Reinin

Reinin

gabapentin

Manufacturer:

Medichem

Distributor:

United Lab
Concise Prescribing Info
Contents
Gabapentin
Indications/Uses
Adult: Monotherapy & adjunctive therapy in the treatment of partial seizures w/ & w/o secondary generalization; peripheral neuropathic pain eg, painful diabetic neuropathy & postherpetic neuralgia. Adolescent >12 yr: Monotherapy in the treatment of partial seizures w/ & w/o secondary generalization; as adjunctive therapy in childn 3-12 yr.
Dosage/Direction for Use
Epilepsy Adult & adolescent >12 yr Effective dose range: 900-3,600 mg/day in 3 equally divided doses. Initial titration: Day 1: 300 mg once daily, Day 2: 300 mg every 12 hr, Day 3: 300 mg every 8 hr. Thereafter, may be increased in 300 mg/day increments every 2-3 days up to max dose of 3,600 mg/day. Childn 5-12 yr Effective dose range: 25-35 mg/kg/day in 3 equally divided doses. Initially 10-15 mg/kg/day in 3 equally divided doses. Max: 50 mg/kg/day. Childn 3-4 yr Effective dose: 40 mg/kg/day. Initially 10-15 mg/kg/day in 3 equally divided doses. Upward titration should be over a period of approx 3 days. Peripheral neuropathic pain Adult Starting dose: 900 mg/day in 3 equally divided doses, can be further increased to 300 mg/day increments every 2-3 days. Max: 3,600 mg/day in 3 equally divided doses. Patient undergoing hemodialysis & renal impairment (Adult) CrCl ≥80 mL/min 900-3,600 mg/day, CrCl 50-79 mL/min 600-1,800 mg/day, 30-49 mL/min 300-900 mg/day, 15-29 mL/min 150-600 mg/day, <15 mL/min 150-300 mg/day. Dose should be taken in 3 divided doses. In patient undergoing hemodialysis, additional 200-300 mg following each 4 hr hemodialysis. Anuric patient undergoing hemodialysis who have never received gabapentin 300-400 mg as a loading dose, 200-300 mg following each 4 hr of hemodialysis.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Increased risk of suicidal thoughts or behavior; neuropsychiatric adverse events in childn 3-12 yr. Avoid abrupt w/drawal. Sudden & unexplained death in patients w/ epilepsy. May affect ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Asthenia, infection, accidental injury, fatigue, viral infection, fever, malaise, face edema, allergy, generalized edema, chill, lassitude, alcohol intolerance, hangover effect, abscess, mucous membrane disorder, body odor, lump in neck; headache, dizziness, somnolence, ataxia, abnormal thinking, abnormal gait, incoordination, amnesia, hypoesthesia, dysesthesia, hyperesthesia, nystagmus, tremor, nervousness, dysarthria, depression, twitching, abnormal coordination, hostility, emotional lability, hyperkinesia, strange feelings, vertigo, paresthesia, decreased or absent reflexes, increased reflexes, anxiety, CNS tumors, abnormal dreaming, aphasia, intracranial hemorrhage, hypotonia, paresis, dystonia, hemiplegia, facial paralysis, stupor, cerebellar dysfunction, +ve Babinski sign, decreased position sense, subdural hematoma, apathy, hallucination, agitation, paranoia, depersonalization, euphoria, feeling high, doped-up sensation, suicide attempt, psychosis, choreathetosis, orofacial dyskinesia, encephalopathy, nerve palsy, personality disorder, subdued temperament, apraxia, fine motor control disorder, meningismus, local myoclonus, hypokinesia, mania, neurosis, hysteria, antisocial reaction, migraine, confusion, insomnia, neuropathy, speech disorder, circumoral paresthesia, hypertonia, movement disorder, vestibular disorder; vasodilation, HTN, hypotension, angina pectoris, peripheral vascular disorder, palpitation, tachycardia, bradycardia, murmur, atrial fibrillation, heart failure, thrombophlebitis, MI, CVA, pulmonary thrombosis, ventricular extrasystoles, premature atrial contraction, pericardial rub, heart block, pulmonary embolus, pericardial effusion, pericarditis, syncope, chest pain, CV disorder, CHF, increased capillary fragility, phlebitis, varicose vein; abdominal pain, diarrhea, dry mouth, constipation, nausea, vomiting, flatulence, dyspepsia, dental