NIZORAL® (ketoconazole) is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine and has the following structural formula:

Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44.

Last updated on RxList: 4/20/2009

NIZORAL® (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. NIZORAL® Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid.

NIZORAL® Tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin.

Adults: The recommended starting dose of NIZORAL® (ketoconazole) Tablets is a single daily administration of 200 mg (one tablet). In very serious infections or if clinical responsiveness is insufficient within the expected time, the dose of NIZORAL® Tablets may be increased to 400 mg (two tablets) once daily.

Children: In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. NIZORAL® Tablets have not been studied in children under 2 years of age.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. Treatment should be continued until tests indicate that active fungal infection has subsided. Inadequate periods of treatment may yield poor response and lead to early recurrence of clinical symptoms. Minimum treatment for candidiasis is one or two weeks. Patients with chronic mucocutaneous candidiasis usually require maintenance therapy. Minimum treatment for the other indicated systemic mycoses is six months.

Minimum treatment for recalcitrant dermatophyte infections is four weeks in cases involving glabrous skin. Palmar and plantar infections may respond more slowly. Apparent cures may subsequently recur after discontinuation of therapy in some cases.

NIZORAL® (ketoconazole) is available as white, scored tablets containing 200 mg of ketoconazole debossed “JANSSEN” and on the reverse side debossed “NIZORAL”. They are supplied in bottles of 100 tablets (NDC 50458-220-10).

Store at controlled room temperature 15°-25°C (59°-77°F).Protect from moisture.

Janssen Pharmaceutica, Titusville, NJ 08560, Rev. March 1997, July 1998.

Last updated on RxList: 4/20/2009

In rare cases, anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported. However, the most frequent adverse reactions were nausea and/or vomiting in approximately 3%, abdominal pain in 1.2%, pruritus in 1.5%, and the following in less than 1% of the patients: headache, dizziness, somnolence, fever and chills, photophobia, diarrhea, gynecomastia, impotence, thrombocytopenia, leukopenia, hemolytic anemia, and bulging fontanelles. Oligospermia has been reported in investigational studies with the drug at dosages above those currently approved. Oligospermia has not been reported at dosages up to 400 mg daily, however sperm counts have been obtained infrequently in patients treated with these dosages. Most of these reactions were mild and transient and rarely required discontinuation of NIZORAL® (ketoconazole) Tablets. In contrast, the rare occurrences of hepatic dysfunction require special attention (see WARNINGS section).

In worldwide postmarketing experience with NIZORAL® Tablets there have been rare reports of alopecia, paresthesia, and signs of increased intracranial pressure including bulging fontanelles and papilledema. Hypertriglyceridemia has also been reported but a causal association with NIZORAL® Tablets is uncertain.

Neuropsychiatric disturbances, including suicidal tendencies and severe depression, have occurred rarely in patients using NIZORAL® Tablets.

Ventricular dysrhythmias (prolonged QT intervals) have occurred with the concomitant use of terfenadine with ketoconazole tablets. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.) Data suggest that coadministration of ketoconazole tablets and cisaspride can result in prolongation of the QT interval and has rarely been associated with ventricular arrhythmias. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)

Ketoconazole is a potent inhibitor of the cytochrome P450 3A4 enzyme system. Coadministration of NIZORAL® Tablets and drugs primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic and adverse effects. Therefore, unless otherwise specified, appropriate dosage adjustments may be necessary. The following drug interactions have been identified involving NIZORAL® Tablets and other drugs metabolized by the cytochrome P450 3A4 enzyme system:

Ketoconazole tablets inhibit the metabolism of terfenadine, resulting in an increased plasma concentration of terfenadine and a delay in the elimination of its acid metabolite. The increased plasma concentration of terfenadine or its metabolite may result in prolonged QT intervals. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.)

Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.)

Human pharmacokinetics data indicate that oral ketoconazole potently inhibits the metabolism of cisapride resulting in a mean eight-fold increase in AUC of cisapride. Data suggest that coadministration of oral ketoconazole and cisapride can result in prolongation of the QT interval on the ECG. Therefore concomitant administration of ketoconazole tablets with cisapride is contraindicated. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.)

Ketoconazole tablets may alter the metabolism of cyclosporine, tacrolimus, and methylprednisolone, resulting in elevated plasma concentrations of the latter drugs. Dosage adjustment may be required if cyclosporine, tacrolimus, or methylprednisolone are given concomitantly with NIZORAL® Tablets.

Coadministration of NIZORAL® Tablets with midazolam or triazolam has resulted in elevated plasma concentrations of the latter two drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. These agents should not be used in patients treated with NIZORAL® Tablets. If midazolam is administered parenterally, special precaution is required since the sedative effect may be prolonged.

