Tenuate

NDC 0068-0697-61
25 mg immediate-release tablets in bottles of 100
Each white, round tablet is debossed TENUATE (diethylpropion) 25 or MERRELL 697
Keep tightly closed, store at room temperature, preferably below 86°F.
Protect from excessive heat.

NDC 0068-0698-61
75 mg controlled-release tablets in bottles of 100

NDC 0068-0698-62
75 mg controlled-release tablets in bottles of 250
Each white, capsule-shaped tablet is debossed TENUATE (diethylpropion) 75 or MERRELL 698
Keep tightly closed. Store at room temperature, below 86°F.

Rev. November 2003. Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA. Manufactured for: Merrell Pharmaceuticals Inc. FDA Rev date: 9/3/2004

Take the missed dose as soon as you remember. Skip the missed dose if it is already evening. Wait until the next morning to take your next scheduled dose. Do not take extra medicine to make up the missed dose.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Tenuate is part of the drug class:

• Centrally acting antiobesity products

In the U.S.

• Tenuate
• Tenuate Dospan

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Diethylpropion

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diethylpropion in children younger than 17 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diethylpropion in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving diethylpropion.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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.

• Brofaromine
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Sibutramine
• Toloxatone
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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:

• Agitated state or
• Arteriosclerosis (hardening of the arteries), advanced or
• Drug abuse or dependence, history of or
• Glaucoma or
• Heart problems (e.g., heart murmur, valvular heart disease) or
• Hypertension (high blood pressure), severe or
• Hyperthyroidism (overactive thyroid) or
• Pulmonary hypertension (increased blood pressure in the lungs)—Should not be used in patients with these conditions.

• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure), mild to moderate or
• Mental illness or
• Seizures or epilepsy—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. Higher blood levels of diethylpropion can occur, which increases the risk of serious side effects.

This section provides information on the proper use of a number of products that contain diethylpropion. It may not be specific to Tenuate. Please read with care.

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. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine is available in two forms: the immediate-release tablets and the controlled-release tablets. Ask your doctor which dosage form is right for you.

Swallow the controlled-release tablets whole. Do not break, crush, or chew it.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of obesity:
  • For oral dosage form (immediate-release tablets):
    • Adults and teenagers 17 years of age and older—25 milligrams (mg) three times a day, taken one hour before meals, and in mid evening to overcome night hunger.
    • Children 16 years of age and younger—Use is not recommended.
  • For oral dosage form (controlled-release tablets):
    • Adults and teenagers 17 years of age and older—75 milligrams (mg) once a day, taken usually in mid morning.
    • Children 16 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Take Tenuate exactly as prescribed. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Diethylpropion may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

The immediate-release Tenuate tablet is usually taken three times a day before meals.

The extended-release Tenuate Dospan tablet is usually taken once a day midmorning.

Tell your doctor if you do not lose at least 4 pounds after taking the medicine for 4 weeks along with a low calorie diet.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

If you need surgery, tell the surgeon ahead of time that you are using Tenuate. You may need to stop using the medicine for a short time.

Do not stop using Tenuate suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Diethylpropion is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.