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Rhodes Pharmaceuticals L.P. expansion
into a branded pharmaceutical company

Aptensio XR® (methylphenidate HCl extended-release), a treatment for attention-deficit/hyperactivity disorder (ADHD), is the first branded product of Rhodes Pharmaceuticals L.P.

Before bringing Aptensio XR to market in 2015, Rhodes Pharmaceuticals L.P. was founded as a developer and supplier of generic pharmaceutical products in 2008.

The company’s emphasis on customer relationships and service, reliability, and quality fueled rapid growth in its generic product portfolio.

Rhodes Pharmaceuticals L.P. maintained those same values as it ventured into the branded pharmaceutical product market with Aptensio XR.

Aptensio XR is a once-daily therapy that helps meet the needs of patients who require 12 hours of ADHD symptom control. It was designed to start working by hour 1 until hour 12.*

Aptensio XR comes in 10, 15, 20, 30, 40, 50, and 60 mg doses. That range of strengths helps physicians address each patients’ needs.

*In a study, patients were tested 1, 2, 3, 4.5, 6, 7.5, 9, 10.5, and 12 hours after taking Aptensio XR. Improvements in ADHD symptoms were seen at each of those times.

Click here for Full Prescribing Information, including Boxed Warning and MedicationGuide.

"The availability of Aptensio XR is an important next step for Rhodes Pharmaceuticals L.P. We are dedicated to helping to meet patients' unmet needs and are proud that Aptensio XR will help meet the needs of those in the ADHD community."

Vincent Mancinelli II, President, Rhodes Pharmaceuticals

INDICATION

Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Limitations of Use

Aptensio XR is not for use in children under 6 years of age because the safety and effectiveness have not been established.

IMPORTANT SAFETY INFORMATION

Aptensio XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Aptensio XR in a safe place to protect it from theft. Never give your rnethylphenidate to anyone else, because it may cause death or harm to them. Selling or giving away Aptensio XR may harm others and is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction. .

Do not take Aptensio XR if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Aptensio XR, or are taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Aptensio XR, as well as other stimulants, including methylphenidate-containing products and amphetamines, can cause serious side effects, including:

• Heart-related problems:

• Sudden death, stroke, and heart attack in adults
• Sudden death in children who have heart problems or heart defects
• Increased blood pressure and heart rate

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Aptensio XR.

• Mental (psychiatric) problems:

• New or worse behavior and thought problems
• New or worse bipolar illness
• New psychotic symptoms (such as hearing voices or seeing or believing things that are not real) or new manic symptoms

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon).

Signs and symptoms may include:

• Fingers or toes may feel numb, cool, or painful
• Fingers or toes may change color from pale, to blue, to red

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child experience any heart-related symptoms, such as chest pain, shortness of breath or fainting, new or worsening mental symptoms or problems, especially hearing voices, seeing or believing things that are not real, new manic symptoms, or signs of unexplained wounds appearing on fingers or toes while taking Aptensio XR. .

Before taking Aptensio XR, tell your healthcare provider about all medical conditions, including if you or your child:

• Have heart problems, heart defects, high blood pressure
• Have mental problems, including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• Have circulation problems in fingers and toes
• Are pregnant or plan to become pregnant. It is not known if Aptensio XR will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
• There is a pregnancy registry for females who are exposed to Aptensio XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Aptensio XR and their babies. If you or your child become pregnant during treatment with Aptensio XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
• Are breastfeeding or plan to breastfeed. Aptensio XR passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Aptensio XR.

Possible serious side effects of Aptensio XR are heart-related problems, psychiatric disorders, circulation problems in fingers and toes, and slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Aptensio XR. Aptensio XR treatment may be stopped if a problem is found during these checkups. Painful and prolonged erections (priapisrn) have happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.

