Zarontin

Pronunciation: ETH-oh-SUX-i-mide
Generic Name: Ethosuximide
Brand Name: Zarontin

Zarontin is used for:

Controlling absence epilepsy (previously known as petit mal seizures). It may also be used for other conditions as determined by your doctor.

Zarontin is an anticonvulsant. It acts in the brain to reduce the number of absence seizures.

Do NOT use Zarontin if:

• you are allergic to any ingredient in Zarontin or similar medicines

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zarontin:

Some medical conditions may interact with Zarontin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney disease, lupus, or a blood disorder (eg, porphyria)


• if you have a history of mood or mental problems, including suicidal thoughts or attempts

Some MEDICINES MAY INTERACT with Zarontin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Zarontin


• Valproic acid because it may affect the amount of Zarontin in your blood

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zarontin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zarontin:

Use Zarontin as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Zarontin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zarontin refilled.


• Take Zarontin by mouth with or without food.


• Taking Zarontin at the same time each day will help you remember to take it. Take Zarontin on a regular schedule to get the most benefit from it.


• Continue to take Zarontin even if you feel well. Do not miss any doses.


• If you miss a dose of Zarontin, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zarontin.

Important safety information:

• Zarontin may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zarontin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zarontin; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Increasing or decreasing the dose as well as adding or stopping other medicines should be done slowly. Rapidly stopping Zarontin may suddenly make absence seizures worse.


• Zarontin may cause swelling and tenderness of your gums. Brush and floss your teeth on a regular schedule and have regular dental checkups.


• Patients who take Zarontin may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Zarontin closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Lab tests, including complete blood cell counts and liver and kidney function tests, may be performed while you use Zarontin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Zarontin should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zarontin while you are pregnant. Zarontin is found in breast milk. If you are or will be breast-feeding while you use Zarontin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zarontin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain; stomach upset; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased number of seizures; lupus symptoms (eg, butterfly-shaped rash on the face, joint pain or swelling); new or worsening mood or mental changes (eg, depression); nightmares; red, swollen, blistered, or peeling skin; signs of infection (eg, fever, sore throat); suicidal thoughts or attempts; trouble concentrating; trouble sleeping; unusual bruising, bleeding, or fatigue.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zarontin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include central nervous system depression (eg, coma with slow, shallow breathing); nausea; vomiting.

Proper storage of Zarontin:

Store Zarontin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Zarontin out of the reach of children and away from pets.

General information:

• If you have any questions about Zarontin, please talk with your doctor, pharmacist, or other health care provider.


• Zarontin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zarontin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zarontin resources

• Zarontin Side Effects (in more detail)
• Zarontin Use in Pregnancy & Breastfeeding
• Drug Images
• Zarontin Drug Interactions
• Zarontin Support Group
• 4 Reviews for Zarontin - Add your own review/rating

• Zarontin Prescribing Information (FDA)


• Zarontin Advanced Consumer (Micromedex) - Includes Dosage Information


• Zarontin Concise Consumer Information (Cerner Multum)


• Zarontin Monograph (AHFS DI)


• Ethosuximide Prescribing Information (FDA)


• Ethosuximide Professional Patient Advice (Wolters Kluwer)

Compare Zarontin with other medications

• Seizures

Zymar eent

Generic Name: Gatifloxacin eent
Class: Antibacterials
VA Class: OP201
Chemical Name: (±-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline- carboxylic acid sesquihydrate
Molecular Formula: C₁₉H₂₂FN₃O₄
CAS Number: 112811-59-3

Introduction

Antibacterial; 8-methoxy fluoroquinolone.^{1 4}

Uses for Zymar

Bacterial Ophthalmic Infections

Treatment of conjunctivitis caused by susceptible Corynebacterium propinquum, Staphylococcus aureus, S. epidermidis, Streptococcus mitis, S. pneumoniae, or Haemophilus influenzae.¹

Role of topical fluoroquinolones in management of uncomplicated bacterial conjunctivitis not fully elucidated; some clinicians suggest that the drugs be reserved principally for severe bacterial conjunctivitis because of potential development of quinolone resistance, and possibly, cost considerations.^{8 10 11 12}

Zymar Dosage and Administration

Administration

For topical use only.¹ Not for injection.¹ Not for subconjunctival injection or introduction directly into anterior chamber of the eye.¹

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.¹

Avoid contamination of applicator tip.¹

Dosage

Pediatric Patients

Bacterial Ophthalmic Infections

Conjunctivitis

Ophthalmic

Children ≥1 year of age: 1 drop of 0.3% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) for 2 days, then 1 drop up to 4 times daily while awake for the next 5 days.¹

Adults

Bacterial Ophthalmic Infections

Conjunctivitis

Ophthalmic

1 drop of 0.3% solution in the affected eye(s) every 2 hours while awake (up to 8 times daily) for 2 days, then 1 drop up to 4 times daily while awake for the next 5 days.¹

Cautions for Zymar

Contraindications

• 
  

  Hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious, potentially fatal hypersensitivity reactions reported following systemic administration of fluoroquinolones; has occurred with the initial dose.¹

If allergic reaction occurs, discontinue use and institute appropriate therapy if indicated.¹

General Precautions

Superinfection

Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue gatifloxacin and institute other appropriate therapy.¹

Patient Monitoring

Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats after systemic administration; not known whether distributed into human milk.¹ Use gatifloxacin ophthalmic preparations with caution.¹

Pediatric Use

Safety and efficacy not established in children <1 year of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Common Adverse Effects

Conjunctival irritation, increased lacrimation, keratitis, papillary conjunctivitis, chemosis, conjunctival hemorrhage, ocular dryness, ocular discharge/irritation/pain, eyelid edema, headache, ocular redness, reduced visual acuity, taste disturbance.¹

