What happens if I overdose Hetradol?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Hetradol extended-release capsules:
Store Hetradol extended-release capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hetradol extended-release capsules out of the reach of children and away from pets.
Overdose of Hetradol in details
Symptoms
Symptoms of overdosage with Hetradol® are respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death.
Deaths due to overdose have been reported with abuse and misuse of Hetradol. Review of case reports has indicated that the risk of fatal overdose is further increased when Hetradol is abused concurrently with alcohol or other CNS depressants, including other opioids.
Treatment
A single or multiple overdose with Hetradol® may be a potentially lethal polydrug overdose, and consultation with a regional poison control centre is recommended.
In treating an overdose of Hetradol®, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. 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 Hetradol, the risk of seizures is also increased with naloxone administration. Seizures may be controlled with diazepam.
In animals, convulsions following the administration of toxic doses of Hetradol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice.
Based on experience with Hetradol, 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.
Emptying of the gastric contents is useful to remove any unabsorbed drug.
What should I avoid while taking Hetradol?
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Hetradol. Check your food and medicine labels to be sure these products do not contain alcohol.
Hetradol may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Hetradol warnings
Seizure Risk
Seizures have been reported in patients receiving Hetradol within the recommended dosage range. Spontaneous postmarketing reports indicate that seizure risk is increased with doses above the recommended range. Concomitant use of Hetradol increases the seizure risk in patients taking:
- Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),
- Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
- Other opioids.
Administration of Hetradol™ (Hetradol extended-release tablets) may enhance the seizure risk in patients taking:
- Monoamine Oxidase (MAO) inhibitors,
- Neuroleptics, or
- Other drugs that reduce the seizure threshold.
Risk of convulsions may also be increased in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, certain metabolic disorders, alcohol and drug withdrawal and CNS infections). In Hetradol overdose, naloxone administration may increase the risk of seizures.
Suicide Risk
Do not prescribe Hetradol™ (Hetradol extended-release tablets) for patients who are suicidal or addiction-prone. Prescribe Hetradol™ (Hetradol extended-release tablets) with caution for patients taking tranquilizers or antidepressant drugs and for patients who use alcohol in excess. Serious potential consequences of overdosage with Hetradol™ (Hetradol extended-release tablets) are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.
Serotonin Syndrome risk
The development of a potentially life-threatening serotonin syndrome may occur with the use of Hetradol products, including Hetradol™ (Hetradol extended-release tablets), particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of Hetradol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.
Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Hetradol products in excessive doses, either alone or in combination with other Central Nervous System (CNS) depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon. Hetradol should not be taken in doses higher than those recommended by the physician. The judicious prescribing of Hetradol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of Hetradol products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, Hetradol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations.
Many of the Hetradol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of Hetradol alone or in combination with other drugs. Patients taking Hetradol should be warned not to exceed the dose recommended by their physician.
Anaphylactoid Reactions
Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with Hetradol. When these events do occur, it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to other opioids may be at increased risk and therefore should not receive Hetradol™.
Respiratory Depression
Hetradol™ (Hetradol extended-release tablets) should be administered cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of Hetradol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Interaction with Central Nervous System (CNS) Depressants
Hetradol™ (Hetradol extended-release tablets) should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Hetradol increases the risk of CNS and respiratory depression in these patients.
Increased Intracranial Pressure or Head Trauma
Hetradol™ (Hetradol extended-release tablets) should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from Hetradol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving Hetradol™ (Hetradol extended-release tablets).
Use in Ambulatory Patients
Hetradol™ (Hetradol extended-release tablets) may impair the mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Patients using this drug should be cautioned accordingly.
Use with MAO Inhibitors and Serotonin Re-uptake Inhibitors
Hetradol™ (Hetradol extended-release tablets) should be used with great caution in patients taking MAO inhibitors. Animal studies have shown increased deaths with combined administration of Hetradol and MAO inhibitors. Concomitant use of Hetradol products with MAO inhibitors or SSRIs increases the risk of adverse events, including seizure and serotonin syndrome.
Withdrawal
Withdrawal symptoms may occur if Hetradol™ (Hetradol extended-release tablets) is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations.
In a 12 week study, 325 patients were followed for 3 and 7 days after discontinuation of treatment with Hetradol™ (Hetradol extended-release tablets). The majority of reported post-treatment adverse events including withdrawal symptoms were mild to moderate in nature. Onset of the post-treatment adverse events occurred more frequently within the first three days after treatment was stopped. Less than 1% of patients taking Hetradol™ (Hetradol extended-release tablets) met the DSM-IV criteria for a diagnosis of opioid withdrawal.
