Generic Gabapentin

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Gabapentin is an anticonvulsant that is also widely used to treat nerve pain, including the burning or shooting pain that follows shingles. It is approved in Canada as add-on therapy for epilepsy that is not controlled by other medications. The drug works by calming overactive nerve signals in the brain and spinal cord.
Dosing starts low and goes up slowly. A common starting schedule is 300 mg on day one, 300 mg twice daily on day two, and 300 mg three times daily from day three onward. For nerve pain, the target is often 1800 mg per day in three divided doses, though some people need less and some need more.
The administration forms are capsules in 100 mg, 300 mg, and 400 mg strengths, and immediate-release tablets in 600 mg and 800 mg. There is also an oral solution for people who have trouble swallowing capsules.
The medication does not work overnight for pain. It may take one to two weeks before you notice a difference, and the dose often needs to be adjusted before it works well.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that gabapentin can cause, and mixing the two can slow your breathing to a dangerous level.
The most common side effects are dizziness, sleepiness, and unsteadiness on your feet.
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Common Use Gabapentin

Gabapentin is a structural analogue of GABA, a chemical messenger that calms nerve activity, but it does not actually bind to GABA receptors. Its exact mechanism is still not fully understood. What researchers do know is that it binds with high affinity to the alpha-2-delta subunit of voltage-gated calcium channels in the nervous system. By attaching there, it reduces the release of excitatory neurotransmitters, which dampens the abnormal electrical signals that cause seizures and neuropathic pain. Health Canada has approved gabapentin as adjunctive therapy for partial-onset seizures in adults with epilepsy who are not adequately controlled by other drugs. It is also commonly prescribed off-label for postherpetic neuralgia, painful diabetic neuropathy, and other neuropathic pain conditions. It is not effective for ordinary back pain or sciatica, and it should not be used as a first-line treatment for those conditions.

Basic Gabapentin Information

• INN (International Nonproprietary Name): Gabapentin
• Brand names available in Canada: Neurontin® (original brand); generics include Apo-Gabapentin, Teva-Gabapentin, Sandoz Gabapentin, ratio-Gabapentin, pms-Gabapentin, Jamp-Gabapentin, Mar-Gabapentin, Mint-Gabapentin, Auro-Gabapentin, Riva-Gabapentin, AG-Gabapentin, Pro-Gabapentin, and others
• ATC Code: N03AX12
• Forms and dosages: Capsules – 100 mg, 300 mg, 400 mg. Immediate-release tablets – 600 mg, 800 mg. Oral solution – 50 mg/mL. All are immediate-release in Canada; extended-release gabapentin (Gralise) is not marketed here.
• Manufacturers in Canada: Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., Jamp Pharma Corporation, Mint Pharmaceuticals Inc., Marcan Pharmaceuticals Inc., Riva Pharmaceuticals, Auro Pharma Inc., Pro Doc Limitée, Glenmark Pharmaceuticals Canada Inc., Accord Healthcare Inc., Sivem Pharmaceuticals ULC, and Nora Pharma Inc. The original Neurontin brand was marketed by Pfizer Canada.
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 02246314, 02246315, and 02246316 (Gabapentin, Sivem – 100 mg, 300 mg, 400 mg); 02355246 (Jamp-Gabapentin); 02391473 (Mar-Gabapentin); 02408880 (Mint-Gabapentin); 02392534 (ACH-Gabapentin 800 mg); and 02260921 (ratio-Gabapentin 800 mg tablet).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Gabapentin is usually started at a low dose and increased gradually over several days to limit side effects. For epilepsy in adults, the starting dose is typically 300 mg three times daily. Your doctor may raise it based on how well it controls seizures and how well you tolerate it. The usual maintenance range is 900 mg to 1800 mg per day, divided into three doses. Some people need up to 2400 mg per day, and short-term studies have used up to 3600 mg per day, but higher doses generally cause more side effects and often do not add much benefit. For nerve pain, a common titration schedule begins with 300 mg on day one, 300 mg twice daily on day two, and 300 mg three times daily from day three onward. The dose is then adjusted upward as needed, usually to a target of 1800 mg per day. Doses above 1800 mg per day do not generally provide greater pain relief. Take gabapentin with or without food. If it upsets your stomach, take it with a meal. Try to take it at the same times each day, and do not let more than 12 hours pass between doses, because that can allow seizures or pain to break through. If you have kidney problems, your doctor will adjust the dose downward. Do not stop gabapentin suddenly. If you and your doctor decide to stop it, the dose should be reduced slowly over at least one week. Stopping abruptly can cause withdrawal symptoms or trigger seizures.