Zymar Pharmacokinetics

Absorption

Bioavailability

Serum gatifloxacin concentrations were undetectable (<5 ng/mL) after topical application to one eye of gatifloxacin 0.3 or 0.5% ophthalmic solution in an escalated dosage regimen (2 drops initially, then 2 drops 4 times daily for 7 days, and then 2 drops 8 times daily for 3 days).¹

Stability

Storage

Ophthalmic

Solution

15–25°C; protect from freezing.¹

Actions and SpectrumActions

• 
  

  Usually bactericidal.¹

  
  


• 
  

  Like other fluoroquinolones, gatifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.^{1 4 6}

  
  


• 
  

  Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria.¹

  
  


• 
  

  Active against C. propinquum, S. aureus, S. epidermidis, S. mitis, S. pneumoniae, and H. influenzae.¹

  
  

Advice to Patients

• 
  

  Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.¹

  
  


• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the product.¹

  
  


• 
  

  Importance of not wearing contact lenses in the presence of signs and symptoms of bacterial conjunctivitis.¹ Contains benzalkonium chloride,¹ which may be absorbed by soft contact lenses.¹³

  
  


• 
  

  Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Gatifloxacin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.3%	Zymar (with benzalkonium chloride)	Allergan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Zymar 0.3% Solution (ALLERGAN): 5/$91.03 or 15/$248.37

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Allergan, Inc. Zymar (gatifloxacin) ophthalmic solution 0.3% prescribing information. Irvine, CA; 2004 Aug.

2. Allergan, Inc. Zymar (gatifloxacin) ophthalmic solution 0.3% formulary kit: summary of efficacy and safety. Irvine, CA; 2003.

3. Tepedino ME, Jensen HG. Efficacy and safety of gatifloxacin 0.3% ophthalmic solution compared with ofloxacin 0.3% for treatment of acute bacterial conjunctivitis. Poster presented at the annual meeting of the American Academy of Ophthalmology (AAO) Orlando, FL: 2002 Oct 20-3. Poster No. 165

4. Mah FS. New antibiotics for bacterial infections. Ophthalmol Clin North Am. 2003; 16:11-27. [PubMed 12683245]

5. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002; 62:13-59. [PubMed 11790155]

6. O’Brien T. Conjunctivitis. In: Mandell GL, Bennett JE, Dolin R eds. Principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:1251-6.

7. Limberg MB. A review of bacterial keratitis and bacterial conjunctivitis. Am J Ophthalmol. 1991; 112:2-9S.

8. Thielen TL, Castle SS, Terry JE. Anterior ocular infections: an overview of pathophysiology and treatment. Ann Pharmacother. 2000; 34:235-46. [IDIS 439875] [PubMed 10676832]

9. Bearden DT, Danziger LH. Mechanism of action of and resistance to quinolones. Pharmacotherapy. 2001; 21:224S-32S. [IDIS 472236] [PubMed 11642689]

10. Yolton DP. New antibacterial drugs for topical ophthalmic use. Optom Clin. 1992; 2:59-72.

11. Gwon A for the Ofloxacin Study Group II. Ofloxacin vs tobramycin for the treatment of external ocular infection. Arch Ophthalmol. 1992; 110:1234-7. [IDIS 301536] [PubMed 1520109]

12. Robert PY, Adenis JP. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001; 61:175-85. [PubMed 11270936]

13. Allergan, Inc, Irvine, CA: Personal communication.

More Zymar eent resources

• Zymar eent Side Effects (in more detail)
• Zymar eent Use in Pregnancy & Breastfeeding
• Zymar eent Support Group
• 6 Reviews for Zymar eent - Add your own review/rating

Compare Zymar eent with other medications

• Conjunctivitis
• Conjunctivitis, Bacterial
• Ophthalmic Surgery

Zyprexa Relprevv

Dosage Form: injection
FULL PRESCRIBING INFORMATION

WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Post-Injection Delirium/Sedation Syndrome — Adverse events with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of Zyprexa Relprevv. Zyprexa Relprevv must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, Zyprexa Relprevv is available only through a restricted distribution program called Zyprexa Relprevv Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment [see Dosage and Administration (2.1), Warnings and Precautions (5.1, 5.2), Overdosage (10.2), and Patient Counseling Information (17.2)].

Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Zyprexa Relprevv is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.3, 5.16) and Patient Counseling Information (17.3)].

Indications and Usage for Zyprexa Relprevv

Zyprexa Relprevv is available only through a restricted distribution program [see Warnings and Precautions (5.2)]. Zyprexa Relprevv must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program. To enroll, call 1-877-772-9390.

Schizophrenia

Zyprexa Relprevv is indicated for the treatment of schizophrenia. Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults [see Clinical Studies (14.1)].

Zyprexa Relprevv Dosage and Administration

Dosage

Zyprexa Relprevv is intended for deep intramuscular gluteal injection only and should not be administered intravenously or subcutaneously.

Be aware that there are two ZYPREXA intramuscular formulations with different dosing schedules. ZYPREXA IntraMuscular (10 mg/vial) is a short-acting formulation and should not be confused with Zyprexa Relprevv. Refer to the package insert for ZYPREXA IntraMuscular for more information about that product.

Establish tolerability with oral olanzapine prior to initiating treatment.

Zyprexa Relprevv should be administered by a healthcare professional every 2 to 4 weeks by deep intramuscular gluteal injection using a 19-gauge, 1.5-inch needle. Following insertion of the needle into the muscle, aspiration should be maintained for several seconds to ensure that no blood is drawn into the syringe. If any blood is aspirated into the syringe, it should be discarded and fresh drug should be prepared using a new convenience kit. The injection should be performed at a steady, continuous pressure. Do not massage the injection site.

