QDOLO - (tramadol hydrochloride) oral solution
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Safety Profile

Contraindications

Children younger than 12 years of age.

Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.

Significant respiratory depression.

Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.

Known or suspected gastrointestinal obstruction, including paralytic ileus.

Hypersensitivity to tramadol, any other component of this product or opioids.

Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.

 

Warnings and Precautions

Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.

Risk of Seizure: Can occur at the recommended dose of tramadol.

Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.

Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.

Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of QDOLO in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of QDOLO in patients with impaired consciousness or coma.

 

Adverse Reactions

The most common incidence of treatment-emergent adverse events (≥15.0%) in patients from clinical trials were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.

 

Table 1: Cumulative Incidence of Adverse Reactions for Tramadol HCl Tablets in Chronic Trials of Nonmalignant Pain (N=427)

Up to 7 Days Up to 30 Days Up to 90 Days
Dizziness/Vertigo 26% 31% 33%
Nausea 24% 34% 40%
Constipation 24% 38% 46%
Headache 18% 26% 32%
Somnolence 16% 23% 25%
Vomiting 9% 13% 17%
Pruritus 8% 10% 11%
CNS Stimulation* 7% 11% 14%
Asthenia 6% 11% 12%
Sweating 6% 7% 9%
Dyspepsia 5% 9% 13%
Dry Mouth 5% 9% 10%
Diarrhea 5% 6% 10%

* CNS Stimulation is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations.
 

To report SUSPECTED ADVERSE REACTIONS, contact Athena Bioscience, LLC. at 1-833-874-2664 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Drug Interactions 

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with QDOLO because they may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.

 

Pregnancy

May cause fetal harm.

 

Lactation

Breastfeeding not recommended.

QDOLO (tramadol hydrochloride) Oral Solution 5mg/1ml C-IV IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, and MISUSE; RISK EVALUATION and MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL and OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

  • Ensure accuracy when prescribing, dispensing, and administering QDOLO. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.
  • QDOLO exposes users to the risks of addiction, abuse and misuse, which can lead to overdose and death.
  • The FDA has required a REMS for all opioid analgesics.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially during initiation or following a dose increase.
  • Accidental ingestion of QDOLO, especially by children, can result in a fatal overdose of tramadol.
  • Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism.
  • QDOLO is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of QDOLO in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
  • Prolonged use of QDOLO, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with QDOLO requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
  • Concomitant use of opioids with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

INDICATION

QDOLO is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve QDOLO for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

  • Have not been tolerated or are not expected to be tolerated.
  • Have not provided adequate analgesia or are not expected to provide adequate analgesia.

DOSAGE AND ADMINISTRATION

  • Ensure accuracy when prescribing, dispensing, and administering QDOLO to avoid dosing errors due to confusion between mg and mL which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed.
  • When writing prescriptions, include both the total dose in mg and the total dose in volume.
  • Instruct patients on how to measure and take the correct dose of QDOLO and to use extreme caution when measuring the dose.
  • Strongly advise patients to always use a calibrated oral syringe or other oral dosing device, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication.
  • Inform patients that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure QDOLO.
  • Do not use QDOLO concomitantly with other tramadol-containing products.
  • Do not administer QDOLO at a dose exceeding 400 mg (80 mL) per day.
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
  • Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with QDOLO and adjust the dosage accordingly.

CONTRAINDICATIONS

  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to tramadol, any other component of this product or opioids
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

WARNINGS AND PRECAUTIONS

  • Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.
  • Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.
  • Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of QDOLO in patients with circulatory shock.
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of QDOLO in patients with impaired consciousness or coma.

ADVERSE REACTIONS

The most common adverse events (≥15.0%) in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Athena Bioscience, LLC at 1-833-874-2664.

See Full Prescribing Information for all adverse reactions associated with QDOLO.

DRUG INTERACTIONS

QDOLO use with Agonist/Antagonist and Partial Agonist Opioid Analgesics should be avoided as it may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.

See Full Prescribing Information for all drug interactions associated with QDOLO.

SPECIAL POPULATIONS

Pregnancy and Lactation: May cause fetal harm; breastfeeding is not recommended.

See Full Prescribing Information for use in specific populations associated with QDOLO.

Please see the accompanying Full Prescribing Information

OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)

To manage serious risks associated with opioid analgesic products, the Food and Drug Administration (FDA) requires a REMS to ensure the benefits of these products outweigh the risks of addiction, abuse, and misuse. This REMS requires providers of opioid analgesics to offer REMS-compliant education programs for healthcare providers and strongly encourages HCPs to:

  • Complete an FDA REMS-compliant accredited continuing education (CE) program
  • Counsel the safe use, serious risks, storage, and disposal of opioid analgesics with patients and caregivers
  • Emphasize to patients and caregivers the importance of reading the Medication Guide provided by their pharmacist
  • Consider other tools to improve patient, household, and community safety

For further information and a list of accredited REMS CME/CE, call 1-800-503-0784 or visit www.opioidanalgesicrems.com.

For the FDA Blueprint, visit www.fda.gov/OpioidAnalgesicREMSBlueprint.