Topiramate (Topamax)

Generic Name: Topiramate

Common Brand Name: Topamax

Buy Topiramate Without a Prescription

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Topiramate medical uses:

• Monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.
• Adjunctive therapy for adults and pediatric patients ages 2 - 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
• Prophylaxis of migraine headache.

Contraindications:

• Hypersensitivity to topiramate or any component of the formulation.

Topiramate dosage:

• Epilepsy, adjunctive therapy
  Adults 17 yr of age and older: 200 to 400 mg daily in 2 divided doses in adults with partial seizures and 400 mg daily in 2 divided doses in adults with primary generalized tonic–clonic seizures. Initiate therapy at 25 to 50 mg daily and titrate to an effective dose in increments of 25 to 50 mg weekly. Doses over 400 mg do not improve response. Daily doses above 1,600 mg have not been studied.
  Children 2 to 16 yr of age: 5 to 9mg/kg/day in 2 divided doses. Initiate therapy at 25 mg or less (based on range of 1 to 3mg/kg/day) nightly for first wk and titrate to an effective dose at 1- to 2-wk intervals by increments of 1 to 3mg/kg/day in 2 divided doses.
• Epilepsy, monotherapy
  Adults and Children 10 yr of age and older: 400 mg daily in 2 divided doses. Initiate therapy at 50 mg daily and titrate to an effective dose in increments of 25 to 50 mg weekly.
• Migraine
  Adults: 50 mg in the morning and evening.

Dosage adjustment:

• Adjustment of dose in renal failure.The major route of elimination of unchanged topiramate and its metabolites is via the kidney. Dosage adjustment may be required in patients with reduced renal function.

Topiramate possible side effects:

• Cardiovascular: Hypertension (2%); bradycardia (1%).
• Central nervous system: Paresthesia (51%); dizziness (32%); fatigue (30%); somnolence (29%); psychomotor slowing (21%); nervousness (19%); ataxia (16%); confusion, difficulty with concentration, difficulty with memory (14%); depression, speech disorders (13%); behavior problems, mood problems, nystagmus (11%); language problems (10%); aggressive reaction, insomnia, tremor (9%); abnormal gait, hypoaesthesia (8%); cognitive problems (7%); anxiety (6%); hyperkinesia (5%); abnormal coordination, involuntary muscle contraction (4%); agitation, apathy, decreased libido, emotional liability, hypertonia (3%); aggravated depression, depersonalization, hyporeflexia, stupor, vertigo (2%); aggravated migraine, convulsions, headache, sensory disturbance, syncope (1% or more).
• Dermatologic: Alopecia (5%); pruritus, rash (4%); acne, skin disorder (3%); dermatitis, erythematous rash, hypertrichosis (2%); eczema, increased sweating, seborrhea, skin discoloration (1%); bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), pemphigus (postmarketing).
• EENT: Taste perversion (15%); abnormal vision (13%); diplopia (10%); pharyngitis (6%); blurred vision (4%); conjunctivitis, decreased hearing, eye abnormality, otitis media, tinnitus (2%); abnormal accommodation, abnormal lacrimation, eye pain, myopia (1% or more).
• Gastrointestinal: Anorexia (24%); nausea (14%); diarrhea (11%); abdominal pain, dyspepsia (7%); increased saliva (6%); constipation, dry mouth (5%); gastritis, gastroenteritis, vomiting (3%); gastroesophageal reflux, taste loss (2%); dysphagia, fecal incontinence, flatulence, GI disorder, gingivitis, glossitis, gum hyperplasia, tooth disorder (1% or more); pancreatitis (postmarketing).
• Genitourinary: Breast pain, urinary incontinence, UTI (4%); cystitis, menstrual disorder, premature ejaculation, renal calculus, vaginal hemorrhage (3%); amenorrhea, dysuria, hematuria, leukorrhea, menorrhagia, micturition frequency, prostatic disorder (2%); abnormal urine, genital moniliasis, intermenstrual bleeding, nocturia (1% or more); renal tubular acidosis (postmarketing).
• Hematologic: Purpura (8%); epistaxis (4%); anemia, leukopenia (2%); hematoma, increased PT, thrombocytopenia (1%).
• Hepatic: Gamma-GT increased (3%); hepatic failure (including fatalities), hepatitis (postmarketing).
• Metabolic: Weight decrease (21%); thirst (2%); hypoglycemia, increased appetite, weight increase (1%).
• Musculoskeletal: Arthralgia (7%); leg cramps, myalgia (2%).
• Respiratory: Upper respiratory tract infection (18%); sinusitis (10%); bronchitis, rhinitis (7%); pneumonia (5%); coughing (4%); dyspnea (3%); asthma, respiratory disorder (1% or more).
• Other: Injury (14%); fever, viral infection (9%); infection (7%); asthenia (6%); back pain (5%); chest pain, flu-like symptoms, leg pain (4%); allergy (3%); allergic reaction, edema, hot flushes, neoplasm (2%); body odor, moniliasis, neurosis, pallor, pain, rigors, skeletal pain (1% or more).

Topiramate precautions:

• Children. Safety and efficacy have not been established in children <2 years of age for adjunctive treatment and <10 years of age for monotherapy.
• Kidney stones. The risk of kidney stones is about 2-4 times that of the untreated population, the risk of this event may be reduced by increasing fluid intake.
• Hyperthermia and Oligohidrosis (decreased sweating). May be associated (rarely) with severe oligohydrosis and hyperthermia, most frequently in children; use caution and monitor closely during strenuous exercise, during exposure to high environmental temperature, or in patients receiving drugs with anticholinergic activity.
• CNS Effects: Cognitive dysfunction, psychiatric disturbances (mood disorders), and sedation (somnolence or fatigue) may occur with topiramate use; incidence may be related to rapid titration and higher doses. Topiramate may also cause paresthesia and ataxia.
• Glaucoma. Has been associated with secondary angle-closure glaucoma in adults and children, typically within 1 month of initiation. Discontinue in patients with acute onset of decreased visual acuity or ocular pain.
• Hepatic/renal impairment. Use cautiously in patients with hepatic or renal impairment; dosage adjustment may be required.
• Metabolic acidosis. Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with topiramate treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase.
• Somnolence/Fatigue. Somnolence and fatigue were the side effects most frequently reported during clinical trials of Topamax for adjunctive epilepsy.
• Paresthesia. Paresthesia (usually tingling of the extremities), an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of Topamax. Paresthesia was more frequently reported in the monotherapy epilepsy trials and migraine prophylaxis trials versus the adjunctive therapy epilepsy trials.

Drug Interactions:
Inhibits CYP2C19 (weak); Induces CYP3A4 (weak) .

• Acetazolamide: Coadministration may increase the chance of nephrolithiasis and/or hyperthermia.
• Anticholinergic drugs (antihistamines, cyclic antidepressants, and antipsychotics): Concurrent administration may increase the risk of oligohydrosis and/or hyperthermia; use caution.
• Carbamazepine: May reduce topiramate levels 40%
• CNS depressants (barbiturates, benzodiazepines, opioid analgesics, ethanol, and other sedative agents): Sedative effects may be additive with topiramate; monitor for increased effect.
• Digoxin: Blood levels of digoxin are decreased when coadministered with topiramate.
• Hydrochlorothiazide: increased topiramate levels, may be required an adjustment of the topiramate dose.
• Lithium: Lithium levels should be monitored when co-administered with topiramate.
• Metformin: Oral plasma clearance of topiramate appears to be reduced when administered with metformin.
• Oral contraceptives, Estrogens: Blood levels of estrogens are decreased when coadministered with topiramate, this may lead to a loss of efficacy.
• Phenytoin: May decrease topiramate levels by as much as 48%; topiramate may increase phenytoin concentration by 25%
• Valproic acid: Hyperammonemia with or without encephalopathy has been reported in patients who tolerated either drug alone. These drugs may modestly decrease the serum concentrations of the other drug.

Pregnancy
Pregnancy Category C.
Topiramate was found to be teratogenic in animal studies; however, there is limited information in pregnant women; use only if benefit to the mother outweighs the risk to the fetus. Based on limited data, topiramate was found to cross the placenta. Postmarketing experience includes reports of hypospadias following in vitro exposure to topiramate.

Nursing Mothers
Based on limited data, topiramate was found in breast milk; low concentrations were detected in nursing infants.

Drug abuse and dependence
The abuse and dependence potential of Topamax has not been evaluated in human studies.

Overdose:
Symptoms of overdose include: abdominal pain, abnormal coordination, agitation, blurred vision, convulsions, death, depression, diplopia, dizziness, drowsiness, hypotension, lethargy, mentation impaired, severe metabolic acidosis, speech disturbance, stupor.

Storage:
Store tablets at controlled room temperature (59° to 86°F). Store capsules at temperatures below 77°F. Keep tightly capped and protect from moisture.

References:

• 1. U.S. Food and Drug Administration Topamax (Topiramate) Prescription Information