Warnings and Precautions ( |
10/2022 |
|
|
|
Week 1 |
25 mg |
25 mg |
Week 2 |
50 mg |
50 mg |
Week 3 |
75 mg |
75 mg |
Week 4 |
100 mg |
100 mg |
Week 5 |
150 mg |
150 mg |
Week 6 |
200 mg |
200 mg |
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|
Up to 11 |
150 |
250 |
12 to 22 |
200 |
300 |
23 to 31 |
200 |
350 |
32 to 38 |
250 |
350 |
Greater than 38 |
250 |
400 |
|
|
|
Week 1 |
None |
25 mg |
Week 2 |
25 mg |
25 mg |
Week 3 |
25 mg |
50 mg |
Week 4 |
50 mg |
50 mg |
|
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|
|
Epilepsy |
1 |
3.4 |
3.5 |
2.4 |
Psychiatric |
5.7 |
8.5 |
1.5 |
2.9 |
Other |
1 |
1.8 |
1.9 |
0.9 |
Total |
2.4 |
4.3 |
1.8 |
1.9 |
Adverse Reaction |
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Asthenia |
0 |
3 |
4 |
6 |
|
Fever |
1 |
12 |
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Leg pain |
2 |
3 |
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Paresthesia |
3 |
12 |
21 |
40 |
|
Dizziness |
13 |
14 |
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Ataxia |
3 |
4 |
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Hypoesthesia |
4 |
5 |
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Hypertonia |
0 |
3 |
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Involuntary muscle contractions |
0 |
3 |
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Vertigo |
0 |
3 |
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Constipation |
1 |
4 |
|||
Diarrhea |
8 |
9 |
|||
Gastritis |
0 |
3 |
|||
Dry mouth |
1 |
3 |
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Increase in Gamma-GT |
1 |
3 |
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Weight loss |
7 |
17 |
6 |
17 |
|
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Epistaxis |
0 |
4 |
|||
|
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Anorexia |
4 |
14 |
|||
Anxiety |
4 |
6 |
|||
Cognitive problems |
1 |
6 |
1 |
4 |
|
Confusion |
0 |
3 |
|||
Depression |
0 |
3 |
7 |
9 |
|
Difficulty with concentration or attention |
7 |
10 |
7 |
8 |
|
Difficulty with memory |
1 |
3 |
6 |
11 |
|
Insomnia |
8 |
9 |
|||
Decrease in libido |
0 |
3 |
|||
Mood problems |
1 |
8 |
2 |
5 |
|
Personality disorder (behavior problems) |
0 |
3 |
|||
Psychomotor slowing |
3 |
5 |
|||
Somnolence |
10 |
15 |
|||
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Anemia |
1 |
3 |
|||
|
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Intermenstrual Bleeding |
0 |
3 |
|||
Vaginal Hemorrhage |
0 |
3 |
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|
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Infection |
3 |
8 |
2 |
3 |
|
Viral Infection |
3 |
6 |
6 |
8 |
|
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Bronchitis |
1 |
5 |
3 |
4 |
|
Upper respiratory tract infection |
16 |
18 |
|||
Rhinitis |
5 |
6 |
2 |
4 |
|
Sinusitis |
1 |
4 |
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Alopecia |
1 |
4 |
3 |
4 |
|
Pruritus |
1 |
4 |
|||
Rash |
3 |
4 |
1 |
4 |
|
Acne |
2 |
3 |
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Taste perversion |
3 |
5 |
|||
|
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Cystitis |
1 |
3 |
|||
Micturition frequency |
0 |
3 |
|||
Renal calculus |
0 |
3 |
|||
Urinary incontinence |
1 |
3 |
|||
|
|||||
Flushing |
0 |
5 |
|
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Adverse Reaction |
|
|
|
|
|
|
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Fatigue |
13 |
15 |
Asthenia |
1 |
6 |
Back pain |
4 |
5 |
Chest pain |
3 |
4 |
Influenza-like symptoms |
2 |
3 |
|
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Dizziness |
15 |
25 |
Ataxia |
7 |
16 |
Speech disorders/Related speech problems |
2 |
13 |
Paresthesia |
4 |
11 |
Nystagmus |
7 |
10 |
Tremor |
6 |
9 |
Language problems |
1 |
6 |
Coordination abnormal |
2 |
4 |
Gait abnormal |
1 |
3 |
|
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Nausea |
8 |
10 |
Dyspepsia |
6 |
7 |
Abdominal pain |
4 |
6 |
Constipation |
2 |
4 |
|
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Weight loss |
3 |
9 |
|
||
Somnolence |
12 |
29 |
Nervousness |
6 |
16 |
Psychomotor slowing |
2 |
13 |
Difficulty with memory |
3 |
12 |
Confusion |
5 |
11 |
Anorexia |
4 |
10 |