Dose Selection — The efficacy of Zyprexa Relprevv has been demonstrated within the range of 150 mg to 300 mg administered every 2 weeks and with 405 mg administered every 4 weeks. Dose recommendations considering oral ZYPREXA and Zyprexa Relprevv are shown in Table 1.

Table 1: Recommended Dosing for Zyprexa Relprevv Based on Correspondence to Oral ZYPREXA Doses

Target Oral ZYPREXA Dose	Dosing of ZYPREXA RELPREVV During the First 8 Weeks	Maintenance Dose After 8 Weeks of ZYPREXA RELPREVV Treatment
10 mg/day	210 mg/2 weeks or 405 mg/4 weeks	150 mg/2 weeks or 300 mg/4 weeks
15 mg/day	300 mg/2 weeks	210 mg/2 weeks or 405 mg/4 weeks
20 mg/day	300 mg/2 weeks	300 mg/2 weeks

Zyprexa Relprevv doses greater than 405 mg every 4 weeks or 300 mg every 2 weeks have not been evaluated in clinical trials.

Post-Injection Delirium/Sedation Syndrome — During premarketing clinical studies, adverse events that presented with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, were reported in patients following an injection of Zyprexa Relprevv [see Boxed Warning, Warnings and Precautions (5.1), and Overdosage (10.1)]. Patients should be informed of this risk and how to recognize related symptoms [see Patient Counseling Information (17.1, 17.2)]. Zyprexa Relprevv must be administered in a registered healthcare facility with ready access to emergency response services. After each Zyprexa Relprevv injection, a healthcare professional must continuously observe the patient at the healthcare facility for at least 3 hours for symptoms consistent with olanzapine overdose, including sedation (ranging from mild in severity to coma) and/or delirium (including confusion, disorientation, agitation, anxiety, and other cognitive impairment). Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension, and convulsion. The potential for onset of an event is greatest within the first hour. The majority of cases have occurred within the first 3 hours after injection; however, the event has occurred after 3 hours. Following the 3-hour observation period, healthcare professionals must confirm that the patient is alert, oriented, and absent of any signs and symptoms of post-injection delirium/sedation syndrome prior to being released. All patients must be accompanied to their destination upon leaving the facility. For the remainder of the day of each injection, patients should not drive or operate heavy machinery, and should be advised to be vigilant for symptoms of post-injection delirium/sedation syndrome and be able to obtain medical assistance if needed. If post-injection delirium/sedation syndrome is suspected, close medical supervision and monitoring should be instituted in a facility capable of resuscitation [see Overdosage (10)].

Dosing in Specific Populations — Tolerance of oral ZYPREXA should be established prior to initiating treatment with Zyprexa Relprevv. The recommended starting dose is Zyprexa Relprevv 150 mg/4 wks in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine. When indicated, dose escalation should be undertaken with caution in these patients [see Warnings and Precautions (5.4), Drug Interactions (7), and Clinical Pharmacology (12.3)].

Zyprexa Relprevv has not been studied in subjects under 18 years of age [see Warnings and Precautions (5.6, 5.7, and 5.8)].

Maintenance Treatment — Although no controlled studies have been conducted to determine how long patients should be treated with Zyprexa Relprevv, efficacy has been demonstrated over a period of 24 weeks in patients with stabilized schizophrenia. Additionally, oral ZYPREXA has been shown to be effective in maintenance of treatment response in schizophrenia in longer-term use. Patients should be periodically reassessed to determine the need for continued treatment.

Switching from Other Antipsychotics — There are no systematically collected data to specifically address how to switch patients with schizophrenia from other antipsychotics to Zyprexa Relprevv.

Instructions to Reconstitute and Administer Zyprexa Relprevv

For deep intramuscular gluteal injection only. Not to be injected intravenously or subcutaneously.

Step 1: Preparing Materials

Convenience kit includes:

• Vial of Zyprexa Relprevv powder


• 3-mL vial of diluent


• One 3-mL syringe with pre-attached 19-gauge, 1.5-inch (38 mm) Hypodermic Needle-Pro® needle with needle protection device


• Two 19-gauge, 1.5-inch (38 mm) Hypodermic Needle-Pro needles with needle protection device
  

  —

  
  

  For obese patients, a 2-inch (50 mm), 19-gauge or larger needle (not included in convenience kit) may be used for administration.

  
  

Zyprexa Relprevv must be suspended using only the diluent supplied in the convenience kit.

It is recommended that gloves are used when reconstituting, as Zyprexa Relprevv may be irritating to the skin. Flush with water if contact is made with skin.

See additional insert entitled “Instructions to Reconstitute and Administer Zyprexa Relprevv” (included) for more information regarding the safe and effective use of the Hypodermic Needle-Pro syringe and needle.

Step 2: Determining Reconstitution Volume

Refer to the table below to determine the amount of diluent to be added to powder for reconstitution of each vial strength.

It is important to note that there is more diluent in the vial than is needed to reconstitute.

Dose	Vial Strength	Diluent to Add
150 mg	210 mg	1.3 mL
210 mg	210 mg	1.3 mL
300 mg	300 mg	1.8 mL
405 mg	405 mg	2.3 mL

Step 3: Reconstituting Zyprexa Relprevv

Please read the Hypodermic Needle-Pro Instructions for Use before proceeding with Step 3. Failure to follow these instructions may result in a needlestick injury.

 

Loosen the powder by lightly tapping the vial.

 

Open the prepackaged Hypodermic Needle-Pro syringe and needle with needle protection device.

 

Withdraw the pre-determined diluent volume (Step 2) into the syringe.

 

Inject the diluent into the powder vial.

 

Withdraw air to equalize the pressure in the vial by pulling back slightly on the plunger in the syringe.

 

Remove the needle from the vial, holding the vial upright to prevent any loss of material.

 

Engage the needle safety device (refer to complete Hypodermic Needle-Pro Instructions for Use).

