Ryzolt

Uses

Doctors prescribe RYZOLT for patients needing around-the-clock protection from moderate to moderately severe chronic pain.

General Drug Information

The Canadian pharmaceutical company, Confab Laboratories, Inc., manufactures RYZOLT. American pharmaceutical companies Purdue Pharma, STAT RX USA, PD-Rx Pharmaceuticals and Quality Care Products package and distributed RYZOLT in various formulas.

Administration/Dosage

RYZOLT is an extended-release formula - one tablet provides comfort for an entire day. Each tablet contains 100, 200 or 300 mg of tramadol hydrochloride, a potent opioid pain reliever.

Physicians should start patients out on 100 mg a day and increase the dosage according to the severity of the patient’s pain and the patient’s response to treatment for that pain. Physicians usually titrate dosages, or increase the strength of RYZOLT, by 100 mg every two to three days until she finds a balance between pain relief provided by RYZOLT and tolerance to its effects. Someone who does not normally take opioids is “opioid-naïve” and sensitive to the effects of RYZOLT. As he continues to take RYZOLT, he becomes opioid-tolerant and less sensitive to their effects. An opioid-tolerant person requires higher doses of RYZOLT to achieve the same analgesic effects. The maximum daily dose of RYZOLT is 300 mg per day.

Slow titration reduces the occurrence and severity of adverse reactions, which helps the patient remain on therapy.

RYZOLT consumers should not use other products containing tramadol to avoid toxic overdose.

Patients should swallow whole tablets without first crushing, chewing, splitting or dissolving RYZOLT. Consumers may take RYZOLT with or without food.

Action

Tramadol depresses the central nervous system, or CNS, to dull the brain’s perception of pain. Other effects of CNS depression include sedation and euphoria. RYZOLT also depresses respiratory centers and reduces respiratory drive in the central nervous system to cause slow, shallow and irregular breathing patterns.

The tramadol in RYZOLT inhibits the reuptake, or re-absorption, of the hormone neurotransmitters serotonin and norepinephrine. Serotonin is associated with mood, sleep and learning. Norepinephrine affects parts of the brain requiring attention and response. Inhibiting reuptake can cause high levels of these hormones.

The liver metabolizes RYZOLT into smaller components. The kidneys eliminate RYZOLT and its metabolites through urine. Dysfunction in these organs can cause the metabolites of tramadol to accumulate and rise to toxic levels.

Warnings

Seizure Risk

RYZOLT increases the risk for seizures, even at therapeutic doses. The risk for seizures increases with doses above the recommended range.

Using some medications alongside RYZOLT increases the risk for seizures, including other opioids, SSRIs, TCAs and MAOIs. Patients commonly take an SSRI, or selective serotonin reuptake inhibitor, to treat depression. TCAs are another type of antidepressant. Physicians routinely order MAOIs, or monoamine oxidase inhibitors, to treat depression or high blood pressure.

Patients with a history of epilepsy or other seizure disorders should avoid RYZOLT use, as should those with head injury, certain metabolic disorders, CNS infections and drug or alcohol withdrawal.

Suicide Risk

RYZOLT can increase the risk for suicide. Physicians should not order RYZOLT for individuals with a history of suicide attempts or suicidal thoughts, or for those who are prone to addiction. Physicians should prescribe RYZOLT with care to those already taking tranquilizers or antidepressants and to those who drink alcohol to excess.

Serotonin Syndrome

RYZOLT slows down the reuptake of serotonin, causing RYZOLT to accumulate in the body. Taking RYZOLT with other serotonin reuptake inhibitors slows the pace at which the body reabsorbs even further, potentially causing a toxic level of serotonin in a condition known as serotonin syndrome.

Symptoms of serotonin syndrome include changes in mental state, such as hallucinations, agitation and coma, along with fast pulse, erratic blood pressure and high body temperature. Serotonin syndrome may also cause a loss of coordination and digestive symptoms, including nausea, vomiting and diarrhea.

Allergic and Anaphylactic Reactions

RYZOLT can cause serious and sometimes fatal allergic and anaphylactic reaction. Anaphylaxis is a severe form of an allergic reaction. Unlike an allergic reaction, someone can suffer anaphylaxis the first time he takes RYZOLT. In fact, when an anaphylactic reaction to RYZOLT does occur, it is usually with the first dose.

