"The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, an"...
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
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.
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/1/2011
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