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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 drug and may not reflect the rates observed in practice.
The safety of PYLERA plus omeprazole (OBMT) to eradicate Helicobacter pylori was assessed in an open-label, randomized, active-controlled clinical trial conducted in North America. The duration of treatment was 10 days with 147 patients exposed to PYLERA plus omeprazole (OBMT) and 152 exposed to control, consisting of omeprazole, amoxicillin, and clarithromycin (OAC). The age of the population in the study ranged from 18 to 75 years, with 59% male patients and 59% Caucasian patients.
Adverse drug reactions were reported in 58% of patients in the OBMT group and 59% of patients in the OAC group. There were no adverse reactions leading to discontinuation of the study during the clinical trial.
Adverse reactions with an incidence of ≥ 5% in OBMT group include abnormal feces, diarrhea, nausea, and headache. Adverse drug reactions with an incidence of ≥ 5% in OAC group include diarrhea, dysgeusia, dyspepsia, nausea and headache.
Table 2 lists adverse reactions with an incidence of ≥ 1%, in either groups (OBMT vs OAC) and in order of decreasing incidence for the OBMT group.
Table 2: Adverse reactions with an incidence of ≥
1% from North American trial, [n (%)]
(n = 147)
(n = 152)
|Abnormal feces***||23 (15.6%)||7 (4.6%)|
|Nausea||12 (8.2%)||14 (9.2%)|
|Abdominal Pain||7 (4.8%)||2(1.3%)|
|Constipation||2 (1.4%)||5 (3.3%)|
|Dry Mouth||2(1.4%)||1 (0.7%)|
|General disorders and administration site conditions|
|Infections and infestations|
|Vaginal infection||4 (2.7%)||3 (2.0%)|
|Nervous svstem disorders|
|Headache||8 (5.4%)||8 (5.3%)|
|Dizziness||4 (2.7%)||4 (2.6%)|
|Laboratory test abnormal||3 (2.0%)||4 (2.6%)|
|Alanine aminotransferase increased||2(1.4%)||0|
|Aspartate aminotransferase increased||2 (1.4%)||0|
|Renal and urinarv disorders|
|Skin and subcutaneous tissue disorders|
|Rash||1 (0.7%)||3 (2.0%)|
|*OBMT = Omeprazole + PYLERA
**OAC = Omeprazole + Amoxicillin + Clarithromycin;
*** Dark stools [See WARNINGS AND PRECAUTIONS]
Adverse reactions with an incidence of < 1% for OBMT group are: back pain, vomiting, tongue darkening [See WARNINGS AND PRECAUTIONS], anxiety, gastritis, gastroenteritis, myalgia, chest pain, increased appetite, blood creatine phosphokinase increased, malaise, somnolence, tachycardia, duodenal ulcer, visual disturbance, weight increased.
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 from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Gastrointestinal disorders: abdominal distention, eructation, flatulence
- General disorders and administration site conditions: chest discomfort, fatigue.
- Infections and infestations: candidiasis.
Other Important Adverse Reactions from Labeling for the Individual Components of PYLERA
Blood and Lymphatic system disorders: reversible neutropenia (leucopenia) in cases of prolonged treatment; rarely reversible thrombocytopenia however no persistent haematological abnormalities attributable to metronidazole have been observed [See WARNINGS AND PRECAUTIONS].
Cardiac disorders: Flattening of the T-wave may be seen in electrocardiographic tracings.
Gastrointestinal disorders: Furry tongue, glositis, stomatitis; these may be associated with a sudden overgrowth of candida which may occur during therapy [See WARNINGS AND PRECAUTIONS].
Metabolism and nutrition disorders: Cases of pancreatitis have been reported, which abated on withdrawal of the drug, have been reported.
Nervous system disorders: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia [See WARNINGS AND PRECAUTIONS].
Gastrointestinal disorders: Rare instances of esophagitis and esophageal ulceration have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of the patients who experienced esophageal irritation took the medication immediately before going to bed. Permanent discoloration of teeth may be caused when tetracycline is used during tooth development. Enamel hypoplasia has also been reported [See WARNINGS AND PRECAUTIONS].
Skin and subcutaneous tissue disorders: Maculopapular and erythematous rashes have been reported. Steven-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported. Exfoliative dermatitis and photosensitivity have been rarely reported [See WARNINGS AND PRECAUTIONS].
Read the Pylera Capsules (bismuth subcitrate potassium) Side Effects Center for a complete guide to possible side effects
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 fatal renal toxicity [See CONTRAINDICATIONS].
Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of PYLERA and disulfiram concurrently. PYLERA should not be given to patients who have taken disulfiram within the last two weeks [See CONTRAINDICATIONS].
Consumption of alcoholic beverages or administration of other products containing propylene glycol during treatment with PYLERA and for at least 3 days afterwards may cause a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) due to the interaction between alcohol or propylene glycol and metronidazole, a component of PYLERA. Discontinue alcoholic beverage or other products containing propylene glycol during and for at least 3 days after therapy with PYLERA [See CONTRAINDICATIONS].
Concurrent use of PYLERA with oral contraceptive may make oral contraceptives less effective due to an interaction with the tetracycline component of PYLERA. Breakthrough bleeding has been reported. Women of child-bearing potential should use a different or additional form of contraception while taking PYLERA.
PYLERA may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. Tetracycline has been shown to depress plasma prothrombin activity. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if PYLERA is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
In patients stabilized on relatively high doses of lithium, short-term use of PYLERA may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Serum lithium and serum creatinine concentrations should be monitored several days after beginning treatment with PYLERA to detect any increase that may precede clinical symptoms of lithium toxicity.
Antacids, Multivitamins, or Dairy Products
The absorption of PYLERA may be reduced if administered with antacids containing aluminium, calcium, or magnesium; preparations containing iron, zinc, or sodium bicarbonate; or milk or dairy products due to the interaction between these products and tetracycline. These products should not be consumed concomitantly with PYLERA. However, the clinical significance of reduced tetracycline systemic exposure is unknown as the relative contribution of systemic versus local antimicrobial activity against Helicobacter pylori has not been established.
Bacteriostatic drugs, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of penicillin; therefore, penicillin should not be used concomitantly with PYLERA.
Inhibitors of CYP450 liver enzymes
The simultaneous administration of PYLERA and drugs that inhibit microsomal liver enzymes, such as cimetidine, may result in a prolonged half-life and decreased plasma clearance of metronidazole.
Inducers of CYP450 liver enzymes
The simultaneous administration of PYLERA and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole. Impaired clearance of phenytoin has also been reported in this situation. Monitor phenytoin concentrations during treatment with PYLERA.
Read the Pylera Capsules Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/7/2013
This monograph has been modified to include the generic and brand name in many instances.
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