Gabapentin Fidia Capsules (Hard Gelatin)

Gabapentin
400mg/Capslue
FIDIA PHARMACEUTICA S.p.A.
Pack size 30's (10's Blister x 3)
Dispensing mode CD
Source ITALY
AgentPHARMALINK
Retail Price 62.00 AED

Available as:

100mg/Capslue - Capsules (Hard Gelatin) 300mg/Capslue - Capsules (Hard Gelatin)

Indications

Gabapentin Fidia Capsules (Hard Gelatin) is used for: Epilepsy, Neuropathic pain, Partial Seizures, Hot flashes, Fibromyalgia, Postherpetic Neuralgia, Pain from diabetic neuropathy.

Adult Dose

Partial Seizures Adjunctive therapy for partial seizures with or without secondary generalization Initial: 300 mg PO q8hr May increase up to 600 mg PO q8hr; up to 2400 mg/day administered and tolerated in clinical studies; up to 3600 mg administered for short duration and tolerated Postherpetic Neuralgia Day 1: 300 mg PO qDay Day 2: 300 mg PO q12hr Day 3: 300 mg PO q8hr Maintenance: Subsequently titrate as needed up to 600 mg PO q8hr; doses >1800 mg/day have demonstrated no additional benefit Restless legs syndrome 100-300 mg PO 2 hr before bedtime on first day; may titrate every 2 weeks until symptom relieve achieved (range 300-1800 mg/day) Diabetic Neuropathy 900 mg/day PO initially; may increase gradually q3Days to 1800-3600 mg/day Hot flashes-cancer related 200-1600 mg PO qDay to q6hr for 4-8 weeks

Child Dose

Partial Seizures Adjunctive therapy for partial seizures with or without secondary generalization in patients older than 12 years of age with epilepsy; also indicated as adjunctive therapy for partial seizures in pediatric patients aged 3-12 years <3 years: Safety and efficacy not established 3-12 years (initial dose): 10-15 mg/kg/day PO divided q8hr initially; titrate up in approximately 3 days to effective maintenance dose 3-4 years (maintenance dose): 40 mg/kg/day PO divided q8hr 5-12 years (maintenance dose): 25-35 mg/kg/day PO divided q8hr >12 years (initial dose): 300 mg PO q8hr; may increase up to 600 mg PO q8hr

Renal Dose

Renal impairment CrCl >60 mL/min: 300-1200 mg PO TID CrCl 30-60 mL/min: 200-700 mg q12hr CrCl 15-29 mL/min: 200-700 mg qDay CrCl <15 mL/min: 100-300 mg qDay Hemodialysis (CrCl <15 mL/min): Administer supplemental dose (range 125-350 mg) posthemodialysis, after each 4 hr dialysis interval; further dose reduction should be in proportion to CrCl (eg, CrCl of 7.5 mL/min should receive one-half daily posthemodialysis dose)

Administration

May be taken with or without food.

Contra Indications

Hypersensitivity. Lactation.

Precautions

Discontinuation or transfer from other antiepileptics, history of psychotic illness; renal impairment; pregnancy. Gradual withdrawal over at least 7 days to prevent an increase in seizure frequency. Lactation: Enters breast milk; use with caution

Pregnancy-Lactation

Pregnancy There are no adequate data on developmental risks associated with use in pregnant women; in nonclinical studies in mice, rats, and rabbits, the drug was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically Lactation Gabapentin is secreted in human milk following oral administration; effects on breastfed infant and on milk production are unknown; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

Interactions

May increase plasma level w/ morphine. Reduced absorption w/ antacids.

Adverse Effects

Side effects of Gabapentin : >10% Ataxia (1-13%), Dizziness (16-20%), Drowsiness (5-21%), Fatigue (11-15%), Somnolence (16-20%) 1-10% Diplopia (6-10%), Nystagmus (6-10%), Tremor (6-10%), Amblyopia (1-5%), Back pain (1-5%), Constipation (1-5%), Depression (1-5%), Dry mouth (1-5%), Dysarthria (1-5%), Dyspepsia (1-5%), Hostility (5-8% children), Hyperkinesia (3-5%), Increased appetite (1-5%), Leukopenia (1-5%), Myalgia (1-5%), Nervousness (1-5%), Peripheral edema (1-5%), Pharyngitis (1-5%), Pruritus (1-5%), Rhinitis (1-5%), Vasodilation (1-5%), Weight gain (1-5%), Abnormal vision (>1%), Anorexia (>1%), Arthralgia (>1%), Asthenia (>1%), HTN (>1%), Malaise (>1%), Paresthesia (>1%), Purpura (>1%), Vertigo (>1%)

Mechanism of Action

Gabapentin is structurally related to the neurotransmitter GABA but is neither a GABA agonist nor antagonist. High affinity gabapentin binding sites are located throughout the brain. These sites correspond to the presence of voltage-gated Ca channels particularly controlling the ?-2/?-1 subunit. This channel appears to be located presynaptically and may modulate the release of excitatory neurotransmitters which participate in epileptogenesis and nociception.

Note

Gabapentin Fidia 400mg/Capslue Capsules (Hard Gelatin) manufactured by FIDIA PHARMACEUTICA S.p.A.. Its generic name is Gabapentin. Gabapentin Fidia is availble in United Arab Emirates. Farmaco UAE drug index information on Gabapentin Fidia Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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