Gabapentin Oral Solution

• It is used to treat seizures.
• It is used to treat painful nerve diseases.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how gabapentin oral solution affects you.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• This medicine is not the same as gabapentin enacarbil (Horizant™). Do not use in its place. Talk with the doctor.
• A very bad and sometimes deadly reaction has happened with gabapentin oral solution. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop gabapentin oral solution, you will want to slowly stop it as ordered by your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using gabapentin oral solution while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Gabapentin Oral Solution is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

7.1 Other Antiepileptic Drugs

Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly co-administered antiepileptic drugs [see Clinical Pharmacology (12.3)].

7.2 Opioids

Hydrocodone

Co-administration of gabapentin with hydrocodone decreases hydrocodone exposure [see Clinical Pharmacology (12.3)]. The potential for alteration in hydrocodone exposure and effect should be considered when gabapentin is started or discontinued in a patient taking hydrocodone.

Morphine

When gabapentin is administered with morphine, patients should be observed for signs of central nervous system (CNS) depression, such as somnolence, sedation and respiratory depression [see Clinical Pharmacology (12.3)].

7.3 Maalox® (aluminum hydroxide, magnesium hydroxide)

The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid (Maalox®) containing magnesium and aluminum hydroxides. It is recommended that gabapentin be taken at least 2 hours following Maalox administration [see Clinical Pharmacology (12.3)].

7.4 Drug/Laboratory Test Interactions

Because false positive readings were reported with the Ames N-Multistix SG® dipstick test for urinary protein when gabapentin was added to other antiepileptic drugs, the more specific sulfosalicylic acid precipitation procedure is recommended to determine the presence of urine protein.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Gabapentin was administered orally to mice and rats in 2-year carcinogenicity studies. No evidence of drug-related carcinogenicity was observed in mice treated at doses up to 2,000 mg/kg/day. At 2,000 mg/kg, the plasma gabapentin exposure (AUC) in mice is approximately 2 times that in humans at the MRHD of 3,600 mg/day. In rats, increases in the incidence of pancreatic acinar cell adenoma and carcinoma were found in male rats receiving the highest dose (2,000 mg/kg), but not at doses of 250 or 1,000 mg/kg/day. At 1,000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 5 times that in humans at the MRHD.

Studies designed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity. It is not known whether gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans.

Gabapentin did not demonstrate mutagenic or genotoxic potential in three in vitro and four in vivo assays. It was negative in the Ames test and the in vitro HGPRT forward mutation assay in Chinese hamster lung cells; it did not produce significant increases in chromosomal aberrations in the in vitro Chinese hamster lung cell assay; it was negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus test in Chinese hamster bone marrow; it was negative in the in vivo mouse micronucleus assay; and it did not induce unscheduled DNA synthesis in hepatocytes from rats given gabapentin.

No adverse effects on fertility or reproduction were observed in rats at doses up to 2,000 mg/kg. At 2,000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 8 times that in humans at the MRHD.

Gabapentin Oral Solution 250 mg per 5 mL, is a clear pale yellow to yellow colored solution and is supplied in a bottle containing 473 mL (NDC 65162-698-90).

Store Gabapentin Oral Solution refrigerated, 2°C to 8°C (36°F to 46°F).

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• worsening of mood, thoughts or actions of suicide or dying

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• difficulty walking or controlling muscle movements
• dizziness
• nausea
• slurred speech
• tremors
• tiredness
• weight gain

Do not take this medicine with any of the following medications:

• other gabapentin products (Gralise, Horizant)

This medicine may also interact with the following medications:

• alcohol
• antacids
• antihistamines for allergy, cough and cold
• certain medicines for anxiety or sleep
• certain medicines for depression or psychotic disturbances
• homatropine; hydrocodone
• naproxen
• narcotic medicines (opiates) for pain
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

Take this medicine by mouth. Carefully measure the dose needed. Use a specially marked spoon or dropper to measure your medicine. Tell your pharmacist if you do not have one. Household spoons are not accurate. If this medicine upsets your stomach, take it with food or milk. Take your medicine at regular intervals. Do not take it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

They need to know if you have any of these conditions:

• kidney disease
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to gabapentin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your doctor or health care professional for regular checks on your progress. You may want to keep a record at home of how you feel your condition is responding to treatment. You may want to share this information with your doctor or health care professional at each visit. You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures. Do not stop taking this medicine or any of your seizure medicines unless instructed by your doctor or health care professional. Stopping your medicine suddenly can increase your seizures or their severity.

Wear a medical identification bracelet or chain if you are taking this medicine for seizures, and carry a card that lists all your medications.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

Keep out of reach of children.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store in the refrigerator, between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze.