Gabimash 800 mg 30 tablets

Gabimash Gabapentin 800 mg 30 Tablets

Composition:

Each 800 mg tablet contains 800 mg of gabapentin.

Indications:

-Epilepsy

Gabimash is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above.

-Gabimash is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.

-Treatment of peripheral neuropathic pain

Gabimash is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post- herpetic neuralgia in aduits.

Dosage and method of administration:

For all indications and Dosing instructions for adults and children under 12 years of age are provided under a separate sub-heading later in this section.

Epilepsy

Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy.

Adults and adolescents

300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. 

Children aged 6 years and above

The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days. The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients

Warnings and precautions for use:

-Anaphylaxis

Gabapentin can cause anaphylaxis. 

-Suicidal ideation and behaviour

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. 

-Acute pancreatitis

If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered.

-Seizures

Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus.

-Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in some patients. Therefore, gabapentin should be used with caution in patients with mixed seizures including absences.

-Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). 

Concomitant use with opioids

Patients who require concomitant treatment with opioids should be carefully observed for signs of central nervous system

(CNS) depression, such as somnolence, sedation and respiratory depression. Patients who use gabapentin and morphine concomitantly may experience increases in gabapentin concentrations. The dose of gabapentin or opioids should be reduced appropriately.

-Respiratory depression

Gabapentin has been associated with severe respiratory depression. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction. Dose adjustments might be necessary in these patients.

Pregnancy:

Specialist advice should be given to women who are likely to become pregnant or who are of childbearing potential and the need for antiepileptic treatment should be reviewed when a woman is planning to become pregnant. 

No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child. Developmental delay in children of mothers with epilepsy has been observed rarely. 

Risk related to gabapentin

Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.

Side Effects:

Possible side effects:

viral infection

pneumonia, respiratory infection, urinary tract infection, leucopenia, thrombocytopenia

allergic reactions (e.g. urticaria)

hypersensitivity syndrome (a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms), anaphylaxis

nutrition disorders

anorexia, increased appetite

hypoglycaemia (most often observed in patients with diabetes)

hyponatraemia

hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal,

hallucinations

convulsions, hyperkinesia, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, hallucinations

vertigo

tinnitus

hypertension, vasodilatation

Respiratory, thoracic and mediastinal disorders

dyspnoea, bronchitis, pharyngitis, cough, rhinitis

vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or dysphagia

Stevens-Johnson syndrome, angioedema, erythema

multiforme, alopecia, drug rash with eosinophilia and systemic symptoms

arthralgia, myalgia, back pain, twitching rhabdomyolysis

impotence, breast hypertrophy, gynaecomastia, sexual dysfunction

Storage Method:

Store at a temperature not exceeding 30 C.

Keep away from reach of children.

Package:

Carton box contains 3 strips each of 10 tablets, with an insert leaflet.