Precautions

Gabapentin can cause drowsiness, dizziness, and problems with coordination. Until you know how it affects you, do not drive, operate heavy machinery, or do anything else that requires you to be alert. These effects are more likely when you first start the medication or when the dose is increased, and they often fade with time. Still, some people continue to feel unsteady, especially older adults, who are also at higher risk of falls and fractures while taking gabapentin. Taking gabapentin with opioids, alcohol, or other central nervous system depressants can cause severe drowsiness, slowed breathing, coma, and death. Health Canada has issued warnings about this risk, even when gabapentin is used without opioids. If you take opioid pain medications, tell your doctor, and use the lowest effective dose of both drugs. Do not drink alcohol while taking gabapentin. Gabapentin can cause swelling in the legs and feet, a condition called peripheral edema. It can also cause weight gain in some people. If you notice unusual swelling or rapid weight gain, contact your doctor. The medication can cause changes in mood or behaviour, including depression, anxiety, and agitation. A small number of people, especially those with a history of mental health conditions, experience suicidal thoughts. If you notice any worsening of your mood or new thoughts of self-harm, get help right away. Gabapentin can cause a severe allergic reaction, sometimes with a rash, fever, and swollen lymph nodes, that can affect internal organs. Stop the medication and seek medical attention if you develop a rash, fever, or swelling. Gabapentin is not recommended during pregnancy. Animal studies suggest a risk to the fetus, and neonatal withdrawal syndrome has been reported in babies exposed to gabapentin in the womb. Women who could become pregnant should use effective contraception while taking it. It also passes into breast milk, so breastfeeding is not recommended without medical advice. Tell your doctor if you have kidney disease, liver disease, or a history of drug or alcohol dependence. Gabapentin has the potential to cause physical dependence, and withdrawal symptoms can occur after stopping, even if you have been taking it at therapeutic doses.

Contraindications

Do not take gabapentin if you are allergic to gabapentin or any of the inactive ingredients in the capsule, tablet, or oral solution. The safety and effectiveness of gabapentin in children under 18 years of age have not been established for epilepsy, so it should not be used in that age group unless specifically directed by a specialist. Gabapentin should not be used during pregnancy unless the potential benefit clearly outweighs the risk to the fetus. It should not be used during breastfeeding, because it passes into breast milk and can cause side effects in the infant. Do not take gabapentin with other central nervous system depressants, including opioids, without close medical supervision, because of the risk of respiratory depression and death. The medication is not approved for the treatment of ordinary back pain or sciatica, and it should not be used for those conditions. If you have severe kidney impairment, gabapentin should be used with caution and at reduced doses.

Possible Side Effects

More than 1 in 10 people experience dizziness, sleepiness, or unsteadiness. These are the most common side effects and are usually dose-related. Other common effects include fatigue, headache, nausea, vomiting, and swelling of the hands, feet, or legs. Some people notice blurred vision, dry mouth, or changes in appetite. These effects often improve as your body adjusts to the medication, but if they persist or bother you, tell your doctor. Serious side effects are less common but require medical attention. Severe drowsiness, slowed breathing, and coma can occur, especially when gabapentin is combined with opioids or alcohol. A severe allergic reaction with rash, fever, and swollen lymph nodes can affect the liver and other organs. Changes in mood, including depression and suicidal thoughts, can occur. If you develop a rash, fever, difficulty breathing, or unusual swelling, stop the medication and get help right away. Gabapentin can also cause withdrawal symptoms if stopped suddenly, including anxiety, insomnia, nausea, pain, sweating, tremor, headache, and depression. These symptoms usually appear within 48 hours of stopping the drug. Do not stop gabapentin abruptly. Work with your doctor to taper the dose slowly.

Drug Interaction

Gabapentin does not interfere much with the liver enzymes that metabolize most other drugs, so it has fewer interactions than many anticonvulsants. It does not interact with phenobarbital, phenytoin, valproic acid, or carbamazepine. However, there are important interactions to know about. Taking gabapentin with opioid pain medications, such as morphine or hydrocodone, can increase the amount of gabapentin your body absorbs and raise the risk of severe drowsiness and respiratory depression. Morphine, in particular, increases gabapentin levels, and this combination should be used only with close medical supervision. Antacids that contain aluminum or magnesium reduce the absorption of gabapentin by about 20 percent. If you take an antacid, take it at least 2 hours after your gabapentin dose. Cimetidine can reduce the kidney's ability to clear gabapentin, which may raise its levels in your body. Naproxen can increase gabapentin absorption slightly. Alcohol and other central nervous system depressants add to gabapentin's sedative effects and should be avoided. Tell your doctor and pharmacist about every medication you take, including over-the-counter products and supplements.

Missed Dose

If you miss a dose of gabapentin, take it as soon as you remember. If it is less than 4 hours until your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at once to make up for a missed one. Do not let more than 12 hours pass between doses, because that can allow seizures or pain to break through. If you miss several doses in a row, call your doctor for advice.

Overdose

Gabapentin overdose is rarely life-threatening on its own. Doses up to 49 grams have been taken without acute, life-threatening toxicity. The main concern is severe drowsiness, dizziness, double vision, slurred speech, and lethargy. When gabapentin is taken with other central nervous system depressants, especially opioids, the overdose can cause coma and death. Treatment is supportive and includes monitoring of breathing and circulation. Hemodialysis can remove gabapentin from the body and may be used in severe cases, especially if you have kidney problems. If you suspect an overdose, call 911 or go to the nearest emergency department. Do not try to manage it at home.

Storage

Store gabapentin capsules, tablets, and oral solution at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Brief exposure to temperatures between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit) is acceptable. Keep the container tightly closed and protect it from light and moisture. Do not store gabapentin in the bathroom or near a sink. Do not freeze the oral solution. Keep all forms out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush gabapentin down the toilet or pour it down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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