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NA | GABAPENTIN [Aphena Pharma Solutions - Tennessee, LLC] | BioPortfolio

13:48 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

What is the most important information I should know about gabapentin?

Do not stop taking gabapentin without first talking to your healthcare provider.

Stopping gabapentin suddenly can cause serious problems.

Gabapentin can cause serious side effects including:

1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

How can I watch for early symptoms of suicidal thoughts and actions?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking gabapentin without first talking to a healthcare provider.

2. Changes in behavior and thinking - Using gabapentin in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

3. Gabapentin may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin. You may or may not have a rash with an allergic reaction caused by gabapentin. Call a healthcare provider right away if you have any of the following symptoms:

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin.

What is gabapentin? Gabapentin is a prescription medicine used to treat:

Who should not take gabapentin? Do not take gabapentin if you are allergic to gabapentin or any of the other ingredients in gabapentin. See the end of this Medication Guide for a complete list of ingredients in gabapentin.

What should I tell my healthcare provider before taking gabapentin?

Before taking gabapentin, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking gabapentin with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take gabapentin?

If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.

What should I avoid while taking gabapentin?

What are the possible side effects of gabapentin?

Gabapentin may cause serious side effects including:

See “What is the most important information I should know about gabapentin?”

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of gabapentin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store gabapentin?

Store gabapentin capsules and tablets between 68°F to 77°F (20°C to 25°C).

Keep gabapentin and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin for a condition for which it was not prescribed. Do not give gabapentin to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about gabapentin. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin that was written for healthcare professionals.

For more information call ScieGen Pharmaceuticals, Inc. at 1-855-724-3436.

What are the ingredients in gabapentin capsules, USP?

Active ingredient: gabapentin, USP

Inactive ingredients in the capsules: Pregelatinized starch (maize), lactose monohydrate, and talc.

The 100-mg capsule shell also contains: gelatin, titanium dioxide, and FD&C Blue 2.

The 300-mg capsule shell also contains: gelatin, titanium dioxide, ferric oxide yellow. 

The 400-mg capsule shell also contains: gelatin, titanium dioxide, ferric oxide yellow, and FD&C Blue 2.

The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

All brands listed are the trademarks of their respective owners.

100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by: Cookeville, TN 38506 20180712JH

Count 300 mg
60 71610-088-53
90 71610-088-60
180 71610-088-80
270 71610-088-92
360 71610-088-94

NDC 71610-088 - Gabapentin 300 mg - Rx Only

Manufacturer

Aphena Pharma Solutions - Tennessee, LLC

Active Ingredients

Source

Clinical Trials [206 Associated Clinical Trials listed on BioPortfolio]

Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy

The evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative opioid-sparing ...

Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy

The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabet...

Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy in...

Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia

The purpose of this study is to determine the efficacy and safety of ramelteon, once daily (QD), taken in combination with Gabapentin for treating insomnia.

Gabapentin Treatment of Alcohol Dependence

This is a study to evaluate the efficacy of the medication gabapentin in treating persons with an alcohol problem.

PubMed Articles [51 Associated PubMed Articles listed on BioPortfolio]

Gabapentin-related Deaths: Patterns of Abuse and Postmortem Levels.

Gabapentin, a GABA analogue, is a nonopioid prescribed for seizure control and neuralgic pain. Its abuse for recreational purposes has been increasing in recent years as the number of prescriptions al...

Preoperative Gabapentin Administration Improves Acute Postoperative Analgesia in Patients Undergoing Craniotomy: A Randomized Controlled Trial.

Gabapentin is an adjuvant antiepileptic agent and helps to reduce acute postoperative pain in several surgery settings. However, the effect of gabapentin on postoperative pain from suboccipital or sub...

Gabapentin in Elastic Liposomes: Preparation, Characterization, Drug Release, and Penetration Through Porcine Skin.

In the outpatient pharmacy compounding, gabapentin, an anti-epileptic agent, has been commonly prescribed to be prepared alone or in combination with other agents in Pluronic lecithin organogel for tr...

Association between gabapentin receipt for any indication and AUDIT-C scores among clinical sub-populations with and without alcohol use disorder.

Current medications for alcohol use disorder (AUD) have limited efficacy and utilization. Some clinical trials have shown efficacy for gabapentin among treatment-seeking individuals. The impact of gab...

Gabapentin increases expression of δ subunit-containing GABA receptors.

Gabapentin is a structural analog of the inhibitory neurotransmitter γ-aminobutyric acid (GABA). Its anticonvulsant, analgesic and anxiolytic properties suggest that it increases GABAergic inhibition...

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