What are the possible side effects of Pakisonal (Artane, Trihexane)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- hot and dry skin, or a lack of sweating even if you feel hot;
- rapid or jerky repetitive involuntary movement;
- severe constipation;
- painful or difficult urination;
- unusual thoughts or behavior;
- confusion, memory problems; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Common side effects may include:
- blurred vision;
- dry mouth;
- constipation, decreased urination;
- dizziness, drowsiness, weakness;
- nausea, vomiting;
- headache; or
- feeling restless or nervous.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The mean oral LD50 of ARTANE (Pakisonal) has been reported to be 365 mg/kg (range, 325 to 410 mg/kg) in mice and 1660 mg/kg (1420 to 1940 mg/kg) in rats. At a dose of 40 mg/kg, dogs have exhibited emesis, restlessness followed by drowsiness, equilibrium disturbances, and mydriasis.
In humans, doses up to 300 mg (5 mg/kg) have been ingested without fatalities or sequelae. However, rare cases of death associated with Pakisonal overdosages taken in conjunction with other CNS-depressant agents have been reported or in patients with a compromised respiratory condition. Pakisonal blood concentrations associated with the fatalities ranged from 0.03 to 0.80 mg/l.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ARTANE (Pakisonal) is administered to a nursing woman. As with other anticholinergics, Pakisonal may cause suppression of lactation. Therefore, Pakisonal should only be used if the expected benefit to the mother outweighs the potential risk to the infant.
What are some things I need to know or do while I take Pakisonal Tablets?
- Tell all of your health care providers that you take this medicine (Pakisonal tablets). This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (Pakisonal tablets) affects you.
- Avoid alcohol or other drugs and natural products that slow your actions.
- Do not stop taking this medicine (Pakisonal tablets) all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine (Pakisonal tablets), you will want to slowly stop it as ordered by your doctor.
- Loss of eyesight has happened in people with narrow-angle glaucoma. Talk with the doctor.
- Have your eye pressure and eyesight checked as you have been told by the doctor.
- Heat stroke has happened in people taking this medicine (Pakisonal tablets). Be careful in hot weather and during physical activity.
- If you are 60 or older, use this medicine (Pakisonal tablets) with care. You could have more side effects.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
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What are some other side effects of Pakisonal Tablets?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Blurred eyesight.
- Feeling sleepy.
- Dry mouth.
- Feeling nervous and excitable.
- Weight loss.
- Trouble sleeping.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Patients with cardiac, liver, or kidney disorders, or with hypertension, should be closely monitored.
Since ARTANE (Pakisonal) has atropine-like properties, patients on long-term treatment should be carefully monitored for untoward reactions.
Since ARTANE (Pakisonal) has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Incipient glaucoma may be precipitated by parasympatholytic drugs such as ARTANE (Pakisonal) .
Tardive dyskinesia may appear in some patients on long-term therapy with antipsychotic drugs or may occur after therapy with these drugs has been discontinued. Antiparkinsonism agents do not alleviate the symptoms of tardive dyskinesia, and in some instances may aggravate them. However, parkinsonism and tardive dyskinesia often coexist in patients receiving chronic neuroleptic treatment, and anticholinergic therapy with ARTANE (Pakisonal) may relieve some of these parkinsonism symptoms. ARTANE (Pakisonal) is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson's disease.
Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Such patients should be allowed to develop a tolerance through the initial administration of a small dose and gradual increase in dose until an effective level is reached. If a severe reaction should occur, administration of the drug should be discontinued for a few days and then resumed at a lower dosage. Psychiatric disturbances can result from indiscriminate use (leading to overdosage) to sustain continued euphoria. (See Drug Abuse And Dependence)
Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided (see DOSAGE AND ADMINISTRATION)
Where can I get more information?
Your pharmacist has more information about Pakisonal written for health professionals that you may read.
Pakisonal is the only anticholinergic with sufficient evidence supporting its use in dystonia . Its mechanism of action is not completely clear. It is thought that a selective M1 muscarinic receptor antagonism offsets synaptic plasticity deficits in the striatum and provides dystonia relief . Pakisonal should be started at a low dose of 1–2 mg daily and weekly titrated to a usual effective dose of 8–10 mg/day. Common side effects are dry mouth, constipation, blurred vision, cognitive impairment, and urinary retention. It is generally well tolerated in younger patients even at high doses, but its use in the elderly, especially in those with cognitive impairment or a history of retentive bladder, should be considered with caution.