Pregabalin 75mg Capsule (PREGAMAX-75) 30s

Indications and Dosage

Oral
Adjunct in partial seizures, Epilepsy

Adult: Initially, 150 mg daily, may increase up to 300 mg daily after 1 week. Max: 600 mg daily after an additional week. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Oral
Fibromyalgia

Adult: Initially, 150 mg daily, may increase to 300 mg daily after 1 week. Max: 450 mg daily, if necessary. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Oral
Neuropathic pain

Adult: Initially, 150 mg daily, may increase up to 300 mg daily after a 3-7 day interval. Max: 600 mg daily after an additional 7 day interval. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Oral
Anxiety

Adult: Initially, 150 mg daily, may increase in increments of 150 mg weekly. Max dose: 600 mg daily. All doses to be given in 2 or 3 divided doses. Adjust dose according to patient response and tolerability.

Renal Impairment

Haemodialysis: Initially, 25mg daily. Max: 100 mg daily. Administered as a single supplementary dose.

Administration

May be taken with or without food.

Special Precautions

Patients with CV disease (including heart failure), history of angioedema episodes or substance abuse. Elderly. Renal impairment. Pregnancy and lactation.

Adverse Reactions

Significant: Hypersensitivity, peripheral oedema, dizziness, somnolence, visual disturbance, suicidal ideation, reduced platelet count, rhabdomyolysis, creatinine kinase elevations, weight gain, PR prolongation.
Blood and lymphatic system disorders: Neutropenia.
Cardiac disorders: Tachycardia, atrioventricular block first degree, sinus bradycardia, CHF.
Ear and labyrinth disorders: Vertigo, hyperacusis.
Eye disorders: Blurred vision, diplopia, peripheral vision loss, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation.
Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhoea, flatulence, abdominal distention, dry mouth, GERD, salivary hypersecretion, hypoaesthesia oral.
General disorders and administration site conditions: Oedema, abnormal gait, fatigue, pyrexia, thirst, chills, asthenia.
Hepatobiliary disorders: Elevated liver enzymes.
Metabolism and nutrition disorders: Appetite increased, anorexia, hypoglycaemia.
Musculoskeletal and connective tissue disorders: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness.
Nervous system disorders: Headache, ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy.
Psychiatric disorders: Euphoric mood, confusion, irritability, disorientation, insomnia, hallucination, panic attack, restlessness, agitation, aggression, mood swings, apathy.
Renal and urinary disorders: Urinary incontinence, dysuria.
Reproductive system and breast disorders: Erectile dysfunction, sexual dysfunction, delayed ejaculation, dysmenorrhoea, breast pain.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness.
Skin and subcutaneous tissue disorders: Rash papular, urticaria, hyperhidrosis, pruritus.
Vascular disorders: Hypotension, hypertension, flushing, peripheral coldness.
Potentially Fatal: Angioedema.

Pregnancy Category (US FDA)

PO: C

Patient Counseling Information

This drug may cause dizziness and somnolence, if affected, do not drive or operate machinery.

MonitoringParameters

Monitor for signs of suicidal ideation and behaviour.

Overdosage

Symptoms: Somnolence, confusional state, agitation, restlessness, and seizures. Rarely, coma. Management: Symptomatic and supportive treatment. May be removed by haemodialysis. Consider administration of activated charcoal if ingestion is within 1 hour.

Drug Interactions

Additive CNS depressant effects with opiates (e.g. oxycodone) and benzodiazepines (e.g. lorazepam). May increase risk of angioedema with ACE inhibitors.

Food Interaction

May enhance CNS depressant effects of alcohol.

Action

Description: Pregabalin is an analog of the neurotransmitter GABA. It binds potently to the α2-δ 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.
Onset: Pain management: Noticeable effects on first 7 days of therapy.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: ≥90%. Time to peak plasma concentration: Within 1.5 hours.
Distribution: Volume of distribution: 0.5L/kg. Not bound to plasma protein.
Metabolism: Negligible metabolism.
Excretion: Mainly via urine (approx 98% as unchanged, minor metabolites). Half-life: Approx 6.3 hours.

Chemical Structure

Pregabalin

Source: National Center for Biotechnology Information. PubChem Database. Pregabalin, CID=5486971, https://pubchem.ncbi.nlm.nih.gov/compound/Pregabalin (accessed on Jan. 23, 2020)

Storage

Store between 15-30°C.

MIMS Class

Drugs for Neuropathic Pain

ATC Classification

N03AX16 – pregabalin ; Belongs to the class of other antiepileptics.

References

Anon. Pregabalin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/05/2019.

Anon. Pregabalin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/05/2019.

Buckingham R (ed). Pregabalin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2019.

Joint Formulary Committee. Pregabalin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/05/2019.

Lyrica Capsule (Remedyrepack Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/05/2019.