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Zonik

Zonik

pregabalin

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Concise Prescribing Info
Contents
Pregabalin
Indications/Uses
Peripheral & central neuropathic pain in adults. Generalised anxiety disorder (GAD) in adults. Adjunctive therapy in adults w/ partial seizures w/ or w/o secondary generalisation.
Dosage/Direction for Use
Dose range: 150-600 mg daily given in 2 or 3 divided doses. Neuropathic pain Initially 150 mg daily in 2 or 3 divided doses, may be increased to 300 mg daily after 3-7 days interval & if needed to max of 600 mg daily after an additional 7-day interval. Epilepsy Initially 150 mg daily in 2 or 3 divided doses, may be increased to 300 mg daily after 1 wk. Max: 600 mg daily after an additional wk. GAD Initially 150 mg daily, may be increased to 300 mg daily after 1 wk, & to 450 mg daily following an additional wk. Max: 600 mg daily after an additional wk. Patient w/ renal impairment CrCl ≥60 mL/min Initially 150 mg daily in 2 or 3 divided doses. Max: 600 mg daily, ≥30-<60 mL/min Initially 75 mg daily in 2 or 3 divided doses. Max: 300 mg daily, ≥15-<30 mL/min Initially 25-50 mg daily as single dose or in 2 divided doses. Max: 150 mg daily, <15 mL/min Initially 25 mg daily as single dose. Max: 75 mg daily, hemodialysis Supplementary dose given immediately following every 4-hr haemodialysis: Initially 25 mg daily as single dose. Max: 100 mg daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue use if symptoms of angioedema eg, facial, perioral, or upper airway swelling occur &/or signs & symptoms suggestive of severe cutaneous adverse reactions including SJS & TEN appear. Reports of loss of consciousness, confusion & mental impairment; vision-related effects; cases of renal failure; CHF (mostly seen in CV-compromised elderly); severe resp depression; suicidal ideation & behaviour; cases of misuse, abuse & dependence; encephalopathy. Risk of w/drawal symptoms; convulsions, including status epilepticus & grand mal convulsions. Diabetic patients who gain wt on pregabalin treatment may need to adjust hypoglycaemic medicinal products. Monitor patients for signs of suicidal ideation & behaviours; & patients w/ history of substance abuse for symptoms of pregabalin misuse, abuse or dependence. Insufficient data for the w/drawal of concomitant anti-epileptics, once seizure control w/ add-on pregabalin has been reached, in order to reach monotherapy on pregabalin. Increased CNS adverse reactions in the treatment of central neuropathic pain due to spinal cord injury; may be attributed to concomitant medicinal products eg, anti-spasticity agents. Reports of reduced lower GIT function when co-administered w/ medications that have the potential to produce constipation eg, opioid analgesics. Risk of depression w/ concomitant opioids. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Associated w/ dizziness & somnolence; may have minor or moderate influence on ability to drive & use machines. Women of childbearing potential should use effective contraception during treatment. May cause major birth defects if used in 1st trimester of pregnancy. Do not use during pregnancy unless clearly necessary. Discontinue breastfeeding or discontinue pregabalin therapy during lactation. Safety & efficacy have not been established in childn <12 yr & adolescents 12-17 yr. May require dose reduction in elderly >65 yr.
Adverse Reactions
Dizziness, somnolence, headache. Nasopharyngitis; increased appetite; euphoric mood, confusion, irritability, depression, disorientation, insomnia, decreased libido; ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy; blurred vision, diplopia; vertigo; vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth; muscle cramp, arthralgia, back & limb pain, cervical spasm; erectile dysfunction; peripheral oedema, oedema, 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 in impairment of cognitive & gross motor function caused by oxycodone.
MIMS Class
Anticonvulsants
ATC Classification
N02BF02 - pregabalin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.
Presentation/Packing
Form
Zonik cap 150 mg
Packing/Price
50's (P2,250/box)
Form
Zonik cap 25 mg
Packing/Price
50's (P750/box)
Form
Zonik cap 50 mg
Packing/Price
50's (P1,000/box)
Form
Zonik cap 75 mg
Packing/Price
50's (P1,250/box)
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