Allergic reactions include itching, hives, rash, wheezing and swelling. Dangerous and sometimes fatal skin reactions may occur. Patients with a history of anaphylaxis face an increased risk for allergic reactions and should avoid RYZOLT use.

Respiratory Depression

RYZOLT depresses respiratory drive to the point of impaired breathing, known as respiratory depression. During respiratory depression, the slow and shallow breathing patterns prevent the lungs from adequately exchanging spent carbon dioxide and other toxins for fresh oxygen. Respiratory depression can result in oxygen starvation and high carbon dioxide levels.

Physicians should consider alternate analgesia for patients at high risk for respiratory depression. Some substances increase the risk for overdose, including alcohol, other opioids or other drugs that depress breathing centers in the brain. Caretakers should treat any signs of respiratory depression as an overdose.

Interaction with CNS Depressants

Taking RYZOLT along with other substances that depress the central nervous system increases the risk for CNS depression and respiratory depression. Examples of other CNS depressants include alcohol, other opioids, sedatives, general anesthetics, tranquilizers and anti-psychotic drugs.

Increased Intracranial Pressure and Head Injuries

Respiratory depression causes high carbon dioxide levels and increases the intracranial fluid pressure inside the patient’s skull. Head injuries and pre-existing high intracranial pressure enhance these effects. Furthermore, the effects of RYZOLT mimic the symptoms of a head injury; taking RYZOLT can obscure the presence or healing process of a head injury.

Dependence and Withdrawal

Anyone who uses RYZOLT continuously for more than a few weeks may become physically dependent on opioids. An opioid-dependent person suffers uncomfortable withdrawal symptoms when he discontinues RYZOLT abruptly. The likelihood for withdrawal symptoms increases the longer the patient takes RYZOLT.

Precautions

Physicians should exercise caution when prescribing RYZOLT to patients with possible abdominal condition. A patient’s RYZOLT use can make it difficult for a physician to assess any abdominal condition the patient may have.

Prescribers should consider an alternate form of pain therapy for patients with certain types of liver and kidney conditions. Some liver problems can slow the metabolism of RYZOLT while kidney dysfunction can slow the pace at which the body eliminates RYZOLT and its metabolites. RYZOLT is a once-a-day drug, limiting dosage flexibility - a patient cannot split the doses throughout the day or take dosages smaller than 100 mg.

Contraindications

RYZOLT is not appropriate for all patients. RYZOLT is not appropriate in any situation where opioids are unsafe, especially for patients suffering respiratory depression in unmonitored settings or in locations without resuscitative equipment. Patients suffering from an acute asthma attack, severe asthma or high carbon dioxide levels should not use RYZOLT outside of monitored and equipped locations.

Patients who are hypersensitive to the active ingredient tramadol, any inactive ingredients in RYZOLT or any other opioids should not use RYZOLT.

Pregnancy, Labor and Delivery, Breastfeeding

There are no adequately controlled studies in humans to determine if RYZOLT poses a risk to a pregnant woman or fetus, or if it affects the reproductive capabilities of males or females; RYZOLT is a .

RYZOLT may pass the placental barrier between the mother and baby. A baby born to a mother who takes RYZOLT late in pregnancy may suffer withdrawal symptoms in the first days or weeks of life.

RYZOLT passes into human milk; scientists have not yet established its safety to the nursing baby. Mothers should discuss the benefits and risks of taking RYZOLT while breastfeeding then discontinue breastfeeding or choose another form of analgesia.

Drug Interactions

RYZOLT may interact with other medications in unsafe or unintended ways. Patients should supply a complete list, including all prescription and over-the-counter remedies, to the prescribing physician to reduce the risk for dangerous drug interactions.

Some medications increase the risk for serotonin syndrome, including SSRIs, MAOIs and TCAs. Other medications can also cause this effect.

The anti-seizure drug carbamazepine increases the metabolism of RYZOLT can reduce its analgesic effects. Furthermore, RYZOLT can increase the risk for seizures, especially in those with a history of convulsive disorders.

RYZOLT can increase bleeding times for those taking blood thinners, including Coumadin and warfarin.

