Nefazodone Hydrochloride (Page 9 of 9)

REFERENCES

1. HALCION ® and XANAX® are registered trademarks of Pharmacia and Upjohn.

2. SELDANE® is a registered trademark of Hoechst Marion Roussel Inc. (now Aventis Pharmaceuticals).

3. HISMANAL® and PROPULSID® are registered trademarks of Janssen Pharmaceutical Products, L.P.

4. ORAP ® is a registered trademark of Gate Pharmaceuticals, a division of Teva Pharmaceuticals USA.

5. TEGRETOL® is a registered trademark of Novartis Pharmaceuticals Corporation.

Manufactured for:

Ranbaxy Pharmaceutical Inc.

Jacksonville FL, 32257 USA

By: Ranbaxy Laboratories Limited

New Delhi – 110 019, India

December 2008

PATIENT INFORMATION ABOUT NEFAZODONE HYDROCHLORIDE TABLETS, USP

Read this information completely before using nefazodone. Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about nefazodone and does not include everything there is to know about your medicine. This information is not meant to take the place of talking with your doctor.

What is the most important information that I should know about nefazodone?

Rarely, people who take nefazodone can develop serious liver problems. If you get any of the following symptoms while taking nefazodone, call your doctor right away because you may be developing a liver problem:

  • Yellowing of the skin or whites of eyes (jaundice)
  • Unusually dark urine
  • Loss of appetite that lasts several days or longer
  • Nausea
  • Abdominal (lower stomach) pain

People who currently have liver problems should not take nefazodone.

What is nefazodone?

Nefazodone is a medicine used to treat depression. Nefazodone is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine, which are in your brain.

Who should not take nefazodone?

Do not take nefazodone if you

  • are allergic to nefazodone or the related medicine Desyrel® (trazodone).
  • are taking Seldane® (terfenadine), an antihistamine; Hismanal® (astemizole), an antihistamine; Propulsid® (cisapride), used for heartburn; Halcion® (triazolam), used for insomnia; Orap® (pimozide), used to treat Tourette’s syndrome; or Tegretol® (carbamazepine), used to control seizures.
  • currently have liver problems.
  • are taking or have taken within the last 14 days one of the medicines for depression known as monoamine oxidase inhibitors (MAOIs), such as Nardil® or Parnate®.

Be sure to tell your doctor if you

  • have ever had liver problems;
  • are taking any other medicine, vitamin supplement, or herbal remedy, including those sold without a prescription (over-the-counter);
  • have heart problems or have had a heart attack or stroke;
  • have had manic episodes (extreme agitation or excitability);
  • have ever attempted suicide;
  • have had convulsions (seizures);
  • are pregnant or breast-feeding.

How should I take nefazodone?

  • Take nefazodone at the same time every day exactly as prescribed by your doctor. You may take nefazodone with or without food.
  • It may take a while for you to feel that nefazodone is working. You may not feel the full effect for several weeks. Once you feel better, it is important to keep taking nefazodone as directed by your doctor.
  • If you miss a dose of nefazodone, skip that dose and continue with your regular schedule. Never take 2 doses at the same time.
  • If you think that you have taken more nefazodone than prescribed, contact your doctor, local poison control center, or emergency room right away.

What should I avoid while taking nefazodone?

  • Do not drive or operate possibly dangerous machinery (such as an automobile, power mower, or power tool) or participate in any hazardous activity that requires full mental alertness until you know how nefazodone affects you.
  • Before taking nefazodone, tell your doctor about any medicines you are taking, including vitamin supplements, herbal remedies, and any non-prescription (over-the-counter) medicines. Some of these medicines may affect how nefazodone works and should not be used in combination without talking to your doctor.
  • Do not drink alcoholic beverages while taking nefazodone.
  • Tell your doctor if you are pregnant, planning to become pregnant, or become pregnant while taking nefazodone. It is not known whether nefazodone can harm your unborn baby.
  • Talk with your doctor before taking nefazodone if you are breast-feeding. It is not known whether nefazodone can pass through your breast milk to the baby.

What are the possible side effects of nefazodone?

The most common side effects of nefazodone are sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, problems with vision, and confusion.