 

Pad a hard surface to cushion impact (see Figure 1). Tap the vial firmly and repeatedly on the surface until no powder is visible.

Figure 1: Tap firmly to mix.

 

Visually check the vial for clumps. Unsuspended powder appears as yellow, dry clumps clinging to the vial. Additional tapping may be required if large clumps remain (see Figure 2).

Figure 2: Check for unsuspended powder and repeat tapping if needed.

 

Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture. The suspended product will be yellow and opaque (see Figure 3).

Figure 3: Vigorously shake vial.

 

If foam forms, let vial stand to allow foam to dissipate.

 

If the product is not used right away, it should be shaken vigorously to re-suspend. Reconstituted Zyprexa Relprevv remains stable for up to 24 hours in the vial.

Step 4: Injecting Zyprexa Relprevv

Before administering the injection, confirm there will be someone to accompany the patient after the 3-hour observation period. If this cannot be confirmed, do not give the injection.

Refer to the table below to determine the final volume to inject. Suspension concentration is 150 mg/mL Zyprexa Relprevv.

Dose	Final Volume to Inject
150 mg	1 mL
210 mg	1.4 mL
300 mg	2 mL
405 mg	2.7 mL

 

Attach a new safety needle to the syringe.

 

Slowly withdraw the desired amount into the syringe.

 

Some excess product will remain in the vial.

 

Engage the needle safety device and remove needle from syringe.

 

For administration, select the 19-gauge, 1.5-inch (38 mm) Hypodermic Needle-Pro needle with needle protection device. For obese patients, a 2-inch (50 mm), 19-gauge or larger needle (not included in convenience kit) may be used. To help prevent clogging, a 19-gauge or larger needle must be used.

 

Attach the new safety needle to the syringe prior to injection. Once the suspension has been removed from the vial, it should be injected immediately.

 

For deep intramuscular gluteal injection only. Do not inject intravenously or subcutaneously.

 

Select and prepare a site for injection in the gluteal area.

 

After insertion of the needle into the muscle, aspirate for several seconds to ensure that no blood appears. If any blood is drawn into the syringe, discard the syringe and the dose and begin with a new convenience kit. The injection should be performed with steady, continuous pressure.

 

Do not massage the injection site.

 

Engage the needle safety device.

 

Dispose of the vials, needles, and syringe appropriately after injection. The vial is for single-use only.

Dosage Forms and Strengths

Zyprexa Relprevv is a powder for suspension for intramuscular use only. Zyprexa Relprevv is present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine per vial. The diluent is a clear, colorless to slightly yellow solution in a glass vial [see Description (11) and How Supplied/Storage and Handling (16)]. The reconstituted suspension will be yellow and opaque [see Dosage and Administration (2.2)].

Contraindications

None.

Warnings and Precautions

Post-Injection Delirium/Sedation Syndrome

During premarketing clinical studies of Zyprexa Relprevv, adverse events that presented with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, were reported in patients following an injection of Zyprexa Relprevv [see Boxed Warning and Dosage and Administration (2.1)]. These events occurred in <0.1% of injections and in approximately 2% of patients who received injections for up to 46 months. These events were correlated with an unintentional rapid increase in serum olanzapine concentrations to supra-therapeutic ranges in some cases. While a rapid and greater than expected increase in serum olanzapine concentration has been observed in some patients with these events, the exact mechanism by which the drug was unintentionally introduced into the blood stream is not known. Clinical signs and symptoms included dizziness, confusion, disorientation, slurred speech, altered gait, difficulty ambulating, weakness, agitation, extrapyramidal symptoms, hypertension, convulsion, and reduced level of consciousness ranging from mild sedation to coma. Time after injection to event ranged from soon after injection to greater than 3 hours after injection. The majority of patients were hospitalized and some required supportive care, including intubation, in several cases. All patients had largely recovered by 72 hours. The risk of an event is the same at each injection, so the risk per patient is cumulative (i.e., increases with the number of injections) [see Overdosage (10.1)].

Healthcare professionals are advised to discuss this potential risk with patients each time they prescribe and administer Zyprexa Relprevv [see Patient Counseling Information (17.1, 17.2)].

Prescribing and Distribution Program for Zyprexa Relprevv

Zyprexa Relprevv is available only through a restricted distribution program [see Boxed Warning, Indications and Usage (1), and Patient Counseling Information (17.2)]. Zyprexa Relprevv must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program. To enroll, call 1-877-772-9390.

Zyprexa Relprevv must be administered in a registered healthcare facility (such as a hospital, clinic, residential treatment center, or community healthcare center) with ready access to emergency response services. After each Zyprexa Relprevv injection, a healthcare professional must continuously observe the patient at the healthcare facility for at least 3 hours and must confirm that the patient is alert, oriented, and absent of any signs and symptoms of post-injection delirium/sedation syndrome prior to being released. All patients must be accompanied to their destination upon leaving the facility. For the remainder of the day of each injection, patients should not drive or operate heavy machinery, and should be advised to be vigilant for symptoms of post-injection delirium/sedation syndrome and be able to obtain medical assistance if needed. If post-injection delirium/sedation syndrome is suspected, close medical supervision and monitoring should be instituted in a facility capable of resuscitation [see Overdosage (10)]. If parenteral benzodiazepines are required for patient management during an event of post-injection delirium/sedation syndrome, careful evaluation of clinical status for excessive sedation and cardiorespiratory depression is recommended.

Elderly Patients with Dementia-Related Psychosis

Increased Mortality

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Zyprexa Relprevv is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions (5.16), and Patient Counseling Information (17.3)].

In placebo-controlled oral olanzapine clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs 1.5%, respectively).

Cerebrovascular Adverse Events (CVAE), Including Stroke

Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of oral olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with oral olanzapine compared to patients treated with placebo. Zyprexa Relprevv is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Patient Counseling Information (17.3)].

