Tuesday, September 20, 2016

ProCentra


Generic Name: dextroamphetamine (Oral route)

dex-troe-am-FET-a-meen

Oral route(Tablet;Capsule, Extended Release)

Amphetamines have a high potential for abuse, and administration for prolonged periods of time may lead to drug dependence and must be avoided. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events .



Commonly used brand name(s)

In the U.S.


  • Dexedrine

  • Dexedrine Spansules

  • Dextrostat

  • Liquadd

  • ProCentra

Available Dosage Forms:


  • Capsule, Extended Release

  • Solution

  • Tablet

Therapeutic Class: CNS Stimulant


Chemical Class: Amphetamine (class)


Uses For ProCentra


Dextroamphetamine belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep) .


Dextroamphetamine increases attention and decreases restlessness in patients who are overactive, cannot concentrate for very long or are easily distracted, and have unstable emotions. It is also used as part of a total treatment program that also includes social, educational, and psychological treatment .


This medicine is available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you or your child needs this medicine .


Before Using ProCentra


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 this medicine, the following should be considered:


Allergies


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


Appropriate studies have not been performed on the relationship of age to the effects of dextroamphetamine in children with attention-deficit hyperactivity disorder below 3 years of age. Safety and efficacy have not been established .


Dextroamphetamine sustained-release capsule is not recommended in children below 6 years of age .


Geriatric


No information is available on the relationship of age to the effects of dextroamphetamine in geriatric patients .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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


Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.


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 this medicine, 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 this medicine 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.


  • Clorgyline

  • Furazolidone

  • Iproniazid

  • Isocarboxazid

  • Moclobemide

  • Nialamide

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Selegiline

  • Sibutramine

  • Toloxatone

  • Tranylcypromine

Using this medicine 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.


  • Citalopram

  • Venlafaxine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Agitation, anxiety, or tension or

  • Arteriosclerosis (hardening of the arteries), severe or

  • Drug abuse or dependence, history of or

  • Glaucoma or

  • Heart disease or

  • High blood pressure, moderate to severe or

  • Overactive thyroid—This medicine should not be used in patients with these conditions .

  • Heart problems or defects or

  • High blood pressure, mild or

  • Mental illness (e.g., aggressive behavior, hostility, psychosis, mania, family history of suicide, bipolar illness, depression) or

  • Seizures, history of or

  • Thyroid problems—Use with caution. Serious side effects may occur .

  • Tourette's syndrome, history of or other tics—Children and their families should be checked by their doctor for this condition before taking this medicine .

Proper Use of dextroamphetamine

This section provides information on the proper use of a number of products that contain dextroamphetamine. It may not be specific to ProCentra. Please read with care.


Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence) .


If you or your child think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor .


This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions .


If you or your child use the tablet form of this medicine, and you take it two or three times a day. Take the first dose in the morning. The other doses may be taken during the day with 4 to 6 hours between doses .


It is best to take the sustained-release capsule in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep .


Swallow the sustained-release capsule whole. Do not crush, break, or chew it .


Dosing


The dose of this medicine 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 this medicine. 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 attention-deficit hyperactivity disorder (ADHD):):
    • For oral dosage form (tablets):
      • Adults and children 6 years of age and older—At first, 5 milligrams (mg) one or two times a day. Your doctor may adjust your dose if needed.

      • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.

      • Children younger than 3 years of age—Use and dose must be determined by your doctor .


    • For oral dosage form (sustained-release capsules):
      • Adults and children 6 years of age and older—At first, 5 milligrams (mg) one or two times a day. Your doctor may adjust your dose if needed.

      • Children younger than 6 years of age—Use and dose must be determined by your doctor .



  • For narcolepsy:
    • For oral dosage form (tablets or sustained-release capsules):
      • Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

      • Children 6 to 12 years of age—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

      • Children younger than 6 years of age—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


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.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using ProCentra


It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .


If you or your child will be taking this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely .


Do not take dextroamphetamine within 14 days of taking an MAO inhibitor such as Eldepryl®, Marplan®, Nardil®, or Parnate®.


This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.


Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor) .


If you or your child have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs that you may be dependent on dextroamphetamine are:


  • A strong desire or need to continue taking the medicine.

  • A need to increase the dose to receive the effects of the medicine.

  • Withdrawal effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) that occur after the medicine is stopped .

This medicine may cause slow growth in children. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly .


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .


ProCentra 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.


Check with your doctor immediately if any of the following side effects occur:


Rare
  • Agitation

  • delusions

  • hallucinations

Incidence not known
  • Blurred vision

  • chest discomfort or pain

  • difficulty breathing

  • dizziness

  • faintness

  • false or unusual sense of well-being

  • fast, pounding, or irregular heartbeat or pulse

  • headache

  • nervousness

  • pounding in the ears

  • restlessness

  • shakiness in legs, arms, hands, or feet

  • shortness of breath

  • sleeplessness

  • swelling of feet or lower legs

  • trembling or shaking of hands or feet

  • trouble sleeping

  • troubled breathing

  • twitching, twisting, or uncontrolled repetitive movements of tongue, lips, face, arms, or legs

  • unable to sleep

  • uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)

  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Change in consciousness

  • dark-colored urine

  • diarrhea

  • discouragement

  • feeling sad or empty

  • fever

  • irritability

  • lack of appetite

  • loss of consciousness

  • loss of interest or pleasure

  • mood or mental changes

  • muscle cramps or spasms

  • muscle pain or stiffness

  • nausea

  • panic state

  • physical attempt to injure

  • rapid breathing

  • seizures

  • stomach cramps

  • sweating

  • trouble concentrating

  • trouble sleeping

  • violent actions

  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Incidence not known
  • Bad, unusual, or unpleasant (after)taste

  • change in taste

  • constipation

  • decreased interest in sexual intercourse

  • dry mouth

  • hives or welts

  • inability to have or keep an erection

  • indigestion

  • itching

  • loss in sexual ability, desire, drive, or performance

  • passing of gas

  • redness of skin

  • skin rash

  • weight loss

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: ProCentra side effects (in more detail)



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More ProCentra resources


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


  • ProCentra Prescribing Information (FDA)

  • ProCentra Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • ProCentra Concise Consumer Information (Cerner Multum)

  • Dextroamphetamine Prescribing Information (FDA)

  • Dextroamphetamine Monograph (AHFS DI)

  • Dexedrine Prescribing Information (FDA)

  • Dexedrine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dexedrine Spansule Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dextrostat Prescribing Information (FDA)



Compare ProCentra with other medications


  • ADHD
  • Narcolepsy
  • Sexual Dysfunction, SSRI Induced

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