Difficulty with concentration/attention |
2 |
6 |
Mood problems |
2 |
4 |
Agitation |
2 |
3 |
Aggressive reaction |
2 |
3 |
Emotional lability |
1 |
3 |
Cognitive problems |
1 |
3 |
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Breast pain |
2 |
4 |
|
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Rhinitis |
6 |
7 |
Pharyngitis |
2 |
6 |
Sinusitis |
4 |
5 |
|
||
Vision abnormal |
2 |
13 |
Diplopia |
5 |
10 |
|
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|
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Adverse Reaction |
|
|
|
|
|
|
|
|
|
||
Fatigue |
5 |
16 |
Injury |
13 |
14 |
|
||
Gait abnormal |
5 |
8 |
Ataxia |
2 |
6 |
Hyperkinesia |
4 |
5 |
Dizziness |
2 |
4 |
Speech disorders/Related speech problems |
2 |
4 |
|
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Nausea |
5 |
6 |
Saliva increased |
4 |
6 |
Constipation |
4 |
5 |
Gastroenteritis |
2 |
3 |
|
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Weight loss |
1 |
9 |
|
||
Purpura |
4 |
8 |
Epistaxis |
1 |
4 |
|
||
Somnolence |
16 |
26 |
Anorexia |
15 |
24 |
Nervousness |
7 |
14 |
Personality disorder (behavior problems) |
9 |
11 |
Difficulty with concentration/attention |
2 |
10 |
Aggressive reaction |
4 |
9 |
Insomnia |
7 |
8 |
Difficulty with memory |
0 |
5 |
Confusion |
3 |
4 |
Psychomotor slowing |
2 |
3 |
|
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Infection viral |
3 |
7 |
|
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Pneumonia |
1 |
5 |
|
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Skin disorder |
2 |
3 |
|
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Urinary incontinence |
2 |
4 |
|
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|
|
|
|
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|
|||
Fatigue |
11 |
14 |
15 |
Injury |
7 |
9 |
6 |
|
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Paresthesia |
6 |
35 |
51 |
Dizziness |
10 |
8 |
9 |
Hypoesthesia |
2 |
6 |
7 |
Language problems |
2 |
7 |
6 |
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Nausea |
8 |
9 |
13 |
Diarrhea |
4 |
9 |
11 |
Abdominal pain |
5 |
6 |
6 |
Dyspepsia |
3 |
4 |
5 |
Dry mouth |
2 |
2 |
3 |
Gastroenteritis |
1 |
3 |
3 |
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Weight loss |
1 |
6 |
9 |
|
|||
Arthralgia |
2 |
7 |
3 |
|
|||
Anorexia |
6 |
9 |
15 |
Somnolence |
5 |
8 |
7 |
Difficulty with memory |
2 |
7 |
7 |
Insomnia |
5 |
6 |
7 |
Difficulty with concentration/ attention |
2 |
3 |
6 |
Mood problems |
2 |
3 |
6 |
Anxiety |
3 |
4 |
5 |
Depression |
4 |
3 |
4 |
Nervousness |
2 |
4 |
4 |
Confusion |
2 |
2 |
3 |
Psychomotor slowing |
1 |
3 |
2 |
|
|||
Menstrual disorder |
2 |
3 |
2 |
|
|||
Ejaculation premature |
0 |
3 |
0 |
|
|||
Viral infection |
3 |
4 |
4 |
|
|||
Upper respiratory tract infection |
12 |
13 |
14 |
Sinusitis |
6 |
10 |
6 |
Pharyngitis |
4 |
5 |
6 |
Coughing |
2 |
2 |
4 |
Bronchitis |
2 |
3 |
3 |
Dyspnea |
2 |
1 |
3 |
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Pruritis |
2 |
4 |
2 |
|
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Taste perversion |
1 |
15 |
8 |
|
|||
Urinary tract infection |
2 |
4 |
2 |
|
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Blurred visionc
|
2 |
4 |
2 |
Adverse Reaction |
|
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|
|
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|
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|
|
||
|
|||
Fatigue |
7 |
7 |
8 |
Fever |
2 |
4 |
6 |
|
|||
Paresthesia |
7 |
20 |
19 |
Dizziness |
4 |
4 |
6 |
|
|||
Abdominal pain |
9 |
7 |
15 |
Nausea |
4 |
4 |
8 |
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Weight loss |
2 |
7 |
4 |
|
|||
Anorexia |
4 |
9 |
10 |
Somnolence |
2 |
2 |
6 |
Insomnia |
2 |
9 |
2 |
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Infection viral |
4 |
4 |
8 |
|
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Upper respiratory tract infection |
11 |
26 |
23 |
Rhinitis |
2 |
7 |
6 |
Sinusitis |
2 |
9 |
4 |
Coughing |
0 |
7 |
2 |
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Taste perversion |
2 |
2 |
6 |
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Conjunctivitis |
4 |
7 |
4 |
