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Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Overview
What is Pylera?
PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Each size 0 elongated capsule contains:
Tetracycline hydrochloride is encapsulated within a smaller capsule to create a barrier to avoid contact with bismuth subcitrate potassium.
Each PYLERA capsule contains the following inactive ingredients: Magnesium Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide NF, Printed in red ink.
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)K●3 HO. The equivalent theoretical molecular formula is BiCHKO. 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 CHNO and the following structural formula:
Tetracycline hydrochloride is a yellow, odorless, crystalline powder. Tetracycline hydrochloride 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 CHNO●HCl and the following structural formula:
What does Pylera look like?
What are the available doses of Pylera?
Each capsule of PYLERAcontains: ()
What should I talk to my health care provider before I take Pylera?
How should I use Pylera?
PYLERA in combination with omeprazole are indicated for the treatment of patients with
infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate . The eradication of
has been shown to reduce the risk of duodenal ulcer recurrence.
Administer three PYLERA capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days ().
Instruct patients to swallow the PYLERA capsules whole with a full glass of water (8 ounces). Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride.
If a dose is missed, patients should continue the normal dosing schedule until medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted.
What interacts with Pylera?
Sorry No Records found
What are the warnings of Pylera?
Sorry No Records found
What are the precautions of Pylera?
Sorry No Records found
What are the side effects of Pylera?
Sorry No records found
What should I look out for while using Pylera?
Concurrent usage of Methoxyflurane.(, )
Disulfiram usage within the last two weeks.(, )
Alcoholic beverage consumption for at least three days during or after therapy. (, )
Severe renal impairment. ()
Women who are pregnant. (, )
Known hypersensitivity to product components. ()
Metronidazole has been shown to be carcinogenic in mice and rats
. It is unknown whether metronidazole is associated with carcinogenicity in humans
[see
]
.
What might happen if I take too much Pylera?
In case of an overdose, patients should contact a physician, poison control center, or emergency room. The available overdosage information for each of the individual components in PYLERA (Metronidazole, Tetracycline and Bismuth subcitrate potassium) are summarized below:
Metronidazole:
Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Metronidazole is dialyzable.
Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.
Treatment of Overdosage
There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
Tetracycline:
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.
Bismuth subcitrate potassium:
Symptoms of a bismuth subcitrate potassium overdosage are not known.
How should I store and handle Pylera?
Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478 Mfg. Rev. 04/14 AV Rev. 08/14 (P) PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALIS logo printed on the body and “BMT” printed on the cap. PYLERA capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules. NDC Number: 58914-601-21, Bottles of 120.NDC Number: 58914-601-20, Blister pack of 120.StorageStore at controlled room temperature [68° to 77°F or 20° to 25°C].PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALIS logo printed on the body and “BMT” printed on the cap. PYLERA capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules. NDC Number: 58914-601-21, Bottles of 120.NDC Number: 58914-601-20, Blister pack of 120.StorageStore at controlled room temperature [68° to 77°F or 20° to 25°C].PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALIS logo printed on the body and “BMT” printed on the cap. PYLERA capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules. NDC Number: 58914-601-21, Bottles of 120.NDC Number: 58914-601-20, Blister pack of 120.StorageStore at controlled room temperature [68° to 77°F or 20° to 25°C].PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALIS logo printed on the body and “BMT” printed on the cap. PYLERA capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules. NDC Number: 58914-601-21, Bottles of 120.NDC Number: 58914-601-20, Blister pack of 120.StorageStore at controlled room temperature [68° to 77°F or 20° to 25°C].PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALIS logo printed on the body and “BMT” printed on the cap. PYLERA capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules. NDC Number: 58914-601-21, Bottles of 120.NDC Number: 58914-601-20, Blister pack of 120.StorageStore at controlled room temperature [68° to 77°F or 20° to 25°C].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
PYLERA is a combination of antibacterial agents (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [
]
Non-Clinical Toxicology
Concurrent usage of Methoxyflurane.(, )Disulfiram usage within the last two weeks.(, )
Alcoholic beverage consumption for at least three days during or after therapy. (, )
Severe renal impairment. ()
Women who are pregnant. (, )
Known hypersensitivity to product components. ()
Metronidazole has been shown to be carcinogenic in mice and rats
. It is unknown whether metronidazole is associated with carcinogenicity in humans
[see
]
.
Concurrent use of PYLERA with oral contraceptive may make oral contraceptives less effective due to an interaction with the tetracycline component of PYLERA. Breakthrough bleeding has been reported. Advise women of child-bearing potential to use a different or additional form of contraception while taking PYLERA [ ].
PYLERA may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. Tetracycline has been shown to depress plasma prothrombin activity. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if PYLERA is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [ ].
In patients stabilized on relatively high doses of lithium, short-term use of PYLERA may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Monitor serum lithium and serum creatinine concentrations daily for several days after beginning treatment with PYLERA to detect any increase that may precede clinical symptoms of lithium toxicity [ ].
Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Do not administer PYLERA concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to PYLERA are available, and concomitant administration with busulfan is medically needed, Monitor for busulfan toxicity and busulfan plasma concentrations and adjust the busulfan dose accordingly [ ].
Metronidazole, a component of PYLERA, has been shown to be carcinogenic in mice and rats. Tumors affecting the liver, lungs, mammary and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters [ ]. It is unknown whether metronidazole is associated with carcinogenicity in humans.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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