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PYLERA™ Capsules

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PYLERA™ Capsules 1 PYLERA™ Capsules 2 (bismuth subcitrate potassium, metronidazole, 3 and tetracycline hydrochloride) 4 140 mg/125 mg/125 mg 5 6 7 To reduce the development of drug-resistant bacteria and maintain the effectiveness of 8 PYLERA™ and other antibacterial drugs, PYLERA™ should be used only to treat or 9 prevent infections that are proven or strongly suspected to be caused by bacteria. 10 WARNING Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS) Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below. 11 12 DESCRIPTION 13 14 PYLERA™ capsules are a combination antimicrobial product containing bismuth 15 subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral 16 administration. Each size 0 elongated hard gelatin capsule contains: 17 18 - bismuth subcitrate potassium, 140 mg 19 - metronidazole, 125 mg 20 - smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg 21 22 Bismuth subcitrate potassium is a white or almost white powder. It is a soluble, complex 23 bismuth salt of citric acid. The schematized empirical molecular formula of bismuth 24 subcitrate potassium is Bi(Citrate)2K5●3 H2O. The equivalent theoretical molecular 25 formula is BiC12H14K5O17. The molecular mass of the theoretical molecular formula of a 26 single unit of bismuth subcitrate potassium is 834.71. 27 28 Metronidazole is a white to pale yellow crystalline powder. Metronidazole is 2-methyl- 29 5-nitroimidazole-1-ethanol, with a molecular formula of C6H9N3O3 and the following 30 structural formula: OH NO2 N CH3 N 1 31 32 33 Molecular weight: 171.2 34 35 Tetracycline hydrochloride is a yellow, odorless, crystalline powder. Tetracycline is 36 stable in air, but exposure to strong sunlight causes it to darken. Tetracycline 37 hydrochloride is (4S,4aS,5aS,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a- 38 octahydro-3,6,10,12,12a-penta-hydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide 39 hydrochloride, with a molecular formula of C22H24N2O8●HCl and the following structural 40 formula: 41 42 43 H3C CH3 HO CH3 N H H OH HCl NH2 OH OH OOHO O 44 45 Molecular weight: 480.90 46 47 Each PYLERA™ capsule contains the following inactive ingredients: Magnesium 48 Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide 49 NF. Printed with red ink. 50 51 CLINICAL PHARMACOLOGY 52 Pharmacokinetics 53 The pharmacokinetics of the individual components of PYLERA™, bismuth subcitrate 54 potassium, metronidazole and tetracycline, are summarized below. In addition, two 55 studies on PYLERA™ were conducted by Axcan to determine the effect of co- 56 administration on the pharmacokinetics of the components. 57 58 Bismuth Subcitrate Potassium (Bismuth) 59 Orally absorbed bismuth is distributed throughout the entire body. Bismuth is highly 60 bound to plasma proteins (>90%). The elimination half-life of bismuth is approximately 61 5 days in both blood and urine. Elimination of bismuth is primarily through urinary and 62 biliary routes. The rate of renal elimination appears to reach steady state 2 weeks after 63 treatment discontinuation with similar rates of elimination at 6 weeks after 2 64 discontinuation. The average urinary elimination of bismuth is 2.6% per day in the first 65 two weeks after discontinuation (urine drug concentrations 24 to 250 µg/mL) suggesting 66 tissue accumulation and slow elimination. 67 68 Metronidazole 69 Following oral administration, metronidazole is well absorbed, with peak plasma 70 concentrations occurring between 1 and 2 hours after administration. Plasma 71 concentrations of metronidazole are proportional to the administered dose, with oral 72 administration of 500 mg producing a peak plasma concentration of 12 µg/mL. 73 74 Metronidazole appears in the plasma mainly as unchanged compound with lesser 75 quantities of the 2-hydroxymethyl metabolite also present. Less than 20% of the 76 circulating metronidazole is bound to plasma proteins. Metronidazole also appears in 77 cerebrospinal fluid, saliva, and breast milk in concentrations similar to those found in 78 plasma. 79 80 The average elimination half-life of metronidazole in normal volunteers is 8 hours. The 81 major route of elimination of metronidazole and its metabolites is via the urine (60% to 82 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. The 83 metabolites that appear in the urine result primarily from side-chain oxidation [1-(β- 84 hydroxyethyl)2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl- 85 acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for 86 approximately 20% of the total. Renal clearance of metronidazole is approximately 10 87 mL/min/1.73 m2. 88 89 Decreased renal function does not alter the single dose pharmacokinetics of 90 metronidazole. In patients with decreased liver function, plasma clearance of 91 metronidazole is decreased. 