Pregamep

Pregamep

pregabalin

Manufacturer:

Meprofarm
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Central & peripheral neuropathic pain in adults; generalized anxiety disorders in adults. Adjunctive treatment of partial seizure w/ or w/o secondary generalization in adults. Relieve pain in the management of fibromyalgia.
Dosage/Direction for Use
150-600 mg daily in 2 or 3 divided doses. Neuropathic pain Initially 75 mg twice daily. May be increased to 150 mg twice daily after 3-7 days interval. Max: 300 mg twice daily after an additional wk. Epilepsy 75 mg twice daily. May be increased to 150 mg twice daily after 1 wk. Max: 300 mg twice daily after an additional wk. Generalized anxiety disorder 150-600 mg daily in 2-3 divided doses. May be increased to 300 mg daily after 1 wk. Following an additional wk, may be increased to 450 mg daily. Max: 600 mg daily may be achieved after an additional wk. Fibromyalgia Recommended dose: 300-450 mg daily in 2 divided doses. Dose of 75 mg twice daily (150 mg daily), may be increased to 150 mg twice daily (300 mg daily) w/in 1 wk. Patients who do not experience sufficient benefit w/ 300 mg daily may be further increased to 225 mg twice daily (450 mg daily). Renal impairment CrCl ≥60 mL/min Initially 150 mg twice daily. Max dose: 600 mg daily, CrCl 30-60 mL/min Initially 75 mg once or twice daily. Max dose: 300 mg daily, CrCl 15-30 mL/min Initially 25-50 mg once or twice daily. Max dose: 150 mg daily, CrCl <15 mL/min Initially 25 mg once daily. Max dose: 75 mg daily. Supplementary dose following haemodialysis Initially 25 mg daily single dose. Max: 100 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
Special Precautions
Discontinue immediately if symptoms of angioedema eg, facial, perioral, or upper airway swelling occur. Patients w/ rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Adjust hypoglycemic medications in some diabetic patients who gain wt on pregabalin treatment. Associated w/ dizziness & somnolence that may increase accidental injury/fall in elderly. Loss of consciousness, confusion & mental impairment. Transient visual blurring & other changes in visual acuity. W/drawal symptoms. Evaluate patients for history of drug misuse & abuse & observe for signs of pregabalin abuse. CHF patients. Increased CNS adverse events especially somnolence in the treatment of central neuropathic pain due to spinal cord injury. May influence ability to drive or use machines due to dizziness & somnolence. Do not drive, operate complex machinery or engage in other potentially hazardous activities. Renal impairment. Pregnancy & lactation. Elderly.
Adverse Reactions
Dizziness, somnolence. Nasopharyngitis; neutropenia; increased appetite, anorexia, hypoglycemia; euphoric mood, confusion, decreased libido, irritability, depression, disorientation, insomnia, hallucination, restlessness, agitation, increased mood, rapid mood changes, depersonalization, abnormal dream, anorgasm, panic attack, apathetic; ataxia, disturbance in attention, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, paraesthesia, hypoesthesia, sedation, balance disorder, lethargy; syncope, myoclonus, psychomotor hyperactivity, dyskinesia, postural dizziness, tremor, nystagmus, cognitive disturbances, aphasia, hyporeflexia, hyperesthesia, burn sensation, stupor, parosmia, hypokinesia, ageusia, dysgraphia; vertigo, hyperacusis; tachycardia, sinus bradycardia, grade 1 AV block, sinus tachycardia, sinus arrhythmia; hot flushes, hypotension, cold extremities, HTN, flushing; dyspnea, epistaxis, cough, nasal congestion, rhinitis, snoring, sore throat, dry nose; dry mouth, constipation, bloating, nausea, abdominal distension, GERD, saliva hypersecretion, hypoesthesia; ascites, pancreatitis, dysphagia; papular rash, urticaria, hyperhidrosis, cold sweating, SJS, itching; muscle cramps, arthralgia, back pain, pain in limb, cervical spasm; joint swelling, myalgia, twitching, neck pain, neck stiffness, rhabdomyolysis; urinary incontinence, dysuria; kidney failure, oliguria; erectile dysfunction, sexual dysfunction, delayed ejaculation, dysmenorrhea, breast tenderness, amenorrhea, breast discharge, breast enlargement; peripheral edema, fall, feeling drunk, oedema, abnormal gait; generalized edema, asthenia, feeling thirsty, fever; increased wt; hypersensitivity, allergic reactions.
Drug Interactions
May potentiate effects of ethanol & lorazepam. Resp failure & coma in patients who have taken pregabalin w/ other CNS depressant medications. Additive impairment of cognitive & gross motor function caused by oxycodone w/ pregabalin. Reduced lower GIT function eg, intestinal obstruction, paralytic ileus, constipation w/ opioid analgesics.
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
Pregamep cap 50 mg
Packing/Price
14's
Form
Pregamep cap 75 mg
Packing/Price
14's
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