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Sedatives

Neuronstad

 

Pack size:

Box of 3 blisters x 10 capsules.

 

Composition:          

Each capsule contains gabapentin 300 mg.

 

Shelf-life:  

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Adjunctive therapy in the treatment of partial seizures.
  • Treatment of peripheral neuropathic pain, pain after zoster.
     
  • Neuronstad is administered orally without regard to meals.
  • Neuronstad is used as an adjunctive therapy in combination with other antiepilepsies. Gabapentin monotherapy may not be effective.
     
  • Antiepileptic:
    Adults and children older than 12 years of age:

    The first day: 300 mg, once daily.
    The second day: 300 mg, twice daily.
    The third day: 300 mg, three times daily.
    Thereafter, the dose can be further increased in 300 mg/day increments, based on individual patient response and tolerability, until reaching the effective dose, usually 900 – 1800 mg/day, given in three divided doses; the maximum dose should not exceed 2400 mg/day. The total daily dose should be taken in three equally divided doses and the maximum dosage interval should not exceed 12 hours. Higher doses can be divided into 4 times/day.
    In patients with renal impairment and undergoing hemodialysis, the dose of gabapentin should be reduced; proper dose should be titrated to creatinine clearance, which is recommended as follows:

    *  The loading dose is 300 - 400 mg for patients first use gabapentin, then 200 - 300 mg following each 4 hours of hemodialysis.

    Children aged 6 to 12 years, weighing 30 – 36 kg:
    The first day: 300 mg/once/day.
    The second day: 300 mg/once/day.
    The third day: 300 mg/once/day.
    The normal dose: 300 mg/3 times /day.
    The maintenance dose: 300 mg/3 times /day.
    Some children cannot tolerate add to daily, prolonged period of increase (up to weekly) may be more appropriate.
    The use of gabapentin in children less than 12 years of age with impaired renal function has not been evaluated.

  • Peripheral neuropathic pain, pain after zoster
    Adults:
    The drug administration should not exceed 1800 mg/day, given in three divided doses. Or administered as:
    The first day: 300 mg.
    The second day: 300 mg, twice daily.
    The third day: 300 mg, three times daily.
    Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day, until dose increased up to a maximum of 1800 mg/day, the total daily dose should be given in three divided doses.
    Elderly patients:
    May require dosage adjustment because of declining renal function.


Or as prescribed by physicians.

 

  • Hypersensitivity to gabapentin or to any ingredient of the drug.

     

Gabapentin is well tolerated. The adverse effects of the drug are usually mild to moderate and tend to decrease as treatment is continued.
Nervous system effects are among the most frequent adverse effects and is generally the cause of the drug discontinuation.

Common:

  • Ataxia, nystagmus, fatigue, dizziness, edema, drowsiness, amnesia.
  • Children aged 3 to 12 years: Having mental problems as anxiety, behavior changes (crying, feelings of euphoria or depression, agitation, hostility...).
  • Dyspepsia, dry mouth, constipation, abdominal pain, and diarrhea.
  • Peripheral edema.
  • Rhinitis, pharyngitis, cough, pneumonia.
  • Diplopia, amblyopia.
  • Myalgia, arthralgia.
  • Pruritus, rash.
  • Leucopenia
  • Erectile dysfunction, viral infections.

Uncommon:

  • Dementia, aphasia, depression, irritability, mood or mental changes, paretic, decrease or loss of libido, headache.
  • Gastrointestinal disorders, gingivitis, stomatitis, loss or disorder taste.
  • Hypotension, angina pectoris, peripheral vascular disorder, anxiety.
  • Weight gaining, hepatomegaly.

Rare:

  • Paralysis, depersonalization, increased libido, decreased movement function, mental disorders.
  • Peptic-duodenal ulcer, esophagitis, colitis, inflammation of the rectum.
  • Cough, hoarseness, respiratory mucosal inflammation, decreased pulmonary ventilation, lung edema.
  • Itching eyes, watery eyes, retinopathy, inflammation of the iris.
  • Inflammation of the cartilage, osteoporosis, back pain.
  • Leucopenia (no symptoms), prolonged bleeding.
  • Fever or chills.
  • Stevens-Johnson syndrome.

     

  • Gabapentin should be used with caution in patients with a history of mental disorders, renal impairment and undergoing hemodialysis, driving vehicles or operating machines.
  • False positive readings have been reported with some urinary protein tests in patients taking gabapentin.
  • Adverse effects usually mild or moderate and tend to decrease within 2 weeks of continued therapy.
  • Ataxia is often related to dosage. If the symptom does not subside after reducing dose, the drug administration should be discontinued.
  • If Stevens-Johnson syndrome is suspected, the drug administration should be discontinued.
  • Gabapentin should not be discontinued abruptly because of the possibility of increasing seizure frequency. Before gabapentin is discontinued or an alternative anticonvulsant is added to the regimen, such changes should be done gradually over a period of at least 7 days.
  • Pregnancy: There are no adequate and controlled studies in pregnant women. However, this drug should be used during pregnancy only if the potential benefits justify the risk to the fetus.
  • Lactation: Gabapentin is distributed into milk following oral administration. The effect on the breast-fed infants is unknown, therefore gabapentin should be administered to nursing women only if the potential benefits justify the risk to the infant.
  • Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effects could be potentially dangerous in patients driving or operating machinery. This is especially true at the beginning of the treatment and after increase in dose.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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