Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA

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ENDONE tablets are white and Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA tablets, with one side embossed "O 5" and a break bar on the other side. Alphapharm Collection Ltd Level 1, 30 The Bond 30-34 Hickson Road Millers Point NSW 2000 www. Excipients of known effect. Endone tablets are white, round, biconvex 10 mm tablet with one side embossed "O 5" with a break bar on other side.

Endone is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Do not divide the tablet. It may be necessary to increase the usual dose in cases of more severe pain or in those who have become tolerant of narcotics. In patients with hepatic and renal impairment, dosage should be reduced tp n adjusted according to the clinical situation (see Section 4. Hypersensitivity to opiate narcotics, cor pulmonale, cardiac arrhythmias, bronchial asthma, Acyclovir Ophthalmic Ointment (Avaclyr)- Multum alcoholism, brain tumour, head injuries, increased cerebrospinal or intracranial pressure, severe CNS depression, severe respiratory levosulpiride, acute respiratory disease and respiratory depression, convulsive disorders, delirium tremens, suspected surgical abdomen and concomitant MAOIs or within 14 days of such therapy.

Hazardous and harmful use. Endone contains the opioid oxycodone and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Endone at recommended doses.

The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses.

Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Endone. All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids are sought by people with addiction and may be subject to diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the safe storage and proper disposal of any unused drugs (see Section 6.

Caution patients that abuse of oral or transdermal forms of opioids by parenteral administration can result in serious adverse events, which may be fatal. Patients should be advised not to share Endone with anyone else. Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even when used as recommended. It can occur at any time during the use of Endone, but the risk is greatest during initiation of therapy or following an increase in dose.

Patients should be monitored closely for respiratory depression at these times. Opioids should be used with caution and with close monitoring in these patients (see Section 4.

The use of opioids is contraindicated in patients with severe respiratory disease, Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA respiratory disease and respiratory depression (see Section 4. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief.

Careful calculation of equianalgesic doses is required when changing opioids or switching from immediate-release to modified-release formulations, together with consideration of pharmacological differences between opioids.

Consider starting the new opioid at a reduced dose to account for individual variation in response. Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol. Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Endone with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA CNS depressants, should be reserved for patients for whom other treatment options are not possible.

If a decision is made to prescribe Endone concomitantly with any of the medicines, the lowest effective dose should Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation.

Patients and their caregivers should be made aware of these symptoms. Patients and their Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA should also be informed of the potential harms of consuming alcohol whilst taking Endone.

Use of opioids in chronic (long-term) non-cancer pain (CNCP). Opioid analgesics have an established role in the treatment of acute pain, cancer pain and palliative and end-of-life care. The development of tolerance and physical dependence and risks of adverse effects, including hazardous and harmful use, increase with the length of time a patient takes an opioid. The Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA of opioids for long-term treatment of CNCP is not recommended.

The use of an opioid to treat CNCP should only be considered after maximised non-pharmacological and non-opioid treatments have been tried and found ineffective, not tolerated or otherwise inadequate to provide sufficient management of pain. Opioids should only be prescribed as a component of comprehensive multidisciplinary and multimodal pain management. Opioid therapy for CNCP should be initiated as a trial in accordance with clinical guidelines and after a comprehensive biopsychosocial assessment has established a cause for the pain and the appropriateness of opioid therapy for the patient (see Hazardous and harmful use).

Careful and regular assessment and monitoring is required to establish the clinical need for ongoing treatment. The patient's condition should be reviewed regularly, and the dose tapered off slowly if opioid treatment is no Pemfexy (Pemetrexed Injection for Intravenous Use)- FDA appropriate (see Ceasing opioids). Tolerance, dependence and withdrawal. Neuroadaptation of the opioid receptors to repeated administration of opioids can produce tolerance and physical dependence.

Tolerance is the need for increasing doses to maintain analgesia.



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