Kemadrin (Procyclidine Hydrochloride Tablets)
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Kemadrin (Procyclidine Hydrochloride Tablets)

KEMADRIN
(procyclidine hydrochloride) 5 mg Scored Tablets

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 asα-cyclohexyl-α-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 »

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

KEMADRIN (procyclidine hydrochloride) is indicated in the treatment of parkinsonism including the postencephalitic, arteriosclerotic, and idiopathic types. Partial control of the parkinsonism symptoms is the usual therapeutic accomplishment. Procyclidine hydrochloride is usually more efficacious in the relief of rigidity than tremor; but tremor, fatigue, weakness, and sluggishness are frequently beneficially influenced. It can be substituted for all the previous medications in mild and moderate cases. For the control of more severe cases, other drugs may be added to procyclidine therapy as indications warrant.

Clinical reports indicate that procyclidine often successfully relieves the symptoms of extrapyramidal dysfunction (dystonia, dyskinesia, akathisia, and parkinsonism) which accompany the therapy of mental disorders with phenothiazine and rauwolfia compounds. In addition to minimizing the symptoms induced by tranquilizing drugs, the drug effectively controls sialorrhea resulting from neuroleptic medication. At the same time, freedom from the side effects induced by tranquilizer drugs, as provided by the administration of procyclidine, permits a more sustained treatment of the patient's mental disorder.

Clinical results in the treatment of parkinsonism indicate that most patients experience subjective improvement characterized by a feeling of well-being and increased alertness, together with diminished salivation and a marked improvement in muscular coordination as demonstrated by objective tests of manual dexterity and by increased ability to carry out ordinary self-care activities. While the drug exerts a mild atropine-like action and therefore causes mydriasis, this may be kept minimal by careful adjustment of the daily dosage.

DOSAGE AND ADMINISTRATION

For Parkinsonism

The dosage of the drug for the treatment of parkinsonism depends upon the age of the patient, the etiology of the disease, and individual responsiveness. Therefore, the dosage must remain flexible to permit adjustment to the individual tolerance and requirements of each patient. In general, younger and postencephalitic patients require and tolerate a somewhat higher dosage than older patients and those with arteriosclerosis.

For Patients Who Have Received No Other Therapy

The usual dose of procyclidine hydrochloride for initial treatment is 2.5 mg administered three times daily after meals. If well tolerated, this dose may be gradually increased to 5 mg three times a day and occasionally 5 mg given before retiring. In some cases smaller doses may be employed with good therapeutic results.

Occasionally a patient is encountered who cannot tolerate a bedtime dose of the drug. In such cases it may be desirable to adjust dosage so that the bedtime dose is omitted and the total daily requirement is administered in three equal daytime doses. It is best administered during or after meals to minimize the development of side reactions.

To Transfer Patients to KEMADRIN from Other Therapy

Patients who have been receiving other drugs may be transferred to procyclidine hydrochloride. This is accomplished gradually by substituting 2.5 mg three times a day for all or part of the original drug. The dose of procyclidine is then increased as required while that of the other drug is correspondingly omitted or decreased until complete replacement is achieved. The total daily dosage may then be adjusted to the level which produces maximum benefit.

For Drug-Induced Extrapyramidal Symptoms

For treatment of symptoms of extrapyramidal dysfunction induced by tranquilizer drugs during the therapy of mental disorders, the dosage of procyclidine hydrochloride will depend on the severity of side effects associated with tranquilizer administration. In general, the larger the dosage of the tranquilizer, the more severe will be the associated symptoms, including rigidity and tremors. Accordingly, the drug dosage should be adjusted to suit the needs of the individual patient and to provide maximum relief of the induced symptoms. A convenient method to establish the daily dosage of procyclidine is to begin with the administration of 2.5 mg three times daily. This may be increased by 2.5 mg daily increments until the patient obtains relief of symptoms. In most cases excellent results will be obtained with 10 to 20 mg daily.

HOW SUPPLIED

White, scored tablets containing 5 mg procyclidine hydrochloride, imprinted with “KEMADRIN” and “S3A” in bottles of 100 (NDC 61570-059-01). Store at 15° to 25°C (59° to 77°F) in a dry place.

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834. Prescribing Information as of August 2003.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Anticholinergic effects can be produced by therapeutic doses although these can frequently be minimized or eliminated by careful dosage. They include: dryness of the mouth, mydriasis, blurring of vision, giddiness, lightheadedness, and gastrointestinal disturbances such as nausea, vomiting, epigastric distress, and constipation. Occasionally an allergic reaction such as a skin rash may be encountered. Feelings of muscular weakness may occur. Acute suppurative parotitis as a complication of dry mouth has been reported.

Read the Kemadrin (procyclidine hydrochloride tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Use in Children: Safety and efficacy have not been established in the pediatric age group; therefore, the use of procyclidine hydrochloride in this age group requires that the potential benefits be weighed against the possible hazards to the child.

Pregnancy Warning

The safe use of this drug in pregnancy has not been established; therefore, the use of procyclidine hydrochloride in pregnancy, lactation, or in women of childbearing age requires that the potential benefits be weighed against the possible hazards to the mother and child.

