Procentra (dextroamphetamine sulfate) CII

The Only Liquid Amphetamine ADHD Therapy
The Only Liquid ADHD Therapy Approved for Children as Young as
3 Years of Age
Proven Efficacy of Dextroamphetamine
Easy to Titrate
Up to 6 Hours of Effective Therapy in Each Dose
Sugar-Free and Bubble Gum Flavored

THE ONLY LIQUID AMPHETAMINE ADHD THERAPY

Effective treatment for children with ADHD

The proven efficacy of dextroamphetamine in a liquid form

Attention Deficit Disorder with Hyperactivity

ProCentra® (dextroamphetamine sulfate) CII is indicated as an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms:

Moderate to severe distractibility
Short attention span
Hyperactivity
Emotional lability
Impulsivity

The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

ProCentra® is contraindicated in patients

With advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension,
hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, agitated states,
and patients with a history of drug abuse.
During, or within 14 days following the administration of monoamine oxidase inhibitors (MAOIs), as hypertensive crisis may result.

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

THE ONLY LIQUID ADHD THERAPY APPROVED FOR CHILDREN AS YOUNG AS 3 YEARS OF AGE

Pediatric-friendly dosage form for younger kids beginning ADHD therapy

Easy to titrate dosage in 2.5 mg increments

Up to 6 hours of effective therapy in each dose

First dose should be given on awakening with additional doses (1 or 2) at intervals of 4 to 6 hours. Late evening doses
should be avoided because of the resulting insomnia.

Sugar-free and bubble gum flavored

DOSING AND ADMINISTRATION

In pediatric patients from 3 to 5 years of age

Start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older

Start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening and additional doses (1 or 2) at intervals of 4 to 6 hours.

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted.
Late evening doses should be avoided because of the resulting insomnia.
Not recommended for pediatric patients under 3 years of age.
Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of
behavioral symptoms sufficient to require continued therapy.

Important Safety Information for ProCentra® (dextroamphetamine sulfate) CII:

ProCentra® (dextroamphetamine sulfate) CII is a prescription medication approved for the treatment of:

Attention Deficit Disorder with Hyperactivity (ADHD) as part of a total treatment program that may include other remedial measures (psychological; educational; social)

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS; AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

CONTRAINDICATIONS: ProCentra is a stimulant medication. ProCentra should not be taken by patients who have any of the following conditions:

Heart-related problems: advanced arteriosclerosis; symptomatic cardiovascular disease; or moderate to severe hypertension.
Hyperthyroidism
Known hypersensitivity or idiosyncrasy to the sympathomimetic amines;
Glaucoma;
Agitated state.

Patients with a history of drug abuse should not take ProCentra. ProCentra should not be taken during or within 14 days following the administration of monoamine oxidase inhibitors as this can cause a hypertensive crisis.

WARNINGS: ProCentra should be used with caution in patients with a history of the following conditions: Hypertension and Other Cardiovascular Conditions; Psychiatric Adverse Events; Pre-Existing Psychosis; Bipolar Illness.

PRECAUTIONS: The following may occur in patients taking stimulant medications: Serious cardiovascular events; including sudden death in patients with pre-existing structural cardiac abnormalities or other serious heart problems; Emergence of new psychotic or manic symptoms such as hallucinations; delusional thinking; or mania in children and adolescents; Aggressive behavior or hostility; Long-Term Suppression of Growth; Seizures; Visual Disturbances.

Other potential side effects of stimulant medications include: Palpitations; Tachycardia; Elevation of blood pressure; Cardiomyopathies; Psychotic episodes at recommended doses (rare); Overstimulation; Restlessness; Dizziness; Insomnia; Euphoria; Dyskinesia; Dysphoria; Tremor; Headache; Worsening of tics and Tourette’s syndrome; Dryness of the mouth; unpleasant taste; diarrhea; or constipation; Urticaria; Impotence or changes in libido.

ProCentra may affect the ability to drive or do other dangerous activities.