Side effects

All drugs, including RYZOLT, can cause adverse reactions in some consumers. The most commonly reported non-serious side effects are nausea, constipation, dizziness, sleepiness, vomiting, itching and headache. Most of these side effects began within the first two weeks of treatment with RYZOLT.

Overdose

RYZOLT overdose is a serious and potentially lethal situation, sometimes causing death within one hour of consumption. Overdose from prescription painkillers claim the lives of nearly each year. The number of deaths associated with prescription drug overdose is on the rise, tripling in the decade between 1999 and 2008.

Serious consequences of RYZOLT include CNS depression, respiratory depression and death. Symptoms of RYZOLT overdose include respiratory depression, sleepiness that worsens into coma, limp muscles and cold, clammy skin. The patient may have pinpoint pupils, slow heartbeat and low blood pressure.

RYZOLT overdose can cause death, especially when the victim uses RYZOLT improperly by chewing, crushing or dissolving RYZOLT and then swallowing, snorting or injecting the product. Using alcohol, other CNS depressants or other opioids along with RYZOLT increases the risk for fatal overdose.

RYZOLT overdose requires immediate medical treatment. Emergency department workers will help the patient breathe by sliding a flexible tube into his throat to hold his airway open; staff may attach this tube to a mechanical ventilator that takes over breathing responsibilities. Nurses will start oxygen, introduce intravenous fluids and administer medications to control the victim’s blood pressure, pulse and fluid in his lungs. Attendants will perform CPR or other lifesaving measures as necessary.

Doctors may order naloxone to reverse respiratory depression only if the patient shows signs of breathing distress. While naloxone reverses some of the effects of RYZOLT, naloxone may cause seizures.

Abuse

Recreational drug abusers target opioids because of the way these drugs produce a pleasant euphoria. Many recreational drug abusers swallow whole RYZOLT, while some crush, chew or dissolve RYZOLT to inhale, swallow or inject into a vein.

Abusing RYZOLT increases the risks for side effects, overdose, addiction and dependence.

Withdrawal

RYZOLT changes body chemistry. When a person takes RYZOLT for a long time, his body becomes accustomed to this altered chemical balance. When the individual stops using RYZOLT, his body struggles to adjust to the new chemical balance; doctors call this detoxification. The detoxification process causes uncomfortable withdrawal symptoms.

Withdrawal symptoms, including restlessness, watery eyes, stuffy or runny nose, yawning, sweating, muscle aches and large pupils, develop a few hours after the last dose of RYZOLT. Other symptoms may develop, including irritability, anxiety, backache and joint pain, weakness, trouble sleeping, stomachache, nausea and vomiting, diarrhea and loss of appetite. The patient may have increased blood pressure, rapid breathing or fast heartbeat.

Without intervention, these withdrawal symptoms last for five or more days before fading. Once the patient’s body is detoxified, the withdrawal symptoms will not return unless the individual become opioid-dependent once again. Someone can stop the withdrawal symptoms at any time by taking more RYZOLT but relapse halts the detoxification process and returns the patient to an opioid-dependent state.

To avoid withdrawal symptoms, physicians suggest patients wean themselves by taking smaller doses of RYZOLT less frequently. For example, a patient that takes 300 mg of RYZOLT every 24 hours might step down to 200 mg every 30 hours and then to 100 mg every 48 hours. This tapering method works well for most people but persistent withdrawal symptoms prevent millions of Americans from stopping RYZOLT when they no longer need it for pain.

Detox

According to estimations offered by the , almost 2 million Americans are opioid-dependent and unable to wean themselves from prescription painkillers. Many local healthcare institutions are developing detoxification programs to address this pressing need. During detoxification, patients receive drugs to counteract the effects of RYZOLT along with medications to ease withdrawal symptoms.

Many informed consumers now consider rapid detox the most humane and efficient approach to detoxification. Rapid detox patients receive anesthesia and sedatives before getting the standard detoxification and anti-withdrawal drugs; these patients doze in a pleasant “twilight sleep” during the difficult detoxification process and awaken a few hours later, refreshed and revitalized.

Storage

Consumers and healthcare providers should store RYZOLT at temperatures between 59 and 86 degrees Fahrenheit, in a tightly closed, light-resistant container. RYZOLT should be stored out of the reach of children.