Rare cases of elevated plasma concentrations of digoxin have been reported. It is not clear whether this was due to the combination of therapy. It is, therefore, advisable to monitor digoxin concentrations in patients receiving ketoconazole.

When taken orally, imidazole compounds like ketoconazole may enhance the anticoagulant effect of coumarin-like drugs. In simultaneous treatment with imidazole drugs and coumarin drugs, the anticoagulant effect should be carefully titrated and monitored.

Because severe hypoglycemia has been reported in patients concomitantly receiving oral miconazole (an imidazole) and oral hypoglycemic agents, such a potential interaction involving the latter agents when used concomitantly with ketoconazole tablets (an imidazole) can not be ruled out.

Concomitant administration of ketoconazole tablets with phenytoin may alter the metabolism of one or both of the drugs. It is suggested to monitor both ketoconazole and phenytoin.

Concomitant administration of rifampin with ketoconazole tablets reduces the blood levels of the latter. INH (Isoniazid) is also reported to affect ketoconazole concentrations adversely. These drugs should not be given concomitantly.

After the coadministration of 200 mg oral ketoconazole twice daily and one 20 mg dose of loratadine to 11 subjects, the AUC and Cmax of loratadine averaged 302% (± 142 S.D.) and 251% (± 68 S.D.), respectively, of those obtained after co-treatment with placebo. The AUC and Cmax of descarboethoxyloratadine, an active metabolite, averaged 155% (± 27 S.D.) and 141% (± 35 S.D.), respectively. However, no related changes were noted in the QTc on ECG taken at 2, 6, and 24 hours after the coadministration. Also, there were no clinically significant differences in adverse events when loratadine was administered with or without ketoconazole.

Rare cases of a disulfiram-like reaction to alcohol have been reported. These experiences have been characterized by flushing, rash, peripheral edema, nausea, and headache. Symptoms resolved within a few hours.

Last updated on RxList: 4/20/2009

Hepatotoxicity, primarily of the hepatocellular type, has been associated with the use of NIZORAL® (ketoconazole) Tablets, including rare fatalities. The reported incidence of hepatotoxicity has been about 1:10,000 exposed patients, but this probably represents some degree of under-reporting, as is the case for most reported adverse reactions to drugs. The median duration of NIZORAL® Tablet therapy in patients who developed symptomatic hepatotoxicity was about 28 days, although the range extended to as low as 3 days. The hepatic injury has usually, but not always, been reversible upon discontinuation of NIZORAL® Tablet treatment. Several cases of hepatitis have been reported in children.

Prompt recognition of liver injury is essential. Liver function tests (such as SGGT, alkaline phosphatase, SGPT, SGOT and bilirubin) should be measured before starting treatment and at frequent intervals during treatment. Patients receiving NIZORAL® Tablets concurrently with other potentially hepatotoxic drugs should be carefully monitored, particularly those patients requiring prolonged therapy or those who have had a history of liver disease.

Most of the reported cases of hepatic toxicity have to date been in patients treated for onychomycosis. Of 180 patients worldwide developing idiosyncratic liver dysfunction during NIZORAL® Tablet therapy, 61.3% had onychomycosis and 16.8% had chronic recalcitrant dermatophytoses.

Transient minor elevations in liver enzymes have occurred during treatment with NIZORAL® Tablets. The drug should be discontinued if these persist, if the abnormalities worsen, or if the abnormalities become accompanied by symptoms of possible liver injury.

In rare cases anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported.

Coadministration of ketoconazole tablets and terfenadine has led to elevated plasma concentrations of terfenadine which may prolong QT intervals, sometimes resulting in life-threatening cardiac dysrhythmias. Cases of torsades de pointes and other serious ventricular dysrhythmias, in rare cases leading to fatality, have been reported among patients taking terfenadine concurrently with ketoconazole tablets. Coadministration of ketoconazole tablets and terfenadine is contraindicated.

Coadministration of astemizole with ketoconazole tablets is contraindicated. (See BOX WARNING, CONTRAINDICATIONS, and PRECAUTIONS sections.)

Concomitant administration of NIZORAL® Tablets with cisapride is contraindicated because it has resulted in markedly elevated cisapride plasma concentrations and prolonged QT interval, and has rarely been associated with ventricular arrhythmias and torsades de pointes. (See BOX WARNING, CONTRAINDICATIONS, and PRECAUTIONS sections.)

