Vantrela ER

Vantrela ER is a prescription medication used to relieve severe pain in adults who require around-the-clock, long-term treatment.

Vantrela ER belongs to a group of drugs called narcotic analgesics. These drugs work by changing the way that the brain and nervous system respond to pain.

This medication comes in extended-release tablet form and is taken twice a day with a full glass of water.

Do not chew, divide, crush, dissolve, or break Vantrela ER tablets. Swallow the tablets whole.

Common side effects include nausea, constipation, and headache. Vantrela ER can make you dizzy or sleepy. Do not drive or operate heavy machinery until you know how it affects you.

Vantrela ER is a prescription medication used to relieve severe pain in patients who require daily, around-the-clock, long-term treatment with opioid analgesics, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat the pain well enough or cannot be tolerated. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range for the treatment of Vantrela ER is 15 to 60mg twice daily. Your doctor will choose the lowest dose for the shortest duration needed.

Your doctor may reduce the dose by one half if you have kidney or liver problems.

WARNING:

• ADDICTION, ABUSE, AND MISUSE 
• LIFE-THREATENING RESPIRATORY DEPRESSION
• ACCIDENTAL INGESTION
• NEONATAL OPIOID WITHDRAWAL SYNDROME
• CYTOCHROME P450 3A4 INTERACTION
• RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

•  Vantrela ER exposes users to risks of addiction, abuse, and misuse which can lead to overdose and death. 

• Serious, life-threatening, or fatal respiratory depression may occur. 

• Accidental ingestion of Vantrela ER, especially by children, can result in a fatal overdose from Vantrela ER.

• Prolonged use of Vantrela ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

• Co-administration with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose from Vantrela ER. 

• Co-administration of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Serious side effects have been reported with Vantrela ER including the following:

• Life-threatening respiratory depression. Increased risk of respiratory depression if you have brain tumors, head injury or altered alertness. Tell your healthcare provider right away if you have some or all of the following symptoms of respiratory depression:
  • Slowed or irregular breathing
  • Chest tightness
• Adrenal Insufficiency. Tell your healthcare provider right away if you have some or all of the following signs and symptoms of adrenal insufficiency:
  • nausea
  • vomiting
  • lack of appetite 
  • fatigue
  • weakness
  • dizziness
  • low blood pressure.
• Severe Hypotension. Tell your healthcare provider right away if you have some or all of the following signs and symptoms of low blood pressure:
  • feeling dizzy after standing up
  • blurry vision
  • weakness
  • fainting
  • confusion
  • nausea
• QT Prolongation. Tell your healthcare provider right away if you have some or all of the following signs and symptoms of QT prolongation:
  • dizziness 
  • fainting or feeling faint
  • skipping a heart beat
• Vantrela ER can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Vantrela ER affects you.

Do not take Vantrela ER if you:

• are allergic to Vantrela ER or to its active ingredient hydrocodone
• are taking any other products containing hydrocodone or other narcotic medications, such as morphine or codeine
• have severe asthma, trouble breathing, or other lung problems
• have a bowel blockage or narrowing of the stomach or intestines

Serious side effects have been reported with Vantrela ER. See the "Vantrela ER Precautions” section.

Common side effects of Vantrela ER include the following:

• constipation
• nausea 
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain 

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antidepressants
• Antihistamines
• Antipsychotics (medications for mental illness)
• Ipratropium (Atrovent)
• Medications for irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• Monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)
• Mixed agonists/antagonists and partial agonist analgesics such as butorphanol, nalbuphine, pentazocine, buprenorphine
• Sedatives
• Sleeping pills
• Tranquilizers
• Medications that may alter heart electrical activity

This is not a complete list of Vntrela ER drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant. Prolonged use of Vantrela ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. 

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Vantrela ER has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from this medication, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.