Primsol® (trimethoprim hydrochloride) is indicated for the treatment of acute otitis media (AOM) in pediatric patients due to susceptible strains of Streptococcus pneumoniae and Haemophilus influenzae, the most common causes of acute otitis media. Primsol is not indicated for prophylactic or prolonged use in otitis media at any age.

Moraxella catarrhalis isolates are consistently resistant to trimethoprim in vitro. When infection with Moraxella catarrhalis is suspected, use of alternative antimicrobial agents should be considered.

The safety of trimethoprim has not been established in pediatric patients below the age of 2 months. The effectiveness of trimethoprim in the treatment of acute otitis media has not been established in patients below the age of 6 months.

CONTRAINDICATIONS: Primsol is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.

WARNINGS: Experience with trimethoprim alone is limited, but is has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods. The presence of clinical signs such as sore throat, fever, pallor, or purpura may be early indications of serious blood disorders.

PRECAUTIONS: Trimethoprim should be given with caution to patients with possible folate deficiency.  Folates may be administered concomitantly without interfering with the antibacterial action of trimethoprim. Trimethoprim should be given with caution to patients with impaired renal or hepatic function.

OTHER ADVERSE EVENTS: Other adverse events: The following adverse reactions have been previously reported with trimethoprim: pruritus, exfoliative dermatitis, epigastric distress, nausea, vomiting, diarrhea, abdominal pain, skin rash, glossitis, thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia, methemoglobinemia, hyperkalemia, and hyponatremia.

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

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)
  

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.

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.

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.