SAGALIN Tablet
Pregabalin
75mg
Samar Pharma Company Pvt. Ltd
| Pack size | 100's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 15.00 NPR |
Indications
SAGALIN Tablet is used for:
Anxiety, Fibromyalgia, Post herpetic Neuralgia, Partial seizures, Pain from diabetic neuropathy, Neuropathic pain associated with spinal cord injury
Adult Dose
Oral
Neuropathic pain, Postherpetic Neuralgia
Adult: Initially, 150 mg/day, may increase to 300 mg/day after 3-7 days. Max: 600 mg/day after a 7-day interval. All doses to be given in 2 or 3 divided doses.
Diabetic Peripheral Neuropathic Pain
Initial: 50 mg PO q8hr
Maintenance: May increase to 100 mg PO q8hr within 1 week, as needed; not to exceed 300 mg/day
Adjunct in partial seizures
Adult: Initially, 150 mg/day, may increase to 300 mg/day after a wk. Max: 600 mg/day. All doses to be given in 2 or 3 divided doses.
Fibromyalgia
Adult: Initially, 150 mg/day, may increase to 300 mg/day after a wk. Max: 450 mg/day, if needed. All doses to be given in 2 or 3 divided doses.
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment: Haemodialysis: 25-100 mg immediately after each 4-hr haemodialysis session.
CrCl (ml/min) Dosage Recommendation
30 to <60 75 mg/day. Max: 300 mg/day. All doses to be given in 2 or 3 divided doses.
15 to <30 Initially, 25-50 mg/day. Max: 150 mg/day. All doses to be given as a single dose or in 2 divided doses.
<15 Initially, 25 mg/day. Max: 75 mg/day. All doses to be given as a single dose.
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Pregnancy, lactation. Driving or working with machines, or do other dangerous activities.
Precautions
Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache and diarrhoea. So Pregabalin should be tapered gradually over a minimum of 1 week rather than discontinued abruptly. Pregabalin treatment may associate with creatine kinase elevations. It should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur. Discontinue treatment if patients develop severe angioedema. Regular vision check is recommended. May decrease platelet count and prolong PR interval. Patient w/ history of angioedema episodes, severe CV disease, renal impairment. Pregnancy and lactation. Patient Counselling May impair ability to drive, operate machinery or engage in hazardous activities. Monitoring Parameters Monitor visual disturbances. Closely observe for clinical worsening, suicidality and unusual changes in behaviour.
Lactation: Unknown if excreted in milk; not recommended
Pregnancy-Lactation
Interactions
May potentiate the effects of lorazepam. Additive CNS depressant effects w/ opiates and benzodiazepines. May increase risk of angioedema w/ ACE inhibitors. May increase risk of wt gain and peripheral oedema w/ thiazolidinediones.
Adverse Effects
Side effects of Pregabalin :
>10%
Dizziness (8-45%),Somnolence (4-36%),Peripheral edema (16%),Ataxia (1-20%),Fatigue (5-11%),Xerostomia (1-15%),Weight gain (16%),Tremor (11%),Blurred vision (1-12%),Diplopia (12%)
1-10%
Asthenia (5%),Edema (8%),Facial edema (<3%),Hypotension (2%),Neuropathy (2-9%),Pain (5%),Disorientation (<2%),Constipation (5%),Weight gain (4%),Accidental injury (4%),Abnormal thinking (2%),Confusion (<7%),Amnesia (<6%),Vertigo (1-4%),Hypoesthesia (2-3%),Euphoria (2%),Decreased libido (>1%),Incoordination (2%),Vomiting (1-3%),Balance disorder (2-9%),Myoclonus (4%),Nasopharyngitis pain (1-3%),Flu-like syndrome (1-2%)
<1%
Addiction,Anemia,Diarrhea,Gynecomastia and breast enlargement,Epididymitis,Esophagitis,Dysmenorrhea,Dystonia,Heart failure,Hirsutism,Uveitis
Mechanism of Action
Pregabalin is an analog of the neurotransmitter GABA. It binds potently to the alpha2-delta subunit resulting in modulation of Ca channels and reduction in the release of several neurotransmitters, including glutamate, norepinephrine, serotonin, dopamine, calcitonin gene-related peptide and substance P.
Note
SAGALIN 75mg Tablet manufactured by Samar Pharma Company Pvt. Ltd. Its generic name is Pregabalin. SAGALIN is availble in Nepal.
Farmaco Nepal drug index information on SAGALIN Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.