Ryzolt

Name: Ryzolt

Ryzolt Precautions

Serious side effects have been reported with Ryzolt including the following:

  • seizures. Tell your healthcare provider right away if you have some or all of the following symptoms of seizures:
    • body convulsions (shaking and trembling)
    • temporary loss of consciousness
  • serotonin syndrome. Tell your healthcare provider right away if you have some or all of the following symptoms of serotonin syndrome:
    • hallucinations
    • fast heart rate
    • overactive reflexes
    • high blood pressure
    • restlessness or agitation
    • nausea or vomiting
    • decline in muscle coordination
    • rise in body temperature
  • discontinuation symptoms. Do not stop Ryzolt without first talking to your healthcare provider. Stopping Ryzolt suddenly may cause serious symptoms including the following:
    • anxiety
    • sweating
    • insomnia
    • shaking or shivering
    • pain
    • nausea
    • diarrhea
    • upper airway symptoms
    • goose bumps
    • rarely hallucinations

Ryzolt can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Ryzolt affects you. 

Avoid drinking alcohol while taking Ryzolt.

Do not take Ryzolt if you:

  • are allergic to Ryzolt or any of its ingredients
  • have a history of respiratory depression in unmonitored settings or the absence of corrective measures
  • have a history of acute or chronic bronchial asthma or hypercapnia in unmonitored settings or the absence of corrective measures

Ryzolt and Lactation

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

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

Ryzolt Usage

Take Ryzolt exactly as prescribed.

Ryzolt comes as an extended-release tablet and is taken once a day, with liquid. 

Do not chew, divide, or break Ryzolt extended-release tablets. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Ryzolt at the same time.

Commonly used brand name(s)

In the U.S.

  • ConZip
  • FusePaq Synapryn
  • Rybix ODT
  • Ryzolt
  • Ultram
  • Ultram ER

Available Dosage Forms:

  • Tablet, Extended Release
  • Suspension
  • Capsule, Extended Release
  • Tablet, Disintegrating
  • Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

What do I need to tell my doctor BEFORE I take Ryzolt?

  • If you have an allergy to tramadol or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have thoughts of suicide or if you have ever had alcohol or other drug abuse or dependence.
  • If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
  • If you are taking carbamazepine.
  • If you are taking another drug that has the same drug in it.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Ryzolt within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Ryzolt.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Seizures.
  • Feeling very tired or weak.
  • Chest pain or pressure or a fast heartbeat.
  • Trouble passing urine.
  • Passing urine more often.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Noisy breathing.
  • Feeling very sleepy.
  • Change in eyesight.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Contraindications

Ryzolt® should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids.

Ryzolt® is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. Ryzolt® is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment.

Precautions

Acute Abdominal Conditions

The administration of Ryzolt® may complicate the clinical assessment of patients with acute abdominal conditions.

Use in Renal and Hepatic Disease

Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1 in patients taking an immediate-release formulation of tramadol. Ryzolt® has not been studied in patients with renal impairment. The limited availability of dose strengths and once daily dosing of Ryzolt® do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, Ryzolt® should not be used in patients with severe renal impairment (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

The metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. Ryzolt® has not been studied in patients with hepatic impairment. The limited availability of dose strengths and once daily dosing of Ryzolt® do not permit the dosing flexibility required for safe use in patients with hepatic impairment. Therefore, Ryzolt® should not be used in patients with hepatic impairment (see CLINICAL PHARMACOLOGYand DOSAGE AND ADMINISTRATION).

Overdosage

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension and death.

Death due to overdose have been reported with abuse and misuse of tramadol, by ingesting, inhaling, or injecting the crushed tablets. The risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol and other CNS depressants, including other opioids.

In the treatment of tramadol overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

While naloxone will reverse some (but not all) symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

What other drugs will affect Ryzolt?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Ryzolt with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with tramadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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