Client Initial
Date
DEPARTMENT OF HEALTH SERVICES
Division of Care and Treatment Services
F-24277 (05/2024)
STATE OF WISCONSIN
42 CFR483.420(a)(2)
DHS 134.31(3)(o)
DHS 94.03 & 94.09
§§ 51.61(1)(g) & (h)
INFORMED CONSENT FOR MEDICATION
Dosage and / or Side Effect information last revised on 05/27/2021
Completion of this form is voluntary. If informed consent is not given, the medication cannot be administered without a court order unless in
an emergency.
This consent is maintained in the client’s record and is accessible to authorized users.
Name – Patient / Client (Last, First MI)
,
ID Number
Living Unit
Date of Birth
Name – Individual Preparing This Form
Name – Staff Contact
Name / Telephone Number – Institution
MEDICATION CATEGORY MEDICATION
RECOMMENDED
DAILY TOTAL DOSAGE RANGE
ANTICIPATED
DOSAGE
RANGE
Anticonvulsant
Gabitril
(tiagabine)
4 mg-56 mg
The anticipated dosage range is to be individualized, may be above or below the recommended range but no medication will be administered
without your informed and written consent.
Recommended daily total dosage range of manufacturer, as stated in Physician’s Desk Reference (PDR) or another standard reference.
This medication will be administered Orally Injection Other – Specify:
1. Reason for Use of Psychotropic Medication and Benefits Expected (note if this is ‘Off-Label’ Use)
Include DSM-5 diagnosis or the diagnostic impression (“working hypothesis.”)
2. Alternative mode(s) of treatment other than OR in addition to medications include
Note: Some of these would be applicable only in an inpatient environment.
Environment and/or staff changes
Rehabilitation treatments/therapy (OT, PT, AT)
Positive redirection and staff interaction
Treatment programs and approaches (habilitation)
Individual and/or group therapy
Use of behavior intervention techniques
Other Alternatives:
3. Probable consequences of NOT receiving the proposed medication are
Impairment of Work Activities Family Relationships Social Functioning
Possible increase in symptoms leading to potential
Use of seclusion or restraint
Limits on recreation and leisure activities
Limits on access to possessions
Intervention of law enforcement authorities
Limits on personal freedoms
Risk of harm to self or others
Limit participation in treatment and activities
Other Consequences
:
Note: These consequences may vary depending upon whether or not the individual is in an inpatient setting. It is also possible that in
unusual situations, little or no adverse consequences may occur if the medications are not administered.
See Page 2
Client Initial
Date
2
F-24277
Medication: Gabitril – (tiagabine)
4. Possible side effects, warnings, and cautions associated with this medication are listed below. This is not an all-inclusive list but is
representative of items of potential clinical significance to you. For more information on this medication, you may consult further with your
physician or refer to a standard text, such as the PDR. As part of monitoring some of these potential side effects, your physician may
order laboratory or other tests. The treatment team will closely monitor individuals who are unable to readily communicate side effects in
order to enhance care and treatment.
Continued – Possible side effects, warnings, and cautions associated with this medication.
Most Common Side Effects: dizziness, drowsiness, nervousness, loss of concentration, nausea, increased risk of infections; weakness;
tremor; accidental injury from clumsiness.
Less Common Side Effects: abdominal pain; flushing; impaired vision; increased appetite; increased cough; mouth ulcers; muscle
weakness; nausea; pain; difficulty falling asleep or staying asleep; burning, numbness, or tingling sensations; confusion; itching; mental
depression; speech or language problems; altered balance; difficulty walking; increased involuntary movements; rash; urinary tract infections;
altered memory; ear ringing; altered vision; vomiting; diarrhea; hair loss; dry skin; flu-like symptoms.
Rare Side Effects: Check with your doctor as soon as possible if you experience any of the following: agitation; bloody or cloudy urine;
burning, pain, or difficulty urinating; frequent urge to urinate; severe generalized weakness; hostility; memory problems; quick to react or
overreact emotionally; rash; uncontrolled back-and-forth and/or rolling eye movements; walking in unusual manner; signs of an allergic
reaction (swelling of the face, lips, or tongue; difficulty breathing, rash/hives).
Caution
Driving and Operating Heavy Machinery
Tiagabine may cause dizziness, drowsiness, trouble thinking, trouble with motor skills, or vision problems. It is recommended to not
drive, operate heavy machinery, or perform any other task that may be dangerous if not fully alert until you know how this
medication affects you.
Seizures in Patients Without Epilepsy
Post-marketing reports have shown that tiagabine use has been associated with new onset seizures and status epilepticus in
patients without epilepsy. Additionally, safety and effectiveness of tiagabine have not been established for any indication other than
as adjunctive therapy for partial seizures in adults and children 12 years and older. If you do experience a seizure while taking this
medication for conditions other than experiencing seizures, please call your doctor promptly.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including tiagabine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for
any indication. If you do experience new or worsening thoughts, please call your doctor immediately.
Withdrawal Seizures
As a rule, antiepilepsy drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. If for
any reason you feel this drug needs to be stopped, please consult with your doctor. Do not stop taking this medication without
talking to your doctor.
Skin Reactions
This medication may cause a rare, but severe rash in certain individuals. If you do notice a severe rash, or any other abnormal skin
changes, please call your doctor promptly.