PRECAUTIONS

Conditions in which inhibition of the parasympathetic nervous system is undesirable, such as tachycardia and urinary retention (such as may occur with marked prostatic hypertrophy), require special care in the administration of the drug. Hypotensive patients who receive the drug should be observed closely. Occasionally, particularly in older patients, mental confusion and disorientation may occur with the development of agitation, hallucinations, and psychotic-like symptoms. Patients with mental disorders occasionally experience a precipitation of a psychotic episode when the dosage of antiparkinsonism drugs is increased to treat the extrapyramidal side effects of phenothiazine and rauwolfia derivatives.

Geriatric Use

Clinical studies of KEMADRIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range(see DOSAGE AND ADMINISTRATION) and the dose should be increased only as needed with monitoring for the emergence of adverse events (see ADVERSE REACTIONS).

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Procyclidine hydrochloride should not be used in angle-closure glaucoma although simple type glaucomas do not appear to be adversely affected.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Pharmacologic tests have shown that procyclidine hydrochloride has an atropine-like action and exerts an antispasmodic effect on smooth muscle. It is a potent mydriatic and inhibits salivation. It has no sympathetic ganglion- blocking activity in doses as high as 4 mg/kg, as measured by the lack of inhibition of the response of the nictitating membrane to preganglionic electrical stimulation.

The intravenous LD50 in mice was about 60 mg/kg. Subcutaneously, doses of 300 mg/kg were not toxic. In dogs, the intraperitoneal administration of procyclidine hydrochloride in doses of 5 mg/kg caused maximal dilation of the pupil and inhibition of salivation, but had no toxic action. When the dose was increased to 20 mg/kg, the same symptoms occurred, and in addition there were tremors and ataxia lasting 4 to 5 hours. In one animal, convulsions occurred which were controlled by pentobarbital. In all animals behavior returned to normal within 24 hours.

Chronic toxicity tests in rats showed that the compound caused only a very slight retardation in growth, and no change in the erythrocyte count or the histological appearance of the lungs, liver, spleen, and kidney when as much as 10 mg/kg body weight was given subcutaneously daily for 9 weeks.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Kemadrin Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PROCYCLIDINE - ORAL

(proe-SYE-kli-deen)

COMMON BRAND NAME(S): Kemadrin

USES: Procyclidine is used to treat symptoms of Parkinson's disease or involuntary movements due to the side effects of certain psychiatric drugs (antipsychotics such as chlorpromazine/haloperidol). Procyclidine belongs to a class of medication called anticholinergics that work by blocking a certain natural substance (acetylcholine). This helps decrease muscle stiffness, sweating, and the production of saliva, and helps improve walking ability in people with Parkinson's disease.

Anticholinergics can stop severe muscle spasms of the back, neck, and eyes that are sometimes caused by psychiatric drugs. It can also decrease other side effects such as muscle stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful in treating movement problems caused by tardive dyskinesia and may worsen them.

HOW TO USE: Take this medication by mouth, usually 3 to 4 times a day after meals and at bedtime or as directed by your doctor. Your doctor may start you at a low dose and increase your dose slowly to find the best dose for you. The dosage is based on your medical condition and response to therapy.

If you are using the liquid form of this medication, measure your dose with a special measuring spoon or device. Do not use a household spoon because it may not provide the correct dose.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

Take this medication at least 1 hour before antacids containing magnesium, aluminum, or calcium. Allow at least 1-2 hours between doses of procyclidine and certain drugs for diarrhea (adsorbent antidiarrheals such as kaolin, pectin, attapulgite). Take this medication at least 2 hours after ketoconazole. Antacids and some drugs for diarrhea may prevent the full absorption of procyclidine, and this product may prevent the complete absorption of ketoconazole when these products are taken together.

If you are taking this medication for side effects from another medication, your doctor may instruct you to take it on a regular schedule or only as needed. If you are taking this medication for Parkinson's disease, your doctor may change the dose of your other medications (e.g., levodopa). Follow your doctor's instructions closely. Do not stop or change the dose of your medication without your doctor's approval.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists or worsens.

Disclaimer

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.

Read the Kemadrin (procyclidine hydrochloride tablets) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Kemadrin Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: pramlintide.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting procyclidine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: amantadine, anticholinergics/antispasmodics (e.g., belladonna alkaloids, clidinium), certain antiarrhythmics (e.g., disopyramide, procainamide, quinidine), cholinesterase inhibitors (e.g., donepezil, galantamine), corticosteroids (e.g., prednisone), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), motion sickness medication (e.g., meclizine, scopolamine), narcotic pain relievers (e.g., meperidine), potassium tablets/capsules, tricyclic antidepressants (e.g., amitriptyline, doxepin).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain anticholinergics or drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unusually fast/slow heartbeat, slow/shallow breathing, unconsciousness, seizures, loss of coordination, fever, hot/dry/flushed skin, widened pupils, change in vision, change in the amount of urine, confusion, hallucinations.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). If you are taking this drug to treat Parkinson's disease, tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2011. Copyright(c) 2011 First Databank, Inc.

KEMADRIN
(procyclidine hydrochloride) 5 mg Scored Tablets

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 asα-cyclohexyl-α-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.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

KEMADRIN
(procyclidine hydrochloride) 5 mg Scored Tablets

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 asα-cyclohexyl-α-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.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

KEMADRIN
(procyclidine hydrochloride) 5 mg Scored Tablets

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 asα-cyclohexyl-α-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.

Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.

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