Hylorel

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of guanadrel in children with use in other age groups.

Geriatric

Dizziness or faintness may be more likely to occur in the elderly, who are usually more sensitive to the effects of guanadrel.

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
• Toloxatone
• Tranylcypromine

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. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Yohimbine

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:

• Asthma (history of) or
• Diarrhea or
• Pheochromocytoma or
• Stomach ulcer (history of)—Guanadrel may worsen these conditions

• Fever—Effects of guanadrel may be increased

• Heart attack or stroke (recent) or
• Heart or blood vessel disease—Lowering blood pressure may make problems resulting from these conditions worse

Applies to guanadrel: oral tablet

Along with its needed effects, guanadrel (the active ingredient contained in Hylorel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur while taking guanadrel:

• Blurred vision
• dizziness or faintness (severe)

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

• Swelling of feet or lower legs

• Chest pain
• shortness of breath

Some side effects of guanadrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty in ejaculating
• dizziness, lightheadedness, or fainting, especially when getting up from a lying or sitting position
• drowsiness
• unusual tiredness or weakness
• weight gain or loss (excessive)

• Diarrhea or increase in bowel movements
• dryness of mouth
• headache
• muscle pain or tremors
• nighttime urination

Applies to guanadrel: oral tablet

Nervous system

The most common problems associated with guanadrel (the active ingredient contained in Hylorel) affect the nervous system. Up to 60% of patients have experienced drowsiness, fatigue, or headaches, 25% of patients experienced paresthesias or visual disturbances, and 2% experienced sleep disorders during therapy[Ref]

Cardiovascular

Cardiovascular side effects can result from excessive sympathetic blockade or a relative increase in parasympathetic tone. Orthostatic hypotension occurs in 8% to 50% of patients, some of whom experience syncope.

Unopposed or excessive parasympathetic tone can cause excessive bradycardia in rare cases. This may cause serious problems in patients with underlying sinus node dysfunction.

Peripheral edema has been reported in up to 30% of patients.

Other cardiovascular problems include chest pain in 28%, dyspnea at rest in 18%, dyspnea on exertion in 46%, and palpitations in 30% of patients. Underlying diseases may account for the relatively high incidence of some of these side effects.[Ref]

The risk of orthostatic hypotension, sometimes followed by syncope, is greatest within the first 10 minutes after dosing or early in the morning, and in hypovolemia. It is accentuated by alcohol, hot weather, or exercise--all of which are associated with peripheral vasodilation. The manufacturer recommends that guanadrel be gradually withdrawn over at least two weeks prior to administration of general anesthetics to avoid cardiovascular collapse during induction.[Ref]

Gastrointestinal

Gastrointestinal side effects are also related to increased parasympathetic tone. Diarrhea has been reported in 5% to 30% of patients, some of whom discontinue therapy because of it. Constipation has been reported in up to 21% of patients. Dry mouth or parotid tenderness have been associated with the use of this drug in approximately 2% of patients.[Ref]

Genitourinary

There is evidence that peripherally-acting antiadrenergic drugs may interfere with ejaculation by inhibiting contraction of the seminal vesicle, ampula and ductus deferens.[Ref]

Sexual impotence is a relatively common genitourinary complaint, occurring in 5% to 18% of male patients. Smaller studies, where specific questions were asked, revealed an incidence of impotence as high as 60% of male patients who were receiving a similar drug, guanethidine. Impotence appears to be reversible upon discontinuation of therapy or reduction in dosage. Urinary frequency or urgency has occurred in 30% to 50% of patients.[Ref]

Musculoskeletal

Musculoskeletal cramping has occurred in approximately 20% to 40% of patients.[Ref]

Some side effects of Hylorel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.