PHENYTOIN SODIUM Capsule, Extended Release [NCS HealthCare Of KY, Inc Dba Vangard Labs]

Extended Phenytoin (fen' i toin)
Sodium Capsules, USP

Read this Medication Guide before you start taking Extended Phenytoin Sodium Capsules, USP 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. If you have any questions about Extended Phenytoin Sodium Capsules, USP ask your healthcare provider or pharmacist.

What is the most important information I should know about Phenytoin?

Do not stop taking Phenytoin without first talking to your healthcare provider.

Stopping phenytoin suddenly can cause serious problems.

Phenytoin can cause serious side effects including:

• 1.Like other antiepileptic drugs, Phenytoin 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 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 Phenytoin without first talking to a healthcare provider. Stopping Phenytoin 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.Phenytoin may harm your unborn baby.
  • If you take Phenytoin during pregnancy, your baby is at risk for serious birth defects.
  • Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
  • If you take Phenytoin during pregnancy, your baby is also at risk for bleeding problems right after birth. Your healthcare provider may give you and your baby medicine to prevent this.
  • All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of Phenytoin. If the decision is made to use phenytoin, you should use effective birth control (contraception) unless you are planning to become pregnant.
  • Tell your healthcare provider right away if you become pregnant while taking Phenytoin. You and your healthcare provider should decide if you will take Phenytoin while you are pregnant.
  • Pregnancy Registry: If you become pregnant while taking Phenytoin, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• 3.Swollen glands (lymph nodes)
• 4.Allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Symptoms can include any of the following:
  • swelling of your face, eyes, lips, or tongue
  • trouble swallowing or breathing
  • a skin rash
  • hives
  • fever, swollen glands (lymph nodes), or sore throat that do not go away or come and go
  • painful sores in the mouth or around your eyes
  • yellowing of your skin or eyes
  • bruising or bleeding
  • severe fatigue or weakness
  • severe muscle pain
  • frequent infections or an infection that does not go away
  • loss of appetite (anorexia)
  • nausea or vomiting

Call your healthcare provider right away if you have any of the symptoms listed above.

What is Phenytoin?

Phenytoin is a prescription medicine used to treat tonic-clonic (grand mal), complex partial (psychomotor or temporal lobe) seizures, and to prevent and treat seizures that happen during or after brain surgery.

Who should not take Phenytoin?

Do not take Phenytoin if you:

• are allergic to phenytoin or any of the ingredients in Extended Phenytoin Sodium Capsules, USP. See the end of this leaflet for a complete list of ingredients in Extended Phenytoin Sodium Capsules, USP.
• have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin).
• take delavirdine

What should I tell my healthcare provider before taking Phenytoin?

Before you take Phenytoin, tell your healthcare provider if you:

• Have or had liver disease
• Have or had porphyria
• Have or had diabetes
• Have or have had depression, mood problems, or suicidal thoughts or behavior
• Are pregnant or plan to become pregnant. If you become pregnant while taking Phenytoin, the level of Phenytoin in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of Phenytoin.
• Are breast feeding or plan to breastfeed. Phenytoin can pass into breast milk. You and your healthcare provider should decide if you will take Phenytoin or breastfeed. You should not do both.

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

Taking Phenytoin 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 Phenytoin?

• Take Phenytoin exactly as prescribed. Your healthcare provider will tell you how much Phenytoin to take.
• Your healthcare provider may change your dose. Do not change your dose of Phenytoin without talking to your healthcare provider.
• Phenytoin can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking Phenytoin can help prevent this.
• If you take too much Phenytoin, call your healthcare provider or local Poison Control Center right away.
• Do not stop taking Phenytoin without first talking to your healthcare provider. Stopping Phenytoin suddenly can cause serious problems.

What should I avoid while taking Phenytoin?

• Do not drink alcohol while you take Phenytoin without first talking to your healthcare provider. Drinking alcohol while taking Phenytoin may change your blood levels of Phenytoin which can cause serious problems.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Phenytoin affects you. Phenytoin can slow your thinking and motor skills.

What are the possible side effects of Phenytoin?

See "What is the most important information I should know about Phenytoin?"

Phenytoin may cause other serious side effects including:

• Softening of your bones (osteopenia, osteoporosis, and osteomalacia). This can cause broken bones.

Call your healthcare provider right away, if you have any of the symptoms listed above.

The most common side effects of Phenytoin include:

• problems with walking and coordination
• slurred speech
• confusion
• dizziness
• trouble sleeping
• nervousness
• tremor
• headache
• nausea
• vomiting
• constipation
• rash

These are not all the possible side effects of Phenytoin. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 Phenytoin?