92 93 Tetracycline Hydrochloride 94 Tetracycline is absorbed (60%-90%) in the stomach and upper small intestine. The 95 presence of food, milk or cations may significantly decrease the extent of absorption. In 96 the plasma, tetracycline is bound to plasma proteins in varying degrees. It is concentrated 97 by the liver in the bile and excreted in the urine and feces at high concentrations in a 98 biologically active form. 99 100 Tetracycline is distributed into most body tissues and fluids. It is distributed into the bile 101 and undergoes varying degrees of enterohepatic recirculation. Tetracycline tends to 102 localize in tumors, necrotic or ischemic tissue, liver and spleen and form tetracycline- 103 calcium orthophosphate complexes at sites of new bone formation or tooth development. 104 Tetracycline readily crosses the placenta and is excreted in high amounts in breast milk. 105 3 106 PYLERA™ Capsules 107 The clinical significance of systemic, as compared to local, drug concentrations for 108 antimicrobial activity against Helicobacter pylori, has not been established. A 109 comparative bioavailability study of metronidazole (375 mg), tetracycline (375 mg) and 110 bismuth subcitrate potassium (420 mg, equivalent to 120 mg Bi2O3) administered as 111 PYLERA™ or as 3 separate capsule formulations administered simultaneously was 112 conducted in healthy male volunteers. The pharmacokinetic parameters for the individual 113 drugs when administered as separate capsule formulations or as PYLERA™ are similar, 114 as shown in Table 1. 115 116 Table 1. Mean (%CV) Pharmacokinetic Parameters for Metronidazole, Tetracycline, and 117 Bismuth Subcitrate Potassium in Healthy Volunteers (N=18) Cmax AUCT AUC∞ (ng/mL) (ng · h/mL) (ng · h/mL) (%C.V.**) (%C.V.**) (%C.V.**) Metronidazole Metronidazole 9044.7 (20) 80289 (15) 81849 (16) Capsule PYLERA™* 8666.3 (22) 83018 (17) 84413 (17) Tetracycline Tetracycline 748.0 (40) 9544 (55) 9864 (53) Capsules PYLERA™* 773.8 (47) 9674 (50) 9987 (49) Bismuth Bismuth Capsule 21.3 (123) 46.5 (129) 65.4 (113) PYLERA™* 16.7 (202) 42.5 (191) 56.5 (178) 118 *PYLERA™ given as a single dose of 3 capsules 119 **C.V. – Coefficient Variation 120 121 The pharmacokinetic parameters for metronidazole, tetracycline and bismuth were also 122 determined when PYLERA™ was administered under fasting and fed conditions, as 123 shown in Table 2. Food reduced the systemic absorption of all three PYLERA™ 124 components, with AUC values for metronidazole, tetracycline and bismuth being reduced 125 by 6%, 34% and 60%, respectively. Reduction in the absorption of all three PYLERA™ 126 components in the presence of food is not considered to be clinically significant. 127 PYLERA™ should be given after meals and at bedtime, in combination with omeprazole 128 twice a day. (See DOSAGE AND ADMINISTRATION) 129 130 Table 2. Mean PYLERA™ Pharmacokinetic Parameters in Fasted and Fed States (N=18)* FED FASTED metronidazole tetracycline bismuth metronidazole tetracycline bismuth Cmax 6835.0 515.8 1.7 8666.3 773.8 16.7 (ng/mL) (%C.V.) 4 (13) (36) (61) (22) (47) (202) Tmax 3.0 4.0 3.5 0.75 3.3 0.6 (hours)** (range) (1.3 – 4.0) (2.5 – 5.0) (0.8 – 6.0) (0.5 - 3.5) (1.3 – 5.0) (0.5 – 1.7) AUC∞ 79225.6 5840.1 18.4 84413.6 9986.7 56.5 (ng · h/mL) (%C.V.) (18) (312) (116) (17) (49) (178) 131 *PYLERA™ given as a single dose of 3 capsules 132 **Tmax is expressed as median (range) 133 134 Omeprazole Capsules 135 The effect of omeprazole on bismuth absorption was assessed in 34 healthy volunteers 136 given PYLERA™ (qid) with or without omeprazole (20 mg bid) for 6 days. In the 137 presence of omeprazole, the extent of absorption of bismuth from PYLERA™ was 138 significantly increased, compared to when no omeprazole was given (Table 3). 139 Concentration-dependent neurotoxicity is associated with long-term use of bismuth and 140 not likely to occur with short-term administration or at steady state concentrations below 141 50 ng/mL. One subject transiently achieved a maximum bismuth concentration (Cmax) 142 higher than 50 ng/mL (73 ng/mL) following multiple dosing of PYLERA™ with 143 omeprazole. The patient did not exhibit symptoms of neurotoxicity during the study. 144 There is no clinical evidence to suggest that short-term exposure to Cmax concentrations 145 above 50 ng/mL is associated with neurotoxicity. 146 147 Table 3. Mean Bismuth Pharmacokinetic Parameters following PYLERA™ 148 Administration* With and Without Omeprazole (N=34) Parameter Without omeprazole With omeprazole Mean %C.V.** Mean %C.V.** Cmax (ng/mL) 8.1 84 25.5 69 AUCT (ng · h/mL) 48.5 28 140.9 42 149 *PYLERA™ given as 3 capsules qid for 6 days with or without 20 mg omeprazole bid 150 **C.V. – Coefficient Variation 151 152 Microbiology 153 The ingredients in PYLERA™ capsules are active as antibacterial agents.
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