Dilantin

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• DILANTIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• DILANTIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• DILANTIN ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

DILANTIN DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

DILANTIN CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

DILANTIN ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●          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

• ●     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.

• ●     Stopping DILANTIN 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).

• ●          If you take DILANTIN 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 DILANTIN 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 DILANTIN. If the decision is made to use DILANTIN, 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 DILANTIN. You and your healthcare provider should decide if you will take DILANTIN while you are pregnant.

• ●          Pregnancy Registry: If you become pregnant while taking DILANTIN, 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.

• ●          swelling of your face, eyes, lips, or tongue

• ●          trouble swallowing or breathing

• ●          a skin rash

• ●          hives

• ●          fever, swollen glands, 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

• ●          unusual bruising or bleeding

• ●          severe fatigue or weakness

• ●          severe muscle pain

• ●          frequent infections or an infection that does not go away

• ●     are allergic to phenytoin or any of the ingredients in DILANTIN. See the end of this leaflet for a complete list of ingredients in DILANTIN.

• ●     have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE (ethotoin), or MESANTOIN (mephenytoin).

• ●     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 DILANTIN, the level of DILANTIN in your blood may decrease, causing your seizures to become worse. Your healthcare provider may change your dose of DILANTIN.

• ●     Are breast feeding or plan to breastfeed. DILANTIN can pass into breast milk. You and your healthcare provider should decide if you will take DILANTIN or breastfeed. You should not do both.

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

• ●     Your healthcare provider may change your dose. Do not change your dose of DILANTIN without talking to your healthcare provider.

• ●     DILANTIN can cause overgrowth of your gums. Brushing and flossing your teeth and seeing a dentist regularly while taking DILANTIN can help prevent this.

• ●     If you take too much DILANTIN, call your healthcare provider or local Poison Control Center right away.

• ●     Do not stop taking DILANTIN without first talking to your healthcare provider. Stopping DILANTIN suddenly can cause serious problems.

• ●     Softening of your bones (osteomalacia). This can cause broken bones.

• ●     problems with walking and coordination

• ●     slurred speech

• ●     confusion

• ●     dizziness

• ●     trouble sleeping

• ●     nervousness

• ●     tremor

• ●     headache

• ●     nausea

• ●     vomiting

• ●     constipation

• ●     rash

• ●     Store DILANTIN-125 Suspension at room temperature between 68to 77(20to 25Protect from light. Do not freeze.

• ●     Store DILANTIN INFATABS at room temperature between 68to 77(20to 25Protect from moisture.

• ●     Store DILANTIN Capsules at room temperature between 68to 77(20to 25in tight, light-resistant containers. Protect from moisture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION