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Zyzyx

Zyzyx

pregabalin

Manufacturer:

Lloyd

Distributor:

InnoGen Pharmaceuticals
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Treatment of generalized anxiety disorder (GAD) in adults. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalization.
Dosage/Direction for Use
Dose range: 150-600 mg daily given in either 2 or 3 divided doses. Epilepsy Initially 150 mg daily as 2 or 3 divided doses, may be increased to 300 mg daily after 1 wk. Max: 600 mg daily may be achieved after an additional wk. GAD Initially 150 mg daily, may be increased to 300 mg daily after 1 wk. Following an additional wk, dose may be increased to 450 mg daily. Max: 600 mg daily may be achieved after an additional wk. Patient w/ renal impairment CrCl ≥60 mL/min Initially 150 mg daily given bid or tid. Max: 600 mg daily, ≥30-<60 mL/min Initially 75 mg daily given bid or tid. Max: 300 mg daily, ≥15-<30 mL/min Initially 25-50 mg daily given once daily or bid. Max: 150 mg daily, <15 mL/min Initially 25 mg daily given once daily. Max: 75 mg daily, supplementary dose following hemodialysis Initially 25 mg as single dose. Max: 100 mg daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use immediately if symptoms of angioedema (eg, facial, perioral, or upper airway swelling) occur. Reports of loss of consciousness, confusion & mental impairment; visual adverse reactions including loss of vision, visual blurring or other changes of visual acuity; CHF mostly seen in elderly CV compromised patients during treatment for neuropathic indication; increased CNS adverse reactions & somnolence in the treatment of central neuropathic pain due to spinal injury; encephalopathy mostly in patients w/ underlying conditions that precipitate encephalopathy. Insufficient data on w/drawal of concomitant antiepileptic medicinal products. W/drawal symptoms after discontinuation of short- & long-term treatment. Adjust hypoglycemic medicinal products in diabetic patients who gained wt during treatment. Monitor patients for signs of suicidal ideation & behaviors. Exercise caution in patients w/ history of substance abuse & monitor for symptoms of misuse, abuse or dependence. Reduced lower GI tract function (eg, intestinal obstruction, paralytic ileus, constipation) when co-administered w/ medications that have the potential to produce constipation (eg, opioid analgesics). Cases of renal failure. Use only during pregnancy if potential benefit justifies potential risk to the fetus. Breastfeeding is not recommended during treatment. Safety & efficacy in childn <1 yr & adolescents 12-17 yr have not been established. Dizziness & somnolence may occur which could increase the occurrence of accidental injury (fall) in elderly.
Adverse Reactions
Dizziness, somnolence, headache. Nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, disorientation, insomnia, decreased libido; ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paresthesia, hypoesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, nausea, constipation, diarrhea, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back pain, pain in limb, cervical spasm; erectile dysfunction; edema, peripheral edema, abnormal gait, fall, feeling drunk/abnormal, fatigue; increased wt.
Drug Interactions
May potentiate effects of ethanol & lorazepam. Reports of resp failure & coma w/ other CNS depressants. Additive effect in the impairment of cognitive & gross motor function caused by oxycodone.
MIMS Class
Anticonvulsants / Anxiolytics
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Zyzyx cap 75 mg
Packing/Price
20's
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