Do NOT use Orap if:

1. You are allergic to any ingredient in Orap.

1. You are treating simple tics or tics other than those associated with Tourette syndrome (e.g. tics that may be caused by certain medicines such as methylphenidate or pemoline).

1. You are taking medicines that may cause a certain type of irregular heartbeat (prolonged QT interval) such as certain heart medicines (eg, quinidine).

1. You are taking astemizole, cisapride, citalopram, delavirdine, dofetilide, escitalopram, fluvoxamine, nefazodone, a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), an azole antifungal (eg, itraconazole, ketoconazole), an HIV protease inhibitor (eg, ritonavir), sertraline, terfenadine, or zileuton.

1. You have congenital long QT syndrome, an irregular heartbeat or history of irregular heartbeat, low blood potassium or magnesium levels, or severe nervous system depression.

Sudden, unexpected deaths have occurred in patients taking high doses of Orap for conditions other than Tourette’s Disorder. These deaths may have been the result of an effect of Orap upon the heart. Therefore, patients should be instructed not to exceed the prescribed dose of Orap and they should realize the need for the initial ECG and for follow-up ECGs during treatment.

Orap (pimozide) may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery, especially during the first few days of therapy.

Orap is intended only for use in patients with Tourette’s Disorder whose symptoms are severe and who cannot tolerate, or who do not respond to Haldol (haloperidol).

Given the likelihood that a proportion of patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk.
Because substances in grapefruit juice may inhibit the metabolism of pimozide by CYP 3A4, patients should be advised to avoid grapefruit juice.

Pediatric Use: Although Tourette's Disorder most often has its onset between the ages of 2 and 15 years, information on the use and efficacy of Orap in patients less than 12 years of age is limited. Because its use and safety have not been evaluated in other childhood disorders, Orap is not recommended for use in any condition other than Tourette’s Disorder.

ORAP SIDE EFFECT: Anorexia

Reduced appetite or total aversion to food.

ORAP SIDE EFFECT: Asthenia

An abnormal loss of strength.

ORAP SIDE EFFECT: Blurred vision

Blurred vision is the loss of sharpness of vision and the inability to see small details.

ORAP SIDE EFFECT: Cataracts

A clouding that develops in the crystalline lens of the eye or in its envelope, varying in degree from slight to complete opacity and obstructing the passage of light.

ORAP SIDE EFFECT: Chest pain

Discomfort or pain that you feel anywhere along the front of your body between your neck and upper abdomen.

ORAP SIDE EFFECT: Confusion

Being unable to think with clarity or act with understanding and intelligence.

ORAP SIDE EFFECT: Dizziness

An impairment in spatial perception and stability.

ORAP SIDE EFFECT: Drooling

When saliva flows outside the mouth. Drooling is generally caused by excess production of saliva, inability to retain saliva within the mouth, or problems with swallowing.

ORAP SIDE EFFECT: Drowsiness

A very sleepy state.

ORAP SIDE EFFECT: Dry mouth

Inability to make saliva.

ORAP SIDE EFFECT: Dyskinesia

An impairment in the ability to control movements, characterized by spasmodic or repetitive motions or lack of coordination.

ORAP SIDE EFFECT: Excitement

An emotional state characterized by its potential for impulsive or poorly controlled activity.

ORAP SIDE EFFECT: Fainting

Loss of consciousness caused by a temporary lack of oxygen to the brain.

ORAP SIDE EFFECT: GI distress

Gastrointestinal disturbances, illness, sickness, unwellness, or malady in the stomach and/or bowel areas.

ORAP SIDE EFFECT: Hypertension

Arterial disease in which chronic high blood pressure is the primary symptom.

ORAP SIDE EFFECT: Hypotension

Low blood pressure, or hypotension, occurs when blood pressure during and after each heartbeat is much lower than usual. This means the heart, brain, and other parts of the body do not get enough blood.

