We are pleased to announce the FDA approval of Pregabalin extended-release tablets, brought to you by Alvogen, a leader in making quality, affordable medicines. Pregabalin extended-release tablets offer convenient QD dosing while maintaining efficacy for DPH and PHN patients.

Eligible Patients

Dosing

Dosing recommendations for Lyrica (pregabalin) CR, CV, and Pregabalin extended-release tablets, CV:

Conversion from Lyrica capsules or oral solution to Pregabalin extended-release tablets

DPN, diabetic peripheral neuropathy; ER, extended-release; PHN, post-herpetic neuralgia.

Pregabalin Extended-Release Tablets, CV, Indications and Important Safety Information

Important Safety Information

PREGABALIN EXTENDED-RELEASE TABLETS are not for everyone.

PREGABALIN EXTENDED-RELEASE TABLETS may cause serious, even life-threatening, allergic reactions. Stop taking PREGABALIN ER and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat, or neck, if you have any trouble breathing, or have a rash, hives, blisters, or skin redness.

PREGABALIN EXTENDED-RELEASE TABLETS may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members, or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self-harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop PREGABALIN EXTENDED-RELEASE TABLETS without first talking to your doctor.

Serious breathing problems can occur when PREGABALIN EXTENDED-RELEASE TABLETS are taken with other medicines that can cause severe sleepiness or decreased awareness or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting PREGABALIN EXTENDED-RELEASE TABLETS or when the dose is Increased. Get help right away if breathing problems occur.

PREGABALIN EXTENDED-RELEASE TABLETS may cause swelling of your hands, legs, and feet, which can be serious for people with heart problems.

PREGABALIN EXTENDED-RELEASE TABLETS may cause dizziness and sleepiness. You should not drive or work with machines until you know how PREGABALIN EXTENDED-RELEASE TABLETS affect you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish or any changes in your eyesight, including blurry vision or if you have any kidney problems or get dialysis.

Tell your doctor immediately if you are taking opioid painkillers. Taking PREGABALIN EXTENDED-RELEASE TABLETS in combination with these medications may reduce central nervous system activity that could lead to death.

Tell your doctor immediately if you are taking any opioid pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam), or insomnia (such as zolpidem). You may have a higher chance for dizziness and sleepiness or serious breathing problems if these medicines are taken with PREGABALIN EXTENDED-RELEASE TABLETS. Taking PREGABALIN EXTENDED-RELEASE TABLETS with opioid pain medicines may lead to death.

Some of the most common side effects of PREGABALIN EXTENDED-RELEASE TABLETS are dizziness, blurry vision, weight gain, sleepiness, tiredness, swelling of hands and feet, dry mouth, and nausea.

If you have diabetes, tell your doctor about any sores or skin problems. You may have a higher chance for swelling and hives if you are also taking angiotensin-converting enzyme (ACE) inhibitors, so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking Avandia (rosiglitazone), Avandamet (contains rosiglitazone and metformin), or Actos (pioglitazone). Do not drink alcohol while on PREGABALIN EXTENDED-RELEASE TABLETS. You may have a higher chance for dizziness and sleepiness if you take PREGABALIN EXTENDED-RELEASE TABLETS with alcohol, narcotic pain medicines, or medicines for anxiety.

In studies, a specific type of blood vessel tumor was seen in mice. The meaning of these findings in humans is not known.

Do not stop taking PREGABALIN EXTENDED-RELEASE TABLETS without talking to your doctor. If you stop suddenly, you may have headaches, nausea, diarrhea, trouble sleeping, Increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.

PREGABALIN EXTENDED-RELEASE TABLETS are available in doses of 82.5 mg, 165 mg, and 330 mg.

INDICATIONS

PREGABALIN EXTENDED-RELEASE TABLETS are indicated to treat pain from damaged nerves (neuropathic pain) that happens with diabetes or that follows healing of shingles.

It is not known if PREGABALIN EXTENDED-RELEASE TABLETS are safe and effective in children. It is not known if PREGABALIN EXTENDED-RELEASE TABLETS are effective when used for the treatment of fibromyalgia or when taken with other seizure medicines for adults with partial-onset seizures.

Please see full PREGABALIN EXTENDED-RELEASE TABLETS Prescribing Information. Lyrica^® is a registered trademark of Upjohn, which has no affiliate with Alvogen.

ALV-PREG-002