Oral to iv phenytoin conversion

Antiepileptic drugs should not be abruptly discontinued because of the possibility of increased seizure frequency, including status epilepticus. When, in the judgment of the clinician, the need for dosage reduction, discontinuation, or substitution of alternative antiepileptic medication arises, this should be done gradually. However, in the event of an allergic or hypersensitivity reaction, rapid substitution of alternative therapy may be necessary. In this case, alternative therapy should be an antiepileptic drug not belonging to the hydantoin chemical class.

Since September 2012, the marketing licence in the UK has been held by Flynn Pharma Ltd, of Dublin, Ireland , and the product, although identical, has been called Phenytoin Sodium xx mg Flynn Hard Capsules. (The xx mg in the name refers to the strength—for example 'Phenytoin sodium 25 mg Flynn Hard Capsules'). [47] The capsules are still made by Pfizer 's Goedecke subsidiary's plant in Freiburg , Germany and they still have Epanutin printed on them. [48] After Pfizer's sale of the UK marketing licence to Flynn Pharma, the price of a 28-pack of 25 mg phenytoin sodium capsules marked Epanutin rose from 66p (about $) to £ (about $). Capsules of other strengths also went up in price by the same factor—2384%, [49] costing the UK's National Health Service an extra £43 million (about $ million) a year. [50] The companies were referred to the Competition and Markets Authority who found that they had exploited their dominant position in the market to charge “excessive and unfair” prices. [51]

phenytoin (Dilantin): The most used AED by general physicians in the US, less so by epilepsy doctors, because of the side effects. Phenytoin alters brain cell sodium channels, which has the effect of limiting rapid firing of the brain cells. It is inexpensive. Common side effects are unsteadiness and moderate cognitive problems. There are long-term potential cosmetic (body/face hair growth, skin problems), and bone problems (osteoporosis). Phenytoin causes a rash rate of a few percent, sometimes even the dangerous rash called Stevens-Johnson syndrome. Typical adult dose is 300-400 mg per day, usually with 100 mg pills. Phenytoin can be started quickly in an emergency with intravenous administration, or a large dose of capsules if an immediate effect is required. Small changes in phenytoin dose can cause large changes in serum drug levels, so the blood levels can be hard to regulate. The target serum level is 10-20 mcg per ml. See information on phenytoin .

For example, for solutions the key aspects that should be addressed during validation include assurance that the drug substance and preservatives are dissolved. Parameters, such as heat and time should be measured. Also, in-process assay of the bulk solution during and/or after compounding according to predetermined limits are also an important aspects of process validation. For solutions that are sensitive to oxygen and/or light, dissolved oxygen levels would also be an important test. Again, the development data and the protocol should provide limits. Review firm's development data and/or documentation for their justification of the process.

Status Epilepticus: Loading Dose:
Infants, Children: 15 to 20 mg/kg IV in a single or divided doses

Anticonvulsant: Loading Dose:
All ages: 15 to 20 mg/kg orally (based on phenytoin serum concentrations and recent dosing history). The oral loading dose should be given in 3 divided doses administered every 2 to 4 hours.

Anticonvulsant: Maintenance Dose:
(IV or oral) (Note: May initially divided daily dose into 3 doses/day, then adjust to suit individual requirements.)
Less than or equal to 4 weeks: Initial: 5 mg/kg/day in 2 divided doses
Usual: 5 to 8 mg/kg/day IV in 2 divided doses (may require dosing every 8 hours).
Greater than or equal to 4 weeks: Initial: 5 mg/kg/day in 2 to 3 divided doses
Usual: (may require up to every 8 hour dosing)
6 months to 3 years: 8 to 10 mg/kg/day
4 to 6 years: to 9 mg/kg/day
7 to 9 years: 7 to 8 mg/kg/day
10 to 16 years: 6 to 7 mg/kg/day

Oral to iv phenytoin conversion

oral to iv phenytoin conversion

For example, for solutions the key aspects that should be addressed during validation include assurance that the drug substance and preservatives are dissolved. Parameters, such as heat and time should be measured. Also, in-process assay of the bulk solution during and/or after compounding according to predetermined limits are also an important aspects of process validation. For solutions that are sensitive to oxygen and/or light, dissolved oxygen levels would also be an important test. Again, the development data and the protocol should provide limits. Review firm's development data and/or documentation for their justification of the process.

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