ORAP SIDE EFFECT: Impaired body movement

Inability to perform ordinary, normal body movements.

ORAP SIDE EFFECT: Increase in prolactin

Prolactin is the hormone associated with breast development and milk production in women. High levels of prolactin in women who are not lactating are associated with infertility and miscarriages.

ORAP SIDE EFFECT: Increased salivation

Excess salivation produces abnormally large amounts of saliva.

ORAP SIDE EFFECT: Loss of consciousness

A loss of the ability to perceive and respond.

ORAP SIDE EFFECT: Loss of libido

A persistent absence of desire for sexual activity.

ORAP SIDE EFFECT: Mask-like face

An expressionless face with little or no sense of animation.

ORAP SIDE EFFECT: Nausea

A feeling of sickness in the stomach characterized by an urge to vomit.

ORAP SIDE EFFECT: Neuroleptic malignant syndrome (NMS)

A life-threatening neurological disorder most often caused by an adverse reaction to neuroleptic or antipsychotic drugs. It generally presents with muscle rigidity, fever, autonomic instability and cognitive changes such as delirium.

ORAP SIDE EFFECT: Nocturia

Excessive urination at night.

ORAP SIDE EFFECT: Palpitations

Sensation in which a person is aware of an irregular, hard, or rapid heartbeat.

ORAP SIDE EFFECT: Parkinsonism

A group of neurological disorders marked by hypokinesia (abnormally decreased muscular movement), tremor, and muscular rigidity.

ORAP SIDE EFFECT: Periorbital edema

Puffy eyes, caused by an abnormal buildup of fluid around the eyes.

ORAP SIDE EFFECT: Postural hypotension

A drop in blood pressure (hypotension) due to a change in body position (posture) which may cause dizziness and fainting.

ORAP SIDE EFFECT: Rash

A group of spots or red, inflamed skin.

ORAP SIDE EFFECT: Restlessness

Marked by a lack of quiet, repose, or rest.

ORAP SIDE EFFECT: Severe muscle spasms/cramping (twisting neck, arching back, eyes rolling up)

Uncontrolled muscle contractions, resulting in disfiguring distortions of the body parts.

ORAP SIDE EFFECT: Skin irritation

Irritability, soreness, roughness, inflammation or pain in the skin.

ORAP SIDE EFFECT: Slow/shuffling walk

To walk slowly and dragging one’s feet.

ORAP SIDE EFFECT: Stiff muscles

Medically defined as “half way to rigidity”, a condition of lacking in suppleness.

ORAP SIDE EFFECT: Sudden death

An instant unexpected death.

ORAP SIDE EFFECT: Sweating

Perspire or excrete moisture in visible quantities through the openings of the sweat glands.

ORAP SIDE EFFECT: Tachycardia

Abnormally rapid heart rate.

ORAP SIDE EFFECT: Tardive dyskinesia

A mostly irreversible neurological disorder of involuntary movements. There is no known effective treatment for tardive dyskinesia.

ORAP SIDE EFFECT: Tremor

A trembling or shaking usually from physical weakness.

ORAP SIDE EFFECT: Trouble swallowing - (dysphagia)

means it takes more time and effort to move food or liquid from your mouth to your stomach. Difficulty swallowing may also be associated with pain. In some cases, you may not be able to swallow at all.

ORAP SIDE EFFECT: Tumors

An abnormal growth of body tissue.

ORAP SIDE EFFECT: Urinary frequency

A person with urinary frequency urinates more often than usual.

ORAP SIDE EFFECT: Vision changes

May involve loss of vision or distortion of vision. E.g. blurriness, blind spots, halos around lights, or dimness of vision.

ORAP SIDE EFFECT: Vomiting

To eject part or all of the contents of the stomach through the mouth, usually in a series of involuntary movements.

ORAP SIDE EFFECT: Weight gain

An increase in body weight.

ORAP SIDE EFFECT: Weight loss
A reduction in body mass from loss of body fat and muscle.