Detailed Drug Information for the Consumer > Phenylpropanolamine (Systemic)

PHENYLPROPANOLAMINE (Systemic) **

Some commonly used brand names are:

In the U.S.-

• Not commercially available

Generic name product may be available in the U.S.

Another commonly used name is PPA

Note:

In November 2000, the Food and Drug Administration (FDA) issued a public health warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by results of a research program, requested that manufacturers voluntarily discontinue marketing products that contain PPA and that consumers work with their healthcare providers to select alternative products.

** Not commercially available in the U.S. and Canada.

Category

• Appetite suppressant
• decongestant, nasal (systemic)
• sympathomimetic (adrenergic) agent

Description

Phenylpropanolamine (fen-ill-proe-pa-NOLE-a-meen), commonly known as PPA, is used as a nasal decongestant or as an appetite suppressant. It acts on many different parts of the body. PPA produces effects that may be helpful or harmful. This depends on a patient's individual condition and response and the amount of medicine taken.

Phenylpropanolamine clears nasal congestion (stuffy nose) by narrowing or constricting the blood vessels. However, this same action may cause an increase in blood pressure in patients who have hypertension (high blood pressure).

Phenylpropanolamine also decreases appetite. However, the way PPA and similar medicines do this is unclear. Stimulation of the central nervous system (CNS) may be a major reason. Phenylpropanolamine in combination with dieting, exercise, and changes in eating habits can help obese patients lose weight. However, this appetite-reducing effect is only temporary, and is useful only for the first few weeks of dieting until new eating habits are established.

Phenylpropanolamine has caused serious side effects (even death) when too much was taken.

Phenylpropanolamine was available in the following dosage forms:

• Oral
• Capsules
• Extended-release capsules
• Tablets
• Extended-release tablets

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For phenylpropanolamine, the following should be considered:

Allergies- Tell your doctor if you have ever had any unusual or allergic reaction to phenylpropanolamine or to amphetamine, dextroamphetamine, ephedrine, epinephrine, isoproterenol, metaproterenol, methamphetamine, norepinephrine, phenylephrine, pseudoephedrine, or terbutaline. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy- Phenylpropanolamine has not been shown to cause birth defects in humans. However, women who take phenylpropanolamine in the weeks following delivery may be more likely to suffer mental or mood changes.

Breast-feeding- Phenylpropanolamine has not been reported to cause problems in nursing babies.

Children- Mental changes may be more likely to occur in young children taking phenylpropanolamine than in adults. Phenylpropanolamine should not be used for weight control in children under the age of 12 years. Children 12 to 18 years old should not take phenylpropanolamine for weight control unless its use is ordered and supervised by a doctor.

Older adults- Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of phenylpropanolamine in the elderly with use in other age groups.

Other 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 phenylpropanolamine, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Medicine for asthma or other breathing problems or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Other appetite suppressants (diet pills) or
• Other medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Pemoline (e.g., Cylert)-Using these medicines while taking phenylpropanolamine may cause severe nervousness, irritability, trouble in sleeping, or possibly irregular heartbeat or seizures

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren])-Taking these medicines with phenylpropanolamine may cause serious high blood pressure (hypertension) and other effects on the heart

• Digitalis glycosides (heart medicine)-Changes in the rhythm of your heart may occur

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])-Taking phenylpropanolamine while you are taking or within 2 weeks of taking MAO inhibitors may cause sudden high body temperature, extremely high blood pressure, and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other

• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil])-Phenylpropanolamine may not work properly when taken with rauwolfia alkaloids

Other medical problems- The presence of other medical problems may affect the use of phenylpropanolamine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes)-Use of phenylpropanolamine may cause an increase in blood glucose levels

• Enlarged prostate or
• Glaucoma or
• High blood pressure-Use of phenylpropanolamine may make the condition worse

• Heart disease or blood vessel disease (including a history of heart attack or stroke) or
• Overactive thyroid-Serious effects on the heart may occur

• Mental illness, history of-Use of phenylpropanolamine may cause the mental illness to return

Proper Use of This Medicine

For patients taking an extended-release form of this medicine:

• Swallow the capsule or tablet whole. Do not crush, break, or chew before swallowing.
• Take with a full glass (at least 8 ounces) of water.
• If taking only one dose of this medicine a day, take it in the morning around 10 a.m.

Dosing- The following section is for information only, since the drug is no longer available.

• For appetite control:
  • oral dosage forms (capsules and tablets):
  • long-acting dosage forms (extended-release capsules and tablets):
• For stuffy nose:
  • oral dosage forms (capsules and tablets):
  • long-acting dosage forms (extended-release capsules and tablets):

Storage- To store this medicine

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Do not drink large amounts of caffeine-containing beverages, such as coffee, tea, or colas while you are taking this medicine. To do so may cause unwanted effects.

This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert .

For patients taking this medicine for nasal congestion :

• If cold symptoms do not improve within 7 days or if you also have a high fever, check with your doctor . These signs may mean that you have other medical problems.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, phenylpropanolamine is used in certain patients with the following medical condition:

• Urinary stress incontinence (loss of bladder control when you cough, sneeze, or laugh)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 06/04/2002

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