Pregabalin Eurodrug

Pregabalin Eurodrug

pregabalin

Manufacturer:

Polipharm

Distributor:

Pacific Healthcare

Marketer:

Pacific Healthcare
Full Prescribing Info
Contents
Pregabalin.
Description
PREGABALIN 25 EURODRUG: Each capsule contains Pregabalin 25 mg.
PREGABALIN 75 EURODRUG: Each capsule contains Pregabalin 75 mg.
Action
Pharmacology: Pharmacodynamics: Pregabalin binds to alpha2-delta subunit of voltage-gated calcium channels within the CNS and modulates calcium influx at the nerve terminals, thereby inhibiting excitatory neurotransmitter release including glutamate, norepinephrine (noradrenaline), serotonin, dopamine, substance P, and calcitonin gene-related peptide. Although structurally related to GABA, it does not bind to GABA or benzodiazepine receptors.
Pharmacokinetics: Onset of action: Pain management: Effect may be noted as early as the first week of therapy.
Distribution: Vd: 0.5 L/kg.
Protein binding: 0%.
Metabolism: Negligible.
Bioavailability: >90%.
Half-life elimination: 6.3 hours.
Time to peak: plasma: 1.5 hours (3 hours with food).
Excretion: Urine (90% as unchanged drug; minor metabolites).
Indications/Uses
Neuropathic Pain: Postherpetic Neuralgia: Pregabalin is used for the management of postherpetic neuralgia (PNH) in adults.
Diabetic Neuropathy: Pregabalin is used for the management of pain associated with diabetic peripheral neuropathy (DPN) in adults.
Seizure Disorder: Pregabalin is used in combination with other anticonvulsant agents in the management of partial seizures in adults.
Fibromyalgia: Pregabalin is used for the management of fibromyalgia in adults.
Dosage/Direction for Use
Pregabalin capsules are administered orally without regard to meals. If pregabalin is discontinued, dosage should be tapered gradually over at least 1 week.
Neuropathic Pain: Postherpetic Neuralgia: For the management of postherpetic neuralgia (PHN) in adults, the recommended dosage of pregabalin is 150-300 mg daily administered in 2 or 3 divided doses. Pregabalin therapy generally is initiated at a dosage of 150 mg daily (75 mg twice daily or 50 mg 3 times daily); dosage may be increased to 300 mg daily within 1 week based on efficacy and tolerability.
Diabetic Neuropathy: For the management of pain associated with diabetic peripheral neuropathy (DPN) in adults, the initial dosage of pregabalin is 150 mg daily administered in 3 divided doses; dosage may be increased within 1 week based on efficacy and tolerability to the maximum recommended dosage of 300 mg daily administered in 3 divided doses.
Seizure Disorder: For adjunctive therapy in the management of partial seizures in adults, the effective dosage of pregabalin is 150-600 mg daily administered in 2 or 3 divided doses. Pregabalin therapy generally is initiated at a dosage of 75 mg twice daily or 50 mg 3 times daily (initial dosage not to exceed 150 mg daily); based on individual patient response and tolerability, dosage may be increased to a maximum dosage of 600 mg daily.
Fibromyalgia: For the management of fibromyalgia in adults, the recommended dosage of pregabalin is 300-450 mg daily. Pregabalin therapy generally is initiated at a dosage of 150 mg daily (75 mg twice daily); dosage may be increased to 300 mg daily (150 mg twice daily) within 1 week based on efficacy and tolerability.
Dosage adjustment in renal impairment: Renal function may be estimated using the Cockcroft-Gault formula. Then determine recommended dosage regimen based on the indication-specific total daily dose for normal renal function (CrCl ≥ 60 mL/minutes). For example, if the indication-specific daily dose is 450 mg daily for normal renal function, the daily dose should be reduced to 225 mg daily (in 2-3 divided doses) for a creatinine clearance of 30-60 mL/minute (see Table).

Click on icon to see table/diagram/image
Overdosage
There is limited experience with overdose of pregabalin. The highest reported accidental overdose of pregabalin during the clinical development program was 8000 mg, and there were no notable clinical consequences.
There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Contraindications
Hypersensitivity to pregabalin or any component of the formulation.
Special Precautions
Antiepileptics are associated with an increased risk of suicidal behavior/thoughts with use; patients should be monitored for sign/symptoms of depression, suicidal tendencies, and other unusual behavior changes during therapy and instructed to inform their healthcare provider immediately if symptoms occur.
Angioedema has been reported; may be life threatening; use with caution in patients with a history of angioedema episodes.
Use In Pregnancy & Lactation
Pregnancy category: C.
Use in Pregnancy: The effect of pregabalin on labor and delivery is not known. Adverse events were observed in animal reproduction studies. In addition, male mediated teratogenicity has been observed in animal reproduction studies; implications in humans are not defined. Impaired male and female fertility has been noted in animal studies.
Lactation: It is not known if pregabalin is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Adverse Reactions
Cardiovascular: chest pain, edema, hyper-/hypotension.
Central nervous system: amnesia, anxiety, ataxia, attention disturbance, dizziness.
Dermatologic: bruising, decubitus ulcer, facial edema, pruritus.
Endocrine and metabolic: fluid retention, hypoglycemia, libido decreased.
Gastrointestinal: abdominal distention, abdominal pain, appetite increased, constipation, flatulence, nausea, vomiting.
Genitourinary: impotence, incontinence, urinary frequency.
Hematologic: Thrombocytopenia.
Neuromuscular and skeletal: abnormal gait, arthralgia, back pain, balance disorder.
Ocular: blurred vision, conjunctivitis, diplopia.
Otic: otitis media, tinnitus.
Respiratory: bronchitis, nasopharyngitis, pharyngolaryngeal pain, sinusitis.
Miscellaneous: accidental injury, allergic reaction, flu-like syndrome.
Drug Interactions
Avoid concomitant use of Pregabalin with any of the following: Azelastine; Orphenadrine; Paraldehyde; Thalidomide.
Pregabalin may increase the levels/effects of: Alcohol; Antidiabetic agents (Thiazolidinedione); Azelastine; CNS Depressant; Orphenadrine; Zolpidem.
The levels/effects of Pregabalin may be increased by Doxylamine; Hydroxyzine.
The levels/effects of Pregabalin may be decreased by Mefloquine; Orlistat.
Storage
Store below 30°C.
ATC Classification
N03AX16 - pregabalin ; Belongs to the class of other antiepileptics.
Presentation/Packing
Hard gel cap 25 mg (yellowish-white, no. 4, printed PCL and 25 on capsule, filled with white granules) x 8 x 7's. 75 mg (scarlet cap with white body, no. 4, printed PCL and 75 on capsule, filled with white granules) x 8 x 7's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in