Suicide

The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high-risk patients should accompany drug therapy.

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including olanzapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.

The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered and tolerability with oral olanzapine should be established prior to initiating treatment with Zyprexa Relprevv [see Dosage and Administration (2.1)]. The patient should be carefully monitored, since recurrences of NMS have been reported [see Patient Counseling Information (17.4)].

Hyperglycemia

Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level (fasting 100-126 mg/dL, nonfasting 140-200 mg/dL). Patients taking olanzapine should be monitored regularly for worsening of glucose control. Patients starting treatment with olanzapine should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug [see Patient Counseling Information (17.5)].

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other atypical antipsychotics.

Mean increases in blood glucose have been observed in patients treated (median exposure of 9.2 months) with olanzapine in phase 1 of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE). The mean increase of serum glucose (fasting and nonfasting samples) from baseline to the average of the 2 highest serum concentrations was 15.0 mg/dL.

In a study of healthy volunteers, subjects who received olanzapine (N=22) for 3 weeks had a mean increase compared to baseline in fasting blood glucose of 2.3 mg/dL. Placebo-treated subjects (N=19) had a mean increase in fasting blood glucose compared to baseline of 0.34 mg/dL.

Olanzapine Monotherapy in Adults — In an analysis of 5 placebo-controlled adult olanzapine monotherapy studies with a median treatment duration of approximately 3 weeks, olanzapine was associated with a greater mean change in fasting glucose levels compared to placebo (2.76 mg/dL versus 0.17 mg/dL). The difference in mean changes between olanzapine and placebo was greater in patients with evidence of glucose dysregulation at baseline (patients diagnosed with diabetes mellitus or related adverse reactions, patients treated with anti-diabetic agents, patients with a baseline random glucose level ≥200 mg/dL, and/or a baseline fasting glucose level ≥126 mg/dL).

Olanzapine-treated patients had a greater mean HbA1c increase from baseline of 0.04% (median exposure 21 days), compared to a mean HbA1c decrease of 0.06% in placebo-treated subjects (median exposure 17 days).

In an analysis of 8 placebo-controlled studies (median treatment exposure 4-5 weeks), 6.1% of olanzapine-treated subjects (N=855) had treatment-emergent glycosuria compared to 2.8% of placebo-treated subjects (N=599). Table 2 shows short-term and long-term changes in fasting glucose levels from adult olanzapine monotherapy studies.

Table 2: Changes in Fasting Glucose Levels from Adult Olanzapine Monotherapy Studies

a Not Applicable.
			Up to 12 weeks exposure		At least 48 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Glucose	Normal to High (<100 mg/dL to ≥126 mg/dL)	Olanzapine	543	2.2%	345	12.8%
		Placebo	293	3.4%	NAa	NAa
	Borderline to High (≥100 mg/dL and <126 mg/dL to ≥126 mg/dL)	Olanzapine	178	17.4%	127	26.0%
		Placebo	96	11.5%	NAa	NAa

The mean change in fasting glucose for patients exposed at least 48 weeks was 4.2 mg/dL (N=487). In analyses of patients who completed 9-12 months of olanzapine therapy, mean change in fasting and nonfasting glucose levels continued to increase over time.

Olanzapine Monotherapy in Adolescents — The safety and efficacy of Zyprexa Relprevv have not been established in patients under the age of 18 years.

In an analysis of 3 placebo-controlled oral olanzapine monotherapy studies of adolescent patients (13-17 years), including those with schizophrenia (6 weeks) or bipolar I disorder (manic or mixed episodes) (3 weeks), olanzapine was associated with a greater mean change from baseline in fasting glucose levels compared to placebo (2.68 mg/dL versus -2.59 mg/dL). The mean change in fasting glucose for adolescents exposed at least 24 weeks was 3.1 mg/dL (N=121). Table 3 shows short-term and long-term changes in fasting blood glucose from adolescent oral olanzapine monotherapy studies.

Table 3: Changes in Fasting Glucose Levels from Adolescent Oral Olanzapine Monotherapy Studies

a Not Applicable.
			Up to 12 weeks exposure		At least 24 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Glucose	Normal to High (<100 mg/dL to ≥126 mg/dL)	Olanzapine	124	0%	108	0.9%
		Placebo	53	1.9%	NAa	NAa
	Borderline to High (≥100 mg/dL and <126 mg/dL to ≥126 mg/dL)	Olanzapine	14	14.3%	13	23.1%
		Placebo	13	0%	NAa	NAa

Hyperlipidemia

Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using olanzapine, is recommended [see Patient Counseling Information (17.6)].

Clinically significant, and sometimes very high (>500 mg/dL), elevations in triglyceride levels have been observed with olanzapine use. Modest mean increases in total cholesterol have also been seen with olanzapine use.

Olanzapine Monotherapy in Adults — In an analysis of 5 placebo-controlled olanzapine monotherapy studies with treatment duration up to 12 weeks, olanzapine-treated patients had increases from baseline in mean fasting total cholesterol, LDL cholesterol, and triglycerides of 5.3 mg/dL, 3.0 mg/dL, and 20.8 mg/dL respectively compared to decreases from baseline in mean fasting total cholesterol, LDL cholesterol, and triglycerides of 6.1 mg/dL, 4.3 mg/dL, and 10.7 mg/dL for placebo-treated patients. For fasting HDL cholesterol, no clinically meaningful differences were observed between olanzapine-treated patients and placebo-treated patients. Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline, where lipid dysregulation was defined as patients diagnosed with dyslipidemia or related adverse reactions, patients treated with lipid lowering agents, or patients with high baseline lipid levels.

