Pylera (Page 6 of 6)

15 REFERENCES

  1. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically ; Approved Standard — – Eight edition. Clinical and Laboratory standards Institute document M7-A8, Vol. 29, No. 2, CLSI, Wayne, PA, January 2009.

16 HOW SUPPLIED/STORAGE AND HANDLING

PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the Axcan Pharma logo printed on the body and “BMT” printed on the cap. PYLERA is supplied in:

Bottles of 120 NDC 54868-6151-0

Storage

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

Relabeling of “Additional Barcode” label by:

Physicians Total Care, Inc.

Tulsa, OK 74146

17 PATIENT COUNSELING INFORMATION

17.1 Pregnant Women

Advise pregnant women that PYLERA capsules can cause fetal harm due to the tetracycline it contains. Tetracycline use during the second and third trimesters of pregnancy can cause permanent discoloraton of the teeth (yellow-gray brown) and may inhibit bone development [See Warnings and Precautions (5.1)] and [See Use in Specific Populations (8.3)].

17.2 Human Milk Feeding

Advise women to avoid feeding their infants with their milk during PYLERA treatment. Women should either discontinue feeding or pump and discard their milk during treatment and for 24 hours after the last dose [See Use in Specific Populations (8.3)].

17.3 Hypersensitivity

Inform patients that PYLERA may cause allergic reactions and to discontinue PYLERA at the first sign of urticaria, erythematous rash, flushing, and fever or other symptoms of an allergic reaction [See Contraindications (4.4)].

17.4 Central Nervous System Effects

Inform patients of the risk of central and peripheral nervous system effects with PYLERA and to discontinue PYLERA and report immediately to their health-care provider if any neurologic symptoms occur [See Warnings and Precautions (5.4)].

17.5 Photosensitivity

Avoid exposure to sun or sun lamps while taking PYLERA [See Warnings and Precautions (5.6)].

17.6 Drug Interactions

Advise patients to report to their health-care provider the use of any other medications while taking PYLERA. The administration of any of the following drugs with PYLERA may result in clinically significant adverse reactions or insufficient drug efficacies [See Contraindications (4)] ;Drug Interactions (7)]:

  • Methoxyflurane
  • Disulfiram
  • Alcoholic Beverages, or Products Containing Propylene Glycol
  • Oral Contraceptives
  • Anticoagulants
  • Lithium
  • Antacids, Multivitamins, or Dairy Products

17.7 Darkening of the Tongue and/or Stool

Inform patients that PYLERA may cause temporary and harmless darkening of the tongue and/or black stool generally reversible within several days after treatment is stopped. Stool darkening should not be confused with melena (blood in the stool) [See Warnings and Precautions (5.7)].

17.8 Dosing Information

Inform patients that each dose of PYLERA includes 3 capsules. Each dose of all 3 capsules should be taken 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.

Missed doses can be made up by continuing the normal dosing schedule until the medication is gone. They should not take double doses. If more than 4 doses are missed, contact their health-care provider [See Dosage and Administration (2)].

17.9 Administration with Fluids

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 [See Dosage and Administration (2)].

17.10 Antibacterial Resistance

Patients should be counseled that antibacterial drugs including PYLERA should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When PYLERA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by PYLERA or other antibacterial drugs in the future.

Principal Display Panel

Pylera
image of package label
(click image for full-size original)
PYLERA bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (140 mg/125 mg/125 mg) capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6151(NDC:58914-600-21)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bismuth subcitrate potassium (BISMUTH) Bismuth subcitrate potassium 140 mg
Metronidazole (Metronidazole) Metronidazole 125 mg
Tetracycline hydrochloride (Tetracycline) Tetracycline hydrochloride 125 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
TALC
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color white (Opaque white) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AxcanPharma;BMT
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6151-0 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE
1 120 CAPSULE (CAPSULE) in 1 BOTTLE This package is contained within the BOX (54868-6151-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050786 08/18/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 02/2011 Physicians Total Care, Inc.

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