最常见的不良反应主要为与中枢神经系统相关的症状,包括:共济失调、注意力受损、意识模糊、头晕、疲劳、感觉异常、嗜睡和思维异常。不常见的不良反应包括焦虑、遗忘、食欲不振、失语、忧郁、复视、情绪不稳、恶心、眼球震颤、言语表达障碍、味觉倒错、视觉异常和体重减轻。罕见肾石症的报道。有个例血栓栓塞的报道,其与药物间的相关性不明确。
Topamax(Topiramate)
Topiramate, sold under the brand name Topamax among others, is a medication used to treat epilepsy and prevent migraines.[1] It has also been used in alcohol dependence.[1] For epilepsy this includes with generalized or focal seizures.[2] It is taken by mouth.[1]
Common side effects include tingling, loss of appetite, feeling tired, abdominal pain, hair loss, and trouble concentrating.[1][2] Serious side effects may include suicide, increased ammonia levels resulting in encephalopathy, and kidney stones.[1] Use in pregnancy may result in harm to the baby and use during breastfeeding is not recommended.[3] How it works is unclear.[1]
Topiramate was approved for medical use in the United States in 1996.[1] It is avaliable as a generic medication.[2] A month supply in the United Kingdom costs the NHS about 1.40 £ per month as of 2019.[2] In the United States the wholesale cost of this amount is about 4.00 USD.[4]
Medical uses
Topiramate is used to treat epilepsy in children and adults, and it was originally used as an anticonvulsant.[5] In children, it is indicated for the treatment of Lennox-Gastaut syndrome, a disorder that causes seizures and developmental delay. It is most frequently prescribed for, the prevention of migraines.[5] It decreases the frequency of attacks.[6][7]
Pain
A 2018 review found topiramate of no use in chronic low back pain.[8] Topiramate has not been shown to work as a pain medicine in diabetic neuropathy, the only neuropathic condition in which it has been adequately tested.[9]
Other
One common off-label use for topiramate is in the treatment of bipolar disorder.[10][11][12] A review published in 2010 suggested a benefit of topiramate in the treatment of symptoms of borderline personality disorder, however the authors noted that this was based only on one randomized controlled trial and requires replication.[13]
Topiramate has been used as a treatment for alcoholism.[14] The VA/DoD 2015 guideline on substance use disorders lists topiramate as a "strong for" in its recommendations for alcohol use disorder.[15]
Other uses include treatment of obesity[16][17] and antipsychotic-induced weight gain.[18][19] It is being studied to treat post traumatic stress disorder.[20] In 2012, the combination phentermine/topiramate was approved in the United States for weight loss.
Adverse effects
People taking topiramate should be aware of the following risks:
§ Avoid activities requiring mental alertness and coordination until drug effects are realized.
§ Topiramate may impair heat regulation,[21] especially in children. Use caution with activities leading to an increased core temperature, such as strenuous exercise, exposure to extreme heat, or dehydration.
§ Topiramate may cause visual field defects.[22]
§ Topiramate may decrease effectiveness of oestrogen-containing oral contraceptives.
§ Taking topiramate in the 1st trimester of pregnancy may increase risk of cleft lip/cleft palate in infant.[23]
§ As is the case for all antiepileptic drugs, it is advisable not to suddenly discontinue topiramate as there is a theoretical risk of rebound seizures.
Frequency
Adverse effects by incidence:[24][25][26][27]
Very common (>10% incidence) adverse effects include:
§ Dizziness
§ Weight loss
§ Paraesthesia - e.g., pins and needles
§ Somnolence
§ Nausea
§ Diarrhea
§ Fatigue
§ Nasopharyngitis
§ Depression
Uncommon (1-10% incidence) adverse effects include:
§ Weight gain
§ Anaemia
§ Disturbance in attention
§ Memory impairment
§ Amnesia
§ Cognitive disorder
§ Mental impairment
§ Psychomotor skills impaired
§ Convulsion
§ Coordination abnormal
§ Tremor
§ Lethargy
§ Hypoaesthesia (reduced sense of touch)
§ Nystagmus
§ Dysgeusia
§ Balance disorder
§ Dysarthria
§ Intention tremor
§ Sedation
§ Blurred vision
§ Diplopia (double vision)
§ Visual disturbance
§ Vertigo
§ Tinnitus
§ Ear pain
§ Dyspnoea
§ Epistaxis
§ Nasal congestion
§ Rhinorrhoea
§ Vomiting
§ Constipation
§ Abdominal pain upper
§ Dyspepsia
§ Abdominal pain
§ Dry mouth
§ Stomach discomfort
§ Paraesthesia oral
§ Gastritis
§ Abdominal discomfort
§ Nephrolithiasis
§ Pollakisuria
§ Dysuria
§ Alopecia (hair loss)
§ Rash
§ Pruritus
§ Arthralgia
§ Muscle spasms
§ Myalgia
§ Muscle twitching
§ Muscular weakness
§ Musculoskeletal chest pain
§ Anorexia
§ Decreased appetite
§ Pyrexia
§ Asthenia
§ Irritability
§ Gait disturbance
§ Feeling abnormal
§ Malaise
§ Hypersensitivity
§ Bradyphrenia (slowness of thought)
§ Insomnia
§ Expressive language disorder
§ Anxiety
§ Confusional state
§ Disorientation
§ Aggression
§ Mood altered
§ Agitation
§ Mood swings
§ Anger
§ Abnormal behaviour
Rarely, the inhibition of carbonic anhydrase may be strong enough to cause metabolic acidosis of clinical importance.[28]
The U.S. Food and Drug Administration (FDA) has notified prescribers that topiramate can cause acute myopia and secondary angle closure glaucoma in a small subset of people who take topiramate regularly.[29] The symptoms, which typically begin in the first month of use, include blurred vision and eye pain. Discontinuation of topiramate may halt the progression of the ocular damage and may reverse the visual impairment.
Preliminary data suggests that, as with several other anti-epileptic drugs, topiramate carries an increased risk of congenital malformations.[30]This might be particularly important for women who take topiramate to prevent migraine attacks. In March 2011, the FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy and placed it in Pregnancy Category D.[23]
Topiramate has been associated with a statistically significant increase in suicidality,[31] and "suicidal thoughts or actions" is now listed as one of the possible side effects of the drug "in a very small number of people, about 1 in 500."[21][32]
Overdose
Symptoms of acute and acute on chronic exposure to topiramate range from asymptomatic to status epilepticus, including in patients with no seizure history.[33][34] In children, overdose may also result in hallucinations.[34] Topiramate has been deemed the primary substance that led to fatal overdoses in cases that were complicated by polydrug exposure.[35] The most common signs of overdose are dilated pupils, somnolence, dizziness, psychomotor agitation, and abnormal, uncoordinated body movements.[33][34][35]
Symptoms of overdose may include but are not limited to:[citation needed]
§ Agitation
§ Depression
§ Speech problems
§ Blurred vision, double vision
§ Troubled thinking
§ Loss of coordination
§ Inability to respond to things around you
§ Loss of consciousness
§ Confusion and coma
§ Fainting
§ Upset stomach and stomach pain
§ Loss of appetite and vomiting
§ Shortness of breath; fast, shallow breathing
§ Pounding or irregular heartbeat
§ Muscle weakness
§ Bone pain
§ Seizures
A specific antidote is not available. Treatment is entirely supportive.