In long-term studies (at least 48 weeks), patients had increases from baseline in mean fasting total cholesterol, LDL cholesterol, and triglycerides of 5.6 mg/dL, 2.5 mg/dL, and 18.7 mg/dL, respectively, and a mean decrease in fasting HDL cholesterol of 0.16 mg/dL. In an analysis of patients who completed 12 months of therapy, the mean nonfasting total cholesterol did not increase further after approximately 4-6 months.

The proportion of patients who had changes (at least once) in total cholesterol, LDL cholesterol or triglycerides from normal or borderline to high, or changes in HDL cholesterol from normal or borderline to low, was greater in long-term studies (at least 48 weeks) as compared with short-term studies. Table 4 shows categorical changes in fasting lipids values.

Table 4: Changes in Fasting Lipids Values from Adult Olanzapine Monotherapy Studies

a Not Applicable.
			Up to 12 weeks exposure		At least 48 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Triglycerides	Increase by ≥50 mg/dL	Olanzapine	745	39.6%	487	61.4%
		Placebo	402	26.1%	NAa	NAa
	Normal to High (<150 mg/dL to ≥200 mg/dL)	Olanzapine	457	9.2%	293	32.4%
		Placebo	251	4.4%	NAa	NAa
	Borderline to High (≥150 mg/dL and <200 mg/dL to ≥200 mg/dL)	Olanzapine	135	39.3%	75	70.7%
		Placebo	65	20.0%	NAa	NAa
Fasting Total Cholesterol	Increase by ≥40 mg/dL	Olanzapine	745	21.6%	489	32.9%
		Placebo	402	9.5%	NAa	NAa
	Normal to High (<200 mg/dL to ≥240 mg/dL)	Olanzapine	392	2.8%	283	14.8%
		Placebo	207	2.4%	NAa	NAa
	Borderline to High (≥200 mg/dL and <240 mg/dL to ≥240 mg/dL)	Olanzapine	222	23.0%	125	55.2%
		Placebo	112	12.5%	NAa	NAa
Fasting LDL Cholesterol	Increase by ≥30 mg/dL	Olanzapine	536	23.7%	483	39.8%
		Placebo	304	14.1%	NAa	NAa
	Normal to High (<100 mg/dL to ≥160 mg/dL)	Olanzapine	154	0%	123	7.3%
		Placebo	82	1.2%	NAa	NAa
	Borderline to High (≥100 mg/dL and <160 mg/dL to ≥160 mg/dL)	Olanzapine	302	10.6%	284	31.0%
		Placebo	1

zolmitriptan

zole-mi-TRIP-tan

Commonly used brand name(s)

In the U.S.

• Zomig


• Zomig-ZMT

Available Dosage Forms:

• Tablet


• Tablet, Disintegrating

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For zolmitriptan

Zolmitriptan is used to treat severe migraine headaches. Many people find that their headaches go away completely after they take zolmitriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Zolmitriptan often relieves symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Zolmitriptan is not an ordinary pain reliever. It should not be used to relieve any kind of pain other than migraine headaches.

Zolmitriptan may cause serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using zolmitriptan as well as the good that it can do.

Zolmitriptan is available only with your doctor's prescription.

Before Using zolmitriptan

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 zolmitriptan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to zolmitriptan 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

There is no specific information comparing use of zolmitriptan in children or teenagers with use in other age groups.

Geriatric

There is no specific information comparing use of zolmitriptan in patients older than 65 years of age with use in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 zolmitriptan, 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 zolmitriptan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan


• Cisapride


• Dihydroergotamine


• Eletriptan


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Frovatriptan


• Isocarboxazid


• Levomethadyl


• Linezolid


• Mesoridazine


• Methylergonovine


• Methysergide


• Naratriptan


• Phenelzine


• Pimozide


• Procarbazine


• Rizatriptan


• Sumatriptan


• Terfenadine


• Thioridazine


• Tranylcypromine


• Ziprasidone

Using zolmitriptan 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.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Azimilide


• Bretylium


• Chloroquine


• Citalopram


• Clarithromycin


• Clovoxamine


• Desipramine


• Desvenlafaxine


• Dibenzepin


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Duloxetine


• Erythromycin


• Escitalopram


• Femoxetine


• Flecainide


• Fluconazole


• Fluoxetine


• Fluvoxamine


• Foscarnet


• Gemifloxacin


• Halofantrine


• Haloperidol


• Hydroquinidine


• Ibutilide


• Imipramine


• Isradipine


• Lidoflazine


• Lorcainide


• Mefloquine


• Milnacipran


• Nefazodone


• Nortriptyline


• Octreotide


• Paroxetine


• Pentamidine


• Pirmenol


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Reboxetine


• Risperidone


• Sematilide


• Sertindole


• Sertraline


• Sibutramine


• Sotalol


• Spiramycin


• St John's Wort


• Sultopride


• Tapentadol


• Tedisamil


• Trifluoperazine


• Trimipramine


• Vasopressin


• Venlafaxine


• Vilazodone


• Zimeldine


• Zotepine

Using zolmitriptan 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.

• Cimetidine

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 zolmitriptan. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or


• Fast or irregular heartbeat or


• Heart or blood vessel disease or


• High blood pressure or


• Kidney disease or


• Liver disease or


• Stroke (history of)—The chance of side effects may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use zolmitriptan, your doctor may need to do some tests to make sure that you do not have any of these conditions.

• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse

Proper Use of zolmitriptan

Do not use zolmitriptan for a headache that is different from your usual migraines . Instead, check with your doctor.

To relieve your migraine as soon as possible, use zolmitriptan as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using zolmitriptan.

Lying down in a quiet, dark room for a while after you use zolmitriptan may help relieve your migraine.

