Drug interactions- summary

Carbamazepine + Rufinamide/ Rufinamide + carbamazepine -

carbamazepine can decrease plasma of levels of rufinamide depending on carbamazepine
concentration, similarly runfinamide can decrease plasma levels of carbamazepine based on
 maximum recommended dose of rufinamide.

Phenobarbital + rufinamide/ rufinamide + phenobarbital-

phenobarbital can decrease rufinamide plasma concentration with greater effects in children
Rufinamide can  increase phenobarbital  concentration  in a concentration-dependent manner
especially in children

Phenytoin + rufinamide/ Rufinamide + phenytoin-

phenytoin can decrease plasma concentration with greater effects in children. Rufinamide
can increase phenytoin concentration in concentration- dependent manner especially
in children 

Primidone + rufinamide -
primidon can decrease rufinamide concentration with greater effects in children

Valproate + rufinamide-
valproate can increase rufinamide concentration with greater effects in children

Rufinamide +  contraceptives, hormonal-
rufinamide decreased Cmax and AUC of ethinyl  norethindrone . Additional non hormonal
forms of contraception recommended

Rufinamide + lamotrigine -
rufinamide can decrease lamotrigine concentration in  concentration- dependent manner
especialy in children

Rufinamide + triazolam  -
rufinamide decreases Cmax and AUC

Seizures

Adverse reactions-

Children-

CNS -    aggresion   2%    ataxia  3%   disturbance in attention 2%    dizziness  7%
              fatigue  7%    headache  15%    psychomotor hyperactivity  2%
              somnolence   15%

GI -     abdominal pain  2%   decreased appetite 4 %     nausea 6% vomiting  16%

Dermatologic -   prutitus   2%    rash  3%

Respiratory -   bronchitis  2%    sinusitis  2%

Special senses-     diplopia  2%   ear infection 2%   nasophryngitis  4%

Miscellaneous-   influenza  4%

Adults-

CNS -      anxiety 2%   ataxia  3%   dizziness 18%    fatigue  14%     headache  25%
               somnolence  10%     tremor 5%

GI -        constipation 3%    dyspepsia  2%     nausea  12%     vomiting 4%

Special senses -   diplopia   8%     nystagmus    5%    vision blurred  5%

Miscellaneous -  back pain  2%   

Patients with short QT syndrome

Special precautions-

Suicidal behaviuor and ideation-   monitor patients   treated with AED( anti-epiletic drug )
 for any indication for emergence or worsening of depression

CNS reactions- use of rufinamide has been associated with CNS- related adverse reactions eg.
somnolence, or fatigue or cordinationabnormalites, dizziness, gait disturbances and ataxia

QT interval - use caution when admninstering rufinamide with other drugs that shorten
QT interval

Hypersensitivity reactions- all patients who develop a rash while taking rufinamide must be
closely supervised.

Pregnancy- use rufinamide during pregnancy only if the potential benefits justifies the  potential
risk to the fetus,

Lactation- decide whether to discontinue breast feeding or the drug depending upon
the importance of drug to the mother,

Children- safety and effectiveness with children younger than 4 years have not been established

Elderly- use caution in drug selection , usually staring with a low dose

Monitoring- monitor patients for any indication of emergence or worsening of depression suicidal
 thoughts or unusal changes in behaviour

Indication-
Seizures

Dosage-
Adults- 
Maximum dose -3200mg/day administered in 2 equally divided  doses

Initial dose - 400 to 800mg administered in 2 equally divided doses  a maximum daily
of 3200mg/day administered in 2 equally divided doses is reached

Children-
Seizures-  4 years of age and older-
initial dose approx 10mg/kg/ day administered in 2 equally divided doses.

Increase the dose by approximately 10mg/kg increments every other day to a target dose of
45mg/kg/day or 3200mg/day  which ever is less , administered in 2 equally divided doses

1.Inform patients , their caregivers and their families that AEDs increase the risk of suicidal
   thought and behaviour and advice them of the need to be alert for the emergence of
   worsening of signs and symptoms of depression

2. Report any abnormal behaviour to their doctor.

3. Inform patients to take rufinamide as prescribed by the doctor

4. Advice patients that all centrally acting medications , alcohol, in combination with
    rufinamide may cause additive CNS effects

5. Advice patients about the potential for somnolence or dizziness and that patients should not
   operate any hazardous machinery or drive until they have gained  sufficient experience
   on rufinamide and its effects

6. Warn woman of child bearing age that concurrent use of rufinamide and hormonal contraceptives
   my render this method of contraception less effective . Additional forms of contraception are
   recommended

7. Advice patients to notify their doctor if they are breast feeding  or intend to breast feed.

8. Advice patients to inform their doctor if they develop rash or fever.

Pregnancy-
Use rufinamide during pregnancy only if the potential benefits justifies the  potential
risk to the fetus,

Lactation-
Decide whether to discontinue breast feeding or the drug depending upon
the importance of drug to the mother,

Children-
Safety and effectiveness with children younger than 4 years have not been established

Elderly-
Use caution in drug selection , usually staring with a low dose