Clinical experience suggests that signs and symptoms of withdrawal may be reduced by tapering medication when discontinuing Hetradol therapy.
Misuse, Abuse and Diversion of Opioids
Hetradol is an opioid agonist of the morphine type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
Like other opioid agonists, legal or illicit, Hetradol can be abused. This should be considered when prescribing or dispensing Hetradol™ (Hetradol extended-release tablets) in situations where the healthcare professional is concerned about a risk of misuse, abuse, or diversion.
Hetradol™ (Hetradol extended-release tablets) could be abused by breaking, crushing, chewing, or dissolving the product which can result in the uncontrolled delivery of the opioid, and as a consequence poses a significant risk of overdose and death.
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.
Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Interactions with Alcohol and Drugs of Abuse
Hetradol may be expected to have additive effects when used in conjunction with alcohol, other opioids or drugs, whether legal or illicit, which cause central nervous system depression.
What should I discuss with my healthcare provider before taking Hetradol?
You should not take Hetradol if you are allergic to Hetradol, or if you have:
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severe asthma or breathing problems;
-
a blockage in your stomach or intestines;
-
if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications.
Seizures have occurred in some people taking Hetradol. Talk with your doctor about your seizure risk, which may be higher if you have:
-
a history of head injury, epilepsy or other seizure disorder;
-
a history of drug or alcohol addiction;
-
a metabolic disorder; or
-
if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).
Some medicines can interact with Hetradol and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
To make sure Hetradol is safe for you, tell your doctor if you have:
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liver or kidney disease;
-
a stomach disorder; or
-
a history of drug abuse, alcohol addiction, mental illness, or suicide attempt.
Hetradol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
Hetradol may be habit forming and should be used only by the person it was prescribed for. Never share Hetradol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Hetradol to any other person is against the law.
It is not known whether Hetradol will harm an unborn baby. If you use Hetradol while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Hetradol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Hetradol.
Do not give this medication to anyone younger than 16 years old without the advice of a doctor. Hetradol ER should not be given to anyone younger than 18 years old.
Hetradol precautions
Acute Abdominal Conditions
The administration of Hetradol™ (Hetradol extended-release tablets) 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 Hetradol and its active metabolite, M1 in patients taking an immediate-release formulation of Hetradol. Hetradol™ (Hetradol extended-release tablets) has not been studied in patients with renal impairment. The limited availability of dose strengths and once daily dosing of Hetradol™ (Hetradol extended-release tablets) do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, Hetradol (Hetradol extended-release tablets) ™ should not be used in patients with severe renal impairment
The metabolism of Hetradol and M1 is reduced in patients with advanced cirrhosis of the liver. Hetradol™ (Hetradol extended-release tablets) has not been studied in patients with hepatic impairment. The limited availability of dose strengths and once daily dosing of Hetradol™ (Hetradol extended-release tablets) do not permit the dosing flexibility required for safe use in patients with hepatic impairment. Therefore, Hetradol™ should not be used in patients with hepatic impairment
Use in Drug and Alcohol Addiction
Hetradol™ (Hetradol extended-release tablets) is an opioid with no approved use for the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission is for the management of pain requiring opioid analgesia.
Carcinogenesis, Mutagenesis and Impairment of Fertility
A slight, but statistically significant increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m or 2.6 times the maximum daily human dose).
There are no adequate and well-controlled studies in pregnant women. Hetradol™ (Hetradol extended-release tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported during post-marketing surveillance of Hetradol immediate-release products.
Labor and Delivery
Hetradol™ (Hetradol extended-release tablets) should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. Hetradol has been shown to cross the placenta. The mean ratio of serum Hetradol in the umbilical veins compared to maternal veins was 0.83 for 40 women given Hetradol during labor.
The effect of Hetradol™ (Hetradol extended-release tablets), if any, on the later growth, development and functional maturation of the child is unknown.
Nursing Mother
Hetradol™ (Hetradol extended-release tablets) is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of Hetradol, the cumulative excretion in breast milk within 16 hours postdose was 100
What happens if I miss a dose of Hetradol?
Since Hetradol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DrugBank. "Tramadol". http://www.drugbank.ca/drugs/DB00193 (accessed September 17, 2018).
- MeSH. "Narcotics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- Burnham Center for Chemical Geno. "SID26663897: Aqueous solubility in buffer at pH 7.4". https://pubchem.ncbi.nlm.nih.gov/bio... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