Ask your doctor ahead of time about other medicine you might take if zolmitriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by zolmitriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of zolmitriptan, but your headache comes back or gets worse after a while, you may use more zolmitriptan. However, use zolmitriptan only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much zolmitriptan may increase the chance of side effects.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of zolmitriptan or other pain medicines that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

For patients using the oral disintegrating tablet form of zolmitriptan:

• Make sure your hands are dry.


• Remove tablet from package, and immediately place the tablet on top of your tongue.


• The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

Dosing

The dose of zolmitriptan 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 zolmitriptan. 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 form (tablets):
  
  • For migraine headaches:
    
    • Adults—2.5 mg or lower (tablet may be broken in half) as a single dose. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 10 mg in any twenty-four-hour period (one day).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (oral disintegrating tablets):
  
  • For migraine headaches:
    
    • Adults—2.5 mg placed on top of your tongue. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 10 mg in any twenty-four-hour period (one day).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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.

Precautions While Using zolmitriptan

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine, or after taking zolmitriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

zolmitriptan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking zolmitriptan and get emergency help immediately if any of the following effects occur:

More common

• Chest pain (severe)


• heaviness, tightness, or pressure in chest and/or neck


• sensation of burning, warmth, heat, numbness, tightness, or tingling

Less common or rare

• Abdominal pain (severe)


• changes in facial skin color


• cough or hoarseness


• diarrhea


• fast or irregular heartbeat


• fever or chills


• loss of appetite


• lower back or side pain


• nausea


• painful or difficult urination


• puffiness or swelling of the eyelids or around the eyes, face, or lips


• shortness of breath, troubled breathing, tightness in chest, and/or wheezing


• skin rash, hives, and/or itching


• weakness

Other side effects may occur that usually do not need medical attention. Some of the following effects, such as nausea, vomiting, drowsiness, dizziness, and general feeling of illness or tiredness, often occur during or after a migraine, even when zolmitriptan has not been used. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

• Dizziness


• nausea


• sleepiness


• unusual tiredness or muscle weakness

Less common

• Agitation


• anxiety


• depression


• discomfort in jaw, mouth, or throat


• difficulty in swallowing


• dry mouth


• fainting


• heartburn


• itching of the skin


• large nonelevated blue or purplish patches in the skin


• muscle aches


• pounding heartbeat


• sudden large increase in frequency and quantity of urine


• sweating


• swelling of face, fingers, feet and/or lower legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: zolmitriptan side effects (in more detail)

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More zolmitriptan resources

• Zolmitriptan Side Effects (in more detail)
• Zolmitriptan Use in Pregnancy & Breastfeeding
• Zolmitriptan Drug Interactions
• Zolmitriptan Support Group
• 33 Reviews for Zolmitriptan - Add your own review/rating

• Zolmitriptan Professional Patient Advice (Wolters Kluwer)


• Zolmitriptan Monograph (AHFS DI)


• Zolmitriptan MedFacts Consumer Leaflet (Wolters Kluwer)


• Zomig Prescribing Information (FDA)


• Zomig Consumer Overview

Compare zolmitriptan with other medications

• Cluster Headaches
• Cyclic Vomiting Syndrome
• Migraine

Zarontin Capsules

Dosage Form: capsule
Zarontin®

(Ethosuximide Capsules, USP)

Zarontin Capsules Description

Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula:

Each Zarontin capsule contains 250 mg ethosuximide, USP. Also contains: polyethylene glycol 400, NF. The capsule contains D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol.

Zarontin Capsules - Clinical Pharmacology

Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.

Indications and Usage for Zarontin Capsules

Zarontin is indicated for the control of absence (petit mal) epilepsy.

CONTRAINDICATION

Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

Warnings

Blood dyscrasias

Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point.

Effects on Liver and Kidneys

Ethosuximide is capable of producing morphological and functional changes in the animal liver. In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.

Systemic Lupus Erythematosus

Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Zarontin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5–100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1 Risk by indication for antiepileptic drugs in the pooled analysis

Indication	Placebo Patients with Events Per 1000 Patients	Drug Patients with Events Per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients	Risk Difference: Additional Drug Patients with Events Per 1000 Patients
Epilepsy	1.0	3.4	3.5	2.4
Psychiatric	5.7	8.5	1.5	2.9
Other	1.0	1.8	1.9	0.9
Total	2.4	4.3	1.8	1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Zarontin or any other AED must balance the risk of suicidal thoughts and behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Usage in Pregnancy

Ethosuximide crosses the placenta.

Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

Cases of birth defects have been reported with ethosuximide. The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodological problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, eg, genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential.

Ethosuximide is excreted in human breast milk. Because the effects of ethosuximide on the nursing infant are unknown, caution should be exercised when ethosuximide is administered to a nursing mother. Ethosuximide should be used in nursing mothers only if the benefits clearly outweigh the risks.

Precautions

General

Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients.

As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.

Information for Patients

Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Zarontin. Instruct patients to take Zarontin only as prescribed.

Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.

Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen.

Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms (e.g., sore throat, fever), suggesting an infection.

Patients, their caregivers, and families should be counseled that AEDs, including Zarontin, may increase the risk of suicidal thoughts and behavior and should be advised 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. Behaviors of concern should be reported immediately to healthcare providers.

Patients should be encouraged to enroll in the North American Antiepileptic Drug (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 (see PRECAUTIONS: Pregnancy section).

Drug Interactions

Since Zarontin (ethosuximide) may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g., ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).

Pregnancy

To provide information regarding the effects of in utero exposure to Zarontin, physicians are advised to recommend that pregnant patients taking Zarontin enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/

See WARNINGS.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established. (See DOSAGE AND ADMINISTRATION section.)

Adverse Reactions

Body As A Whole: Allergic reaction.

Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.

Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, and eosinophilia.

Nervous System: Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia. Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness. These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions.

Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, Stevens-Johnson syndrome, systemic lupus erythematosus, pruritic erythematous rashes, and hirsutism. DRESS syndrome (drug rash, eosinophilia and systemic symptoms) has been reported in the post-marketing database.

