/ teh-truh-SYE-kleen)
BRAND NAME(S): Helidac
USES: This product contains 3 medications: tetracycline, metronidazole, and bismuth subsalicylate. It is used with an acid blocker (e.g., H2 blockers such as ranitidine, proton pump inhibitors such as omeprazole) to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.Tetracycline and metronidazole are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria. Bismuth subsalicylate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria.This product treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.This product is not recommended for use in children.
HOW TO USE: Read the Patient Information Booklet contained in the package before you start using this product. If you have any questions, consult your doctor or pharmacist.This product comes as a package with 14 separate dosing cards. Each card contains enough medication for 1 day (4 doses). Each dose contains 4 pills. For the 2 round pink tablets, chew thoroughly and swallow. For the 1 round white tablet and 1 orange/white capsule, swallow whole with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. For best results, 1 dose (4 pills) must be taken 4 times daily.Take this product at mealtimes and at bedtime for 14 days. Do not lie down for 30 minutes after taking this medication.Take this medication 2-3 hours before or after taking any products containing magnesium, aluminum, or calcium. Some examples include quinapril, certain forms of didanosine (e.g., chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and antacids. Dairy products (e.g., milk, yogurt), calcium-enriched juice, sucralfate, iron, and zinc are also included. These products bind with tetracycline, preventing its full absorption.Take this medication regularly in order to get the most benefit from it. Continue to take this medication and the acid blocker until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection/ulcer.Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: Nausea, vomiting, diarrhea, abdominal pain, constipation, loss of appetite, headache, metallic taste in mouth, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Your tongue may turn dark in color while taking this medication. This is harmless and the effect will disappear when you stop the medication.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: ringing in the ears, sore mouth, joint pain, numbness/tingling of arms/legs, frequent/painful urination, discolored teeth, mental/mood changes (e.g., nervousness, irritability, depression).Tell your doctor immediately if any of these rare but very serious side effects occur: severe headache, difficult/painful swallowing, heartburn, unusual tiredness, change in the amount of urine, dark urine, unusual weakness, yellowing eyes/skin, persistent nausea/vomiting, severe constipation, severe stomach/abdominal pain, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest/jaw/left arm pain, confusion, slurred speech, vision changes.This product can commonly cause dark stools that are usually not serious. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any dark stools.This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Tell your doctor immediately if you develop persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subsalicylate, metronidazole, or tetracycline; or to aspirin or salicylates; or to other nitroimidazoles (e.g., tinidazole); or to other tetracyclines (e.g., doxycycline); or to other bismuth products; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, diabetes, brain/spinal cord disorders (e.g., seizures), trouble swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), asthma, growths in the nose (nasal polyps).Before having surgery, tell your doctor or dentist that you are using this product.Tetracycline may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages or alcohol-containing products (e.g., certain cough-and-cold products) while taking this product and for at least 1 day afterward because alcohol may increase dizziness or cause a severe reaction with metronidazole (including abdominal cramping, nausea, vomiting, headache, and flushing).The elderly may be at greater risk for side effects while using this product.Children should not take this product because it contains an aspirin-related drug (bismuth subsalicylate) and tetracycline. Tetracycline may cause permanent tooth discoloration and other problems in children younger than 8 years. Tooth discoloration has also occurred in older children and young adults. Use of aspirin-related drugs in children, especially if they have chickenpox, flu, or any undiagnosed illness or if they have received the flu vaccine inhaled through the nose, has been associated with Reye's syndrome, a rare but serious illness. Consult your doctor for more information.This product is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective, non-hormonal birth control (e.g., condom, diaphragm with spermicide) while taking this medication. Consult your doctor for more details. See also Drug Interactions.This combination product contains drugs that may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.This drug should not be used with the following medications because very serious interactions may occur: acitretin, amprenavir oral solution, isotretinoin, strontium, tretinoin taken by mouth.Avoid disulfiram within 2 weeks before and during treatment with this medication.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: atovaquone, "blood thinners" (e.g., warfarin, heparin), busulfan, capecitabine, carbonic anhydrase inhibitors (e.g., acetazolamide), certain drugs for gout (e.g., uricosuric drugs such as probenecid, sulfinpyrazone), corticosteroids (e.g., prednisone), diabetes medications (e.g., sulfonylureas such as glyburide), digoxin, drugs affecting liver enzymes that remove metronidazole from your body (such as cimetidine, certain anti-seizure medicines including phenytoin, phenobarbital), fluorouracil, lithium, live bacterial vaccines, methotrexate, methoxyflurane, penicillins (e.g., amoxicillin, dicloxacillin), tretinoin applied to the skin, valproic acid.Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that are similar to the bismuth subsalicylate in this product and, if taken together, may increase your risk for side effects. Low-dose aspirin should be continued if it has been prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details.This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. Ask your doctor or pharmacist for details. Discuss whether you should use additional reliable birth control methods while taking any of these drugs. See also Precautions section.This product may interfere with certain laboratory tests (including liver function tests, triglycerides, hexokinase glucose, lactate dehydrogenase), possibly causing false test results. This product may also interfere with X-ray exams of the stomach/intestines. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast breathing, nausea, vomiting, ringing in the ears, fast heartbeat, seizures.
NOTES: Do not share this medication with others.Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Contact your doctor if you miss more than 4 doses.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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Peptic Ulcer (Stomach Ulcer)
Peptic or stomach ulcers are ulcers are an ulcer in the lining of the stomach, duodenum, or esophagus. Ulcer formation is related to H. pylori bacteria in the stomach, use of anti-inflammatory medications, and cigarette smoking. Symptoms of peptic or stomach ulcers include abdominal burning or hunger pain, indigestion, and abdominal discomfort after meals. Treatment for stomach ulcers depends upon the cause.
Vancomycin-Resistant Enterococci (VRE)
Vancomycin-resistant enterococci (VRE) infection is the most common type of infection acquired by patients while hospitalized. Patients at risk for VRE are those who are already ill, and hospitalized, including individuals with diabetes, elderly, ICU patients, kidney failure patients, or patients requiring catheters. Enterococci can survive for months in the digestive tract and female genital tract. Other risk factors for acquiring VRE include those how have been previously treated with vancomycin and combinations of other antibiotics. Treatment of VRE is generally with other antibiotics other than vancomycin. Prevention of VRE can be achieved by proper hand hygiene.
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