KEPPRA ORAL SOLUTION 300ML
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ACTIVE-INGREDIENT OF KEPPRA ORAL SOLUTION 300ML
levetiracetam
INDICATION OF KEPPRA ORAL SOLUTION 300ML
The antiseizure agent is used in the treatment of focal onset seizures and generalized onset seizures, prophylaxis against craniotomy-induced seizure, and traumatic brain injury.
Dosage & Administration OF KEPPRA ORAL SOLUTION 300ML
KEPPRA ORAL SOLUTION 300ML
Intravenous formulations: infuse over 15 minutes. Various rates of IV administration have been reported; doses ≤1 g (undiluted) have been administered over 2 to 5 minutes, doses ≤3 g (diluted) over 5 to 6 minutes, and doses ≤4.5 g (diluted) over 10 minutes.
Do not use if the solution contains particulate matter or is discolored. In the case of pediatrics, vials must be diluted prior to use.
It is recommended to dilute the dose to 100 ml of NS, LR, or D5W. If a smaller volume is required (eg, pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg/mL of diluted solution. A 1:1 dilution of the drug from the vial with D5W or NS (eg, 1 g per 10 mL diluted in 10 mL of NS; total volume 20 mL) has also been safely used. Alternatively, doses up to 1 g have been safely administered undiluted. -Oral: -Administer without regard to meals. A-Oral solution:
Administer with a calibrated measuring device (not a household teaspoon or tablespoon). B-Tablet: 1-Disintegrating soluble tablet for oral suspension: Place the whole tablet on the tongue with a dry hand, follow with a sip of water, and swallow only after the tablet disintegrates. Do not swallow tablets intact.
Tablet disintegrates in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of water. Or allow whole tablet to disperse in a small volume of water (one tablespoon or enough to cover the tablet) in a cup; consume entire contents immediately; resuspend any residue by adding an additional small volume of water and swallow the full amount. 2-Immediate release: Tablets should be swallowed whole, not chewed or crushed. 3-Extended release: Only administer as the whole tablet; do not crush, break, or chew.
Side Effects OF KEPPRA ORAL SOLUTION 300ML
-Fatigue, dizziness, somnolence and drowsiness, hypersensitivity reactions, hallucinations, and behavioral problems (including aggressive behavior, agitation, anger, anxiety, apathy, confusion, depersonalization, depression, emotional lability, hostility, dyskinesia, irritability, nervousness) -Increased blood pressure, vomiting, headache, nasopharyngitis, anorexia, constipation, decreased appetite, diarrhea, gastroenteritis, nausea, upper abdominal pain, bruise, eosinophilia, amnesia, anxiety, ataxia, confusion, depression, dizziness, arthralgia, joint sprain, neck pain, conjunctivitis, otalgia, cough, nasal congestion, pharyngitis, pharyngolaryngeal pain, rhinitis, and sinusitis. -Pediatric dosing continues: -Tonic-clonic seizures: Children ≥6 years and adolescents <16 years: IV: Initial: 10 mg/kg/dose twice daily; increase the dosage every 2 weeks by 10 mg/kg/dose twice daily based on response and tolerability to the recommended dose of 30 mg/kg/dose twice daily. Oral: Immediate release: 1-Weight-directed: Oral solution or tablets: Initial: 10 mg/kg/dose twice daily; increase the dosage every 2 weeks by 10 mg/kg/dose twice daily based on response and tolerability to the recommended dose of 30 mg/kg/dose twice daily. 2-Fixed-dosing: Orally disintegrating tablets: If the patient weight is 20 to 40 kg: Initial: 250 mg twice daily; increase dosage every 2 weeks by 250 mg twice daily based on response and tolerability to the maximum recommended dose of 750 mg twice daily.
If the patient weight is >40 kg: Initial: 500 mg twice daily; increase dosage every 2 weeks by 500 mg twice daily based on response and tolerability to the maximum recommended dose of 1,500 mg twice daily.
While in the case of adolescents ≥16 years: IV, Oral: Initial: 500 mg twice daily; increase the dosage every 2 weeks by 500 mg/dose twice daily based on response and tolerability to the recommended dose of 1,500 mg twice daily.
Pregnancy & Lactation OF KEPPRA ORAL SOLUTION 300ML
-Levetiracetam crosses the placenta and can be detected in the newborn following delivery. An increase in the overall rate of major congenital malformations has not been observed following maternal use of levetiracetam. Available studies have not been large enough to determine if there is an increased risk of specific birth defects. -Levetiracetam is present in breast milk, the relative infant dose (RID) of levetiracetam is 7.9%, in general, breastfeeding is considered acceptable when the RID is <10%. Adverse effects, including hypotonia, sedation, vomiting, weight loss, and poor suckling have been reported in breastfed infants, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. -Ask your physician before taking any medication during pregnancy or lactation.
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