Pregabalin 75 mg Capsule

Some medical conditions may interact with pregabalin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems (eg, congestive heart failure, irregular heartbeat), high blood pressure, muscle problems, diabetes, or bleeding problems or low platelets
• if you have kidney problems or are on dialysis
• if you have a history of mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or drug abuse
• if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or unusual hoarseness)
• if you plan to father a child

Some MEDICINES MAY INTERACT with pregabalin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) because the risk of angioedema may be increased
• Benzodiazepines (eg, lorazepam) or narcotic pain medicines (eg, oxycodone) because the risk of drowsiness may be increased
• Thiazolidinedione antidiabetic agents (eg, rosiglitazone) because the risk of weight gain or swelling of the hands and feet may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if pregabalin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine

Drowsiness, dizziness, dry mouth, constipation, difficulty concentrating, swollen arms/legs, and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any unlikely but serious side effects, including: blurred vision, unusual bleeding/bruising, unsteadiness, confusion, muscle pain/tenderness/weakness (especially if you are tired or have a fever), swelling of hands/legs/feet, signs of kidney problems (such as change in the amount of urine).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Pharmacology

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 (Gajraj, 2007; McKeage, 2009). Although structurally related to GABA, it does not bind to GABA or benzodiazepine receptors. Exerts antinociceptive and anticonvulsant activity. Pregabalin may also affect descending noradrenergic and serotonergic pain transmission pathways from the brainstem to the spinal cord.

Distribution

V_d: 0.5 L/kg

Metabolism

Negligible

Excretion

Urine (90% as unchanged drug; minor metabolites)

Onset of Action

Pain management: Effects may be noted as early as the first week of therapy

Time to Peak

1.5 hours (3 hours with food)

Half-Life Elimination

6.3 hours

Protein Binding

0%

Special Populations: Renal Function Impairment

Cl is nearly proportional to CrCl. Plasma concentrations reduced by approximately 50% following a 4-h hemodialysis treatment.

Before taking pregabalin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart failure), kidney disease, history of an allergic reaction which included itching/swelling of the face/lips/tongue/throat (angioedema).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, unsteadiness, and confusion.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.