• Store Extended Phenytoin Sodium Capsules, USP at room temperature between 20°C to 25°C (68°F to 77°F) in tight, light-resistant containers. Protect from moisture.

Keep Phenytoin and all medicines out of the reach of children.

General information about Phenytoin

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

For more information about Extended Phenytoin Sodium Capsules, USP, call 1-866-923-4914.

What are the ingredients in Extended Phenytoin Sodium Capsules?

Extended Phenytoin Sodium Capsules, USP 100 mg: Each capsule contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide.

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

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PHENYTOIN SODIUM Capsule, Extended Release [NCS HealthCare Of KY, Inc Dba Vangard Labs]

CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

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Updated Date: Apr 25, 2016 EST CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

Adverse Events Associated With Discontinuation of Treatment

Overall, the incidence of discontinuation due to adverse events was 17% in clonazepam compared to 9% for placebo in the combined data of two 6 to 9 week trials. The most common events (≥ 1%) associated with discontinuation and a dropout rate twice or greater for clonazepam than that of placebo included the following:

Adverse Events Occurring at an Incidence of 1% or More Among Clonazepam-Treated Patients

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6 to 9 week trials. Events reported in 1% or more of patients treated with clonazepam (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.

The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.

Treatment-Emergent Depressive Symptoms

In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term “depression” were reported in 7% of clonazepam-treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. In these same trials, adverse events classified under the preferred term “depression” were reported as leading to discontinuation in 4% of clonazepam-treated patients compared to 1% of placebo-treated patients. While these findings are noteworthy, Hamilton Depression Rating Scale (HAM-D) data collected in these trials revealed a larger decline in HAM-D scores in the clonazepam group than the placebo group suggesting that clonazepam-treated patients were not experiencing a worsening or emergence of clinical depression.

Other Adverse Events Observed During the Premarketing Evaluation of Clonazepam in Panic Disorder

Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with clonazepam at multiple doses during clinical trials. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and events reported only once and which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the events occurred during treatment with clonazepam, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency. These adverse events were reported infrequently, which is defined as occurring in 1/100 to 1/1000 patients.

Body as a Whole: weight increase, accident, weight decrease, wound, edema, fever, shivering, abrasions, ankle edema, edema foot, edema periorbital, injury, malaise, pain, cellulitis, inflammation localized

Cardiovascular Disorders: chest pain, hypotension postural

Central and Peripheral Nervous System Disorders: migraine, paresthesia, drunkenness, feeling of enuresis, paresis, tremor, burning skin, falling, head fullness, hoarseness, hyperactivity, hypoesthesia, tongue thick, twitching

Gastrointestinal System Disorders: abdominal discomfort, gastrointestinal inflammation, stomach upset, toothache, flatulence, pyrosis, saliva increased, tooth disorder, bowel movements frequent, pain pelvic, dyspepsia, hemorrhoids

Hearing and Vestibular Disorders: vertigo, otitis, earache, motion sickness

Heart Rate and Rhythm Disorders: palpitation

Metabolic and Nutritional Disorders: thirst, gout

Musculoskeletal System Disorders: back pain, fracture traumatic, sprains and strains, pain leg, pain nape, cramps muscle, cramps leg, pain ankle, pain shoulder, tendinitis, arthralgia, hypertonia, lumbago, pain feet, pain jaw, pain knee, swelling knee

Platelet, Bleeding and Clotting Disorders: bleeding dermal

Psychiatric Disorders: insomnia, organic disinhibition, anxiety, depersonalization, dreaming excessive, libido loss, appetite increased, libido increased, reactions decreased, aggressive reaction, apathy, attention lack, excitement, feeling mad, hunger abnormal, illusion, nightmares, sleep disorder, suicide ideation, yawning

Reproductive Disorders, Female: breast pain, menstrual irregularity

Reproductive Disorders, Male: ejaculation decreased

Resistance Mechanism Disorders: infection mycotic, infection viral, infection streptococcal, herpes simplex infection, infectious mononucleosis, moniliasis

Respiratory System Disorders: sneezing excessive, asthmatic attack, dyspnea, nosebleed, pneumonia, pleurisy

Skin and Appendages Disorders: acne flare, alopecia, xeroderma, dermatitis contact, flushing, pruritus, pustular reaction, skin burns, skin disorder

Special Senses Other, Disorders: taste loss

Urinary System Disorders: dysuria, cystitis, polyuria, urinary incontinence, bladder dysfunction, urinary retention, urinary tract bleeding, urine discoloration

Vascular (Extracardiac) Disorders: thrombophlebitis leg

Vision Disorders: eye irritation, visual disturbance, diplopia, eye twitching, styes, visual field defect, xerophthalmia

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