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Phenytoin |
NC or 25% increase a
|
48 % decrease |
Carbamazepine (CBZ ) |
NC |
40 % decrease |
CBZ epoxide b
|
NC |
NE |
Valproic acid |
11 % decrease |
14 % decrease |
Phenobarbital |
NC |
NE |
Primidone |
NC |
NE |
Lamotrigine |
NC at TPM doses up to 400 mg/day |
13 % decrease |
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2 |
N |
42 |
42 |
40 |
41 |
- |
- |
Mean Dose |
5.9 |
200 |
390 |
556 |
- |
- |
|
Median Dose |
6 |
200 |
400 |
600 |
- |
- |
|
3 |
N |
44 |
- |
- |
40 |
45 |
40 |
Mean Dose |
9.7 |
- |
- |
544 |
739 |
796 |
|
Median Dose |
10 |
- |
- |
600 |
800 |
1,000 |
|
4 |
N |
23 |
- |
19 |
- |
- |
- |
Mean Dose |
3.8 |
- |
395 |
- |
- |
- |
|
Median Dose |
4 |
- |
400 |
- |
- |
- |
|
5 |
N |
30 |
- |
- |
28 |
- |
- |
Mean Dose |
5.7 |
- |
- |
522 |
- |
- |
|
Median Dose |
6 |
- |
- |
600 |
- |
- |
|
6 |
N |
28 |
- |
- |
- |
25 |
- |
Mean Dose |
7.9 |
- |
- |
- |
568 |
- |
|
Median Dose |
8 |
- |
- |
- |
600 |
- |
|
7 |
N |
90 |
157 |
- |
- |
- |
- |
Mean Dose |
8 |
200 |
- |
- |
- |
- |
|
Median Dose |
8 |
200 |
- |
- |
- |
- |
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2 |
N |
45 |
45 |
45 |
46 |
- |
- |
- |
Median % Reduction |
12 |
27a
|
48b
|
45c
|
- |
- |
- |
|
% Responders |
18 |
24 |
44d
|
46d
|
- |
- |
- |
|
3 |
N |
47 |
- |
- |
48 |
48 |
47 |
- |
Median % Reduction |
2 |
- |
- |
41c
|
41c
|
36c
|
- |
|
% Responders |
9 |
- |
- |
40c
|
41c
|
36d
|
- |
|
4 |
N |
24 |
- |
23 |
- |
- |
- |
- |
Median % Reduction |
1 |
- |
41e
|
- |
- |
- |
- |
|
% Responders |
8 |
- |
35d
|
- |
- |
- |
- |
|
5 |
N |
30 |
- |
- |
30 |
- |
- |
- |
Median % Reduction |
-12 |
- |
- |
46f
|
- |
- |
- |
|
% Responders |
10 |
- |
- |
47c
|
- |
- |
- |
|
6 |
N |
28 |
- |
- |
- |
28 |
- |
- |
Median % Reduction |
-21 |
- |
- |
- |
24c
|
- |
- |
|
% Responders |
0 |
- |
- |
- |
43c
|
- |
- |
|
7 |
N |
91 |
168 |
- |
- |
- |
- |
- |
Median % Reduction |
20 |
44c
|
- |
- |
- |
- |
- |
|
% Responders |
24 |
45c
|
- |
- |
- |
- |
- |
|
|
||||||||
8 |
N |
45 |
- |
- |
- |
- |
- |
41 |
Median % Reduction |
11 |
- |
- |
- |
- |
- |
33d
|
|
% Responders |
20 |
- |
- |
- |
- |
- |
39 |
|
|
||||||||
9 |
N |
40 |
- |
- |
- |
- |
- |
39 |
Median % Reduction |
9 |
- |
- |
- |
- |
- |
57d
|
|
% Responders |
20 |
- |
- |
- |
- |
- |
56c
|
|
|
||||||||
10 |
N |
49 |
- |
- |
- |
- |
- |
46 |
Median % Reduction |
-5 |
- |
- |
- |
- |
- |
15d
|
|
% Responders |
14 |
- |
- |
- |
- |
- |
28g
|
|
Improvement in Seizure Severityj |
28 |
- |
- |
- |
- |
- |
52d
|
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Median |
3.6 |
4 |
4 |
|
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|
|
Median |
2.3 |
2.3 |
1 |
|
|
|
|
Median |
44.4 |
44.6 |
72.2 |
P-value versus Placeboa,b
|
0.7975 |
0.0164c
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Sometimes people with metabolic acidosis will: |
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Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with topiramate. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. |
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Topiramate is a prescription medicine used:
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Especially tell your healthcare provider if you take:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider. |
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Topiramate may cause serious side effects including: See
The most common side effects of topiramateinclude: |
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Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of topiramate. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use topiramate for a condition for which it was not prescribed. Do not give topiramate to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about topiramate that is written for health professionals. Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779. |
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DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. |
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Ahmedabad, India Pennington, NJ 08534 |
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Rev.: 05/23 |