Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA

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During Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA course of treatment, serum ALT should be monitored weekly for the duration of treatment. If ALT values increase to a level above the upper limit of normal or 30 percent above baseline, or if the patient develops symptoms, ketoconazole treatment should be interrupted and a full set of liver tests should be obtained.

Liver tests should be repeated to ensure normalization of values. Hepatotoxicity has been reported with restarting oral ketoconazole (rechallenge). If it is decided to restart oral ketoconazole, monitor the patient frequently to detect any recurring liver injury from the drug.

Ketoconazole can prolong the QT interval. Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, and cisapride. Ketoconazole can cause elevated plasma concentrations of these drugs which may prolong the QT interval, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes.

This effect is not shared with other azoles. The recommended dose of 200 mg - 400 mg daily should not be exceeded. Ketoconazole has been used in high doses for the treatment of advanced prostate cancer and for Cushing's syndrome when other treatment options have failed.

The safety and effectiveness of ketoconazole have not been established in these settings and the use of ketoconazole for these indications is not approved by FDA. It is not possible to ascertain from the information available whether death was related to ketoconazole therapy or adrenal insufficiency in these patients with serious underlying disease. Anaphylaxis has been reported after the first Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA. Several cases of hypersensitivity reactions including urticaria have also been reported.

This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Testosterone levels are impaired with doses of 800 mg per day and abolished by 1600 mg per day.

Clinical manifestations of decreased testosterone concentrations may include gynecomastia, impotence and oligospermia. Ketoconazole did not show any signs of mutagenic potential when evaluated using the dominant lethal mutation test or the Ames Salmonella microsomal activator assay. However, these effects may be related to maternal toxicity, evidence of which also was seen at this and higher dose levels.

In addition, dystocia (difficult labor) was noted in rats administered oral ketoconazole during the third trimester of gestation. Ketoconazole has been shown examination male physical be excreted in the milk.

In the event of acute accidental overdose, treatment consists of supportive and symptomatic Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA. Within the first hour after ingestion, activated charcoal may be administered.

Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Medications are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information, talk to your healthcare provider. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Hepatotoxicity Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA with the use of oral ketoconazole.

QT Prolongation and Drug Interactions Leading to QT Prolongation Co-administration of the hematemesis drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride. Children In small numbers of children over 2 years of age, a single daily dose of 3. Janssen Pharmaceuticals, Inc, Titusville, New Jersey 08560. Post-Marketing Experience The following adverse reactions have been identified during postapproval use of Nizoral tablets.

The following adverse reactions were reported during post-marketing experience: Blood and Lymphatic System Disorders: thrombocytopenia Immune System Disorders: allergic conditions including anaphylactic Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA, anaphylactic reaction, angioneurotic edema Endocrine Disorders: adrenocortical insufficiency Nervous System Disorders: reversible intracranial pressure increased (e.

For others, monitoring of plasma concentrations is advised when possible. Clinical signs and symptoms associated with these drugs should Proair HFA (Albuterol Sulfate Inhalation Aerosol)- FDA monitored, with dosage adjusted as needed. Inducers of CYP3A4 may decrease the plasma concentrations of ketoconazole (see Table 2). Other inhibitors of CYP3A4 may increase the plasma concentrations of ketoconazole (see Table 2).

Cisapride Oral ketoconazole potently inhibits the metabolism of cisapride resulting in a mean eight-fold increase in AUC of cisapride, which can lead to prolongation of QT interval. Alfentanil, sufentanil, fentanyl In vitro data suggest that alfentanil, sufentanil and fentanyl are metabolized by CYP3A4. Bosentan Acular LS (Ketorolac Tromethamine Ophthalmic Solution)- Multum administration of ketoconazole increased the Cmax and AUC of bosentan 2.

Buspirone Concomitant administration of ann emerg med with ketoconazole may result in significant increases in plasma concentrations of buspirone. Carbamazepine In vivo studies have demonstrated an increase in plasma carbamazepine concentrations in subjects concomitantly receiving ketoconazole.

Cyclosporine Ketoconazole tablets may alter the metabolism of cyclosporine, thereby resulting in elevated cyclosporine plasma concentrations. Digoxin Rare cases of elevated plasma concentrations of digoxin have been reported. Oral anti-coagulants Oral imidazole compounds such as ketoconazole may enhance the anticoagulant effect of coumarin-like drugs, thus the anticoagulant effect should be carefully titrated and monitored.

Oral hypoglycemic agents 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) cannot be ruled out.

Rifabutin Ketoconazole was shown to inhibit the CYP-mediated metabolism of rifabutin in vitro. Sildenafil Ketoconazole had been shown to increase sildenafil plasma concentrations.

Sirolimus Multiple-dose ketoconazole had been shown to increase sirolimus Cmax and AUC by 4. Tacrolimus Ketoconazole had topic exercise shown to decrease the oral clearance of tacrolimus thereby leading to a 2-fold increase in tacrolimus oral bioavailability.

Telithromycin Ketoconazole increased the AUC of telithromycin by 1. Tolterodine In the presence of ketoconazole, the apparent oral clearance of tolterodine decreased resulting in at least a two-fold increase in tolterodine.

Trimetrexate In vitro data suggest that trimetrexate is extensively metabolized by CYP3A4. Verapamil Findings of in vitro metabolic studies indicate that verapamil is metabolized by enzymes including CYP3A4. Carbamazepine Concomitant administration of ketoconazole tablets with carbamazepine may alter the metabolism of one or both of the drugs. Phenytoin Concomitant administration of ketoconazole with phenytoin may alter the metabolism of one or both of the drugs.

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