Topiramate (Page 10 of 12)

16.1 How Supplied

Topiramate tablets, USP are available as debossed, film-coated, circular tablets in the following strengths and colors:

25 mg white (coded “S” on one side; “707” on the other)
50 mg yellow (coded “S” on one side; “710” on the other)
100 mg yellow (coded “S” on one side; “711” on the other)
200 mg brown (coded “S” on one side; “712” on the other)

They are supplied as follows:
25 mg tablets

Bottles of 30 with Child Resistant Cap……………NDC 47335-707-83

Bottles of 60 with Child Resistant Cap……………NDC 47335-707-86

Bottles of 100 with Child Resistant Cap ……………NDC 47335-707-88

Bottles of 100…………………………………………………NDC 47335-707-08

Bottles of 500………………………………………….. ……NDC 47335-707-13

Bottles of 1000………………………………………….. …..NDC 47335-707-18

50 mg tablets

Bottles of 30 with Child Resistant Cap……………..NDC 47335-710-83

Bottles of 60 with Child Resistant Cap…………..NDC 47335-710-86

Bottles of 100 with Child Resistant Cap …………..NDC 47335-710-88

Bottles of 100…………………………………………………NDC 47335-710-08

Bottles of 500………………………………………….. ……NDC 47335-710-13

Bottles of 1000………………………………………….. ….NDC 47335-710-18

100 mg tablets

Bottles of 30 with Child Resistant Cap………………NDC 47335-711-83

Bottles of 60 with Child Resistant Cap……………NDC 47335-711-86

Bottles of 100 with Child Resistant Cap ……………NDC 47335-711-88

Bottles of 100……………………………………………….…NDC 47335-711-08

Bottles of 500………………………………………….. …….NDC 47335-711-13

Bottles of 1000………………………………………………..NDC 47335-711-18

200 mg tablets

Bottles of 30 with Child Resistant Cap………………NDC 47335-712-83

Bottles of 60 with Child Resistant Cap……………NDC 47335-712-86

Bottles of 100 with Child Resistant Cap ……………NDC 47335-712-88

Bottles of 100………………………………………………….NDC 47335-712-08

Bottles of 500………………………………………………….NDC 47335-712-13

Bottles of 1000………………………………………………..NDC 47335-712-18

16.2 Storage and Handling


Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

17 PATIENT COUNSELING INFORMATION


Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Eye Disorders
Instruct patients taking topiramate tablets 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 topiramate-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 topiramate tablets, 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 topiramate tablets to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions (5.6)].

Even when taking topiramate or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Therefore, advise all patients taking topiramate 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 topiramate during pregnancy can cause fetal harm. Topiramate 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 topiramate 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 topiramate, 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 topiramate, 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 topiramate tablets 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 topiramate tablets 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 topiramate treatment alone or with topiramate 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 DoseInstruct patients that if they miss a single dose of topiramate, 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 topiramate, 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.

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