Kemadrin

DRUG DESCRIPTION

KEMADRIN (procyclidine hydrochloride) is a synthetic antispasmodic compound of relatively low toxicity. It has been shown to be useful for the symptomatic treatment of parkinsonism (paralysis agitans) and extrapyramidal dysfunction caused by tranquilizer therapy. Procyclidine hydrochloride was developed at The Wellcome Research Laboratories as the most promising of a series of antiparkinsonism compounds produced by chemical modification of antihistamines. Procyclidine hydrochloride is a white crystalline substance which is soluble in water and almost tasteless. It is known chemically as?-cyclohexyl-?-phenyl-1-pyrrolidinepropanol hydrochloride and has the following structural formula:

KEMADRIN is available in tablet form for oral administration. Each scored tablet contains5 mg procyclidine hydrochloride and the inactive ingredients corn and potato starch, lactose, and magnesium stearate.

What are the precautions when taking procyclidine hydrochloride tablets (Kemadrin)?

Before taking procyclidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blockage of the bladder, certain eye problem (narrow-angle glaucoma), blockage of the esophagus/stomach/intestines (e.g., bowel obstruction), severe ulcerative colitis, certain muscle disease (myasthenia gravis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, breathing problems (e.g., asthma,...

Read All Potential Precautions of Kemadrin


Kemadrin Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, constipation, flushing, nausea, nervousness, blurred vision, or dry mouth may occur. These effects usually lessen as your body gets used to the medicine. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual ability, severe stomach/abdominal pain, difficult/painful swallowing, difficulty urinating, vision changes, weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness/fainting, high fever, fast/irregular/slow heartbeat, mental/mood changes (e.g., confusion, hallucinations, memory problems).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking procyclidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blockage of the bladder, certain eye problem (narrow-angle glaucoma), blockage of the esophagus/stomach/intestines (e.g., bowel obstruction), severe ulcerative colitis, certain muscle disease (myasthenia gravis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, breathing problems (e.g., asthma, emphysema), diarrhea caused by an infection, certain eye problem (open-angle glaucoma), heart problems (e.g., angina, heart attack, heart failure, fast/irregular heartbeat), high/low blood pressure, intestinal problems (e.g., chronic constipation, ileus, ulcerative colitis), kidney disease, liver disease, mental/mood problems (e.g., anxiety, dementia, psychosis), certain nerve disease (autonomic neuropathy), seizure, stomach problems (e.g., acid reflux, hiatal hernia, ulcer), stroke, overactive thyroid (hyperthyroidism), problems urinating (e.g., due to enlarged prostate, neurogenic bladder).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication decreases saliva production, an effect that can increase gum and tooth problems (e.g., cavities, gum disease). Take special care with your dental hygiene (e.g., brushing, flossing) and have regular dental check-ups.

This drug can cause decreased sweating, which could cause a severe rise in your body temperature (hyperthermia). The risk of this serious side effect is greater in hot weather, during vigorous exercise, and/or if you drink alcohol. Drink plenty of fluids and dress lightly while in hot weather and when exercising. If you experience signs of hyperthermia such as mental/mood changes, headache, or dizziness, promptly seek cool or air-conditioned shelter and/or stop exercising, and seek immediate medical attention. Consult your doctor for more details.

Liquid forms of this product may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Some medications (e.g., disulfiram, metronidazole) may cause a serious reaction when combined with alcohol. Tell your doctor if you are taking any medication that should not be used with alcohol. Ask your doctor or pharmacist about using this product safely.

The elderly may be more sensitive to the effects of this drug, especially dizziness, hyperthermia, memory problems, and constipation.

Children may be more sensitive to the effects of this drug, especially effects on heart rate.

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.



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