PYLERA Capsule (2021)

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Allergan, Inc.

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1. Indications and Usage

1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease PYLERA in combination with omeprazole are indicated for the treatment of patients with ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

Each PYLERA capsule contains 140 mg of bismuth subcitrate potassium, 125 mg of metronidazole, and a smaller capsule inside containing 125 mg of tetracycline hydrochloride. The capsules are white and opaque, ...

4. Contraindications

4.1 Methoxyflurane Do not administer methoxyflurane to patients taking PYLERA. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in ...

5. Warnings and Precautions

5.1 Potential for Carcinogenicity 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 ...

6. Adverse Reactions

6.3 Other Important Adverse Reactions from Labeling for the Individual Components of PYLERA Metronidazole Blood and Lymphatic system disorders: Reversible neutropenia (leucopenia) in cases of prolonged ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

Additionally, the following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of PYLERA. Because these reactions are reported voluntarily ...

7. Drug Interactions

7.1 Methoxyflurane Do not administer methoxyflurane to patients taking PYLERA. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in ...

8.1. Pregnancy

Risk Summary PYLERA is contraindicated in women who are pregnant because treatment of Helicobacter pylori infection can be delayed in pregnant women, and the use of drugs of the tetracycline class ...

8.2. Lactation

Risk Summary Two of the individual components of PYLERA, tetracycline and metronidazole, are present in human milk at concentrations similar to maternal serum levels. It is not known whether bismuth subcitrate, ...

8.4. Pediatric Use

Safety and effectiveness of PYLERA in pediatric patients infected with Helicobacter pylori have not been established. Tetracycline use in children may cause permanent discoloration of the teeth. ...

8.5. Geriatric Use

Clinical studies of PYLERA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. Other reported clinical experience has not ...

8.6. Renal Impairment

The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). In patients with severe renal impairment, higher serum concentrations of tetracycline may lead to azotemia, ...

8.7. Hepatic Impairment

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. Patients with mild to moderate hepatic impairment should ...

10. Overdosage

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, ...

11. Description

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

12.1. Mechanism of Action

PYLERA is a combination of antibacterial agents (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [see Microbiology (12.4)].

12.3. Pharmacokinetics

The pharmacokinetics of the individual components of PYLERA, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride are summarized below. In addition, two studies on PYLERA were conducted ...

12.4. Microbiology

Mechanism of Action PYLERA is a combination of antibacterial agents (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium. Tetracycline hydrochloride interacts with the 30S subunit ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been performed to evaluate the effect of PYLERA on carcinogenesis, mutagenesis, or impairment of fertility. Bismuth Subcitrate Potassium No carcinogenicity or reproductive toxicity ...

14. Clinical Studies

14.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease An open-label, parallel group, active-controlled, multicenter study in Helicobacter ...

16.1. How Supplied

PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALISTM logo printed on the ...

16.2. Storage and Handling

Store at controlled room temperature [68° to 77°F or 20° to 25°C].

17. Patient Counseling Information

Lactation Advise the lactating women to pump and discard their milk during treatment with PYLERA and for 2 days after the therapy ends [see Use in Specific Populations (8.2)]. Hypersensitivity ...