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

Call your doctor right away if you have any of the following side effects:

  • Yellowing of the skin or whites of eyes (jaundice)
  • Unusually dark urine
  • Loss of appetite that lasts several days or longer
  • Severe nausea
  • Abdominal (lower stomach) pain
  • Rash or hives
  • Seizure (convulsion)
  • Fainting
  • Erection that lasts too long

Tell your doctor right away about any side effects that you have or discomfort that you experience. Do not change your dose or stop taking nefazodone without talking with your doctor first.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Your doctor has prescribed nefazodone for you and you alone. Do not give nefazodone to other people even if they have the same condition. It may harm them.

This leaflet provides a summary of the most important information about nefazodone. If you would like more information, talk with your doctor or pharmacist. You can ask for information about nefazodone that is written for healthcare professionals.

Seldane® is a registered trademark of Hoechst Marion Roussel Inc. (now Aventis Pharmaceuticals).

Hismanal® and Propulsid® are registered trademarks of Janssen Pharmaceutica Products, L.P.

Nardil® is a registered trademark of Parke-Davis.

Parnate® is a registered trademark of SmithKline Beecham Pharmaceuticals.

Halcion® is a registered trademark of Pharmacia & Upjohn.

Orap® is a registered trademark of Gate Pharmaceuticals, a division of TEVA Pharmaceuticals USA.

Tegretol® is a registered trademark of Novartis Pharmaceuticals Corporation.

MEDICATION GUIDE

NEFAZODONE HYDROCHLORIDE TABLETS, USP

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:-

• all risks and benefits of treatment with antidepressant medicines

• all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following 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 very agitated or restless

• panic attacks

• trouble sleeping (insomnia)

• new or worse irritability

• acting aggressive, being angry, or violent

• acting on dangerous impulses

• an extreme increase in activity and talking (mania)

• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

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

Manufactured for:

Ranbaxy Pharmaceutical Inc.

Jacksonville FL, 32257 USA

by: Ranbaxy Laboratories Limited

New Delhi – 110 019, India

December 2008

NEFAZODONE HYDROCHLORIDE
nefazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-541
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nefazodone hydrochloride (nefazodone) nefazodone 50 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
ferric oxide (red and/or yellow)
magnesium stearate
microcrystalline cellulose
povidone
sodium starch glycolate
Product Characteristics
Color pink (light) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code RX541
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-541-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:63304-541-05 500 TABLET (500 TABLET) in 1 BOTTLE None
NEFAZODONE HYDROCHLORIDE
nefazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-542
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nefazodone hydrochloride (nefazodone) nefazodone 100 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
magnesium stearate
microcrystalline cellulose
povidone
sodium starch glycolate
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code RX542
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-542-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:63304-542-05 500 TABLET (500 TABLET) in 1 BOTTLE None
NEFAZODONE HYDROCHLORIDE
nefazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-543
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nefazodone hydrochloride (nefazodone) nefazodone 150 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
ferric oxide (red and/or yellow)
magnesium stearate
microcrystalline cellulose
povidone
sodium starch glycolate
Product Characteristics
Color brown (peach) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code RX543
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-543-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:63304-543-05 500 TABLET (500 TABLET) in 1 BOTTLE None
NEFAZODONE HYDROCHLORIDE
nefazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-544
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nefazodone hydrochloride (nefazodone) nefazodone 200 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
ferric oxide (red and/or yellow)
magnesium stearate
microcrystalline cellulose
povidone
sodium starch glycolate
Product Characteristics
Color yellow (light) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code RX544
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-544-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:63304-544-05 500 TABLET (500 TABLET) in 1 BOTTLE None
NEFAZODONE HYDROCHLORIDE
nefazodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-545
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nefazodone hydrochloride (nefazodone) nefazodone 250 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
magnesium stearate
microcrystalline cellulose
povidone
sodium starch glycolate
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code RX545
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-545-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:63304-545-05 500 TABLET (500 TABLET) in 1 BOTTLE None
Labeler — Ranbaxy Pharmaceuticals Inc.

Revised: 12/2008 Ranbaxy Pharmaceuticals Inc.

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