FusePaq Fanatrex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gabapentin for treating partial seizures in children. However, safety and efficacy have not been established in children younger than 3 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of gabapentin for treating postherpetic neuralgia in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gabapentin in the elderly. However, elderly patients are more likely to have unwanted effects (eg, problems with balance or walking, swelling in the feet or legs) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gabapentin.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Calcifediol
• Orlistat

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Ginkgo
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Morphine
• Morphine Sulfate Liposome

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Mood or mental changes, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain gabapentin. It may not be specific to FusePaq Fanatrex. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using Gralise® tablets:

• These should be taken with the evening meal.
• Swallow the tablet whole. Do not crush, break, or chew it.

For patients with epilepsy who take gabapentin three times per day, do not allow more than 12 hours to pass between any 2 doses. The medicine works best if a constant amount is in the blood.

Neurontin® capsules, tablets, and solution may be taken with or without food.

You may break the scored Neurontin® tablets into two pieces, but make sure you use the second half of the tablet as the next dose. Do not use the half-tablet if the whole tablet has been cut or broken after 28 days. Ask your doctor or pharmacist if you have any questions.

Swallow the capsule whole with plenty of water. Do not open, crush, or chew it.

Measure the oral liquid using a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If you take an antacid that contains aluminum or magnesium, wait at least 2 hours before taking gabapentin. Some examples of these antacids are Di-Gel®, Gaviscon®, Gelusil®, Maalox® and Mylanta®.

Only use the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, liquid, and tablets):
  • For epilepsy:
    • Adults and children 12 years of age and older—At first, 300 milligrams (mg) three times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2400 mg per day.
    • Children 3 to 11 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight per day and divided in 3 doses. Your doctor may adjust your dose as needed.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
  • For postherpetic neuralgia:
    • Adults— At first, 300 milligrams (mg) as a single dose in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1800 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

You should store the Neurontin® oral liquid in the refrigerator. Do not freeze.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take gabapentin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

The Horizant brand of gabapentin should not be taken during the day. For best results, take Horizant with food at about 5:00 in the evening.

Both Gralise and Horizant should be taken with food.

Neurontin can be taken with or without food.

If you break a Neurontin tablet and take only half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If your doctor changes your brand, strength, or type of gabapentin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of gabapentin you receive at the pharmacy.

Do not stop using gabapentin suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Wear a medical alert tag or carry an ID card stating that you take gabapentin. Any medical care provider who treats you should know that you take seizure medication.

Gabapentin can cause you to have a false positive urine protein screening test. If you provide a urine sample for testing, tell the laboratory staff that you are taking gabapentin.

Store tablets and capsules at room temperature away from light and moisture.

Store the liquid medicine in the refrigerator. Do not freeze.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking gabapentin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other gabapentin drug interactions with prescription and over-the-counter medicines, vitamins, and herbal products may occur. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to gabapentin: compounding powder, oral capsule, oral solution, oral tablet, oral tablet extended release

Cardiovascular

Common (1% to 10%): Peripheral edema, vasodilation, hypertension
Rare (less than 0.1%): Atrial fibrillation, heart failure, myocardial infarction, cerebrovascular accident, ventricular extrasystoles, bradycardia, premature atrial contraction, pericardial rub, heart block, pericardial effusion, pericarditis
Postmarketing reports: Cardiac arrest, chest pain, palpitation, tachycardia[Ref]

Dermatologic

Common (1% to 10%): Abrasion, facial edema, purpura, rash, pruritus, acne
Uncommon (0.1% to 1%): Alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cyst, herpes simplex
Rare (less than 0.1%): Stevens-Johnson syndrome, angioedema, erythema multiforme, drug rash (with eosinophilia and systemic symptoms), herpes zoster, skin discolor, skin papules, photosensitive reaction, psoriasis, desquamation, maceration, skin nodules, subcutaneous nodule, melanosis, skin necrosis, local swelling
Frequency not reported: DRESS/multiorgan hypersensitivity[Ref]

Endocrine

Rare (less than 0.1%): Hyperthyroid, hypothyroid, goiter, hypoestrogenism, ovarian failure, epididymitis, cushingoid appearance[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth or throat, constipation, nausea, vomiting, dyspepsia, dental abnormalities, gingivitis, abdominal pain, flatulence
Uncommon (0.1% to 1%): Glossitis, gum hemorrhage, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence
Rare (less than 0.1%): Pancreatitis, dysphagia, eructation, pancreatitis, peptic ulcer, colitis, blisters in mouth, tooth discoloration, perlèche, salivary gland enlarged, lip hemorrhage, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal hemorrhage, esophageal spasm
Frequency not reported: Dehydration[Ref]

General

The most common adverse reactions associated with the use of this drug were dizziness, somnolence, and peripheral edema.[Ref]

Genitourinary

Common (1% to 10%): Incontinence, impotence
Uncommon (0.1% to 1%): Hematuria, dysuria, urinary frequency, cystitis, urinary retention, vaginal hemorrhage, amenorrhea, dysmenorrhea, menorrhagia
Frequency not reported: Breast hypertrophy, gynecomastia, sexual dysfunction (including changes in libido, ejaculation disorders, and anorgasmia)[Ref]

