Allergic rhinitis (AR) is a heterogeneous disorder that despite its high prevalence is often

undiagnosed. It is characterized by one or more symptoms including sneezing, itching,

nasal congestion, and rhinorrhea. Many causative agents have been linked to AR
including pollens, molds, dust mites, and animal dander. Seasonal allergic rhinitis (SAR)
is fairly easy to identify because of the rapid and reproducible onset and offset of
symptoms in association with pollen exposure. Perennial AR is often more difficult to
detect than SAR because of the overlap with sinusitis, respiratory infections, and
vasomotor rhinitis. SAR can result in hyperresponsiveness to allergens such as cigarette
smoke, once pollen season is over. Perennial AR is defined as occurring during
approximately 9 months of the year. AR affects an estimated 20 to 40 million people in
the United States alone, and the incidence is increasing; an estimated 20% of cases are
SAR; 40% of cases are perennial rhinitis; and 40% of cases are mixed. The
pathophysiology of SAR is complex. There is a strong genetic component to the allergic
response, which is driven through mucosal infiltration and action on plasma cells, mast
cells, and eosinophils. The allergic response occurs in two phases, which are considered
the "early" and "late" phase responses. Early phase response occurs within minutes of
exposure to the allergen and tends to produce sneezing, itching, and clear rhinorrhea; late
phase response occurs 4 to 8 hours after allergen exposure and is characterized by
congestion, fatigue, malaise, irritability, and possibly neurocognitive deficits. The key to
diagnosis of AR is awareness of signs and symptoms. IgE antibody tests to detect specific
allergens are the standard method used today; however, in addition, diagnosis must be
confirmed with a positive history and demonstration that the symptoms are the result of
IgE-mediated inflammation.

Allergy rhinitis results from an IgE-mediated allergy associated with nasal inflammation
of variable intensity. The mechanisms of allergic rhinitis have been clarified using nasal
challenge with allergen or proinflammatory mediators and measuring cells and mediators
released during the early- and late-phase allergic reaction. However, the priming effect of
the nasal mucosa is of importance since a single challenge does not perfectly mimic the
ongoing allergic reactions induced by repeated allergen exposure. In seasonal and chronic
allergic rhinitis, the same cells and mediators are of importance but nonspecific nasal
hyperreactivity develops. The regulation of the inflammation of allergic rhinitis is
dependent on adhesion molecules and cytokines

In individuals with allergic rhinitis, exposure to antigens, such as pollens, can activate the
nasal mast cells to initiate the allergic process. During this process, the patient develops
symptoms and mediators are released (including histamine, prostaglandin D2,
thromboxane B2, and leukotriene C4) to produce the inflammation characteristic of
allergic rhinitis. The allergic process can be divided into three phases: early, occurring
within minutes of allergen challenge; late, occurring in about half those challenged about
3 to 10 hours later; and rechallenge, occurring 12 to 24 hours after the first exposure.
Mediators are released in each phase; in the late and rechallenge phases, cells, including
basophils, eosinophils, neutrophils, and mononuclear cells, enter the nose in large
numbers. The basophils can release mediators, increasing the allergic response.
Pretreatment of patients with allergic rhinitis with systemic steroids, such as prednisone,
prevents the late and rechallenge phases of the allergic process. However, with the
exception of kinin generation, such pretreatment has no effect on the early phase. In
contrast, pretreatment with the topical steroid flunisolide prevents many more aspects of
the allergic process: the production of symptoms and the release of mediators in the early
phase and the further development of symptoms and mediator release in the late and
rechallenge phases. Flunisolide pretreatment also prevents the influx into the nose of
mediator-releasing cells, including basophils. Therefore, physicians should consider
pretreating their patients with allergic rhinitis with flunisolide several days before the
pollen season begins. Early response to the antigen will be reduced, and the inflammation
associated with chronic allergic rhinitis will be suppressed.

