Acema

Acema

A synthetic opioid that is used as a hydrochloride. It is an opioid analgesic, which is primarily a mu-opioid agonist. It has actions and uses the same ones as morphine. It also has a depressing effect on the cough center and can be given to control the intractable cough associated with terminal lung cancer. Acema is also used as part of the treatment of opioid drug addiction, although long-term use of methadone itself can lead to addiction. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

An indication is a term used to refer to a list of conditions, symptoms, or diseases for which a medication is prescribed or used by a patient. For example, acetaminophen or paracetamol is used by the patient for fever, or the doctor prescribes it for headaches or body aches. Now fever, headache, and body aches are all signs of paracetamol. The patient should be aware of the indications of medications used for common conditions, because they can be taken without a prescription at the pharmacy.

Adults

Acema® (Acema hydrochloride) is indicated for the treatment of moderate to moderately severe pain in adults.

Geriatric ( > 65 years old)

Healthy elderly people aged 65 to 75 years who receive Acema have a plasma concentration and a half-life comparable to those observed in healthy people under the age of 65 years. Acema® should be administered with greater caution in patients over 75 years of age due to the high potential for adverse events in this population.

Pediatrics ( < 18 years old)

The safety and efficacy of Acema® in the pediatric population have not been studied. Therefore, the use of Acema ® tablets is not recommended for patients under the age of 18 years.

Acema it's a narcotic painkiller.

Acema is used to treat moderate to severe pain.

The extended form of Acema is intended for round-the-clock treatment of pain. This form of Acema is not intended to be used as needed for pain.

Acema may also be used for purposes not specified in this medication guide.

General Recommendations For Dosing

Acema®is a long-acting drug intended for dosing once a day to adults aged 18 years and older. Capsules should be swallowed whole with liquid and should not be separated, chewed, dissolved or crushed. Chewing, crushing, or splitting the capsule can lead to uncontrolled Acema delivery, overdose, and death.

Do not prescribe Acema® at a dose exceeding 300 mg per day. Do not use Acema® more than once a day or at the same time as other Acema products.

Patients not currently taking Acema Immediate Release Medications

Start treatment with Acema® at a dose of 100 mg once a day and titrate it as needed in increments of 100 mg every five days to achieve a balance between pain relief and tolerability.

Patients currently taking Acema Immediate-release Medications

Calculate the 24-hour dose of Acema IR and start the total daily dose of Acema®, rounded to the next smallest increment of 100 mg. The dose can then be individualized according to the patient's needs. Due to limitations in the flexibility of Acema® dose selection, some patients receiving Acema IR medications may not be able to switch to Acema®.

Patients aged 65 years and older

Start dosing an elderly patient (over 65 years of age) with caution, usually starting at the lower end of the dosage range, reflecting the greater frequency of decreased liver, kidney or heart function, as well as concomitant diseases or other drug therapy. Acema® should be administered with even greater caution to patients over 75 years of age due to the higher frequency of adverse events observed in this population.

Patients with impaired renal function

The limited availability of strong doses and a single daily dosage of Acema® do not provide the dosage flexibility necessary for safe use in patients with severe renal insufficiency. Do not use Acema® in patients with a creatinine clearance of less than 30 ml / min.

Patients with hepatic insufficiency

The limited availability of strong doses and a single daily dosage of Acema hydrochloride capsules do not provide the dosage flexibility necessary for safe use in patients with severe hepatic insufficiency. Acema® should not be used in patients with severe hepatic insufficiency (Child-Pugh class C).

Discontinuation of treatment

Withdrawal symptoms may occur if Acema® is discontinued abruptly. Clinical experience with Acema suggests that withdrawal symptoms can be reduced by narrowing the dose of Acema®.

The Influence of Food

Acema® can be taken regardless of the meal.

See also:
What is the most important information I need to know about Asema?

You should not take Acema if you are allergic to it, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide. Do not take Acema while under the influence of alcohol (intoxication) or while taking any of the following medications: alcohol or street drugs, narcotic painkillers, sedatives or tranquilizers, medications for depression, anxiety, or mental illness.

Some people who take Acema have had seizures. Akema may be a more likely cause of a seizure if you have a history of seizures or head trauma, a metabolic disorder, or if you are taking certain medications, such as antidepressants, muscle relaxants, drugs, or medications for nausea and vomiting.

Seek emergency medical attention if you believe you have used too much of this medication. In Acema, an overdose can be fatal.

Acema can be addictive and it should only be used by the person to whom it was prescribed Keep the medicine in a safe place where others can't get to it .

Do not crush the Acema tablet. This medicine is intended for oral (oral) use only. The powder from the crushed tablet should not be inhaled or diluted with liquid and injected into the body. Use of this medication by inhalation or injection can cause life-threatening side effects, overdose, or death.

Use Acema disintegrating tablets orally as directed by your doctor. Check the label on the medicine for accurate dosage instructions.