In European clinical trials involving 350 patients with metastatic prostatic cancer, eleven deaths were reported within two weeks of starting treatment with high doses of ketoconazole tablets (1200 mg/day). It is not possible to ascertain from the information available whether death was related to ketoconazole therapy in these patients with serious underlying disease. However, high doses of ketoconazole tablets are known to suppress adrenal corticosteroid secretion.

In female rats treated three to six months with ketoconazole at dose levels of 80 mg/kg and higher, increased fragility of long bones, in some cases leading to fracture, was seen. The maximum “no-effect” dose level in these studies was 20 mg/kg (2.5 times the maximum recommended human dose). The mechanism responsible for this phenomenon is obscure. Limited studies in dogs failed to demonstrate such an effect on the metacarpals and ribs.

General

NIZORAL® (ketoconazole) Tablets have been demonstrated to lower serum testosterone. Once therapy with NIZORAL® Tablets has been discontinued, serum testosterone levels return to baseline values. Testosterone levels are impaired with doses of 800 mg per day and abolished by 1600 mg per day. NIZORAL® Tablets also decrease ACTH induced corticosteroid serum levels at similar high doses. The recommended dose of 200 mg - 400 mg daily should be followed closely.

In four subjects with drug-induced achlorhydria, a marked reduction in ketoconazole absorption was observed. NIZORAL® Tablets require acidity for dissolution. If concomitant antacids, anticholinergics, and H₂-blockers are needed, they should be given at least two hours after administration of NIZORAL® Tablets. In cases of achlorhydria, the patients should be instructed to dissolve each tablet in 4 mL aqueous solution of 0.2 N HCl. For ingesting the resulting mixture, they should use a drinking straw so as to avoid contact with the teeth. This administration should be followed with a cup of tap water.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames Salmonella microsomal activator assay was also negative. A long term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.

Pregnancy

Teratogenic effects

Pregnancy Category C: Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given in the diet at 80 mg/kg/day (10 times the maximum recommended human dose). However, these effects may be related to maternal toxicity, evidence of which also was seen at this and higher dose levels.

There are no adequate and well controlled studies in pregnant women. NIZORAL® Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Ketoconazole has also been found to be embryotoxic in the rat when given in the diet at doses higher than 80 mg/kg during the first trimester of gestation.

In addition, dystocia (difficult labor) was noted in rats administered oral ketoconazole during the third trimester of gestation. This occurred when ketoconazole was administered at doses higher than 10 mg/kg (higher than 1.25 times the maximum human dose).

It is likely that both the malformations and the embryotoxicity resulting from the administration of oral ketoconazole during gestation are a reflection of the particular sensitivity of the female rat to this drug. For example, the oral LD50 of ketoconazole given by gavage to the female rat is 166 mg/kg whereas in the male rat the oral LD50 is 287 mg/kg.

Nursing Mothers

Since ketoconazole is probably excreted in the milk, mothers who are under treatment should not breast feed.

Pediatric Use

NIZORAL® (ketoconazole) Tablets have not been systematically studied in children of any age, and essentially no information is available on children under 2 years. NIZORAL® Tablets should not be used in pediatric patients unless the potential benefit outweighs the risks.

Last updated on RxList: 4/20/2009

In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.

Coadministration of terfenadine or astemizole with ketoconazole tablets is contraindicated. (See BOX WARNING, WARNINGS, and PRECAUTIONS sections.)

Concomitant administration of NIZORAL® Tablets with cisapride is contraindicated. (See BOX WARNING, WARNINGS, and PRECAUTIONS sections.)

Concomitant administration of NIZORAL® Tablets with oral triazolam is contraindicated. (See PRECAUTIONS section.)

NIZORAL® is contraindicated in patients who have shown hypersensitivity to the drug.

Last updated on RxList: 4/20/2009

Mean peak plasma levels of approximately 3.5 μg/mL are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal. Subsequent plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter. Following absorption from the gastrointestinal tract, NIZORAL® (ketoconazole) is converted into several inactive metabolites. The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation. About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged drug. The major route of excretion is through the bile into the intestinal tract. In vitro, the plasma protein binding is about 99% mainly to the albumin fraction. Only a negligible proportion of ketoconazole reaches the cerebral-spinal fluid. Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption.

NIZORAL® Tablets are active against clinical infections with Blastomyces dermatitidis, Candida spp., Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis, and Phialophora spp. NIZORAL® Tablets are also active against Trichophyton spp., Epidermophyton spp., and Microsporum spp. Ketoconazole is also active in vitro against a variety of fungi and yeast. In animal models, activity has been demonstrated against Candida spp., Blastomyces dermatitidis, Histoplasma capsulatum, Malassezia furfur, Coccidioides immitis, and Cryptococcus neoformans.

