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PYLERA capsules(bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride)
PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration.
Name：PYLERA®
Description：PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline HCl) is an effective 3-in-1 capsule for the first line option in the eradication treatment of H. pylori, a bacteria that is now believed to cause up to 90% of duodenal ulcers.
Active substance：Bismuth subcitrate potassium 140 mg, metronidazole 125 mg, tetracycline hydrochloride 125 mg given as 3 capsules q.i.d. plus omeprazole for 10 days.
Indication：PYLERA® capsules, in combination with omeprazole (20 mg b.i.d), are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
Regulatory Status：Approved by US FDA in September 2006, (NDA) 050786.
MEA region approved countries: Bahrain, Kuwait, Lebanon, Morocco, Qatar Under registration in Tunisia
PYLERA Rx
Generic Name and Formulations:
Bismuth subcitrate potassium 140mg, metronidazole 125mg, tetracycline HCl 125mg; caps.
Company:
Allergan
Hyperacidity, GERD, and ulcers:
Indications for PYLERA:
To eradicate H. pylori, in combination with omeprazole, in patients with H. pylori infection and duodenal ulcer disease (active or history of).
Adult:
Swallow whole with 8 oz water. 3 caps 4 times daily after meals and at bedtime for 10 days (give with omeprazole 20mg twice daily with breakfast and dinner for 10 days).
Children:
Not established.
Contraindications:
Concomitant methoxyflurane. During or within 14 days of disulfiram. Alcohol or propylene-glycol containing products (during and for ≥3days after treatment). Severe renal impairment. Pregnancy.
Warnings/Precautions:
Potential for carcinogenicity. May cause permanent teeth discoloration during 2nd/3rd trimester of pregnancy and children up to 8yrs of age; avoid. Discontinue if superinfection, skin erythema or cutaneous reaction occurs. Blood dyscrasias. Monitor CBC with differential before and after treatment. Avoid sun, UV light. Severe hepatic impairment: not recommended; monitor in mild to moderate. Children ≤8yrs: avoid. High tetracycline doses may cause hepatotoxicity in pregnancy. Nursing mothers: not recommended.
Pharmacologic Class:
Antimicrobial/antibiotics.
Interactions:
See Contraindications. May antagonize oral contraceptives (use non-hormonal backup method). Absorption reduced by antacids containing aluminum, magnesium, or calcium; and by iron, zinc, sodium bicarbonate, and dietary calcium (clinical significance unknown). Potentiated by CYP450 inhibitors (eg, cimetidine). Antagonized by CYP450 inducers (eg, phenytoin, phenobarbital); monitor phenytoin levels. Potentiates busulfan; avoid or monitor if clinically indicated. Monitor lithium, warfarin. Intracranial hypertension with concomitant isotretinoin; avoid. May interfere with GI X-rays, liver function tests, others.
Adverse Reactions:
Abnormal stool, diarrhea, nausea, headache; encephalopathy, peripheral neuropathy, aseptic meningitis, intracranial hypertension (monitor), neurotoxicity, tongue darkening, leukopenia, rash
How Supplied:
Caps—120
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a762e164-b390-4e8c-bd46-bf6c31eeb486 |
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