Funxion Plus

Funxion Plus

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Pregabalin 75 mg, mecobalamin 750 mcg
Indications/Uses
Dosage/Direction for Use
1 cap bid. Renal impairment CrCl ≥60 mL/min 150 mg/day bid. Max: 600 mg/day. ≥30-<60 mL/min 75 mg/day once daily or bid. Max: 300 mg/day. ≥15-<30 mL/min 25-50 mg/day once daily or bid. Max: 150 mg/day. <15 mL/min 25 mg/day once daily. Max: 75 mg/day. Supplementary dosage after hemodialysis 25 mg as single dose. Max: 100 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to pregabalin, mecobalamin, & to other forms of vit B12.
Special Precautions
Pregabalin: Patients w/ previous episode of angioedema, taking other drugs associated w/ angioedema (eg, ACE inhibitors). Serious skin reactions. Increase the risk of suicidal thoughts or behavior. W/drawal symptoms after abrupt or rapid discontinuation; taper gradually over 1 wk. Carefully evaluate history of substance abuse & observe for signs of misuse or abuse (eg, development of tolerance, increase in dose, drug-seeking behavior). Encephalopathy. Elderly w/ age-related compromised renal function & patients w/ kidney disease or risk factors for renal failure. Treatment of central neuropathic pain due to spinal cord injury. Peripheral edema. CHF. Wt gain. GI effect. Discontinue if myopathy is diagnosed or suspected or if markedly elevated creatinine kinase levels occur. Blurred vision in continued dosing. Renal impairment. Dizziness & somnolence may impair ability to perform tasks eg, driving or operating machinery. Effective contraception must be used in women of childbearing potential. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Anaphylaxis, hypersensitivity reactions, urticaria; anorexia; dizziness, headaches, paresthesia, tremor; diarrhea, GI disturbances, nausea, vomiting; pruritus, rash; chills, fever, hot flushing; malaise. Pregabalin: Abscess, cellulitis, fungal/bacterial/viral infection, infections, moniliasis, nasopharyngitis, peripheral gangrene, sepsis, sinusitis; adenoma, carcinoma, cyst, neoplasm; anemia, chronic leukemia, coagulation disorder, cyanosis, ecchymosis, eosinophilia, abnormal erythrocytes, hypochromic & Fe deficiency anemia, leukemoid reaction, leukocytosis, leukopenia, lymphadenopathy, lymphangitis, lymphedema, lymphocytosis, lymphoma-like reaction, macrocytic & megaloblastic anemia, myelofibrosis, neutropenia, pancytopenia, polycythemia, purpura, rupture of spleen, splenomegaly, thrombocythemia, thrombocytopenia, thrombocytopenic purpura; allergic & anaphylactoid reaction, angioedema, immune system disorder, sarcoidosis; adrenal insufficiency, DM, goiter, hyperthyroidism, hypothyroidism, parathyroid disorder, increased prolactin, thyroid carcinoma, disorder, neoplasia & neoplasm, thyroiditis, virilism; acidosis, alcohol intolerance, increased appetite, avitaminosis, Ca disorder, dehydration, enzymatic abnormality, fluid retention, decreased glucose tolerance, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperlipemia, hyperkalemia, hypernatremia, hyperuricemia, hypocalcemia, hypochloremia, hypoglycemia, hypoglycemic reaction, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, hypoproteinemia, hyperuricemia, impaired healing, ketosis, lactic acidosis, obesity, uremia; abnormal dreams, addiction, agitation, aggression, anorgasmia, anxiety, akathisia, apathy, aphasia, confusion, confusional state, decreased libido, delirium, delusions, depersonalization, depressed mood, depression, disinhibition, disorientation, drug dependence, elevated mood, euphoric mood, hallucination, hostility, increased libido, irritability, insomnia, manic reaction, mood swings, neurosis, panic attack, paranoid reaction, personality disorder, psychosis, psychotic depression & disorder, restlessness, schizophrenic reaction, suicide attempt, word finding difficulty; abnormal coordination, amnesia, arachnoiditis, ataxia, balance disorder, brain edema, burning sensation, cerebellar syndrome, cerebral infarct & ischemia, cerebrovascular disorder, circumoral paresthesia, CNS depression, neoplasia & stimulation, cognitive disorder, cogwheel rigidity, coma, convulsions, dementia, disturbance in attention, dizziness postural, dysarthria, dysautonomia, dysgraphia, dyskinesia, dystonia, encephalopathy, euphoria, extrapyramidal syndrome, facial paralysis, foot drop, Guillain-Barre syndrome, hemiplegia, hypalgesia, hyperalgesia, hyperesthesia, hyperkinesia, hyperreflexia, hypesthesia, hypertonia, hypoesthesia, hypokinesia, hyporeflexia, hypotonia, incoordination, intention