What is Oxycodone powder;
Oxycodone powder is a semisynthetic opioid synthesized from thebaine which has been in clinical use since 1916, and it is used for managing moderate to moderately severe acute or chronic pain. An opioid alkaloid found in the Persian poppy, and one of the many alkaloids found in the opium poppy. It has been found to improve the quality of life for those with many types of pain. Experts are divided regarding use for non-cancer-related chronic pain, as most opioids have great potential for dependence and may also create paradoxical pain sensitivity. Oxycodone powder for sale online in the USA, Buy Oxycodone Powder Online.
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Oxycodone powder (oxycodone hydrochloride tablets USP) is an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg or 30 mg of oxycodone hydrochloride USP.
Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).
Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one hydrochloride and has the following. Structural formula:
The 5 mg Roxicodone (oxycodone hydrochloride) tablet (oxycodone powder) contains inactive ingredients: microcrystalline cellulose and stearic acid. The 15 and 30 mg tablets contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10 (15 mg tablet); and FD&C Blue No. 2 (15 mg and 30 mg tablets).
The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.6 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.
ROXICODONE (oxycodone hydrochloride) ® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
DOSAGE AND ADMINISTRATION
ROXICODONE (oxycodone hydrochloride) ® is intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.
Patients who have not been receiving opioid analgesics should be started on ROXICODONE (oxycodone hydrochloride) ® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their initial dose of ROXICODONE (oxycodone hydrochloride) ®. Patients with chronic pain should have their dosage given on an aroundthe-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.
For control of severe chronic pain, ROXICODONE (oxycodone hydrochloride) ® should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.
As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of ROXICODONE (oxycodone hydrochloride) ®, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.
Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs
When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of ROXICODONE (oxycodone hydrochloride) ® in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose ROXICODONE (oxycodone hydrochloride) ® should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.
Patients Currently on Opioid Therapy
If a patient has been receiving opioid-containing medications prior to taking ROXICODONE (oxycodone hydrochloride) ®, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
In converting patients from other opioids to ROXICODONE (oxycodone hydrochloride) ® close observation and adjustment of dosage based upon the patient’s response to ROXICODONE (oxycodone hydrochloride) ® is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of ROXICODONE (oxycodone hydrochloride) ® may be necessary, especially in patients who have disease states that are changing rapidly.
Maintenance of Therapy
Continual re-evaluation of the patient receiving ROXICODONE (oxycodone hydrochloride) ® is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.
During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
Cessation of Therapy
When a patient no longer requires therapy with ROXICODONE (oxycodone hydrochloride) ® or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal).
If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of ROXICODONE (oxycodone hydrochloride) ® that treatment may be discontinued without risk of the opioid abstinence syndrome.
Some Side effects:
ROXICODONE (oxycodone hydrochloride) ® tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. ROXICODONE (oxycodone hydrochloride) ® tablets are associated with adverse experiences similar to those seen with other opioids.
Serious adverse reactions that may be associated with ROXICODONE (oxycodone hydrochloride) ® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock (see OVERDOSE, WARNINGS).
The less severe adverse events seen on initiation of therapy with ROXICODONE (oxycodone hydrochloride) ® are also typical opioid side effects. These events are dose dependent, and their frequency depends on the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent of these include nausea, constipation, vomiting, headache, and pruritus.
In many cases the frequency of adverse events during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse events will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy.
In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving ROXICODONE (oxycodone hydrochloride) ®, the following adverse events were recorded in ROXICODONE (oxycodone hydrochloride) ® treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The following adverse experiences occurred in less than 3% of patients involved in clinical trials with oxycodone:
- Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.
- Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.
- Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.
- Hemic and Lymphatic: anemia and leukopenia.
- Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.
- Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture.
- Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.
- Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.
- Skin and Appendages: herpes simplex, rash, sweating, and urticaria.
- Special Senses: amblyopia.
- Urogenital: urinary tract infectio
Drug Abuse And Dependence
Controlled Substance Roxicodone (oxycodone hydrochloride) contains oxycodone, a mu-agonist opioid of the morphine type and is a Schedule II controlled substance. Roxicodone (oxycodone hydrochloride) , like other opioids used in analgesia, can be abused and is subject to criminal diversion.
Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Roxicodone (oxycodone hydrochloride) is intended for oral use only. Abuse of Roxicodone (oxycodone hydrochloride) poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued.
Oxycodone is metabolized in part to oxymorphone via the cytochrome p450 isoenzyme CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent. However, clinicians should be aware of this possible interaction.
Neuromuscular Blocking Agents: Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
CNS Depressants: Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with ROXICODONE (oxycodone hydrochloride) ® may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of ROXICODONE (oxycodone hydrochloride) ®. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as ROXICODONE (oxycodone hydrochloride) ®. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of ROXICODONE (oxycodone hydrochloride) ® and/or may precipitate withdrawal symptoms in these patients.
Monoamine Oxidase Inhibitors (MAOIs): MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of ROXICODONE (oxycodone hydrochloride) ® is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.