Galtenix 300

As additional treatment for partial seizure and partial seizure with secondary generalization in patients who haven't been controlled by standard anticonvulsant using as monotherapy or combined therapy or patients who are intolerance to therapeutic dose of this medication. As an additional treatment for anticonvulsant, Gabapentin is indicated for simple and complex partial seizure, especially secondary generalized seizure, especially secondary generalized tonic-clonic seizure.

Adult and children >12 years old: Gabapentin is administered orally with or without meals. In clinically controlled study, the effective dose are 900-1,800 mg daily. The titration to reach the effective dose can progress rapidly and may be achieved within a few days with a 300 mg dose once daily on the first day: 300 mg twice daily on the second day: 300 mg 3 times daily on the third day. After that, doses may be increased to 1,200 mg daily in 3 divided doses, and if necessary, titration can continue using 300 mg/day increments given in 3 divided doses until a maximum of 2,400 mg/day. The maximum period between doses when administering three times a day should not exceed 12 hours. If Gabapentin is discontinued and/or an alternative anticonvulsant is added, this should be performed gradually for at least of 1 week.
Patients with impaired kidney function or undergoing hemodialysis: Adjustment dose is recommended (see table).
Unlike other drugs in the same group, plasma level monitoring is not required for optimal therapeutic effects of Gabapentin. Furthermore, Gabapentin can be used in combination with other anticonvulsant medications without affecting the plasma or serum levels of these drugs. If Gabapentin treatment is stopped and/or if another anticonvulsant is added, monitoring should be carried out gradually for at least 1 week. (See table.)


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Administration: With or without food.

Patients with hypersensitivity to Gabapentin.

Although there are no evidence of rebound phenomenon of gabapentin, the abrupt withdrawal of anticonvulsant agents in epileptic patients may trigger status epilepticus. If there is a dose reduction, discontinuation or substitution with an alternative anticonvulsant should be done gradually over a minimum of 1 week.
Gabapentin is generally not considered effective in the treatment of seizures and may aggravate seizures in some patients. Therefore, gabapentin should be taken carefully in patients who experienced mixed seizure, including abscence seizures.
Due to reports of false-positive result with the Ames N-Multistix sg dipstick test for urine protein when Gabapentin is added to other antiepileptic medications, the more specific sulfosalicylic acid precipitation procedure is recommended for detecting the presence of urine protein.

The safety of gabapentin has been evaluated in nearly 1,200 subjects, including patients. Gabapentin is most commonly administered in combination with other antiepileptic agents, making it difficult to determine which agent, if any, is associated with the adverse reactions.
Other adverse reactions: General: Weakness, pain, fatigue, weight loss, facial edema, and chest pain.
Gastrointestinal system: Flatulence.
Lymphatic system: Purpura.
Neurological system: Vertigo, hyperkinesia, decreased or loss of reflex.
Psychologic function: Agitation.
Respiratory system: Bronchitis, sinusitis, pneumonia.
Skin and adnexa: Laceration, maculopapular rash.
Urogenital system: Urinary tract infection.
Specific sensation: Visual changes, commonly visual disturbances.
Laboratory reaction: Increased concentration of antiepileptic drugs in plasma.
Withdrawal treatment: Drowsiness, ataxia, dizziness, fatigue, nausea, and/or vomiting.

There is no interaction between Gabapentin with phenobarbital, phenytoin, carbamazepine. Steady-state pharmacokinetic of Gabapentin is the same in healthy subjects and in patients with epilepsy who are receiving antiepileptic agents.
Concomitant use with oral contraceptives, including norethisterone and/or ethinylestradiol, will not affect the steady-state pharmacokinetics of each component.
Concomitant use with antacids can reduce the bioavailability of Gabapentin by up to 24%, but this is not clinically significant.
Renal excretion of Gabapentin is unaffected by probenecid. A slight reduction in Gabapentin excretion has been observed when administered together with cimetidine, which is not expected to be of clinical significance.

Anticonvulsants

N02BF01 - gabapentin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.

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