Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride

Bismuth subcitrate Potassium/Metronidazole/Tetracycline Hydrochloride is a combination of prescription medications used for the treatment of stomach ulcers associated with H pylori infection.

• Bismuth subcitrate Potassium/Metronidazole/Tetracycline Hydrochloride is available under the following different brand names: Pylera

Common side effects of Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride include:

• nausea,
• diarrhea,
• upset stomach,
• abdominal pain,
• changes in taste,
• headache,
• dizziness,
• vaginal itching or discharge, or
• diarrhea or other changes in the stools.

Serious side effects of Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride include:

• numbness and tingling of arms or legs,
• discolored teeth,
• mental/mood changes (such as confusion, anxiety, irritability, depression),
• difficult or painful swallowing, heartburn,
• fast or pounding heartbeat,
• ringing in the ears, or
• frequent or painful urination.

Rare side effects of Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 125mg/125mg/140mg

Duodenal Ulcer

Adult dosage

• 3 capsules (375 mg/375 mg/420 mg) orally every 6 hours for 10 days in combination with omeprazole

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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 your doctor, health care provider, or pharmacist first

• Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride has severe interactions with no other drugs
• Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride has serious interactions with no other drugs
• Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride has moderate interactions with no other drugs
• Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracycline
• Coadministration with methoxyflurane; reports of fatal renal toxicity with concurrent use of tetracycline and methoxyflurane
• Use of disulfiram within previous 2 weeks; psychotic reactions reported with concurrent use of metronidazole and disulfiram
• Avoid alcohol or propylene glycol-containing products for at least 3 days after therapy with metronidazole-containing products is discontinued; a disulfiram-like reaction may occur
• Severe renal impairment; tetracyclines may increase BUN; higher tetracycline serum concentrations may lead to azotemia, hyperphosphatemia, and acidosis
• Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride?”

Cautions

• Metronidazole has shown to be carcinogenic in mice and rats; tumors affecting the liver, lungs, mammary and lymphatic tissues were detected in several studies of metronidazole in rats and mice; unknown whether metronidazole is associated with carcinogenicity in humans
• Tetracycline can cause fetal harm when administered to a pregnant woman; tetracycline administered during pregnancy at high doses (above2 g IV) is associated with rare but serious cases of maternal hepatotoxicity (see Pregnancy)
• Use of tetracyclines during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown); this adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses
• Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole that requires treatment with an antifungal agent
• Photosensitivity, manifested by an exaggerated sunburn reaction, was observed in patients taking tetracycline
• Bismuth subcitrate potassium may cause temporary and harmless darkening of the tongue and/or black stools, generally reversible within several days after treatment is stopped
• Metronidazole should be used with care in patients with evidence of or history of blood dyscrasias
• Skin and subcutaneous disorders including Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome (drug rash with eosinophilia and systemic symptoms) reported
• Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome reported with products containing metronidazole for systemic use
• Prescribing therapy in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
• Metronidazole may interfere with certain types of determinations of serum chemistry values, such as AST, SGOT, ALT, SGPT, LDH, triglycerides, and hexokinase glucose
• Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of the gastrointestinal tract

Central and peripheral nervous system effects

• Metronidazole
  • Convulsive seizures, encephalopathy, aseptic meningitis, and peripheral neuropathy reported
  • Encephalopathy was reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria; CNS lesions seen on MRI were described in reports of encephalopathy
  • CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole
• Tetracycline
  • Intracranial hypertension (IH), including pseudotumor cerebri, associated with the use of tetracyclines
  • Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy
  • Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline-associated IH
• Bismuth-containing products
  • Cases of neurotoxicity associated with excessive doses of various bismuth-containing products reported
  • Effects have been reversible with discontinuation of bismuth therapy
  • The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy

Drug interactions overview

• Avoid use with isotretinoin; both tetracycline and isotretinoin are known to cause intracranial hypertension
• Tetracyclines may decrease the effectiveness of oral contraceptives; instruct women to use backup contraception during treatment
• Coadministration with anticoagulants may alter the effects of warfarin and other oral coumarin anticoagulants; metronidazole was reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time; tetracycline shown to depress plasma prothrombin activity
• In patients stabilized on relatively high doses of lithium, short-term use of metronidazole may cause elevation of serum lithium concentrations and signs of lithium toxicity
• Metronidazole is reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity; do not administer concomitantly with busulfan unless the benefit outweighs the risk
• Coadministration with drugs that inhibit CYP450 liver enzymes (.g, cimetidine) may result in a prolonged half-life and decreased plasma clearance of metronidazole
• Coadministration with drugs that induce CYP450 liver enzymes (.g, phenytoin, phenobarbital) may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole
• QT prolongation was reported, particularly when metronidazole was administered with drugs with potential for prolonged QT interval; flattening of T-wave may be seen in electrocardiographic tracings

Pregnancy & Lactation

• Contraindicated in women who are pregnant because treatment of H Pylori infection can be delayed in pregnant women
• The use of tetracyclines during the second and third-trimester pregnancy can cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development in infant
• Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals; maternal risks with high IV doses of tetracycline reported
• Metronidazole usage in pregnancy is associated with certain congenital anomalies
• Tetracycline administered during pregnancy at high doses (above2 g IV) was associated with rare but serious cases of maternal hepatotoxicity; the syndrome may result in stillborn or premature birth due to maternal pathology

Lactation

• Tetracycline and metronidazole are present in human milk at concentrations similar to maternal serum levels
• It is unknown whether bismuth substrate is present in human milk
• It is unknown the effect of therapy have the breastfed infant or on milk production
• Tetracycline binds with calcium in human milk
• Data indicate that oral absorption of tetracycline in infants is low due to the calcium-binding in human milk
• Metronidazole transfers to human milk, and infant serum levels can be close to or comparable to infant therapeutic levels
• Because of the potential risk of the tumorigenicity shown in animal studies with metronidazole, breastfeeding women should pump and discard human milk for the duration of therapy, and for 2 days after therapy ends, and feed their infant stored human milk (collected before therapy) or formula