tremor, intracranial aneurysm/HTN, lethargy, loss of consciousness, memory impairment, meningitis, mental impairment, migraine, movement disorder, multiple sclerosis, muscle spasticity, myoclonus, nervousness, neuralgia, neuritis, neuropathy, nystagmus, paralysis, parosmia, peripheral neuritis, psychomotor hyperactivity, sedation, sleep disorder, somnolence, speech disorder, stupor, subarachnoid hemorrhage, syncope, thinking abnormal, torticollis, trismus, twitching, w/drawal syndrome; abnormality of accommodation, abnormal vision, altered visual depth perception, anisocoria, asthenopia, blepharitis, blindness, blurred vision, cataract, color blindness, conjunctivitis, corneal lesion/opacity/ulcer, diplopia, dry eye, exophthalmos, extraocular palsy, eye disorder, hemorrhage, irritation, pain & swelling, glaucoma, increased lacrimation, iritis, keratitis, keratoconjunctivitis, lacrimation disorder, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, oscillopsia, papilledema, peripheral vision loss, photophobia, photopsia, ptosis, reduced visual acuity, refraction disorder, retinal artery occlusion/degeneration/depigmentation/detachment/disorder/edema/hemorrhage, scleritis, strabismus, uveitis, vision loss, visual brightness/disturbance/field defect, vitreous disorder; deafness, ear disorder & pain, hyperacusis, otitis externa/media, tinnitus, vertigo, vestibular disorder; angina pectoris, aortic stenosis, arrhythmia, atrial arrhythmia/flutter/fibrillation, AV block (1st-degree, 2nd-degree, complete), bigeminy, bradycardia, bundle branch block, cardiomegaly, cardiomyopathy, CV disorder, CHF, coronary artery disorder/occlusion, cor pulmonale, abnormal ECG, endocarditis, extrasystoles, heart arrest/block/failure, left heart failure, MI, myocardial ischemia, nodal tachycardia, palpitations, pulmonary embolus, QT interval shortened/prolongation, sinus arrhythmia, sinus bradycardia/tachycardia, ST segment depression/elevation, supraventricular extrasystoles/tachycardia, tachycardia, T wave inversion, ventricular arrhythmia/extrasystoles/fibrillation/tachycardia; arterial anomaly, arteriosclerosis, carotid occlusion/thrombosis, cerebral hemorrhage, cerebrovascular accident, deep thrombophlebitis, embolism lower extremity, flushing, hemorrhage, HTN, hypotension, increased capillary fragility, occlusion, peripheral coldness, petechia, phlebitis, postural HTN/hypotension, retinal vascular disorder, shock, thrombophlebitis, thrombosis, varicose vein, vascular anomaly/disorder/headache, vasculitis, vasodilatation; apnea, aspiration pneumonia, asthma, atelectasis, bronchiectasis, bronchiolitis, carcinoma of lung, cough, dyspnea, emphysema, epistaxis, flu syndrome, hemoptysis, hiccup, hyperventilation, hypoventilation, hypoxia, laryngeal neoplasia, laryngismus, laryngitis, lung disorder, edema & fibrosis, lung function decreased, nasal congestion, dryness & septum disorder, parosmia, pharyngitis, pharyngolaryngeal pain, pleural disorder/effusion, pneumonia, pneumothorax, pulmonary edema, pulmonary HTN, resp disorder & failure, rhinitis, snoring, sputum increased, throat tightness, voice alteration, yawn; abdomen enlargement, abdominal distention, & pain, abnormal stools, aphthous stomatitis, ascites, bloody diarrhea, cardiospasm, cheilitis, colitis, constipation, dry mouth, duodenal ulcer, dysphagia, enteritis, enterocolitis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal impaction, fecal incontinence, flatulence, gastritis, gastroenteritis, GERD, GI carcinoma, disorder & hemorrhage, gingivitis, glossitis, gum hemorrhage/hyperplasia, halitosis, hematemesis, hemorrhagic gastritis, intestinal obstruction/perforation/stenosis/ulcer, leukoplakia of the mouth, melena, mouth ulceration, necrotizing pancreatitis, oral hypoesthesia/moniliasis, pancreas disorder, pancreatitis, paralytic ileus, peptic ulcer, periodontal abscess, periodontitis, pseudomembranous colitis, rectal disorder/hemorrhage, salivary gland enlargement/hypersecretion, sialadenitis, stomach atony/ulcer/ulcer hemorrhage, stomatitis, swollen tongue, taste loss, taste perversion, tenesmus, tongue discoloration/disorder/edema, tooth caries, ulcerative colitis/stomatitis; biliary pain, bilirubinemia, cholecystitis, cholelithiasis, cholestatic jaundice, hepatitis, hepatoma, hepatomegaly, jaundice, liver fatty deposit/tenderness; acne, alopecia, angioedema, blister, body