• Take orally decomposing Acema tablets orally with or without food.
• To open the blister pack, remove the foil from the blister. Do not push the tablet through the foil.
• Do not chew, break, or split the tablet.
• To take Acema orally decomposing tablets, place the tablet in your mouth. Let it dissolve and then swallow it with saliva. Acema orally disintegrate tablets can be taken with or without water.
• If you have missed a dose of Acema oral decomposing tablets and are taking it regularly, take it as soon as possible. If it's almost time for the next dose, skip the missed dose and return to your normal dosing schedule. Do not take 2 doses at the same time.

Ask your healthcare provider any questions you may have about how to use Acema oral disintegrating tablets.

Usage: Marked indications

Pain relief:

Long-term release: Treatment of pain severe enough to require daily, round-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Immediate release: Treatment of pain severe enough to require an opioid analgesic and for which alternative treatments are insufficient.

Limitations of use: Reserve Acema for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated, or would otherwise be inadequate to provide adequate pain management. Acema Er is not indicated as an analgesic if necessary.

Off-label use

Premature ejaculation

Evidence from mostly placebo-controlled clinical trials suggests that Acema may be useful for the treatment of premature ejaculation.

See also:
What other drugs will affect Acema?

CYP2D6 and CYP3A4 inhibitors: Concomitant use of CYP2D6 and/or CYP3A4 inhibitors, such as quinidine, fluoxetine, paroxetine, and amitriptyline (CYP2D6 inhibitors), as well as ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce the metabolic clearance of Acema, increasing the risk of serious adverse events, including seizures and serotonin the syndrome.

Serotonergic drugs

There are post-marketing reports of serotonin syndrome when using Acema and SSRIS/SNRIS or MAOIs and α2-blockers. Caution should be exercised when concomitantly using Acema with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid (an antibiotic that is a reversible non-selective MAOI), lithium, or St. John's Wort. If concomitant treatment of Acema with a drug that affects the serotonergic neurotransmitter system is clinically justified, careful monitoring of the patient is recommended, especially at the beginning of treatment and with an increase in the dose.

Triptans

Based on the mechanism of action of Acema and the potential for serotonin syndrome, caution is recommended when concomitantly using Acema with tryptane. If concomitant treatment of Acema with triptan is clinically justified, careful monitoring of the patient is recommended, especially during the start of treatment and increasing the dose.

Use With Carbamazepine

Patients taking medication carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of Acema. Since carbamazepine increases the metabolism of Acema and due to the risk of attacks associated with Acema, the simultaneous use of Acema and carbamazepine is not recommended.

Use With Quinidine

Simultaneous application quinidine with Acema resulted in a 50-60% increase in Acema exposure and a 50-60% decrease in M1 exposure. The clinical implications of these findings are unknown.

Use with Digoxin and Warfarin

Post-marketing surveillance of Acema revealed rare reports of digoxin toxicity and changes in the effect of warfarin, including an increase in prothrombin time.

The possibility of the influence of other drugs on Acema

Artificial drug interaction studies in human liver microsomes indicate that concomitant use with CYP2D6 inhibitors such as fluoxetine, paroxetine, and amitriptyline may lead to some inhibition of Acema metabolism.

The administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampicin and St. John's wort, in Acema may affect the metabolism of Acema, leading to a change in the exposure of Acema.

Potential for Acema to affect other drugs

Artificial studies of drug interactions in human liver microsomes show that Acema has no effect on quinidine metabolism. In vitro studies show that Acema is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when used concomitantly at therapeutic doses. Acema is a weak inducer of the selected pathway of drug metabolism measured in animals.

See also:
What are the possible side effects of Acema?

Overview Of Adverse Drug Reactions

The most commonly reported adverse reactions are dizziness, nausea, constipation, headache, drowsiness, and vomiting, as shown in Table 1.1.

Clinical Trials Adverse Reactions

Since clinical trials are conducted under very specific conditions, the frequency of adverse reactions observed in clinical trials may not reflect the frequency observed in practice, and should not be compared with the frequency of clinical trials of another drug. Information about adverse drug reactions obtained in clinical trials is useful for identifying drug-related side effects and for approximating the frequency of their occurrence.

The frequency of adverse reactions to Acema® in Chronic studies of Non-malignant pain (Studies without titration)

Acema® was administered to 550 patients during a double-blind or open extension period in studies of chronic non-malignant pain. Of these patients, 375 were over 65 years of age. Table 1.1 reports the cumulative frequency of adverse reactions at 7, 30, and 90 days for the most frequent reactions (5% or more at 7 days). The most frequently recorded events were in the central nervous system and gastrointestinal tract. The overall adverse event rates in these studies were the same for Acema® and the active control groups, acetaminophen with codeine and aspirin with codeine, but the frequency of withdrawal due to adverse events was higher in the Acema®group. In the treatment groups of Acema 16.8-24.5% of patients refused treatment due to AE, compared to 9.6-11.6% for acetaminophen with codeine and 18.5% for aspirin with codeine

Table 1.1: Cumulative frequency of adverse reactions to Acema ® in Chronic studies of Non-malignant pain

Incidence from 1% to less than 5%, possibly causal: The following are adverse reactions that have occurred with a frequency of 1% to less than 5% in clinical trials and for which there is a possibility of a causal relationship with Acema®.

