Lyrica 20mg/ml Solution

Pregabalin binds with high affinity to the alpha2-delta (α2-δ) subunit of voltage-gated calcium channels in the central nervous system. While the precise mechanism of action is unknown, binding to the α2-δ subunit is thought to reduce the release of several neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain, seizure, and anxiety pathways.

Serious Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Muscle pain or weakness
Changes in balance
Feeling confused
Shakiness
Trouble breathing, slow breathing, or shallow breathing
Blue or gray color of the skin, lips, nail beds, fingers, or toes
Memory problems or loss
Shortness of breath, significant weight gain, or swelling in the arms or legs
Fast or abnormal heartbeat
Fever, chills, or sore throat
Skin sores or any skin changes
Trouble speaking
Trouble sleeping
Trouble walking
Feeling high (easily laughing and feeling good)
Twitching

If you feel extremely sleepy, dizzy, or pass out, seek medical help immediately. Caregivers or others should seek medical help right away if the patient is unresponsive, does not answer or react normally, or cannot be awakened.

Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal thoughts or actions. Contact your doctor immediately if you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Other changes in mood or behavior
Suicidal thoughts or actions

Low platelet counts have been reported with this medication, which may increase the risk of bleeding. Contact your doctor immediately if you experience any unexplained bruising or bleeding.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak
Weight gain
Difficulty focusing
Headache
Dry mouth
Constipation
Increased appetite
Upset stomach
Joint pain
* Nose or throat irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, to ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems you have

This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.

If you experience changes in your seizures or if they worsen after starting this medication, consult your doctor promptly.

Do not abruptly stop taking this medication without first consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will instruct you on how to gradually stop taking it to minimize potential risks.

While taking this medication, it is recommended that you avoid consuming alcohol.

Before using marijuana, other cannabis products, or prescription and over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.

A severe and potentially life-threatening reaction known as angioedema has been associated with this medication. Symptoms may include swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness. If you experience any of these symptoms, seek immediate medical attention.

There is a risk of severe breathing problems when taking this medication, particularly in individuals who are also taking opioid pain medications or have pre-existing lung or breathing issues. This risk may be higher in people over 65 years old, and in some cases, breathing problems have been fatal. If you have concerns, consult your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Men who plan to father a child should discuss the potential risks with their doctor, as this medication has been shown to reduce fertility and cause sperm changes in male animals, and has also been linked to birth defects in the offspring of treated male animals. Although it is unclear if these effects occur in humans, it is crucial to weigh the benefits and risks.

If you are pregnant or plan to become pregnant, inform your doctor, as you will need to discuss the benefits and risks of using this medication during pregnancy.

• CNS depressants (e.g., opioids, benzodiazepines, alcohol, other sedatives): Increased risk of additive CNS depression (somnolence, dizziness, respiratory depression, coma).

• ACE inhibitors (e.g., captopril, enalapril): Potential for increased risk of angioedema.
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Potential for additive weight gain and/or peripheral edema.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands/feet)
• Weight gain
• Blurred vision or other visual disturbances
• Unusual changes in mood or behavior (e.g., agitation, depression, anxiety)
• Suicidal thoughts or ideation
• Muscle pain or weakness (rhabdomyolysis, though rare)
• Signs of hypersensitivity reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
• Signs of angioedema (swelling of face, mouth, or airway)

Data from observational studies suggest a possible increased risk of major congenital malformations (e.g., neural tube defects, oral clefts, cardiovascular defects) when pregabalin is taken during the first trimester of pregnancy. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available.

Pregabalin is excreted into human milk. Infant exposure is low, and adverse effects in breastfed infants are generally not expected. However, monitor breastfed infants for sedation, poor feeding, and weight gain. Use with caution.

Dosing for partial onset seizures is established for pediatric patients 1 month and older. Safety and efficacy for other indications (neuropathic pain, fibromyalgia) have not been established in pediatric patients. Monitor for behavioral changes and suicidal ideation.

Start with lower doses and titrate slowly due to the higher likelihood of decreased renal function in elderly patients, which necessitates dose adjustment. Elderly patients may also be more susceptible to adverse effects such as dizziness, somnolence, and falls.

• Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize the risk of withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, flu-like syndrome, nervousness, depression, pain, convulsions).
• Monitor for signs of angioedema, especially in patients concurrently taking ACE inhibitors.
• Can cause weight gain and peripheral edema; monitor patients with pre-existing cardiovascular conditions.
• Has a potential for abuse and dependence, particularly in patients with a history of substance abuse. Prescribe with caution in such populations.
• The oral solution is particularly useful for pediatric patients or those with difficulty swallowing tablets/capsules.

• For Neuropathic Pain: Gabapentin, Duloxetine, Venlafaxine, Amitriptyline, Carbamazepine (for trigeminal neuralgia).
• For Fibromyalgia: Duloxetine, Milnacipran, Amitriptyline, Cyclobenzaprine.
• For Partial Onset Seizures: Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Valproic acid, Topiramate.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it occurred.