The nasal cavity, with turbinates protruding from each lateral wall, is lined with
pseudostratified columnar ciliated epithelium. It has important physiological functions of
air-conditioning and filtering inspired air. Critical to this function is an extensive vascular
bed, especially in the turbinates, that may lead to severe pathologic obstruction from
acute or chronic inflammation. Many inflammatory and neurogenic mediators, such as
histamine and arachidonic acid metabolites and sensory neuropeptides, released during
allergic or irritant reactions,[4] are able to cause plasma exudation and vasodilatation, with
resultant edema and swelling of the nasal mucosa. Moreover, other mediators stimulate
trans-endothelial leukocyte migration into the nasal mucosa, and activate these
inflammatory cells to produce a slowly developing complex network of interactions
between various mediators, cytokines, chemokines and cell adhesion molecules and their
respective target cell types. In patients with PAR, continuous allergen exposure causes a
persistent mucosal inflammation and thus persistent nasal obstruction.

What is phenylpropanolamine?
Phenylpropanolamine is a decongestant. It works by constricting (shrinking) blood
vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses,
nose, and chest allows drainage of those areas, which decreases congestion.

Phenylpropanolamine is used to treat the congestion associated with allergies, hay fever,
sinus irritation, and the common cold. Phenylpropanolamine also causes a decrease in
appetite and is used in some over-the-counter diet aids.

Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke

(bleeding into the brain or into tissue surrounding the brain) in women. Men may also be
at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug
Administration (FDA) recommends that consumers not use any products that contain
phenylpropanolamine.

Phenylpropanolamine may also be used for purposes other than those listed in this
medication guide.
What is the most important information I should know
about phenylpropanolamine?
Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke
(bleeding into the brain or into tissue surrounding the brain) in women. Men may also be
at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug
Administration (FDA) recommends that consumers not use any products that contain
phenylpropanolamine.

Do not take phenylpropanolamine for longer than 7 days if your condition does not
improve or if your symptoms are accompanied by a high fever.

Do not take more of this medication than is recommended on the package or by your
doctor. Use caution when driving, operating machinery, or performing other hazardous
activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience
dizziness or drowsiness, avoid these activities.

Who should not take phenylpropanolamine?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor
(MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine
(Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to
serious side effects.

Before taking this medication, tell your doctor if you have

• high blood pressure;

• any type of heart disease, hardening of the arteries, or irregular heartbeat;
• thyroid problems;
• diabetes;
• glaucoma or increased pressure in your eye;
• an enlarged prostate or difficulty urinating; or
• liver or kidney disease.

You may not be able to take phenylpropanolamine, or you may require a lower dose or
special monitoring during treatment if you have any of the conditions listed above.

It is not known whether phenylpropanolamine will harm an unborn baby. Do not take this
medication without first talking to your doctor if you are pregnant. Infants are especially
sensitive to the effects of phenylpropanolamine. Do not take this drug if you are breast-
feeding a baby. If you are over 60 years of age, you may be more likely to experience
side effects from phenylpropanolamine. You may require a lower dose of this medication.
Using a short-acting formulation of phenylpropanolamine (not a long-acting or a
controlled-release formulation) may be safer if you are over 60 years of age.
How should I take phenylpropanolamine?
Take phenylpropanolamine exactly as directed by your doctor, or follow the instructions
that accompany the package. If you do not understand these directions, ask your
pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Never take this medication in larger doses or
more often than is recommended. Too much phenylpropanolamine could be very
harmful.

If your symptoms are accompanied by a high fever, or if they do not improve in 7 days,
see your doctor.

Store phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your
next dose, skip the missed dose and take only your next regularly scheduled dose. Do not
take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a phenylpropanolamine overdose include extreme tiredness, sweating,

dizziness, a slow heart beat, and a coma.

What should I avoid while taking

phenylpropanolamine?
Use caution when driving, operating machinery, or performing other hazardous activities.
Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or
drowsiness, avoid these activities. Never take this medication in larger doses or more
often than is recommended. Too much phenylpropanolamine could be very harmful.