Common side effects include:

• Decreased appetite
• Decreased appetite
• Weight loss
• Nausea
• Stomach pain
• Indigestion
• Dry mouth
• Vomiting
• Trouble sleeping

• Anxiety
• Anxiety
• Nervousness
• Restlessness
• Mood swings
• Agitation
• Irritability
• Headache
• Dizziness

• Vertigo
• Vertigo
• Shaking (tremor)
• Blurred vision
• Increased blood pressure
• Fast heart beat
• Increased sweating
• Fever

These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information.

ADX-9-00282-1

Click here for Full Prescribing Information, including Boxed Warning and MedicationGuide.

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.

Aptensio XR® is a registered trademark of Rhodes Pharmaceuticals L.P.

© 2019 Rhodes Pharmaceuticals L.P. Coventry, RI 02816

ADX-4-00116-1

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Buprenorphine Sublingual Tablets

  • StrengthPack
  • 2mg30
  • 8mg30

Buprenorphine Transdermal System

  • StrengthPack
  • 5mcg/hour4
  • 7.5mcg/hour4
  • 10mcg/hour 4
  • 15mcg/hour4
  • 20mcg/hour4

Dexmethylphenidate Hydrochloride Tablets

  • StrengthPack
  • 2.5mg100
  • 5mg100
  • 10mg100

Dilaudid® (hydromorphone HCl) Oral Solution, USP

  • StrengthPack
  • 1mg/mL473 mL

Dilaudid® (hydromorphone HCl) Tablets, USP

  • StrengthPack
  • 2mg 100
  • 4mg100
  • 4mg500
  • 8mg100

Dronabinol Capsules, USP

  • StrengthPack
  • 2.5mg60
  • 5mg60
  • 10mg60

Fenofibrate Capsules (micronized)

  • StrengthPack
  • 67mg100
  • 134mg100
  • 200mg100

Fenofibrate Tablets, USP

  • StrengthPack
  • 54mg90
  • 160mg90

Hydrocodone Bitartrate & Acetaminophen 300 mg tablets, USP

  • StrengthPack
  • 5 mg / 300 mg100
  • 7.5 mg / 300 mg100
  • 10 mg / 300 mg 100

Important Safety Information

WARNING: 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 (see WARNINGS).

Hydrocodone Bitartrate & Acetaminophen 325 mg Tablets, USP

  • StrengthPack
  • 5mg/325mg100
  • 5mg/325mg500
  • 7.5mg/325mg100
  • 10mg/325mg100
  • 10mg/325mg500

Important Safety Information

WARNING: 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 (see WARNINGS).

Hydromorphone Hydrochloride Oral Solution, USP

  • StrengthPack
  • 5mg/5mL1 Pint Bottle (473 mL)

Important Safety Information

WARNING: HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION, USP CONTAINS HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDS AND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVEHYPNOTICS) POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTS OF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORY DEPRESSION THAT MIGHT RESULT IN DEATH.

Hydromorphone Hydrochloride Tablets, USP

  • StrengthPack
  • 2mg100
  • 2mg100 (Unit Dose)
  • 4mg100
  • 4mg500
  • 4mg100 (Unit Dose)
  • 8mg100

Important Safety Information

WARNING: HYDROMORPHONE HYDROCHLORIDE TABLETS, USP CONTAIN HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDS AND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVEHYPNOTICS) POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTS OF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORY DEPRESSION THAT MIGHT RESULT IN DEATH.

Lidocaine Patch 5%

  • StrengthPack
  • 5%30 Patches

Methylphenidate HCl ER Capsules

  • StrengthPack
  • 10 mg90
  • 15 mg90
  • 20 mg90
  • 30 mg90
  • 40 mg90
  • 50 mg90
  • 60 mg90

Mixed Amphetamine Salts Extended-Release Capsules

  • StrengthPack
  • 5mg100
  • 10mg100
  • 15mg100
  • 20mg100
  • 25mg100
  • 30mg100

Important Safety Information

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=690e1ef4-caf7-4c48-a4ae-d2a0ab684e82

