Why is moclobemide not approved in the us

Alcohol abuse; Significant adverse reaction to nicotine patches, in the past. Known hypersensitivity to moclobemide or other MAO-A inhibitors. Current participation or recent participation in the past 30 days in another smoking study at our center or another research facility. Current participation or recent participation in the past six months in another medical research study. Contacts and Locations.

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. Duke University. More Information. Layout table for additonal information Responsible Party: Jed E. Rose, Duke University:. National Library of Medicine U. National Institutes of Health U.

Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Nicotine Dependence. Drug: Nicotine Patch Drug: Moclobemide. Phase 2. Study Type :. Moclobemide is a monoamine oxidase MAO inhibitor used to treat certain types of mental depression.

It works by blocking the action of a chemical substance known as monoamine oxidase MAO in the nervous system. Although this medicine is very effective for certain patients, it may also cause some unwanted reactions if taken the wrong way. It is very important to avoid certain beverages and medicines while you are using moclobemide. Your doctor may provide a list as a reminder of which products you should avoid. All rights reserved. For this medicine, the following should be considered:. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines.

Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Studies on moclobemide have been done only in adult patients, and there is no specific information comparing use of moclobemide in children with use in other age groups. Older adults are especially sensitive to the effects of moclobemide.

This may increase the chance of side effects during treatment. Dizziness or lightheadedness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to these effects. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended.

Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases.

If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur.

Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:. Sometimes this medicine must be taken for several weeks before you begin to feel better. Your doctor should check your progress at regular visits, especially during the first few months of treatment, to make sure that this medicine is working properly and to check for unwanted effects.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Moclobemide should be taken after a meal.