Lyrica

What is Lyrica?

• LYRICA (Pregabalin) is an inhibitor of neuronal activity used for therapy of neuropathy and as an anticonvulsant.

Pregabalin Structural Formulae

PregabalinMolecule3D

What are the uses of this medicine?

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

LYRICA is a prescription medicine used in people 1 month of age and older to treat:

• partial-onset seizures when taken together with other seizure medicines.
• For the treatment of partial-onset seizures when taken together with other seizure medicines, it is not known if LYRICA is safe and effective in children under 1 month of age.

How does this medicine work?

• Pregabalin (pre gab' a lin) is a structural analogue of gamma-aminobutyric acid (GABA) but is novel in its activity, having no effects on GABA-A or GABA-B receptors.
• Instead, the neuronal acitivity of pregabalin appears to be mediated by its binding to the alpha-2-delta subunit of the presynaptic voltage-gated calcium channel whcih leads to a decrease in release of neuroexcitatory neurotransmitters by hyperexcited neurons.
• Pregabalin has been shown to be effective in reducing neuropathic pain from diabetic and postherpetic neuropathy and is an effective anticonvulsant.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to pregabalin or any of its components.

What drug interactions can this medicine cause?

• No clinically important drug interactions were observed.

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

Recommended dosage: Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults

• 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.

Postherpetic Neuralgia in Adults

• The recommended dose of LYRICA is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min.
• Begin dosing at 75 mg two times a day, or 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.

Management of Fibromyalgia in Adults

• The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day.
• Begin dosing at 75 mg two times a day (150 mg/day).
• The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.

Neuropathic Pain Associated with Spinal Cord Injury in Adults

• The recommended dose range of LYRICA for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day.
• The recommended starting dose is 75 mg two times a day (150 mg/day).
• The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.

• Dose should be adjusted in adult patients with reduced renal function.

Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More:

• 2 or 3 divided doses per day
• Maximum dose of 600 mg/day.

Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg:

• 1 month to less than 4 years:

14 mg/kg/day in 3 divided doses per day

• 4 years and older:

14 mg/kg/day in 2 or 3 divided doses per day

Administration:

• LYRICA may be taken with or without food.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Do not stop taking LYRICA without talking to your healthcare provider. If you stop taking LYRICA suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking LYRICA suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop LYRICA slowly.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much LYRICA, call your healthcare provider or poison control center, or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
• Oral Solution: 20 mg/mL

This medicine is available in fallowing brand namesː

• LYRICA

What side effects can this medication cause?

The most common side effects of this medicine include:

• weight gain
• increase in appetite
• sleepiness

LYRICA may cause serious side effects, including:

• Serious, even life-threatening, allergic reactions
• suicidal thoughts
• Swelling of your hands, legs and feet
• Dizziness and sleepiness

What special precautions should I follow?

• Do not drive a car, work with machines, or do other dangerous activities until you know how LYRICA affects you.
• Do not drink alcohol while taking LYRICA. LYRICA and alcohol can affect each other and increase side effects such as sleepiness and dizziness.
• Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in these cases.
• Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue LYRICA immediately in these patients.
• Increased seizure frequency or other adverse reactions may occur if LYRICA is rapidly discontinued. Withdraw LYRICA gradually over a minimum of 1 week.
• Antiepileptic drugs, including LYRICA, increase the risk of suicidal thoughts or behavior.
• LYRICA may cause peripheral edema. Exercise caution when co-administering LYRICA and thiazolidinedione antidiabetic agents.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There were no notable clinical consequences.

Management of overdosage:

• There is no specific antidote for overdose with LYRICA.
• If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway.
• General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
• Contact a Certified Poison Control Center for up-to-date information on the management of overdose with LYRICA.
• Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with LYRICA in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYRICA during pregnancy.
• This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Can this medicine be used in children?

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury:

• Safety and effectiveness in pediatric patients have not been established.

Fibromyalgia:

• Safety and effectiveness in pediatric patients have not been established.

Adjunctive Therapy for Partial-Onset Seizures:

• Safety and effectiveness in pediatric patients below the age of 1 month have not been established.
• The safety and effectiveness of LYRICA as adjunctive treatment for partial-onset seizures in pediatric patients 4 to less than 17 years of age have been established.
• The safety and effectiveness of LYRICA as adjunctive treatment for partial-onset seizures in pediatric patients 1 month to less than 4 years of age have been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: pregabalin

• Inactive ingredients:

• LYRICA capsules: lactose monohydrate, cornstarch, talc

• Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells.

• Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.

• LYRICA oral solution: methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water.

Who manufactures and distributes this medicine?

• Distributed By:

Cardinal Health Dublin, OH

What should I know about storage and disposal of this medication?

• Store LYRICA capsules and oral solution at room temperature between 68°F to 77°F (20°C to 25°C) in its original package.
• Safely throw away any LYRICA that is out of date or no longer needed.

• Dailymed label info on Lyrica
• FDA Lyrica

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