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PYLERA™ Capsules
(bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride)
140 mg/125 mg/125 mg

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA™ and other antibacterial drugs, PYLERA™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS) Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.

DRUG DESCRIPTION

PYLERA™ capsules (bismuth subcitrate potassium) are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated hard gelatin capsule contains:

-           bismuth subcitrate potassium, 140 mg
-           metronidazole, 125 mg
-           smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg

Bismuth subcitrate potassium is a white or almost white powder. It is a soluble, complex bismuth salt of citric acid. The schematized empirical molecular formula of bismuth subcitrate potassium is Bi(Citrate)2K5•3 H2O. The equivalent theoretical molecular formula is BiC12H14K5O17. The molecular mass of the theoretical molecular formula of a single unit of bismuth subcitrate potassium is 834.71.

Metronidazole is a white to pale yellow crystalline powder. Metronidazole is 2-methyl-5-nitroimidazole-1-ethanol, with a molecular formula of C6H9N3O3 and the following structural formula:

Pylera (Metronidazole) structural formula illustration

Molecular weight: 171.2

Tetracycline hydrochloride is a yellow, odorless, crystalline powder. Tetracycline is stable in air, but exposure to strong sunlight causes it to darken. Tetracycline hydrochloride is (4S,4aS,5aS,6S,12aS)-4- (dimethylamino)-1,4,4a,5,5a,6,11, 12a-octahydro-3,6,10,12, 12a-penta-hydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide hydrochloride, with a molecular formula of C22H24N2O8•HCl and the following structural formula:

Pylera (Tetracycline hydrochloride) structural formula illustration

Each PYLERA™ capsule contains the following inactive ingredients: Magnesium Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide NF. Printed with red ink.

What are the possible side effects of bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • seizures (convulsions);
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • burning or irritation in your throat, chest, or upper stomach;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding,...

Read All Potential Side Effects and See Pictures of Pylera Capsules »

What are the precautions when taking bismuth subcitrate potassium (Pylera Capsules)?

Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subcitrate, metronidazole, or tetracycline; or to other nitroimidazoles (e.g., tinidazole); or to other tetracyclines (e.g., doxycycline); or to other bismuth products (e.g., bismuth subsalicylate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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, brain/spinal cord...

Read All Potential Precautions of Pylera Capsules »

Last reviewed on RxList: 6/13/2007
This monograph has been modified to include the generic and brand name in many instances.