Morphine Sulfate Extended-Release Tablets

  • StrengthPack
  • 15mg100
  • 30mg100
  • 60mg100
  • 100mg100
  • 200mg100

Important Safety Information

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME See full prescribing information for complete boxed warning. Morphine sulfate extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow morphine sulfate extended-release tablets whole to avoid exposure to a potentially fatal dose of morphine. (5.2) Accidental ingestion of morphine sulfate extended-release tablets, especially in children, can result in fatal overdose of morphine. (5.2) Prolonged use of morphine sulfate extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3)

MS Contin® (morphine sulfate extended-release) Tablets

  • StrengthPack
  • 15mg100
  • 30mg100
  • 60mg100
  • 100mg100
  • 200mg100

Oxycodone and Acetaminophen Tablets, USP

  • StrengthPack
  • 5mg/325mg100
  • 5mg/325mg500
  • 7.5mg/325mg100
  • 7.5mg/325mg500
  • 10mg/325mg100
  • 10mg/325mg500

Important Safety Information

WARNING: 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 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS.)

Oxycodone Hydrochloride Tablets, USP

  • StrengthPack
  • 5mg100
  • 5mg100 (Unit Dose)
  • 10mg100
  • 10mg100 (Unit Dose)
  • 15mg100
  • 20mg100
  • 30mg100

Paroxetine Extended-Release Tablets

  • StrengthPack
  • 12.5mg30
  • 25mg30
  • 37.5mg30

Theophylline (Anhydrous) Extended-Release Tablets

  • StrengthPack
  • 400mg100
  • 600mg100

Bottles

2mg bottles of 30 tablets
8mg bottles of 30 tablets

Drug Label Info

Bottles

5mcg/hour carton of 4 patches
7.5mcg/hour carton of 4 patches
10mcg/hour carton of 4 patches
15mcg/hour carton of 4 patches
20mcg/hour cartons of 4 patches

Drug Label Info

Bottles

2.5mg bottles of 100 tablets
5mg bottles of 100 tablets
10mg bottles of 100 tablets

Drug Label Info

Bottles

1mg/mL bottle of 473 mL oral solution

Drug Label Info

Bottles

2mg bottle of 100 tablets
4mg bottle of 100 tablets
4mg bottle of 500 tablets
8mg bottle of 100 tablets

Drug Label Info

Bottles

2.5mg bottles of 60 capsules
5mg bottles of 60 capsules
10mg bottles of 60 capsules

Drug Label Info

Bottles

67mg bottles of 100 capsules
134mg bottles of 100 capsules
200mg bottles of 100 capsules

Drug Label Info

Bottles

54mg bottles of 90 tablets
160mg bottles of 90 tablets

Drug Label Info

Bottles

5 mg / 300 mg bottle of 100 tablets
7.5 mg /300 mg bottle of 100 tablets
10 mg /300 mg bottle of 100 tablets

Drug Label Info

Important Safety Information

WARNING: 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 (see WARNINGS).

Bottles

5mg/325mg bottle of 100 tablets
5mg/325mg bottle of 500 tablets
7.5mg/325mg bottle of 100 tablets
10mg/325mg bottle of 100 tablets
10mg/325mg bottle of 500 tablets

Drug Label Info

Important Safety Information

WARNING: 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 (see WARNINGS).

Product Name
Buprenorphine Sublingual Tablets Get Details
Buprenorphine Transdermal System Get Details
Dexmethylphenidate Hydrochloride Tablets Get Details
Dilaudid® (hydromorphone HCl) Oral Solution, USP Get Details
Dilaudid® (hydromorphone HCl) Tablets, USP Get Details
Dronabinol Capsules, USP Get Details
Fenofibrate Capsules (micronized) Get Details
Fenofibrate Tablets, USP Get Details
Hydrocodone Bitartrate & Acetaminophen 300 mg tablets, USP Get Details
Hydrocodone Bitartrate & Acetaminophen 325 mg Tablets, USP Get Details

Rhodes Pharmaceuticals Distribution Map



Download our current list of distributors, or contact us for more information.