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TEVA-EMTEC-30 is a brand name for Acetaminophen (also known as Paracetamol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Adverse effects of TEVA-EMTEC-30 (acetaminophen and codeine phosphate) tablets are similar to those of other opioid analgesics and represent an extension of pharmacological effects of the drug class. The major hazards of opioids include respiratory and central nervous system depression and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.
The most frequently observed adverse effects of acetaminophen and codeine phosphate are gastrointestinal upset, drowsiness, nausea, vomiting and constipation.
Sedation:
Sedation is a common side effect of opioid analgesics, especially in opioid naïve individuals. Sedation may also occur partly because patients often recuperate from prolonged fatigue after the relief of persistent pain. Most patients develop tolerance to the sedative effects of opioids within three to five days and, if the sedation is not severe, will not require any treatment except reassurance.
If excessive sedation persists beyond a few days, the dose of the opioid should be reduced and alternate causes investigated. Some of these are: concurrent CNS depressant medication, hepatic or renal dysfunction, brain metastases, hypercalcemia and respiratory failure.
If it is necessary to reduce the dose, it can be carefully increased again after three or four days if it is obvious that the pain is not being well controlled. Dizziness and unsteadiness may be caused by postural hypotension, particularly in elderly or debilitated patients, and may be alleviated if the patient lies down.
Nausea and Vomiting:
Nausea is a common side effect on initiation of therapy with opioid analgesics and is thought to occur by activation of the chemoreceptor trigger zone, stimulation of the vestibular apparatus and through delayed gastric emptying. The prevalence of nausea declines following continued treatment with opioid analgesics.
When instituting therapy with an opioid for chronic pain, the routine prescription of an antiemetic should be considered. In the cancer patient, investigation of nausea should include such causes as constipation, bowel obstruction, uremia, hypercalcemia, hepatomegaly, tumor invasion of celiac plexus and concurrent use of drugs with emetogenic properties.
SERIOUS WARNINGS AND PRECAUTIONS
, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Addiction, Abuse, and Misuse TEVA-EMTEC-30 poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Each patient’s risk should be assessed prior to prescribing TEVA- EMTEC-30, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). TEVA-EMTEC-30 should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of TEVA- EMTEC-30. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of TEVA-EMTEC-30 or following a dose increase.
Tablets:
TEVA-EMTEC-30 must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving TEVA-EMTEC-30 can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS). Further, instruct patients of the hazards related to taking opioids including fatal overdose.
Accidental Exposure Accidental ingestion of even one dose of TEVA-EMTEC-30, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of TEVA-EMTEC-30 during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS). Interaction with Alcohol The co-ingestion of alcohol with TEVA-EMTEC-30 should be avoided as it may result in dangerous additive effects causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Persistent nausea which does not respond to dosage reduction may be caused by opioid-induced gastric stasis and may be accompanied by other symptoms including anorexia, early satiety, vomiting and abdominal fullness. These symptoms respond to chronic treatment with gastrointestinal prokinetic agents.
Constipation:
Practically all patients become constipated while taking opioids on a persistent basis. In some patients, particularly the elderly or bedridden, fecal impaction may result. It is essential to caution the patients in this regard and to institute an appropriate regimen of bowel management at the start of prolonged opioid therapy.
Stimulant laxatives, stool softeners, and other appropriate measures should be used as required. As fecal impaction may present as overflow diarrhea, the presence of constipation should be excluded in patients on opioid therapy prior to initiating treatment for diarrhea.
The following adverse effects occur less frequently with opioid analgesics, whether related or not to acetaminophen and codeine phosphate, are rash, urticaria, neutropenia, methemoglobinemia, thrombocytopenia, palpitations, pruritus, hyperhidrosis, agitation, and a slight increase in TEVA-EMTEC-30 Page 17 of 35 prothrombin time in patients receiving oral anticoagulants.
Respiratory depression may be seen at higher doses, and the possibility of habituation or true addiction should be avoided.
Post-marketing Experience Androgen deficiency:
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.
Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.
DRUG INTERACTIONS Overview Interaction with Serotonin:
Coadministration of codeine phosphate with a serotonergic agent, such as a Selective Serotonin Re-uptake Inhibitor or a Serotonin Norepinephrine Re-uptake Inhibitor, may increase the risk of serotonin syndrome, a potentially life-threatening condition (see WARNINGS AND PRECAUTIONS).
, other opioids, sedatives/hypnotics, antidepressants, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, phenothiazines, neuroleptics, antihistamines, antiemetics and alcohol) and beta-blockers, increases the risk of respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limited dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation (see WARNINGS AND PRECAUTIONS, Neurologic, Interactions with Central Nervous System Depressants (including benzodiazepines and alcohol) and Psychomotor Impairment).
TEVA-EMTEC-30 should not be consumed with alcohol as it may increase the chance of experiencing dangerous side effects. The concurrent use of anticholinergic with codeine may produce paralytic ileus.
Drug-Drug Interactions Anticholinergics:
Concomitant use of drugs with antimuscarinic activity may increase the risk of severe constipation and/or urinary retention.
Cimetidine:
Concurrent administration of cimetidine may lead to increased […]
TEVA-EMTEC-30 Page 6 of 35 SERIOUS WARNINGS AND PRECAUTIONS Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
Reserve concomitant prescribing of TEVA-EMTEC-30 and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
General Patients should be instructed not to give TEVA-EMTEC-30 (acetaminophen and codeine phosphate) tablets to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
TEVA- EMTEC-30 should be stored securely to avoid theft or misuse. TEVA-EMTEC-30 should only be prescribed by persons knowledgeable in the continuous administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
Patients should be cautioned not to consume alcohol while taking TEVA-EMTEC-30 as it may increase the chance of experiencing serious adverse events, including death. Hyperalgesia that will not respond to a further dose increase of acetaminophen and codeine phosphate can occur at particularly high doses.
An acetaminophen and codeine phosphate dose reduction or change in opioid may be required. Patients should be counselled to discontinue codeine products and to seek urgent medical help at the earliest sign of codeine toxicity including symptoms such as confusion, shallow breathing, or extreme sleepiness which may be life threatening.
Abuse and Misuse Like all opioids, TEVA-EMTEC-30 is a potential drug of abuse and misuse, which can lead to overdose and death. Therefore, TEVA-EMTEC-30 should be prescribed and handled with caution. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. TEVA-EMTEC-30 Page 7 of 35 Opioids, such as TEVA-EMTEC-30, should be used with particular care in patients with a history of alcohol and illicit/prescription drug abuse.
However, concerns about abuse, addiction, and diversion should not prevent the proper management of pain. TEVA-EMTEC-30 is intended for oral use only. The tablets should be swallowed whole, and not chewed or crushed. Abuse of oral dosage forms can be expected to result in serious adverse events, including death.
Cardiovascular Codeine phosphate administration may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of drugs such as phenothiazines and other tranquilizers, sedative/hypnotics, tricyclic antidepressants or general anesthetics.
These patients should be monitored for signs of hypotension after initiating or titrating the dose of TEVA-EMTEC-30. The use of TEVA-EMTEC-30 in patients with circulatory shock should be avoided as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Dependence/Tolerance As with other opioids, tolerance and physical dependence may develop upon repeated administration of TEVA-EMTEC-30 and there is a potential for development of psychological […]