abnormalities, gingivitis, glossitis, gum hemorrhage, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, eructation, pancreatitis, peptic ulcer, colitis, blisters in mouth, tooth discolor, perleche, enlarged salivary gland, lip hemorrhage, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal hemorrhage, esophageal spasm, oral moniliasis, gastritis, tooth disorder, abnormal stools, periodontal abscess, cholecystitis, cholelithiasis, duodenal ulcer, γ-glutamyl transpeptidase increased, intestinal obstruction, intestinal ulcer, melena, mouth ulceration, rectal disorder; peripheral edema, wt gain, wt loss, hyperglycemia, increased appetite, hyperlipidemia, hypercholesterolemia, anorexia, impotence, decreased libido, increased libido, ejaculation abnormal, hyperthyroid, hypothyroid, goiter, hypoestrogen, ovarian failure, epididymitis, swollen testicle, cushingoid appearance, DM, gout, hypoglycemia, alkaline phosphatase increased, diabetic ketoacidosis, lactic dehydrogenase increased; leukopenia, decreased WBC count, increased WBC count, purpura, anemia, thrombocytopenia, lymphadenopathy, lymphocytosis, non-Hodgkin's lymphoma, increased bleeding time, sepsis, ecchymosis, lymphoma-like reaction, prothrombin decreased; hematuria, dysuria, urination frequency, cystitis, abnormal blood urea nitrogen (BUN) value, UTI, urinary incontinence, vag moniliasis, breast pain, menstrual disorder, polyuria, urinary retention, cystitis, swollen penis, gynecomastia, nocturia, pyelonephritis, swollen scrotum, urinary urgency, urine abnormality; liver function tests abnormal; back pain, myalgia, fracture, arthralgia, tendonitis, arthritis, joint stiffness, joint swelling, +ve Romberg test, costochondritis, osteoporosis, bursitis, contracture, neck pain, pelvic pain, arthrosis, leg cramps, myasthenia, shin bone pain, joint disorder, tendon disorder; pharyngitis, coughing, bronchitis, resp infection, pneumonia, epistaxis, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccup, laryngitis, nasal obstruction, snoring, bronchospasm, hypoventilation, lung edema, rhinitis, sinusitis, asthma, lung disorder, hemoptysis, voice alteration; rash, abrasion, pruritus, alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cyst, herpes simplex, herpes zoster, skin discolor, skin papules, photosensitive reaction, leg ulcer, scalp seborrhea, psoriasis, desquamation, maceration, skin nodules, subcutaneous nodule, melanosis, skin necrosis, local swelling, cellulitis, skin ulcer, skin disorder, fungal dermatitis, furunculosis, vesiculobullous rash, acne, hair disorder, maculopapular rash, nail disorder, skin carcinoma, skin hypertrophy; amblyopia, conjunctivitis, diplopia, eyes pain/dry, visual field defect, photophobia, bilateral or unilateral ptosis, eye hemorrhage/twitching/itching, hordeolum, retinal vein thrombosis, conjunctival hyperemia, diabetic retinopathy, fundi w/ microhemorrhage, abnormal vision/accommodation, eye focusing problem, watery eyes, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, degenerative eye changes, blindness, retinal degeneration, miosis, chorioretinitis, strabismus, otitis media/externa, hearing loss, earache, tinnitus, inner ear infection, deafness, ear fullness/pain, perforated ear drum, sensitivity to noise, Eustachian tube dysfunction, labyrinthitis, tongue disorder, taste perversion/loss, unusual taste, odd smell.
Drug Interactions
Reduced bioavailability w/ antacids. Decreased oral clearance & CrCl w/ cimetidine. Increased AUC w/ hydrocodone. Increased plasma conc w/ morphine. Increased absorption w/ naproxen. OCs, probenecid, anticonvulsants.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain
ATC Classification
N03AX12 - gabapentin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Reinin cap 100 mg
Packing/Price
100's (P3,400/pack, P35.25/cap)
Form
Reinin cap 300 mg
Packing/Price
100's (P3,700/pack, P38.5/cap)
Form
Reinin tab 600 mg
Packing/Price
30's (P2,272.5/box, P75.75/tab)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in