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DEPARTMENT OF HEALTH SERVICES
Division of Care and Treatment Services F-24277 (09/2016)
STATE OF WISCONSIN
42 CFR483.420(a)(2) DHS 134.31(3)(o) DHS 94.03 & 94. §§ 51.61(1)(g) & (h )
INFORMED CONSENT FOR MEDICATION
Dosage and / or Side Effect information last revised on 06/08/
Completion of this form is voluntary. If not completed, the medication cannot be administered without a court order unless in an emergency. This consent is maintained in the clientâs record and is accessible to authorized users. Name â Patient / Client (Last, First MI) ID Number Living Unit Date of Birth
Name â Individual Preparing This Form Name â Staff Contact Name / Telephone Number â Institution
MEDICATION CATEGORY MEDICATION
RECOMMENDED
DAILY TOTAL DOSAGE RANGE
ANTICIPATED
DOSAGE
RANGE
Anticonvulsant Trileptal
(oxcarbazepine)
300mg - 2400mg
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 Physicianâs Desk Reference (PDR) or another standard reference.
This medication will be administered Orally Injection Other â Specify:
1. Reason for Use of Psychotropic Medication and Benefits Expected (note if this is âOff-Labelâ Use) Include DSM-5 diagnosis or the diagnostic âworking hypothesis.â 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
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 â Possible side effects, warnings, and cautions associated with this medication.
Most Common Side Effects Check with your doctor as soon as possible if any of the following side effects occur: change in vision; change in walking or balance; clumsiness or unsteadiness; cough, fever, sneezing, or sore throat; crying; dizziness; double vision; false sense of well-being; feeling of constant movement of self or surroundings; mental depression; sensation of spinning; uncontrolled back-and-forth and/or rolling eye movements.
Other more common possible side effects may include: abdominal pain; burning feeling in chest or stomach; nausea and vomiting; runny or stuffy nose; sleepiness or unusual drowsiness. Less Common Side Effects Check with your doctor as soon as possible if any of the following less common side effects occur: agitation; awkwardness; bloody or cloudy urine; blurred vision; bruising; confusion; congestion; convulsions (seizures); decreased urination; difficulty in focusing eyes; disorientation; faintness or light-headedness when getting up from a lying or sitting position; fast or irregular heartbeat; frequent falls; frequent urge to urinate; general feeling of illness; headache; hoarseness; increased thirst; itching of the vagina, with or without white vaginal discharge; loss of consciousness; memory loss; muscle cramps; pain or burning while urinating; pain or tenderness around eyes or cheekbones; poor control in body movements; problems with coordination; shaking or trembling of arms, legs, hands, and feet; shortness of breath; skin rash; stuffy or runny nose; tightness in chest; trouble in walking; troubled breathing; unusual feelings; unusual tiredness or weakness; wheezing.
Other less common side effects may include: acid or sour stomach; acne; back pain; belching; bloody nose; blurred vision; change in your sense of taste; constipation; diarrhea; difficulty in speaking; dryness of mouth; feeling of warmth and redness of face, neck, arms, and occasionally chest; heartburn; increased sweating; increased urination; nervousness; trouble in sleeping. Rare Side Effects Although rare, check with your doctor as soon as possible if any of the following side effects occur: anxiety; bleeding or crusting sores on lips; burning feeling in chest or stomach; chest pain; chills; decreased response to stimulation; hives or itching; irritability; joint pain; muscle pain or weakness; nervousness; purple spots on skin; rectal bleeding; redness, blistering, peeling, or loosening of skin; restlessness; sores, ulcers, or white spots in mouth or on lips; stomach upset; swelling of legs; swollen glands. Caution Do not take other medicines unless they have been discussed with your doctor. This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert).
This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Oral contraceptives (birth control pills) containing estrogen or progestin, contraceptive progestin injections (e.g., Depo-Provera), and implant contraceptive forms of progestin (e.g., Norplant) may not work properly if you take them while you are taking oxcarbazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking oxcarbazepine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. Warning Hyponatremia Clinically significant hyponatremia (sodium <125 mmol/L) can develop during TrileptalÂŽ (oxcarbazepine) use. In the 14 controlled epilepsy studies, 2.5% of Trileptal-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies). Clinically significant hyponatremia generally occurred during the first three months of treatment with Trileptal, although there were patients who first developed a serum sodium <125 mmol/L more than one year after initiation of therapy. Most patients who developed hyponatremia were asymptomatic but patients in the clinical trials were frequently monitored and some had their Trileptal dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia have been reported during post-marketing use. In clinical trials, patients whose treatment with Trileptal was discontinued due to hyponatremia generally experienced normalization of serum sodium within a few days without additional treatment. Measurement of serum sodium levels should be considered for patients during maintenance treatment with Trileptal, particularly if the patient is receiving other medications known to decrease serum sodium levels (for example, drugs associated with inappropriate ADH secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity).
Anaphylactic Reactions and Angioedema. Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Trileptal. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Trileptal, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug.
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:
- 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.
- 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.
- Questions regarding any behavior support plan or behavior intervention plan, which correspond with the use of the medication, can be directed to the clientâs social worker, case manager, or psychologist.
- 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).
- I have a legal right to file a complaint if I feel that client rights have been inappropriately restricted. The clientâs social worker, case manager, or agency/facility client rights specialist may be contacted for assistance.
- My consent permits the dose to be changed within the anticipated dosage range without signing another consent.
- 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.
- 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 â 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 â PRINT â Staff Name Date Obtained Written Consent Received Yes No
Obtained from â PRINT â Parent / Guardian (POA-HC) Name Date Expires Date Received