odor, bullous skin reactions, cold sweat, cutaneous moniliasis, decreased sweating, decubitus ulcer, dermatitis, dry skin, eczema, erythema multiforme, exfoliative dermatitis, face swelling, fungal dermatitis, furunculosis, granuloma, hair disorder, Henoch-Schonlein purpura, herpes simplex/zoster, hirsutism, hyperhidrosis, ichthyosis, lichenoid dermatitis, maculopapular, papular, petechial, purpuric, pustular & vesiculobullous rash, melanosis, miliaria, nail disorder, photosensitivity reaction, psoriasis, seborrhea, skin atrophy/benign neoplasm/carcinoma/discoloration, disorder, hypertrophy, melanoma, necrosis, nodule & ulcer, Stevens-Johnson syndrome, SC nodule, sweating, toxic epidermal necrolysis; arthralgia, arthritis, arthrosis, back pain, bone disorder/neoplasm/pain, bursitis, cervical spasm, chondrodystrophy, generalized spasms, joint disorder, joint swelling, leg cramps, lupus erythematosus syndrome, muscle atrophy/cramp/spasms/stiffness/twitching, muscular weakness, musculoskeletal congenital anomaly, myalgia, myasthenia, myopathy, myositis, neck pain, neck rigidity, osteomyelitis, osteoporosis, pain in extremity, pain in limb, pathological fracture, pyogenic arthritis, rhabdomyolysis, RA, sarcoma, tendinous contracture, tendon disorder/rupture, tenosynovitis; acute kidney failure, albuminuria, bladder calculus/carcinoma/neoplasm, calcium crystalluria, cervix neoplasm, decreased CrCl, cystitis, dysuria, glomerulitis, glycosuria, hematuria, hydronephrosis, kidney calculus, abnormal kidney function, kidney pain, nephritis, nephrosis, nocturia, oliguria, polycystic kidney, polyuria, pyelonephritis, pyuria, renal failure, suspicious papanicolaou smear, urate crystalluria, urethral pain, urethritis, urinary frequency/incontinence/retention/urgency, UTI, impaired urination, urine abnormality, urogenital disorder, urolithiasis, uterine fibroids enlarged; abnormal/delayed ejaculation, amenorrhea, balanitis, breast abscess/carcinoma/discharge/enlargement/neoplasm/pain, cervicitis, cervix disorder, dysmenorrhea, dyspareunia, endometrial carcinoma/disorder, epididymitis, erectile dysfunction, female lactation, fibrocystic breast, gynecomastia, hypomenorrhea, impotence, leucorrhea, mastitis, menopause, menorrhagia, menstrual disorder, metrorrhagia, orchitis, ovarian cancer, ovarian disorder, pelvic pain, prostate neoplasia, prostatic cancer, prostatic disorder, salpingitis, sexual dysfunction, unintended pregnancy, urogenital anomaly, urogenital neoplasia, uterine disorder, uterine hemorrhage, vag hemorrhage/moniliasis, vaginitis, vulvovag disorder; asthenia, chest pain substernal, chest tightness, death, edema, face edema, fall, fatigue, feeling abnormal/drunk, gait abnormality, generalized edema, hangover effect, hernia, hypothermia, increased drug effect, mucous membrane disorder, pain, peripheral edema/swelling, pyrexia, reaction unevaluable, retroperitoneal fibrosis, sudden death, thirst, decreased tolerance, unexpected benefit; abnormal lab test, decreased blood K/drug level/platelet count/prothrombin/wt/WBC count, hormone level altered, increased ALT/AST/aspartate aminotransferase/blood creatinine/blood creatinine phosphokinase/blood glucose/BUN/drug level, γ-globulins/γ-glutamyl transpeptidase/gonadotropic follicle stimulating hormone, increased nonprotein nitrogen/prostatic specific antigen sedimentation rate/Na/wt; injury, poisoning & procedural complications. Mecobalamin: Acneform/bullous eruptions; chromaturia.
Drug Interactions
Pregabalin: Increased risk of developing angioedema w/ ACE inhibitors. Reduced absorption w/ gabapentin. May potentiate the effects of alcohol & lorazepam. Additive impairment of cognitive & gross motor function w/ oxycodone. Wt gain &/or fluid retention w/ thiazolidinediones. Mecobalamin: Decreased absorption w/ metformin. Decreased enterohepatic reabsorption w/ chloramphenicol, colchicine, H2-antagonists, neomycin, para-aminosalicylic acid & proton-pump inhibitors (eg, omeprazole). Nitrous oxide forms a complex w/ cobalt. Lowered homocysteine levels w/ folate & vit B6. Reduced serum conc w/ OCs. May invalidate folic acid & vit B12 diagnostic blood assays w/ most antibiotics, methotrexate & pyrimethamine.
MIMS Class
Anticonvulsants / Drugs for Neuropathic Pain
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Funxion Plus cap
Packing/Price
30's (P1,143.3/box, P38.11/cap)
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