Gabapentin Capsules USP

INDICATIONS AND USAGE

Gabapentin capsules, USP are indicated for:

• Management of postherpetic neuralgia in adults
• Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS

Capsules:

• 100 mg: white-white, opaque hard gelatin capsules printed with “IP 101” on both cap and body.
• 300 mg: buff-buff, opaque hard gelatin capsules printed with “IP 102” on both cap and body.
• 400 mg: light caramel-light caramel, opaque hard gelatin capsules printed with “IP 103” on both cap and body.

CONTRAINDICATIONS

Gabapentin capsules, USP are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
• Anaphylaxis and Angioedema
• Withdrawal Precipitated Seizure, Status Epilepticus
• Suicidal Behavior and Ideation
• Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age)
• Sudden and Unexplained Death in Patients with Epilepsy

1. Clinical Trials Experience

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with gabapentin.

Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

If overexposure occurs, call your poison control center at 1-800-222-1222.

DESCRIPTION

The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:

Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.

Each gabapentin, USP capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: magnesium stearate, pregelatinized starch (corn), starch (corn) and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1.

CLINICAL PHARMACOLOGY

NONCLINICAL TOXICOLOGY

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 2000 mg/kg/day. At 2000 mg/kg, the plasma gabapentin exposure (AUC) in mice is approximately 2 times that in humans at the MRHD of 3600 mg/day. In rats, increases in the incidence of pancreatic acinar cell adenoma and carcinoma were found in male rats receiving the highest dose (2000 mg/kg), but not at doses of 250 or 1000 mg/kg/day. At 1000 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 vivoassays. 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 vitroChinese 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 2000 mg/kg. At 2000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 8 times that in humans at the MRHD.

CLINICAL STUDIES

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration Information

Inform patients that gabapentin is taken orally with or without food.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Prior to initiation of treatment with gabapentin, instruct patients that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.

Anaphylaxis and Angioedema

Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema.

Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery

Advise patients that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although patients’ ability to determine their level of impairment can be unreliable, advise them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely. Inform patients that it is not known how long this effect lasts.

Suicidal Thinking and Behavior

Counsel the patient, their caregivers, and families that AEDs, including gabapentin, may increase the risk of suicidal thoughts and behavior. Advise patients of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients to report behaviors of concern immediately to healthcare providers.

Use in Pregnancy

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy.

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334.

This product’s label may have been updated. For full prescribing information, please visit www.amneal.com.

*Trademarks are the property of their respective owners.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad, INDIA 382220

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 10-2015-04

MEDICATION GUIDE

Gabapentin (GA-be-PEN-tin) Capsules

Read the Medication Guide before you start taking gabapentin capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about gabapentin capsules? Do not stop taking gabapentin capsules without first talking to your healthcare provider.

Stopping gabapentin capsules suddenly can cause serious problems.

Gabapentin capsules can cause serious side effects including:

1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin capsules 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:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

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

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

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

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

• Stopping gabapentin capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

2. Changes in behavior and thinking - Using gabapentin capsules 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 capsules 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 capsules. You may or may not have a rash with an allergic reaction caused by gabapentin capsules. Call a healthcare provider right away if you have any of the following symptoms:

• skin rash
• hives
• difficulty breathing
• fever
• swollen glands that do not go away
• swelling of your face, lips, throat, or tongue
• yellowing of your skin or of the whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

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 capsules.

What are gabapentin capsules?

Gabapentin capsules are a prescription medicine used to treat:

• Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
• Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.

Who should not take gabapentin capsules?

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

What should I tell my healthcare provider before taking gabapentin capsules?

Before taking gabapentin capsules, tell your healthcare provider if you:

• have or have had kidney problems or are on hemodialysis
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have diabetes
• are pregnant or plan to become pregnant. It is not known if gabapentin capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin capsules. You and your healthcare provider will decide if you should take gabapentin capsules while you are pregnant.
  • If you become pregnant while taking gabapentin capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

• are breast-feeding or plan to breast-feed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules.

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

Taking gabapentin capsules 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 capsules?

• Take gabapentin capsules exactly as prescribed. Your healthcare provider will tell you how much gabapentin capsules to take.

• Do not change your dose of gabapentin capsules without talking to your healthcare provider.
• Take gabapentin capsules with water.

• Gabapentin capsules can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox®, Mylanta®, Gelusil®, Gaviscon®, or Di-Gel®, you should wait at least 2 hours before taking your next dose of gabapentin capsules.

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

What should I avoid while taking gabapentin capsules?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin capsules affects you. Gabapentin capsules can slow your thinking and motor skills.

What are the possible side effects of gabapentin capsules?

Gabapentin capsules may cause serious side effects including:

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

• problems driving while using gabapentin capsules. See “What I should avoid while taking gabapentin capsules?”
• sleepiness and dizziness, which could increase the occurrence of accidental injury, including falls
• The most common side effects of gabapentin capsules include:
• lack of coordination
• viral infection
• feeling drowsy
• nausea and vomiting
• difficulty with speaking
• tremor
• swelling, usually of legs and feet
• feeling tired
• fever
• jerky movements
• difficulty with coordination
• double vision
• unusual eye movement

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 capsules. 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 capsules?

• Store Gabapentin Capsules between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of gabapentin capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin capsules for a condition for which it was not prescribed. Do not give gabapentin capsules 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 capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin capsules that was written for healthcare professionals.

For more information go to WWW.AMNEAL.COM or call 1-877-835-5472.

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin, USP

Inactive ingredients in the capsules: magnesium stearate, pregelatinized starch (corn), starch (corn) and talc.

The 100-mg capsule shell contains: gelatin, sodium lauryl sulfate, and titanium dioxide.

The 300-mg capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow.

The 400-mg capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No. 6, and FD&C Blue No. 1.

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

This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com

*Trademarks are the property of their respective owners.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad, INDIA 382220

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 10-2015-04

VITACIN CREAM

ACTIVE INGREDIENT

Active Ingredient:

Methyl Salicylate 20.00% Topical Analgesic

Menthol 5.00% Topical Analgesic

Capsaicin 0.0375% Topical Analgesic

PURPOSE

Indications: For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, consult physician.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
• Children under two-years of age: consult a physician.

Warnings

For external use only.

Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Do not apply to wounds or damaged skin.

Do not bandage tightly.

If pregnant or breast feeding, contact physician prior to use.

INACTIVE INGREDIENT

aqua (deionized water), arnica montana flowe rextract, C13-14 isoparaffin, cetearyl alcohol, chondroitin sulfate, emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, methylsulfonylmethane (MSM), PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, triethanolamine, urea.

VITACIN CREAM 120G (69677-010-01)

GABAPENTIN CAPSULES USP 300MG 90 COUNT (69677-208-90)

SMARTRX GABA-V KIT (69677-069-02)