Tag: Gralise

What Ingredients Are in Gabapentin?

Gabapentin is an anti-epileptic drug, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain.

Gabapentin
Gabapentin

Some inactive ingredients in the gabapentin tablets or capsules include:

      • Lactose
      • Talc
      • Cornstarch
      • Gelatin
      • Colors such as FD&C blue no. 2, yellow iron oxide
      • Titanium dioxide
      • Poloxamer 407
      • Magnesium stearate
      • Copovidone, cornstarch
      • Candelilla wax
      • Hydroxypropyl cellulose

Dosing information

Usual Adult Dose for Epilepsy:

Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
Maintenance dose: 300 to 600 mg orally 3 times a day
Maximum dose: 3600 mg orally daily (in 3 divided doses)
-Maximum time between doses in the 3 times a day schedule should not exceed 12 hours

-The safety and effectiveness of gabapentin available under the trade name Gralise or Horizant in patients with epilepsy has not been studied.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization

Usual Adult Dose for Postherpetic Neuralgia:

-Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
-Titrate up as needed for pain relief
-Maximum dose: 1800 mg per day (600 mg orally 3 times a day)
Gabapentin available under the trade name Gralise:
-Maintenance dose: Gralise should be titrated to 1800 mg orally once daily with the evening meal.
-Recommended titration schedule:
Day 1: 300 mg orally with the evening meal
Day 2: 600 mg orally with the evening meal
Days 3 through 6: 900 mg orally with the evening meal
Days 7 through 10: 1200 mg orally with the evening meal
Days 11 through 14: 1500 mg orally with the evening meal
Day 15: 1800 mg orally with the evening meal

COMMENT:
-Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Gabapentin enacarbil extended release tablets are available under the trade name Horizant:

-The recommended dosage is 600 mg orally 2 times a day. Therapy should be initiated at a dose of 600 mg orally in the morning for 3 days of therapy, then increased to 600 mg 2 times a day (1200 mg/day) on day four.

COMMENT:
Gabapentin enacarbil extended release tablets available under the trade name Horizant and gabapentin are not interchangeable.

Use: Postherpetic neuralgia

Usual Adult Dose for Restless Legs Syndrome:

Gabapentin enacarbil available under the trade name Horizant:
600 mg orally once daily with food at about 5 PM

Use: For the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults

Usual Pediatric Dose for Epilepsy:

Less than 3 years: Not recommended

Greater than or equal to 3 and less than 12 years:
Starting Dose: Ranges from 10 to 15 mg/kg/day in 3 divided doses
Effective Dose: Reached by upward titration over a period of approximately 3 days; the effective dose in patients 5 years of age and older is 25 to 35 mg/kg/day in divided doses (3 times a day).

The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (3 times a day). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long term clinical study. The maximum time interval between doses should not exceed 12 hours.

Greater than 12 years:
-Initial dose: 300 mg orally on day one, 300 mg orally 2 times a day on day two, then 300 mg orally 3 times a day on day three
-Maintenance dose: 900 to 1800 mg orally in 3 divided doses; the dose may be increased up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization in patients 3 years of age and older

Gabapentin is used together with other medicines to treat partial seizures in adults and children at least 3 years old.

Gabapentin is also used to treat neuropathic pain (nerve pain) caused by herpes virus or shingles (herpes zoster) in adults.

Use only the brand and form of gabapentin your doctor has prescribed. Check your medicine each time you get a refill to make sure you receive the correct form.

The Gralise brand of gabapentin is indicated for the management of neuropathic pain only. It is not used for epilepsy.

Horizant is used to treat nerve pain and restless legs syndrome (RLS).

The Neurontin brand is used to treat seizures in adults and children who are at least 3 years old, in addition to neuropathic pain.

Gabapentin is part of its own drug class, called gabapentinoids. Typical dosages range from 100 milligrams to 800 milligrams of the drug.

 

Neurontin, Gralise, Horizant (Gabapentin) and Lyrica, Lyrica CR (pregabalin): Serious Breathing Problems

TOPIC: Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Serious Breathing Problems

AUDIENCE: Patient, Neurology, Pain Management, Pulmonology, Pharmacy

BACKGROUND: Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome.

ISSUE:FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. The elderly are also at higher risk.

FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. FDA has also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.

RECOMMENDATION: Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. Symptoms to watch for include:

  • Confusion or disorientation
  • Unusual dizziness or lightheadedness
  • Extreme sleepiness or lethargy
  • Slowed, shallow, or difficult breathing
  • Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
  • Bluish-colored or tinted skin, especially on the lips, fingers, and toes

Always inform your health care professional about all the drugs you are taking, including prescription and over-the-counter medicines and other substances such as alcohol.

Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system depressant such as a benzodiazepine.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Is Gabapentin Considered a Painkiller?

Gabapentin is commonly used to treat some types of nerve pain but is classified as an anticonvulsant medicine, not as an opioid or painkiller.

Gabapentin was first approved in 1993 and is used to treat:

    • postherpetic neuralgia, a nerve pain caused by the shingles virus (herpes zoster),
    • restless legs syndrome (RLS), a painful movement disorder in the legs
    • partial seizures in adults and children at least 3 years old who have epilepsy

Gabapentin works by affecting chemicals and nerves in the body that are involved in the cause of seizures and in some types of nerve pain.

Gabapentin is not a federally-controlled drug substance and does not contain an opioid (narcotic) medication. However, gabapentin misuse and abuse has been reported, and it may be restricted in some states through their state drug-monitoring program. Gabapentin abuse can boost the high a person gets from opioid painkillers, muscle relaxants, and anxiety medications. This can be dangerous and potentially life-threatening.

In 2019, the FDA issued an alert that serious breathing problems have been reported with gabapentin and other related drugs, like Lyrica (pregabalin) in people at risk of slowed breathing.

    • This includes people who use opioid pain medicine or CNS depressants, people with chronic obstructive pulmonary disease (COPD, and the elderly.
    • These serious breathing problems may be fatal.
    • Read more about this serious FDA warning here.

Avoid or limit the use of alcohol (in beverages or medicines) with gabapentin as it can worsen drowsiness or dizziness. Ask you doctor about drinking alcohol while you are taking gabapentin.

What type of pain does gabapentin treat?

Gabapentin is approved by the FDA to treat:

Postherpetic neuralgia: nerve pain that can occur due to an outbreak of shingles. Shingles, also known as herpes zoster, occurs when the chicken pox virus deep-seated in your nerve activates again later in life and causes a serious skin rash. Not everyone gets postherpetic neuralgia from shingles, but it can be painful if you do. It causes a burning nerve pain that lasts for months, or even years, after the rash and blisters have cleared up.

Restless legs syndrome (RLS): an uncontrollable urge to move your legs around, often at night. This is usually due to leg discomfort. It may occur most often when you are sitting, laying down, or during bedtime. It can be disruptful to sleep and travel. It is thought RLS may occur due to an imbalance of the chemical dopamine in the brain.

Gabapentin has also been used off-label for the treatment of other types of neuropathic (nerve) pain like peripheral diabetic neuropathy, fibromyalgia and trigeminal neuralgia. “Off-label” uses of gabapentin are uses that have not been approved by the FDA and are not found in the package insert, but may have been accepted for use by healthcare providers based on clinical use.

How does gabapentin come?

There are several brand names of gabapentin including Gralise, Horizant, and Neurontin. Use only the brand and form of gabapentin your doctor has prescribed.

Gralise (gabapentin) is indicated for the management of postherpetic neuralgia only. It is not used for epilepsy. Gralise comes as a 300 and 600 milligram (mg) extended-release (ER) tablet and in a 30-day starter pack of 78 tablets. A generic option is not yet available.

Horizant (gabapentin enacarbil) is used in adults to treat either nerve pain due to postherpetic neuralgia (PHN) or restless legs syndrome (RLS). Horizont is also an extended-release 300 mg or 600 mg tablet and is not interchangeable with other gabapentin products. A generic option is not yet available.

Neurontin (gabapentin) is an immediate-release form used to treat seizures in adults and children who are at least 3 years old, in addition to nerve pain due to shingles. It comes as 100, 300, or 400 mg oral capsules; 600 mg and 800 mg oral tablets, and as a 250 mg per 5 mL oral solution. It is also available as a generic option.

Some brands are only used for certain conditions, and these products may not be interchangeable. Check your medicine each time you get a refill to make sure you have received the correct form.

Some of these medicines may be expensive. Ask your healthcare provider if you are able to use a generic form of gabapentin for your condition (this may not always be possible). Generic options could save you hundreds of dollars each month, or may be less expensive than your insurance copay.

Also, check with the manufacturer who may offer copay cards or patient assistance programs to lessen your overall costs, if you qualify. Be sure to check for online coupons, too, that can save you money on both generics and brands.

To learn more about gabapentin, join the Drugs.com gabapentin Support Group and Q&A Section where you can ask questions, share experiences and keep up with the latest news.

This is not all the information you need to know about gabapentin for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full gabapentin information here, and discuss this information and any questions you have with your doctor or other health care provider.