Mode of Action

In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.

Last updated on RxList: 4/20/2009

Patients should be instructed to report any signs and symptoms which may suggest liver dysfunction so that appropriate biochemical testing can be done. Such signs and symptoms may include unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine or pale stools (see WARNINGS section).

Last updated on RxList: 4/20/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

KETOCONAZOLE TABLET - ORAL

(kee-toe-CON-uh-zole)

COMMON BRAND NAME(S): Nizoral

WARNING: Rarely, ketoconazole has caused severe (sometimes fatal) liver problems. Immediately tell your doctor if you develop symptoms of liver problems (persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin, severe tiredness). Your doctor will perform liver function tests while you are taking ketoconazole to monitor for side effects. Do not drink alcohol while taking this medication because doing so increases the risk of serious liver problems.

Ketoconazole should never be taken with the following medications: cisapride, astemizole, terfenadine. Doing so has caused severe (sometimes fatal) heart rhythm problems. Although astemizole and terfenadine are no longer available, if you have any of these medications, take them to your pharmacist for proper disposal.

USES: This drug is used to treat certain fungal infections of the skin/mouth/lungs/bladder (e.g., severe athlete's foot, oral thrush, Coccidioides, candiduria). Some of these infections may require several months of treatment.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat certain protozoal infections (e.g., Acanthamoeba, Leishmaniasis), prevention of certain fungal infections in patients with cancer or HIV, Cushing's syndrome, treatment of advanced prostate cancer, and treatment of high calcium levels in the blood from sarcoidosis.

HOW TO USE: Take this medication exactly as prescribed by your doctor by mouth with or without food, usually once daily. Do not take ketoconazole within 2 hours of taking an antacid (liquid or tablets). Doing so can prevent the absorption of the medication.

Dosage is based on your age, weight, medical condition, and response to therapy.

It is very important to continue taking this medication exactly as prescribed by your doctor.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the infection to get worse or make the infection more difficult to treat (resistant).

Inform your doctor if your condition persists or worsens after 7 days.

Nausea, vomiting, stomach pain, constipation, and gas may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: headache, dizziness, sleepiness, diarrhea, enlarged breasts in men, decreased sexual ability, mental/mood changes (depression, thoughts of suicide), unusual dreams, eye sensitivity to bright light, tingling/numbness of hands or feet, hair loss, muscle aches.

Tell your doctor immediately if any of these rare but very serious side effects occur: fever, chills, persistent sore throat, easy bruising/bleeding, severe tiredness, pale lips/nails/skin, fast heartbeat, fast breathing, headache, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other "azole" drugs (e.g., fluconazole, itraconazole); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, hepatitis B, alcohol use, low testosterone levels, low levels of a certain hormone (e.g., low cortisol, Addison's disease, adrenal insufficiency), decreased or absent stomach acid production (e.g., achlorhydria).

This drug may rarely make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages while taking this medication because they increase the risk of dizziness/drowsiness as well as serious liver problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Ketoconazole passes into breast milk. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: triazolam, midazolam, estazolam, drugs that decrease stomach acid (e.g., omeprazole, lansoprazole), alfuzosin, conivaptan, dofetilide, eletriptan, eplerenone, ergot alkaloids (e.g., bromocriptine, ergotamine, dihydroergotamine), isoniazid, ivabradine, vardenafil, irinotecan, nevirapine, amiodarone, pimozide, ranolazine, cholesterol lowering drugs (HMG-COA reductase inhibitors such as atorvastatin, lovastatin, simvastatin, cerivastatin).

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting ketoconazole.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: sucralfate, H2 blockers (e.g., ranitidine, cimetidine), rifampin, warfarin, phenytoin, sildenafil, tadalafil, fentanyl, HIV protease inhibitors (e.g., lopinavir, ritonavir, darunavir, tipranavir, fosamprenavir, indinavir), efavirenz, certain drugs that weaken the immune system (cyclosporine, sirolimus, tacrolimus), certain chemotherapy drugs (dasatinib, lapatinib, sunitinib), theophylline, erythromycin, prednisolone, methylprednisolone, digoxin, certain drugs for diabetes (e.g., glyburide, glipizide), trazodone, quetiapine, tolterodine, solifenacin, zolpidem.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical and laboratory appointments.

MISSED DOSE: If you miss a dose, take the missed dose as soon as you remember. Do not take the missed dose if it is within 2 hours of your next dose. In that case, skip the missed dose and resume your usual dosing schedule.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.