Lyrica

Active ingredient: Pregabalin

Pregabalin is a medication used world-wide in the treatment of partial onset seizures, postherpetic neuralgia, diabetic neuropathy, fibromyalgia, spinal cord injury neuropathic pain, and generalized anxiety disorder. The actions of pregabalin are mediated through binding with high affinity to alpha-2-delta proteins, which attenuates calcium influx into presynaptic neurons and thereby blocks the release of neurotransmitters, including the excitatory neurotransmitter l-glutamate.

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What is LYRICA?

LYRICA is a prescription medicine used in adults, 18 years of age and older to treat:

• Pain from damaged nerves (neuropathic pain) that happens with diabetes;
• Pain from damaged nerves (neuropathic pain) that follows healing of shingles;
• Fibromyalgia (pain all over your body);
• Pain from damaged nerves (neuropathic pain) that follows spinal cord injury.

Description

LYRICA (pregabalin) binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calciumdependent release of pro-nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha2-delta containing-calcium channel trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage and persistent pain suggest the anti-nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord.

LYRICA (pregabalin) is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.

Dosage

Pregabalin pharmaceutical products are available to be taken orally. The maximum recommended dose of LYRICA is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Capsule strengths: 25, 50, 75, 100, 150, 200, 225, 300 mg

Side effects

LYRICA may cause serious side effects including:

• Serious, even life-threatening, allergic reactions;
• Swelling of your hands, legs and feet;
• Suicidal thoughts or actions;
• Dizziness and sleepiness.

What is Epilepsy

Epilepsy affects up to 1% of the population, making it second to stroke as one of the most common serious neurologic disorders. About 50 million people world wide have epilepsy and 90% of them are from developing countries. In the past several years, our understanding of epilepsy has increased in several respects. It is a common chronic neurological disorder in which the balance between cerebral excitability and inhibition is tipped toward uncontrolled excitability and characterized by recurrent unprovoked 3-5 seizures. There is now clear evidence that there are distinct differences between the immature and mature brain in the pathophysiology and consequences of seizures. It is a collection of many different types of seizures that vary widely in severity, appearance, cause, consequence and management.

Epilepsy is a common medical and social disorder or group of disorders with unique characteristics. Epilepsy is usually defined as a tendency to recurrent seizures. The word "epilepsy" is derived from Latin and Greek words for "seizure" or "to seize upon". This implies that epilepsy is an ancient disorder; indeed, in all civilizations it can be traced as far back as medical records exist. In fact, epilepsy is a disorder that can occur in all mammalian species, probably more frequently as brains have become more complex. Epilepsy is also remarkably uniformly distributed around the world.
There are no racial, geographical or social class boundaries. It occurs in both sexes, at all ages, especially in childhood, adolescence and increasingly in ageing populations.

Causes of epilepsy

The cause of epilepsy is completely unknown. The word epilepsy does not indicate anything about the cause or severity of the person's seizures, some cases of epilepsy are induced by genetic factors, but it can also result form brain injuries caused by blows to 19 the head, stroke, infections, high fever or tumors. It has been observed that heredity (genetics) play an important role in many causes of epilepsy in very young children, but it can be a factor for people of any age. For instances, not everyone who has a serious head injury (a clear cause of seizures) will develop epilepsy.

There are different causes of epilepsy that are common in different age groups;

• 1. In neonatal period and early infancy, the most common causes are hypoxic–ischemic encephalopathy, CNS infections, trauma, congenital CNS abnormalities and metabolic disorder.
• 2. In late infancy and early childhood, the most common febrile seizures may be caused by CNS infections and trauma.
• 3. In child hood well defined epilepsy syndromes are generally observed.
• 4. In adolescence and adult hood the causes are more likely to be secondary to any CNS lesion.
• 5. In old persons, cerebrovascular disease is the most common cause, the other causes, includes CNS tumors, head trauma and 22 other degenerative diseases like dementia.

Symptoms of seizure

The seizure is the characteristic event in epilepsy associated with the episodic high frequency discharge of impulses by a group of neurons in the brain. The clinical signs and symptoms of seizure depend on the location of the epileptic discharges in the cortex and the extent and pattern of the propagation of the epileptic discharge in the brain. e.g. involvement of the motor cortex causes convulsions, hypothalamus causes peripheral autonomic discharge and the involvement of the reticular formation of the upper brain stem leads to the loss of consciousness.

Seizure type and epilepsy syndrome

Generalized seizures are common in field studies, especially in developing countries, often because partial seizures are missed. In developed countries, over half the incidence cases are partial. Partial and generalized seizures vary with age, partial seizures being more common in the very young and in elderly people. Generalized tonic–clonic seizures occur uniformly throughout the life-course; absence seizures occur maximally between 5 and 10 years of age; and myoclonic seizures in the under-five-year-olds and around 15 years. Idiopathic epilepsy is usually seen in the young, and remote symptomatic epilepsy at the extremes. In developing countries, however, symptomatic epilepsy caused by infections should be considered at any age.

Diagnosis by syndrome is important for prognosis and treatment. For example, a cryptogenic/symptomatic localization syndrome, the commonest paediatric syndrome, is likely to be caused by a brain lesion which may be amenable to surgery if seizures are medically uncontrollable. Childhood absence epilepsy, the commonest idiopathic generalized epilepsy, whose prognosis is poor if untreated and excellent if treated, may be missed altogether in population screening.

Management of Epilepsy

The terms anticonvulsant and antiepileptic are used inter changeably. An anticonvulsant is an agent that blocks experimentally produced seizures in laboratory animals and antiepileptic drug is a drug used medically to control the epilepsies such as Lyrica (Pregabalin).