Pronunciation:

GWAHN-i-deen

Classifications:

Pharmacologic—

Cholinesterase Inhibitor

Uses of This Medicine:

Guanidine is used to treat muscle weakness and tiredness caused by the Eaton-Lambert syndrome. The Eaton-Lambert syndrome is an autoimmune disorder that affects the nervous system. Guanidine works on the nervous system to restore muscle strength.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of guanidine in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of guanidine in geriatric patients.

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.

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 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 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.

• Amifampridine
• Bupropion
• Donepezil

Other interactions—

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:

• Anemia (low red blood cells) or
• Kidney disease or
• Leukopenia (low white blood cells) or
• Mood changes, history of or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly 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.

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 oral dosage form (tablets):
  • For Eaton-Lambert syndrome:
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually between 10 and 15 milligrams (mg) per kilogram (kg) of body weight per day and divided in 3 or 4 doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 35 mg/kg/day.
    • Children—Use and dose must be determined by your doctor.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

Incidence not known

Ammonia-like breath odor

black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in frequency or amount of urine

chest pain

chills

cloudy urine

cold sensations in the hands and feet

confusion

cough

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, irregular, pounding, or racing heartbeat or pulse

fever

increased thirst

loss of appetite

nausea or vomiting

painful or difficult urination

pale skin

pinpoint red spots on the skin

shakiness in the legs, arms, hands, or feet

shortness of breath, especially with exercise

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swollen glands

unsteadiness, trembling, or problems with muscle control

unusual bleeding or bruising

unusual tiredness or weakness

weight loss

Some 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. 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:

Incidence not known

Abdominal or stomach cramps

burning, itching, and pain in hairy areas

crying for no reason

dry mouth

dryness and scaling of the skin

false or unusual sense of well-being

feeling irritated

feeling of warmth

feeling paranoid

jitteriness

large, flat, blue or purplish patches in the skin

mood or mental changes

pinpoint red or purple spots on the skin

quick to react or overreact emotionally

rash

redness of the face, neck, arms, and occasionally, upper chest

restlessness

seeing or hearing things that are not there

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.