Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate ER (Page 9 of 9)

Medication Guide

DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspartate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE sulfate extended-release capsules CII

(dex”troe am fet’a meen, sak’a-rat, am fet’a meen, ah-spahr’tat, mon’o-hi’drat , dex”troe am fet’a meen, sul’fate, am fet’a meen, sul’fate extended-release) CII

Read the Medication Guide that comes with Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release.

What is the most important information I should know about Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is a stimulant medicine. The following have been reported with use of stimulant medicines.

1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release.

Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3.Circulationproblemsinfingersandtoes [Peripheralvasculopathy,includingRaynaud’s phenomenon]:

  • Fingersortoesmayfeelnumb,cool, painful
  • Fingersortoesmaychangefrompale,to blue,tored

Tellyourdoctorif youhaveoryourchildhas numbness,pain,skincolorchange,orsensitivityto temperatureinyourfingersortoes.

Callyourdoctorrightawayifyouhaveoryour childhasanyunexplainedwoundsappearingon fingersortoeswhiletakingDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release

What Is Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is a once daily central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release should not be taken if you or your child:

  • have heart disease or hardening of the arteries
  • have moderate to severe high blood pressure
  • have hyperthyroidism
  • have an eye problem called glaucoma
  • are very anxious, tense, or agitated
  • have a history of drug abuse
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release has not been studied in children less than 6 years old.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release may not be right for you or your child. Before starting Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release tell your or your child’s doctor about all health conditions (or a family history of) including if you or your child:

  • have heart problems, heart defects, or high blood pressure
  • have mental problems including psychosis, mania, bipolar illness, or depression
  • have tics or Tourette’s syndrome
  • have liver problems
  • have kidney problems
  • have end stage renal disease (ESRD)
  • have thyroid problems
  • have seizures or have had an abnormal brain wave test (EEG)
  • have circulation problems in fingers and toes
  • are pregnant or plan to become pregnant. It is not known if Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release will harm your unborn baby.

There is a pregnancy registry for females who are exposed to Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and their baby. If you or your child becomes pregnant during treatment with Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, talk to your healthcare provider about registering with the National Pregnancy Registry of Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical -and -researchprograms/pregnancyregistry/othermedications/.

are breastfeeding or plan to breastfeed. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release passes into breast milk. You or your child should not breastfeed during treatment with Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release.

Can Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release.

Your doctor will decide whether Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • anti-depression medicines including MAOIs
  • anti-psychotic medicines
  • lithium
  • narcotic pain medicines
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • stomach acid medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release without talking to your doctor first.

How should Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release be taken?

  • Take Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release once a day in the morning when you first wake up. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is an extended release capsule. It releases medicine into your body throughout the day.
  • Swallow Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules whole with water or other liquids. If you or your child cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow all of the applesauce and medicine mixture without chewing immediately. Follow with a drink of water or other liquid. Never chew or crush the capsule or the medicine inside the capsule.
  • Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release can be taken with or without food.
  • From time to time, your doctor may stop Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the heart and blood pressure while taking Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. Children should have their height and weight checked often while taking Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release?

See “What is the most important information I should know about Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release? ” for information on reported heart and mental problems.

Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision

Common side effects include:

  • headache
  • decreased appetite
  • stomach ache
  • nervousness
  • trouble sleeping
  • mood swings
  • weight loss
  • dizziness
  • dry mouth
  • fast heart beat

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release may affect you or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

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 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release?

  • Store Dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate extended-release in a safe place at room temperature, 59 to 86º F (15 to 30º C)
  • Keep Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release and all medicines out of the reach of children.

General information about Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release for a condition for which it was not prescribed. Do not give Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release that was written for healthcare professionals. For more information, you may also contact Par Pharmaceuticals (the maker of Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release) at 1-800-828-9393 or visit www.parpharm.com.

What are the ingredients in Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release?

Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate USP

Inactive Ingredients: methacrylic acid copolymer, methocel E5 premium, sugar spheres, talc, and triethyl citrate. The gelatin capsules contain edible inks: ammonium hydroxide, ammonia solution, dehydrated alcohol, iron oxide black, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol, shellac glaze and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1, FD&C red #40, and iron oxide red. The 20 mg, 25 mg, and 30 mg contain FD&C yellow #6.

For Medication Guide, please visit www.parpharm.com .

Manufactured by:

PAR PHARMACEUTICAL

Chestnut Ridge, NY 10977

Revised: 12/2019

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

Mixed Amphetamine Salt (CII) ER 10mg #100

Label
(click image for full-size original)
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE ER
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate er capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2103(NDC:49884-840)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 2.5 mg
AMPHETAMINE ASPARTATE (AMPHETAMINE) AMPHETAMINE ASPARTATE 2.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 2.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (5 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TALC
TRIETHYL CITRATE
AMMONIA
ALCOHOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE RED
ISOPROPYL ALCOHOL
Product Characteristics
Color blue, blue Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code P;840
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-2103-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206159 06/25/2019
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-2103), RELABEL (63629-2103)

Revised: 04/2022 Bryant Ranch Prepack

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.