Phenylpropanolamine side effects

If you experience any of the following serious side effects from this medication, stop
taking phenylpropanolamine and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your

lips, tongue, or face; or hives);
 • seizures;
• unusual behavior or hallucinations; or
• an irregular or fast heartbeat.

Other, less serious side effects may be more likely to occur. Continue to take
phenylpropanolamine and talk to your doctor if you experience

• dizziness, lightheadedness, or drowsiness;

• headache;
• insomnia;
• anxiety;
• tremor (shaking) or restlessness;
• nausea or vomiting; or
• sweating.

Side effects other than those listed here may also occur. Talk to your doctor about any
side effect that seems unusual or that is especially bothersome.

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Phenylpropanolamine Dosing Information

Usual Adult Dose for Nasal Congestion:

25 mg orally every 4 hours.

-or-

75 mg orally extended release every 12 hours.

Not to exceed 150 mg/day.

Usual Adult Dose for Weight Loss:

25 mg orally 3 times a day, one-half hour before meals.

-or-

75 mg orally extended release once a day in the morning.

The use of phenylpropanolamine for weight loss should be limited to 12 weeks.

Usual Pediatric Dose for Nasal Congestion:

2 to 6 years:

6.25 mg orally every 4 hours. Maximum daily dose is 37.5 mg.

6 to 12 years:

12.5 mg orally every 4 hours. Maximum daily dose is 75 mg.

> 12 years:

25 mg orally every 4 hours.

-or-

75 mg orally extended release every 12 hours.

Not to exceed 150 mg/day.

What other drugs will affect phenylpropanolamine?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor
(MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine
(Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to
serious side effects.

Phenylpropanolamine may also interact with the following medicines:

• furazolidone (Furoxone);
• guanethidine (Ismelin);
• indomethacin (Indocin);
• methyldopa (Aldomet);
• bromocriptine (Parlodel);
• caffeine in cola, tea, coffee, chocolate, and other products;
• theophylline (Theo-Dur, Theochron, Theolair, others);
• tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin
(Sinequan), and nortriptyline (Pamelor);
 • other commonly used tricyclic antidepressants, including amoxapine (Asendin),
clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil),
protriptyline (Vivactil), and trimipramine (Surmontil);
• phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and
prochlorperazine (Compazine); and
• other commonly used phenothiazines, including fluphenazine (Prolixin),
perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with phenylpropanolamine. Talk to
your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has more information about phenylpropanolamine written for
health professionals that you may read.

What does my medication look like?

Phenylpropanolamine is available over the counter under the brand name Propagest, and
with a prescription under the brand name Rhindecon. Other brand or generic formulations
may also be available. Ask your pharmacist any questions you have about this
medication, especially if it is new to you.

• Propagest 25 mg--oval, white, scored tablets

• Rhindecon 75 mg--timed-release capsules

• Remember, keep this and all other medicines out of the reach of children, never
share your medicines with others, and use this medication only for the indication
prescribed.
• Every effort has been made to ensure that the information provided by Cerner
Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is
made to that effect. Drug information contained herein may be time sensitive.
Multum information has been compiled for use by healthcare practitioners and
consumers in the United States and therefore Multum does not warrant that uses
outside of the United States are appropriate, unless specifically indicated
otherwise. Multum's drug information does not endorse drugs, diagnose patients
or recommend therapy. Multum's drug information is an informational resource
designed to assist licensed healthcare practitioners in caring for their patients
and/or to serve consumers viewing this service as a supplement to, and not a
substitute for, the expertise, skill, knowledge and judgment of healthcare
practitioners. The absence of a warning for a given drug or drug combination in
no way should be construed to indicate that the drug or drug combination is safe,
effective or appropriate for any given patient. Multum does not assume any
responsibility for any aspect of healthcare administered with the aid of
information Multum provides. The information contained herein is not intended to
cover all possible uses, directions, precautions, warnings, drug interactions,
allergic reactions, or adverse effects. If you have questions about the drugs you
are taking, check with your doctor, nurse or pharmacist.