General Muscle Weakness
Moderately severe to generalized weakness has been reported after administration of tiagabine. The weakness resolved in all
cases after a reduction in dose or discontinuation of tiagabine.
Warning
Seizures in Patients Without Epilepsy
Post-marketing reports have shown that tiagabine use has been associated with new onset seizures and status epilepticus in patients
without epilepsy. Dose may be an important predisposing factor in the development of seizures, although seizures have been reported in
patients taking daily doses of tiagabine as low as 4mg/day. In most cases, patients were using concomitant medications (antidepressants,
antipsychotics, stimulants, narcotics) that are thought to lower the seizure threshold. Some seizures occurred near the time of a dose
increase, even after periods of prior stable dosing.
The tiagabine dosing recommendations in current labeling for treatment of epilepsy were based on use in patients with partial seizures 12
years of age and older, most of whom were taking enzyme-inducing antiepileptic drugs (AEDs; e.g., carbamazepine, phenytoin, primidone
and phenobarbital) which lower plasma levels of tiagabine by inducing its metabolism. Use of tiagabine without enzyme-inducing antiepileptic
drugs results in blood levels about twice those attained in the studies on which current dosing recommendations are based.
Safety and effectiveness of tiagabine have not been established for any indication other than as adjunctive therapy for partial seizures in
adults and children 12 years and older.
Client Initial
Date
3
F-24277
Medication: Gabitril – (tiagabine)
In nonepileptic patients who develop seizures while on tiagabine treatment, tiagabine should be discontinued and patients should be
evaluated for an underlying seizure disorder. Seizures and status epilepticus are known to occur with tiagabine overdosage.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including tiagabine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any
indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal
thoughts or behavior, and/or any unusual changes in mood or behavior. The increased risk of suicidal thoughts or behavior with AEDs was
observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most
trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be
assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk
with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any
indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. The relative risk for suicidal thoughts or
behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were
similar for the epilepsy and psychiatric indications. Anyone considering prescribing tiagabine or any other AED must balance the risk of
suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are
themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and
behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be
related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal
thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of
depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Behaviors of concern should be reported immediately to healthcare providers.
Withdrawal Seizures
As a rule, antiepilepsy drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. In a placebo-
controlled, double-blind, dose-response study designed, in part, to investigate the capacity of tiagabine to induce withdrawal seizures, study
drug was tapered over a 4-week period after 16 weeks of treatment. Patients’ seizure frequency during this 4-week withdrawal period was
compared to their baseline seizure frequency (before study drug). For each partial seizure type, for all partial seizure types combined, and for
secondarily generalized tonic-clonic seizures, more patients experienced increases in their seizure frequencies during the withdrawal period
in the three tiagabine groups than in the placebo group. The increase in seizure frequency was not affected by dose. Tiagabine should be
withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.
See standard reference text for an all-inclusive list of side effects.
Client Initial
Date
4
F-24277
Medication: Gabitril – (tiagabine)
By my signature below, I GIVE consent for the named medication on Page 1 and anticipated dosage range. My signature also
indicates that I understand the following:
1. I can refuse to give consent or can withdraw my consent at any time with written notification to the institution director or designee. This
will not affect my right to change my decision at a later date. If I withdraw consent after a medication is started, I realize that the
medication may not be discontinued immediately. Rather, it will be tapered as rapidly as medically safe and then discontinued so as to
prevent an adverse medical consequence, such as seizures, due to rapid medication withdrawal.
2. Questions regarding this medication can be discussed with the Interdisciplinary Team, including the physician. The staff contact person
can assist in making any necessary arrangements.
3. Questions regarding any behavior support plan or behavior intervention plan, which correspond with the use of the medication, can be
directed to the client’s social worker, case manager, or psychologist.
4. I have the right to request a review at any time of my record, pursuant to § 51.30(4)(d) or § 51.30(5)(b).
5. I have a legal right to file a complaint if I feel that client rights have been inappropriately restricted. The client’s social worker, case
manager, or agency/facility client rights specialist may be contacted for assistance.
6. My consent permits the dose to be changed within the anticipated dosage range without signing another consent.
7. I understand the reasons for the use of the medication, its potential risks and benefits, other alternative treatment(s), and the probable
consequences that may occur if the proposed medication is not given. I have been given adequate time to study the information and find
the information to be specific, accurate, and complete.
8. This medication consent is for a period effective immediately and not to exceed fifteen (15) months from the date of my signature. The
need for and continued use of this medication will be reviewed at least quarterly by the Interdisciplinary Team. The goal, on behalf of the
client, will be to arrive at and maintain the client at the minimum effective dose.
SIGNATURES
DATE SIGNED
Client – If Presumed Competent to Consent/Parent of Minor/Guardian (POA-HC)
Relationship to Client Self
Parent Guardian (POA-HC)
Staff Present at Oral Discussion
Title
Client / Parent of Minor / Guardian (POA-HC) Comments
As parent/guardian (POA-HC) was not available for signature, he/she was verbally informed of the information in this consent.
Verbal Consent
Obtained by – PRINT – Staff Name
Date Obtained
Written Consent Received
Yes No
Obtained from – PRINT – Parent / Guardian (POA-HC) Name
Date Expires
Date Received