Hematologic

Common (1% to 10%): Leucopenia, purpura
Uncommon (0.1% to 1%): Anemia, lymphadenopathy
Rare (less than 0.1%): Thrombocytopenia, thrombophlebitis, leukocytosis, lymphocytosis, increased bleeding time
Frequency not reported: Blood creatine phosphokinase increased, coagulation defect[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, jaundice, elevated liver function tests SGOT (AST), SGPT (ALT), and bilirubin, hepatomegaly, hepatotoxicity[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity syndrome, a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms[Ref]

Metabolic

Common (1% to 10%): Weight gain, hyperglycemia
Postmarketing reports: Hyponatremia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, myalgia, twitching
Uncommon (0.1% to 1%): Tendonitis, arthritis, joint stiffness, joint swelling
Frequency not reported: Rhabdomyolysis, myoclonus
Postmarketing reports: Elevated creatine kinase, rhabdomyolysis[Ref]

Nervous system

Very common (10% or more): Somnolence (21%), dizziness (17%), ataxia (13%)
Common (1% to 10%): Abnormal gait, incoordination, neuralgia, tremor, dysarthria, hyperkinesia, seizures, dysarthria, paresthesia, hypesthesia, coordination abnormal, increased/decreased/absent reflexes, vertigo
Uncommon (less than 1%): Hypokinesia
Rare (less than 0.1%): Movement disorders (e.g., choreoathetosis, dyskinesia, dystonia), loss of consciousness
Frequency not reported: Withdrawal precipitated seizure/status epilepticus
Postmarketing reports: Movement disorder[Ref]

Ocular

Common (1% to 10%): Amblyopia, conjunctivitis, diplopia, nystagmus
Uncommon (0.1% to 1%): Cataract, dry eyes, eye pain, visual field defect, photophobia, bilateral or unilateral ptosis, eye hemorrhage, hordeolum, eye twitching
Rare (less than 0.1%): Eye itching, abnormal accommodation, eye focusing problem, watery eyes, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, degenerative eye changes, blindness, retinal degeneration, miosis, chorioretinitis, strabismus[Ref]

Oncologic

Uncommon (0.1% to 1%): Breast cancer
Rare (less than 0.1%): Non-Hodgkin's lymphoma[Ref]

Other

Very common (10% or more): Fatigue (11%), fever (11%)
Common (1% to 10%): Asthenia, accidental injury, otitis media, tremor, pain
Rare (0.01% to 0.1%): Tinnitus
Very rare (less than 0.01%): Sudden unexplained death in patients with epilepsy
Frequency not reported: Sleepwalking, withdrawal symptoms, hearing loss, earache, tinnitus, inner ear infection, otitis, taste loss, unusual taste, ear fullness, perforated ear drum, sensitivity to noise, eustachian tube dysfunction, otitis externa, odd smell, labyrinthitis[Ref]

Psychiatric

Common (1% to 10%): Abnormal thinking, amnesia, depression, hostility, confusion, emotional liability, anxiety, nervousness, amnesia, insomnia
Uncommon (0.1% to 1%): Mental impairment
Rare (less than 0.1%): Hallucinations
Frequency not reported: Suicidal behavior and ideation, hypomania[Ref]

Renal

Rare (less than 0.1%): Acute renal failure[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, dyspnea, cough, bronchitis, respiratory infection, rhinitis
Rare (less than 0.1%): Pulmonary thrombosis, pulmonary embolism
Frequency not reported: Pseudo-croup, hoarseness[Ref]

Some side effects of gabapentin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Dizziness, drowsiness, tiredness, fever, and nystagmus (a rapid and uncontrollable movement of the eyes) are some of the more common side effects.
• May cause behavioral problems, hostility or aggression, or thought disturbances when used to treat epilepsy in children aged three to twelve years.
• Other side effects may include blurred vision, amblyopia (lazy eye), dry mouth, peripheral edema (fluid retention in the feet and hands), tremor, sexual dysfunction and gastrointestinal disturbances.
• Best titrated up slowly to reduce the risk of side effects; however, this may delay the onset of an effect.
• Similar to other anticonvulsant medicines, gabapentin may increase the risk of depression and suicidal thoughts, particularly in young adults under the age of 24.
• Gabapentin has been associated with a discontinuation syndrome when abruptly stopped. Symptoms include anxiety, insomnia, nausea, pain, and sweating. It should be tapered off slowly under a doctor's advice.
• The dosage of gabapentin needs to be reduced in kidney disease.
• Rarely, hypersensitivity reactions may occur. Symptoms may include fever, rash, swollen lymph nodes, swollen facial features or throat.
• May interact with some other medications including antacids, hydrocodone, morphine, and other drugs that cause sedation or dizziness. May also cause false positive results on some urinary protein tests.
• There have been some reports of gabapentin misuse and abuse, particularly in people with a history of drug abuse. Be alert for this possibility.
• Gabapentin requires three times daily administration because of its short duration of effect. Gabapentin enacarbil (brand name Horizant) only requires once-daily dosing.
• Only effective for partial onset seizures, not other types of seizure disorders.
• Some branded and generic forms of gabapentin are not interchangeable.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Gabapentin may be used in the treatment of partial onset seizures and nerve pain but is likely to cause dizziness or drowsiness. Gabapentin enacarbil (brand name Horizant), a prodrug of gabapentin that can be taken once daily, may be used in the treatment of RLS and postherpetic neuralgia.