Keppra, children's claritin chewable tablets.
The Food and Drug Administration approved a new indication for Keppra (levetiracetam) as an adjunctive treatment for myoclonic seizures in adults and adolescents 12 years and older with juvenile myoclonic epilepsy.
* Recommended Dosage: Initiate treatment at 1,000 mg/day given as 500 mg twice daily. Dosage should be increased every 2 weeks by 1,000 mg/day to the recommended daily dose of 3,000 mg/day.
* Special Considerations: Somnolence and behavioral abnormalities (aggression and irritability) were reported in adolescents and adults with myoclonic seizures treated with Keppra. Depressed mood, depression, and mood swings also occurred more frequently in patients treated with the agent versus placebo.
Somnolence, neck pain, and pharyngitis were the most common adverse events reported in a clinical trial of 60 adolescents and adults for myoclonic seizures treated with Keppra in combination with other antiepileptic drugs. These effects were more common in the treatment group, compared with 60 patients taking a placebo.
Withdraw patients from Keppra gradually to minimize the risk of withdrawal seizures.
* Comment: Safety and efficacy are based on a phase III, double-blind, randomized trial that demonstrated a greater than 50% reduction in myoclonic seizure days versus baseline for 60% of 54 patients treated with Keppra. A similar reduction was observed for 24% of 59 participants in a placebo group. A total of 15% of the Keppra group achieved freedom from myoclonic seizures during treatment, compared with 3% of the placebo group. The majority of participants had juvenile myoclonic epilepsy (JME), although the study also included patients with juvenile absence epilepsy or tonic-clonic seizures upon awakening.
The current drug of choice for JME is valproic acid (Depakote), but risks include genetic malformations and weight gain, Dr. Joan A. Conry said. "We know valproic acid is a bad actor."
Benefits of Keppra include ease of use, very few drug interactions, and a lack of increased appetite. Keppra will be preferable to valproic acid if shown to carry a lower risk for fetal teratogenicity, added Dr. Conry, director of the EEG Laboratory and Epilepsy Program, Children's National Medical Center, Washington.
A small but real number of children and adolescents will develop behavioral or psychiatric problems when taking Keppra, Dr. Conry said. Irritable and/or aggressive behavior are possible, and in rare cases, psychosis. The behavior "will be blatantly apparent if it happens, and physicians will get calls right away from parents."
Dr. Conry was a clinical investigator for UCB Inc. in the past on partial seizure and pharmacokinetic studies.
Children's Claritin Chewable Tablets (Ioratadine 5 mg, Schering-Plough HealthCare Products)
The FDA approved Children's Claritin Grape Chewable Tablets (loratadine 5 mg) for temporary relief of symptoms due to hay fever or other upper respiratory allergies: runny nose; sneezing; itchy, watery eyes; and itching of the nose and throat. This over-the-counter product is indicated for patients 2 years and older.
* Recommended Dosage: Children 2 years to younger than 6 years should chew one tablet daily and not exceed one tablet in 24 hours. Children 6 years or older and adults should chew two tablets daily and not exceed two tablets in 24 hours.
* Special Considerations: Patients with liver or kidney disease should first check with a physician, according to product labeling. Taking more than the recommended dose can cause drowsiness.
* Comment: No new safety or efficacy trials were required for this new formulation of loratadine. Required bioequivalency testing was conducted, according to a company spokesperson.
Children's Claritin Chewable Tablets is the only over-the-counter, nonsedating antihistamine available. A prescription is required for Zyrtec chewable tablets. "There are other chewable antihistamines such as Benadryl, but they are all first-generation and may cause the side effects of sedation or drowsiness," Dr. Anna Nowak-Wegrzyn said.
Liquid Claritin is less expensive than prescription antihistamines for patients without a pharmacy plan, said Dr. Nowak-Wegrzyn, a pediatric allergist and immunologist at Mount Sinai School of Medicine, New York. It is unknown how the price for the chewable tablets will compare with liquid Claritin.
"I would expect similar effects on symptoms with chewable tablets and liquid." Children's Claritin Chewable Tablets "is a very good first choice to treat mild allergy symptoms such as hay fever--runny, itchy, or stuffy nose--or allergic conjunctivitis," said Dr. Nowak-Wegrzyn. She does not have a financial relationship with Claritin or Schering-Plough Corporation.
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|Title Annotation:||New & Approved|
|Date:||Oct 1, 2006|
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