Zonegran

Get emergency medical help if you have signs of an allergic reaction: any form of skin rash, hives; fever, swollen glands, feeling weak or tired, severe muscle pain, unusual bruising or bleeding; yellowing of your skin or eyes; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• eye pain or redness or any changes in your vision;
• decreased sweating, feeling very hot;
• signs of metabolic acidosis--confusion, vomiting, lack of energy, irregular heartbeats;
• symptoms of a blood cell disorder--fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• symptoms of a kidney stone--severe pain in your stomach or lower back, blood in your urine;
• increased or worsening seizures;
• the first sign of any skin rash, no matter how mild; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• drowsiness, dizziness;
• problems with memory or concentration;
• feeling agitated or irritable;
• loss of coordination, trouble walking; or
• loss of appetite.

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.

Read the entire detailed patient monograph for Zonegran (Zonisamide)

 

Zonegran Professional Information

SIDE EFFECTS

The most common adverse reactions with ZONEGRAN (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration.

In controlled clinical trials, 12% of patients receiving ZONEGRAN as adjunctive therapy discontinued due to an adverse reaction compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received ZONEGRAN in clinical studies discontinued treatment because of an adverse reaction. The most common adverse reactions leading to discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse reactions were dose-related (see WARNINGS and PRECAUTIONS).

Adverse Reaction Incidence In Controlled Clinical Trials

Table 4 lists adverse reactions that occurred in at least 2% of patients treated with ZONEGRAN in controlled clinical trials that were numerically more common in the ZONEGRAN group. In these studies, either ZONEGRAN or placebo was added to the patient’s current AED therapy.

Table 4. Adverse Reactions in Placebo-Controlled, Add-On Trials (Events that occurred in at least 2% of ZONEGRAN-treated patients and occurred more frequently in ZONEGRAN-treated than placebo-treated patients)

BODY SYSTEM/ PREFERRED TERM	ZONEGRAN (n=269) %	PLACEBO (n=230) %
BODY AS A WHOLE
Headache	10	8
Abdominal Pain	6	3
Flu Syndrome	4	3
DIGESTIVE
Anorexia	13	6
Nausea	9	6
Diarrhea	5	2
Dyspepsia	3	1
Constipation	2	1
Dry Mouth	2	1
HEMATOLOGIS AND LYMPHATIC
Ecchymosis	2	1
METABOLIC AND NUTRITIONAL
Weight Loss	3	2
NERVOUS SYSTEM
Dizziness	13	7
Ataxia	6	1
Nystagmus	4	2
Paresthesia	4	1
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-ALTERED COGNITIVE FUNCTION
Confusion	6	3
Difficulty Concentrating	6	2
Difficulty with Memory	6	2
Mental Slowing	4	2
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (NON-PSYCHOSISRELATED)
Agitation/Irritability	9	4
Depression	6	3
Insomnia	6	3
Anxiety	3	2
Nervousness	2	1
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (PSYCHOSIS-RELATED)
Schizophrenic/Schizophreniform Behavior	2	0
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-CNS DEPRESSION
Somnolence	17	7
Fatigue	8	6
Tiredness	7	5
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-SPEECH AND LANGUAGE ABNORMALITIES
Speech Abnormalities	5	2
Difficulties in Verbal Expression	2	<1
RESPIRATORY
Rhinitis	2	1
SKIN AND APPENDAGES
Rash	3	2
SPECIAL SENSES
Diplopia	6	3
Taste Perversion	2	0

Other Adverse Reactions In Clinical Trials

ZONEGRAN has been administered to 1,598 individuals during all clinical trials, only some of which were placebo-controlled. The frequencies represent the proportion of the 1,598 individuals exposed to ZONEGRAN who experienced an event on at least one occasion. All events are included except those already listed in the previous table or discussed in WARNINGS or PRECAUTIONS, trivial events, those too general to be informative, and those not reasonably associated with ZONEGRAN.

Events are further classified within each category and listed in order of decreasing frequency as follows: frequent occurring in at least 1:100 patients; infrequent occurring in 1:100 to 1:1000 patients; rare occurring in fewer than 1:1000 patients.

Body As A Whole

Frequent: Accidental injury, asthenia. Infrequent: Chest pain, flank pain, malaise, allergic reaction, face edema, neck rigidity. Rare: Lupus erythematosus.

Cardiovascular

Infrequent: Palpitation, tachycardia, vascular insufficiency, hypotension, hypertension, thrombophlebitis, syncope, bradycardia. Rare: Atrial fibrillation, heart failure, pulmonary embolus, ventricular extrasystoles.

Digestive

Frequent: Vomiting. Infrequent: Flatulence, gingivitis, gum hyperplasia, gastritis, gastroenteritis, stomatitis, cholelithiasis, glossitis, melena, rectal hemorrhage, ulcerative stomatitis, gastro-duodenal ulcer, dysphagia, gum hemorrhage. Rare: Cholangitis, hematemesis, cholecystitis, cholestatic jaundice, colitis, duodenitis, esophagitis, fecal incontinence, mouth ulceration.

Hematologic And Lymphatic

Infrequent: Leukopenia, anemia, immunodeficiency, lymphadenopathy. Rare: Thrombocytopenia, microcytic anemia, petechia.

Metabolic And Nutritional

Infrequent: Peripheral edema, weight gain, edema, thirst, dehydration. Rare: Hypoglycemia, hyponatremia, lactic dehydrogenase increased, SGOT increased, SGPT increased.

Musculoskeletal

Infrequent: Leg cramps, myalgia, myasthenia, arthralgia, arthritis.

Nervous System

Frequent: Tremor, convulsion, abnormal gait, hyperesthesia, incoordination. Infrequent: Hypertonia, twitching, abnormal dreams, vertigo, libido decreased, neuropathy, hyperkinesia, movement disorder, dysarthria, cerebrovascular accident, hypotonia, peripheral neuritis, reflexes increased. Rare: Dyskinesia, dystonia, encephalopathy, facial paralysis, hypokinesia, hyperesthesia, myoclonus, oculogyric crisis.

Behavioral Abnormalities –Non-Psychosis-Related

Infrequent: Euphoria.

Respiratory

Frequent: Pharyngitis, cough increased. Infrequent: Dyspnea. Rare: Apnea, hemoptysis.

Skin And Appendages

Frequent: Pruritus. Infrequent: Maculopapular rash, acne, alopecia, dry skin, sweating, eczema, urticaria, hirsutism, pustular rash, vesiculobullous rash.

Special Senses

Frequent: Amblyopia, tinnitus. Infrequent: Conjunctivitis, parosmia, deafness, visual field defect, glaucoma. Rare: Photophobia, iritis.

Urogenital

Infrequent: Urinary frequency, dysuria, urinary incontinence, hematuria, impotence, urinary retention, urinary urgency, amenorrhea, polyuria, nocturia. Rare: Albuminuria, enuresis, bladder pain, bladder calculus, gynecomastia, mastitis, menorrhagia.

Post Marketing Experience

The following serious adverse reactions have been reported since approval and use of ZONEGRAN worldwide. These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, rhabdomyolysis, increased creatine phosphokinase, drug reaction with eosinophilia and systemic symptoms (DRESS), acute myopia and secondary angle closure glaucoma, and hyperammonemia and encephalopathy (see WARNINGS).

To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals at 1-877-370-1142 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Zonegran (Zonisamide)

&Copy; Zonegran Patient Information is supplied by Cerner Multum, Inc. and Zonegran Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.