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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 discoloration of the teeth (yellow-gray brown) and may inhibit bone development [See WARNINGS AND PRECAUTIONS and Use In Specific Populations].
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].
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].
Central Nervous System Effects
Inform patients of the risk of central and peripheral nervous system effects with PYELRA and to discontinue PYLERA and report immediately to their health-care provider if any neurologic symptoms occur [See WARNINGS AND PRECAUTIONS].
Avoid exposure to sun or sun lamps while taking PYLERA [See WARNINGS AND PRECAUTIONS].
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; DRUG INTERACTIONS]:
- Alcoholic Beverages, or Products Containing Propylene Glycol
- Oral Contraceptives
- Antacids, Multivitamins, or Dairy Products
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].
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].
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].
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.
Last reviewed on RxList: 2/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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