Topamax (Page 11 of 12)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TOPAMAX ® Tablets
TOPAMAX ® (topiramate) Tablets are available as debossed, coated, round tablets in the following strengths and colors:
- 25 mg cream tablet (debossed “OMN” on one side; “25” on the other) and are available in bottles of 60 count with desiccant (NDC 50458-639-65)
- 50 mg light yellow tablet (debossed “OMN” on one side; “50” on the other) and are available in bottles of 60 count with desiccant (NDC 50458-640-65)
- 100 mg yellow tablet (debossed “OMN” on one side; “100” on the other) and are available in bottles of 60 count with desiccant (NDC 50458-641-65)
- 200 mg salmon tablet (debossed “OMN” on one side; “200” on the other) and are available in bottles of 60 count with desiccant (NDC 50458-642-65)
TOPAMAX ® Sprinkle Capsules
TOPAMAX ® (topiramate capsules) Sprinkle Capsules contain small, white to off-white spheres. The gelatin capsules are white and clear and are marked as follows:
- 15 mg capsule with “TOP” and “15 mg” on the side and are available in bottles of 60 (NDC 50458-647-65)
- 25 mg capsule with “TOP” and “25 mg” on the side and are available in bottles of 60 (NDC 50458-645-65)
16.2 Storage and Handling
TOPAMAX ® Tablets
TOPAMAX ® Tablets should be stored in tightly-closed containers at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from moisture.
TOPAMAX ® Sprinkle Capsules
TOPAMAX ® Sprinkle Capsules should be stored in tightly-closed containers at or below 25°C (77°F). Protect from moisture.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Eye Disorders
Instruct patients taking TOPAMAX ® to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions (5.1, 5.2)] .
Oligohidrosis and Hyperthermia
Closely monitor TOPAMAX ® -treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Warnings and Precautions (5.3)] .
Metabolic Acidosis
Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)] .
Suicidal Behavior and Ideation
Counsel patients, their caregivers, and families that AEDs, including TOPAMAX ® , may increase the risk of suicidal thoughts and behavior, and advise 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, or behavior or thoughts about self-harm. Instruct patients to immediately report behaviors of concern to their healthcare providers [see Warnings and Precautions (5.5)] .
Interference with Cognitive and Motor Performance
Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on TOPAMAX ® to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions (5.6)] .
Even when taking TOPAMAX ® or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Therefore, advise all patients taking TOPAMAX ® for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). Some patients with refractory epilepsy will need to avoid such activities altogether. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities.
Fetal Toxicity
Inform pregnant women and women of childbearing potential that use of TOPAMAX ® during pregnancy can cause fetal harm. TOPAMAX ® increases the risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Use in Specific Populations (8.1)] . There may also be risks to the fetus from chronic metabolic acidosis with use of TOPAMAX ® during pregnancy [see Warnings and Precautions (5.7), Use in Specific Populations (8.1)] . When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options.
Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using TOPAMAX ® , keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing or progestin-only contraceptives with topiramate [see Drug Interactions (7.4)] .
Encourage pregnant women using TOPAMAX ® , to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations (8.1)] .
Decrease in Bone Mineral Density
Inform the patient or caregiver that long-term treatment with TOPAMAX ® can decrease bone formation and increase bone resorption in children [see Warnings and Precautions (5.9)].
Negative Effects on Growth (Height and Weight)
Discuss with the patient or caregiver that long-term TOPAMAX ® treatment may attenuate growth as reflected by slower height increase and weight gain in pediatric patients [see Warnings and Precautions (5.10)].
Serious Skin Reactions
Inform patients about the signs of serious skin reactions. Instruct patients to immediately inform their healthcare provider at the first appearance of skin rash [see Warnings and Precautions (5.11)] .
Hyperammonemia and Encephalopathy
Warn patients about the possible development of hyperammonemia with or without encephalopathy. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. This hyperammonemia and encephalopathy can develop with TOPAMAX ® treatment alone or with TOPAMAX ® treatment with concomitant valproic acid (VPA).
Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status [see Warnings and Precautions (5.12)].
Kidney Stones
Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see Warnings and Precautions (5.13)].
Instructions for a Missing Dose
Instruct patients that if they miss a single dose of TOPAMAX ® , it should be taken as soon as possible. However, if a patient is within 6 hours of taking the next scheduled dose, tell the patient to wait until then to take the usual dose of TOPAMAX ® , and to skip the missed dose. Tell patients that they should not take a double dose in the event of a missed dose. Advise patients to contact their healthcare provider if they have missed more than one dose.
Manufactured by:
Janssen Ortho LLC
Gurabo, Puerto Rico 00778
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560, USA
© 2009 Janssen Pharmaceutical Companies
MEDICATION GUIDE TOPAMAX ® (TOE-PA-MAX) (topiramate) TABLETS, for oral use TOPAMAX ® (TOE-PA-MAX) (topiramate capsules) SPRINKLE CAPSULES, for oral use | ||||
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This Medication Guide has been approved by the U.S. Food and Drug Administration | Revised:5/2023 | |||
What is the most important information I should know about TOPAMAX?
TOPAMAX may cause eye problems.
Serious eye problems include:
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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 TOPAMAX. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, TOPAMAX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: | ||||
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Do not stop TOPAMAX without first talking to a healthcare provider.
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What is TOPAMAX? TOPAMAX is a prescription medicine used:
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Before taking TOPAMAX, tell your healthcare provider about all of your medical conditions, including if you:
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How should I take TOPAMAX?
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What should I avoid while taking TOPAMAX?
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What are the possible side effects of TOPAMAX?
TOPAMAX may cause serious side effects including:
See ”
What is the most important information I should know about TOPAMAX?”
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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 TOPAMAX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736). | ||||
How should I store TOPAMAX?
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General information about the safe and effective use of TOPAMAX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TOPAMAX for a condition for which it was not prescribed. Do not give TOPAMAX 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 TOPAMAX that is written for health professionals. | ||||
What are the ingredients in TOPAMAX? Active ingredient: topiramate
Inactive ingredients:
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