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|
|
 bismuth subcitrate potassium, metronidazole, tetracycline |
| Pylera |
Pharmaceutical
company:
Axcan Pharma
www.axcan.com |
Pharmacologic classification: antimicrobial, antibiotic
Therapeutic classification: antiulcerative
Pregnancy risk category: D
AVAILABLE FORMS
Capsules: 140 mg bismuth subcitrate potassium, 125 mg metronidazole, 125 mg tetracycline
INDICATIONS AND DOSAGES
In combination with omeprazole, to eradicate Haemophilus pylori in patients with H. pylori infection and duodenal ulcer disease--
Adults: Three Pylera capsules P.O. q.i.d. with 8 oz water; taken after meals and at bedtime for 10 days. Should be taken with 20 mg omeprazole P.O. b.i.d. after breakfast and dinner for 10 days.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients with known hypersensitivity to any component of the drug, pediatric patients, those with renal or hepatic impairment, and in pregnant or breast-feeding women.
Use cautiously in patients with a history of blood dyscrasias or CNS disease.
INTERACTIONS
Drug-drug.
Aluminum, magnesium, calcium, iron, zinc, sodium bicarbonate: May decrease absorption of tetracycline. Avoid antacids and multivitamins containing these products for one hour before and two hours after Pylera dose.
Anticoagulants: Pylera may alter anticoagulant effects. Monitor frequently.
Cimetidine: May increase metronidazole levels. Monitor patient closely.
CYP enzyme inducers such as phenytoin and phenobarbital: May decreased metronidazole levels. Monitor for effectiveness.
Disulfiram: May cause psychotic reactions in alcoholic patients taking metronidazole. Avoid disulfiram for at least 2 weeks prior to and during therapy.
Lithium: Pylera may increase lithium levels. Monitor serum lithium and creatinine closely.
Methoxyflurane: May cause fatal renal toxicity. Avoid this combination.
Oral contraceptives: Pylera may decrease effectiveness. Recommend use of back-up contraceptive method.
Penicillin: Tetracycline may decrease penicillin effectiveness. Avoid use together.
Phenytoin: Pylera may increase phenytoin levels. Monitor patient closely and consider dosage adjustment.
Drug-food.
Dairy products: May decrease absorption of tetracycline. Avoid dairy products for one hour before and two hours after Pylera dose.
Drug-lifestyle.
Alcohol: May cause severe adverse effects. Discourage use during and for at least 2 days after therapy.
ADVERSE REACTIONS
CNS: headache, dizziness, anxiety, weakness.
CV: chest pain, palpitations.
GI: stool abnormalities, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, dry mouth, taste perversion, gastritis, gastroenteritis.
GU: vaginitis, urinary abnormalities.
Respiratory: rhinitis, pharyngitis.
Skin: rash.
Other: back pain, flulike syndrome, infection.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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