This is not a complete summary of safety information.For additional safety information, please click here for Full Prescribing Information and Medication Guide. You may also call FSC Pediatrics at 1-866-764-7822.

Important Safety information for Hycet® (hydrocodone bitartrate and acetaminophen) CIII.

Hycet® (hydrocodone bitartrate and acetaminophen) CIII is indicated for the relief of moderate to moderately severe pain in patients over the age of 2 years.

HEPATOTOXICITY

ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE; AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY; AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.

CONTRAINDICATIONS: Hycet should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone; acetaminophen; or any other component of this product.

WARNINGS:
Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure; at times resulting in liver transplant and death. Most cases of liver injury are associated with doses exceeding 4000 mg of acetaminophen per day; and often involve more than one acetaminophen-containing product. The risk of acute liver failure is higher in individuals with underlying liver disease; and with individuals who consume alcohol while taking acetaminophen. Instruct patients to look for acetaminophen on package labels and not to use more than one product containing acetaminophen. Instruct patients to seek immediate medical attention if they ingest more than 4000 mg per day; even if they feel well.

Hypersensitivity/Anaphylaxis: There have been post-marketing reports of hypersensitivity reactions and anaphylaxis associated with acetaminophen. Clinical signs include swelling of face; mouth; throat; respiratory distress; urticaria; rash; pruritus; and vomiting. There have been infrequent reports of life-threatening anaphylaxis requiring medical attention. Instruct patients to discontinue Hycet and seek immediate medical attention if they experience these symptoms.

Respiratory Depression: Hydrocodone; in high doses and in certain patients; may cause dose-related respiratory depression or irregular breathing. Young children may have increased sensitivity to the respiratory depressant effects. If use of Hycet is contemplated in such patients it should be administered cautiously and with monitoring.

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury; intracranial lesions; or elevated intracranial pressure. Narcotics may also produce adverse effects that obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: Narcotics may also obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Misuse; Abuse; and Diversion of Opioids: Hycet contains hydrocodone; an opioid agonist; and is a Schedule III controlled substance. Opioid agonists can produce drug dependence; have the potential for being abused; are sought by abusers and those with addiction disorders; and are subject to diversion. Hycet can be abused in a manner similar to other opioid agonists. This should be considered when prescribing or dispensing Hycet in situations where there is a concern about misuse; abuse; or diversion.

PRECAUTIONS:
Special caution should be used when prescribing hydrocodone to elderly or debilitated patients; as well as individuals with impaired hepatic or renal function; hypothyroidism; Addison’s disease; prostatic hypertrophy; or urethral stricture.

Like all narcotics; hydrocodone suppresses the cough reflex. Caution should be exercised when prescribing Hycet postoperatively; or to patients with pulmonary disease.

Hydrocodone may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving or operating machinery. Such tasks should be avoided when taking this product.

Caution should also be exercised with patients who are likely to take acetaminophen-containing medications. Alcohol and other central nervous system (CNS) depressants; such as antihistamines; antipsychotics; and anti-anxiety medications; may produce an additive effect when taken with this product; and should be avoided. Use of MAO inhibitors or tricyclic antidepressants with hydrocodone may increase the effect of either drug.

ADVERSE REACTIONS:
The most common side effects of Hycet are abdominal pain; dizziness; drowsiness; light-headedness; nausea; shortness of breath; unusual tiredness; and vomiting. Other side effects which may occur include anxiety; mood and other psychological changes; sedation; somnolence; mental clouding; hypoglycemic coma; constipation; gastric distress; heartburn; hepatic necrosis; hepatitis; peptic ulcer; agranulocytosis; hemolytic anemia; iron deficiency anemia; prolonged bleeding time; thrombocytopenia; ureteral or vesical sphincter spasms; muscle flaccidity; acute airway obstruction; apnea; hearing impairment or loss with chronic overdose; cold; clammy skin; diaphoresis; pruritus; rash

This is not a complete summary of safety information.For additional safety information, please click here for Full Prescribing Information and Patient Information Leaflet and discuss with your doctor. You may also call Eclat Pharmaceuticals at 1-636-449-1834.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.