The body as a whole: Malaise.

Cardiovascular: Vasodilation.

Central Nervous System: Anxiety, Confusion, Lack of coordination, Euphoria, Miosis, Nervousness, Sleep disturbance.

Gastrointestinal: Abdominal pain, Anorexia, Flatulence.

Musculoskeletal system: Hypertension.

Skin: Rash.

Special feelings: Visual impairment.

Urogenital: Menopausal symptoms, frequency of urination, urinary retention.

Incidence less than 1%, possibly causal: the following adverse reactions occurred with a frequency of less than 1% in clinical trials and/or were reported in post-marketing experience.

The body as a whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendencies, Weight loss, Serotonin syndrome (altered mental status, hyperreflexia, fever, tremor, tremor, agitation, sweating, convulsions, and coma).

Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.

Central Nervous System: Abnormal gait, Amnesia, Cognitive Dysfunction, Depression, Difficulty Concentrating, Hallucinations, Paresthesia, Seizures, Tremor.

Respiratory: Shortness of breath.

Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.

Special feelings: Perversion of taste.

Urogenital: Dysuria, a violation of the menstrual cycle.

Other adverse experiences, cause-effect relationship unknown

A number of other adverse events were infrequently reported in patients taking Acema® during clinical trials and/or in post-marketing experience. A causal relationship between Acema® and these events has not been established. However, the most significant events are listed below as warning information for the doctor.

Cardiovascular: ECG Disorders, Arterial Hypertension, Arterial Hypotension, Myocardial Ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.

Central Nervous System: Migraine, speech disorders.

Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.

Deviations Of Laboratory Parameters: Increased creatinine, Increased liver enzymes, Decreased hemoglobin, Proteinuria.

Touch screen: Cataracts, Deafness, tinnitus.

Other side effects Previously reported in Clinical Trials or Post-marketing reports with Acema Hydrochloride

Side effects reported with Acema medications include: allergic reactions (including anaphylaxis, angioedema, and urticaria), bradycardia, seizures, drug dependence, drug withdrawal (including agitation, anxiety, gastrointestinal symptoms, hyperkinesia, insomnia, nervousness, tremor), hyperactivity, hypotension, worsening asthma, and respiratory depression. Other adverse events that have been reported with Acema medications and for which a causal relationship has not been determined include: difficulty concentrating, hepatitis, liver failure, pulmonary edema, Stevens-Johnson syndrome, and suicidal tendencies

Serotonin syndrome (symptoms of which may include changes in mental status, hyperreflexia, fever, tremor, tremor, agitation, sweating, convulsions, and coma) has been reported when used concomitantly with other serotonergic agents, such as SSRIs and MAOIs. Post-marketing experiences with products containing Acema included rare reports of delirium, myosis, mydriasis, and speech disorders, as well as very rare reports of motor disorders, including dyskinesia and dystonia.

Cases of hypoglycemia have been reported in patients taking Acema, mainly in patients with predisposing risk factors, including diabetes, old age, and kidney failure. Caution should be exercised when prescribing Acema to patients with diabetes mellitus. More frequent monitoring of blood glucose levels may be appropriate, including when starting or increasing the dose.

Drug Abuse, Drug Addiction And Addiction

Acema can cause mental and physical dependence of the morphine type (µ-opioid). Addiction and abuse, including drug-seeking behavior and engaging in illegal activities to obtain the drug, are not limited to those patients who have previously had opioid addiction. It was noted that the risk in patients who abuse psychoactive substances is higher. Acema is associated with the development of cravings and tolerance.

A risk management program has been created to support the safe and effective use of Acema®. The main components of the risk management program are the following:

1. A commitment not to emphasize or highlight the Acema ® planning status (i.e., not to list it according to the CDSA schedule) in your advertising or promotional activities.
2. Inclusion of the PAAB-approved fair balance report in all Acema®advertising and promotional materials.
3. Ensure that Acema® pain management health education includes balanced, evidence-based, and up-to-date information. A commitment to take reasonable steps to inform health professionals that there is Health Canada-approved information about the benefits and risks to patients, and to provide easy access to this information through electronic and / or printed sources.

Withdrawal Symptoms

Withdrawal symptoms may occur if Acema® is discontinued abruptly. These symptoms may include: restlessness, sweating, insomnia, rigor mortis, pain, nausea, tremor, diarrhea, upper respiratory tract symptoms, piloerection, and rarely hallucinations. Other symptoms that were less common when Acema® was discontinued include panic attacks, severe anxiety, and paresthesia. Clinical experience shows that withdrawal symptoms can be alleviated by repeated administration of opioid therapy followed by a gradual reduction in the dose of the drug in combination with symptomatic support.