Special Senses: Myopia.

Genitourinary System: Vaginal bleeding, microscopic hematuria.

Overdosage

Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity.

Treatment

Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are ineffective.

Zarontin Capsules Dosage and Administration

Zarontin is administered by the oral route. The initial dose for patients 3 to 6 years of age is one capsule (250 mg) per day; for patients 6 years of age and older, 2 capsules (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Zarontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.

How is Zarontin Capsules Supplied

Zarontin is supplied as:

NDC 0071-0237-24:Bottles of 100. Each capsule contains 250 mg ethosuximide.

Store at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].

LAB-0094-7.0

April 2011

MEDICATION GUIDE


ZARONTIN, (Ză rŏn' tĭn)

(ethosuximide)


Capsules, Oral Solution

Read this Medication Guide before you start taking ZARONTIN 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 ZARONTIN, ask your healthcare provider or pharmacist.

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

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

Stopping ZARONTIN suddenly can cause serious problems.

ZARONTIN can cause serious side effects, including:

1. Rare but serious blood problems that may be life-threatening. Call your healthcare provider right away if you have:
   
   • fever, swollen glands, or sore throat that come and go or do not go away
   
   
   • frequent infections or an infection that does not go away
   
   
   • easy bruising
   
   
   • red or purple spots on your body
   
   
   • bleeding gums or nose bleeds
   
   
   • severe fatigue or weakness
   
   


2. Systematic Lupus Erythematosus. Call your healthcare provider right away if you have any of these symptoms:
   
   • joint pain and swelling
   
   
   • muscle pain
   
   
   • fatigue
   
   
   • low-grade fever
   
   
   • pain in the chest that is worse with breathing
   
   
   • unexplained skin rash
   
   


3. Like other antiepileptic drugs, ZARONTIN 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 ZARONTIN without first talking to a healthcare provider.

   
   
   • Stopping ZARONTIN 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.

   
   

What is ZARONTIN?

ZARONTIN is a prescription medicine used to treat absence (petit mal) seizures.

Who should not take ZARONTIN?

Do not take ZARONTIN if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in ZARONTIN. See the end of this Medication Guide for a complete list of ingredients in ZARONTIN.

What should I tell my healthcare provider before taking ZARONTIN?

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

• have or had liver problems


• have or have had depression, mood problems or suicidal thoughts or behavior


• have any other medical conditions


• are pregnant or plan to become pregnant. It is not known if ZARONTIN can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ZARONTIN. You and your healthcare provider should decide if you should take ZARONTIN while you are pregnant.
  
  • If you become pregnant while taking ZARONTIN, 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. It is not known if ZARONTIN can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take ZARONTIN.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking ZARONTIN 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 with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ZARONTIN?

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


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


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

What should I avoid while taking ZARONTIN?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking ZARONTIN without first talking to your healthcare provider. ZARONTIN taken with alcohol or medicines 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 ZARONTIN affects you. ZARONTIN can slow your thinking and motor skills.
  
  

What are the possible side effects of ZARONTIN?

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

ZARONTIN may cause other serious side effects, including:

• Serious allergic reactions. Call your healthcare provider right away if you have any of these symptoms:
  
  • skin rash
  
  
  • hives
  
  
  • sores in your mouth
  
  
  • blistering or peeling skin
  
  
  • Changes in thinking, mood, or behavior. Some patients may get abnormally suspicious thoughts, hallucinations (seeing or hearing things that are not there), or delusions (false thoughts or beliefs).
  
  
  • Grand mal seizures can happen more often or become worse
  
  

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

The most common side effects of ZARONTIN include

nausea or vomiting indigestion, stomach pain diarrhea weight loss loss of appetite hiccups

fatigue dizziness or lightheadedness unsteadiness when walking headache loss of concentration

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

These are not all the possible side effects with ZARONTIN. 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 ZARONTIN?

• Store Zarontin Capsules at room temperature, between 59°F to 86°F (15°C to 30°C).


• Store ZARONTIN syrup (oral solution) at 20°–25°C (68°–77°F). Preserve in tight containers. Protect from freezing and light.

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

General information about ZARONTIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZARONTIN for a condition for which it was not prescribed. Do not give ZARONTIN to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ZARONTIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZARONTIN that is written for healthcare professionals.

For more information, go to www.pfizer.com or call 1-800-438-1985.

What are the ingredients in ZARONTIN?

Active ingredient: ethosuximide

Capsules

Inactive ingredients: Polyethylene glycol 400, NF; D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol.

Oral Solution

Inactive ingredients: Each 5 ml (teaspoonful) of oral solution contains 250 mg ethosuximide in a raspberry flavored base. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No. 6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; Sodium Citrate, USP; sucrose, NF.

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

LAB-0403-1.0

September 2010

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

NDC 0071-0237-24

100 Capsules

Rx only

Zarontin®

(Ethosuximide

Capsules, USP)

250 mg

Pfizer

Distributed by

Parke-Davis

Division of Pfizer Inc, NY, NY 10017

ZARONTIN  ethosuximide  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0071-0237 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ethosuximide (Ethosuximide) Ethosuximide 250 mg

Inactive Ingredients Ingredient Name Strength polyethylene glycol 400   D&C yellow No. 10   FD&C red No. 3   gelatin   glycerin   sorbitol

Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 8mm Flavor Imprint Code P;D;237 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0071-0237-24 100 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012380	09/22/2000

Labeler - Parke-Davis Div of Pfizer Inc (829076962)

Establishment
Name	Address	ID/FEI	Operations
Katwijk Chemie B.V.		416984441	Manufacture

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions		051762268	Manufacture

Revised: 04/2011Parke-Davis Div of Pfizer Inc

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