SYNTHESIS |
capsule shell: gelatin
EEN without threshold dose: sucrose , azorubine
SHAPES AND PRESENTATIONS |
Capsule.
Box of 14, in blister packs
COMPOSITION |
For one capsule :
Morphine sulfate: 10 mg
Excipients with known effect : sucrose, azorubine (E122).
Neutral microgranules (sucrose, corn starch), hypromellose, talc.
Composition of the capsule shell: azorubine (E122), gelatin.
| DC | DIRECTIONS |
Intense pain or pain resistant to weaker analgesics, in particular pain of cancerous origin.
| DC | WARNINGS AND PRECAUTIONS FOR USE |
Special warnings
Respiratory depression
The main risk in opioid abuse is respiratory depression.
Opioids can cause sleep-related breathing disorders, including central sleep apnea (CSA) and sleep-related hypoxemia, which can lead to nocturnal awakenings and daytime sleepiness. The use of opioids may increase the risk of CSA in a dose-dependent manner in some patients. Opioids may also cause worsening of pre-existing sleep apnea (see section 4.8 ). In patients with CSA, a reduction in total opioid dose should be considered.
Acute Chest Syndrome (ATS) in Patients with Sickle Cell Disease
Due to a possible association between ATS and morphine use in patients with sickle cell disease receiving morphine treatment for a vaso-occlusive crisis, affected patients should be closely monitored with a view to to detect the symptoms of ATS.
Risk related to the concomitant use of sedatives such as benzodiazepines or related drugs :
Concomitant use of ACTISKENAN and sedatives such as benzodiazepines or related drugs may lead to sedation, respiratory depression, coma or death. Because of these risks, the concomitant prescription of these sedatives should be reserved for patients for whom there are no other therapeutic options. If the decision is made to prescribe Actiskenan concomitantly with sedatives, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
Patients should be closely monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended that patients and their caregivers be informed about the symptoms to watch out for (see Interactions ).
Others :
Plasma morphine concentrations may be reduced by rifampicin. The analgesic effect of morphine should be monitored and morphine doses adjusted during and after treatment with rifampicin (see Interactions ).
The increase in doses, even if these are high, is not most often a process of habituation.
Indeed, in case of prolonged and repeated use, the patient may develop a tolerance to the drug and need to gradually increase the doses to maintain analgesia.
A pressing and repeated demand necessitates frequent reassessment of the patient's condition. It most often testifies to a genuine need for painkillers, not to be confused with addictive behavior.
Hyperalgesia unresponsive to further increase in morphine dose may occur, especially at high doses. A reduction in the morphine dose or a change in opioid may be necessary.
Oral P2Y12 inhibitor antiplatelet therapy
A reduction in the efficacy of treatment with a P2Y12 inhibitor has been observed, from the first day of concomitant treatment with a P2Y12 inhibitor and morphine (see section Interactions ).
Dependence and withdrawal syndrome (abstinence):
The use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. The longer the drug is used, the greater the risk. Similarly, higher doses increase the risk involved. Symptoms can be reduced as much as possible by adjusting the dose or pharmaceutical form and by gradually withdrawing from morphine. For individual symptoms, see section Undesirable effects .
Morphine is a narcotic that can be abused (misused) and has a similar risk of abuse as other strong opioid agonists and should be used with caution in patients with a history of alcoholism or drug abuse.
A history of abuse and/or dependence, however, allows the prescription of morphine if it appears essential for the treatment of pain, but special monitoring is recommended.
Morphine is not suitable for the treatment of major opioid drug dependence.
The misuse of oral forms by parenteral injection can lead to serious adverse effects that can be fatal.
Vehicle:
Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) should not take this medicine.
Precautions for use
Morphine may lower the seizure threshold in patients with a history of epilepsy.
Morphine should be used with caution in the following cases:
Renal failure :
The renal elimination of morphine, in the form of an active metabolite, makes it necessary to start the treatment at a reduced dosage, subsequently adapting, as in any patient, the doses or the frequency of administration to the clinical condition. .
When the etiology of the pain is treated simultaneously:
Morphine doses should then be adapted to the results of the treatment applied.
In case of non-decompensated respiratory failure, sleep apnea syndrome, severe chronic obstructive respiratory disease, severe bronchial asthma, chronic cor pulmonale:
Respiratory rate will be carefully monitored. Drowsiness is a warning sign of decompensation.
It is important to reduce the doses of morphine when other centrally acting analgesic treatments are prescribed simultaneously, as this favors the sudden onset of respiratory failure.
In case of hepatic insufficiency:
Administration of morphine should be cautious and accompanied by clinical monitoring .
In the elderly and very elderly:
Their particular sensitivity to analgesic effects but also to central (confusion) or digestive adverse effects, associated with a physiological decline in renal function, should prompt caution, in particular by reducing the initial dosage (see section Dosage and method of administration ) .
A urethro-prostatic or bladder pathology, frequent in this population, exposes to the risk of urinary retention.
The co-prescriptions of psychotropic treatments, CNS depressants or with an anti-cholinergic effect increase the occurrence of adverse effects.
Constipation :
It is imperative to ensure the absence of occlusive syndrome before starting the treatment. Constipation is a known side effect of morphine. Preventive treatment must be systematically prescribed.
In infants over six months of age (see section Contraindications ):
The effects of morphine are more intense and prolonged due to the lack of maturation of its metabolism. Initial doses should be reduced. Monitoring will be done in an intensive care unit for the treatment of acute pain. The initiation of chronic treatment must be done under hospital supervision.
Intracranial hypertension:
In case of increased intracranial pressure, the use of morphine during chronic pain should be cautious.
In patients with hypotension accompanied by hypovolaemia
In case of hypovolaemia, morphine can induce collapse. Hypovolaemia will therefore be corrected before administration of morphine.
Voiding disorders:
There is a risk of dysuria or urinary retention mainly with the intrathecal and epidural routes.
Adrenal insufficiency
Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. Symptoms of adrenal insufficiency may include the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure.
Hypothyroidism
Opioids should be used with caution in patients with myxedema or hypothyroidism.
Decreased sex hormones and increased prolactin
Long-term use of opioid painkillers may be associated with decreased levels of sex hormones and increased prolactin. Symptoms include the following events: decreased libido, impotence and amenorrhea.
Athletes:
Athletes' attention should be drawn to the fact that this specialty contains morphine and that this active ingredient is on the list of doping substances.
Related to excipients:
This medication contains an azo coloring agent: azorubine (E122) and may cause allergic reactions.
| DC | FERTILITY / PREGNANCY / BREASTFEEDING |
Pregnancy
Animal studies have shown a teratogenic effect of morphine.
Clinically, no particular malformative effect of morphine has appeared to date. However, only epidemiological studies would make it possible to verify the absence of risk.
High doses, even in brief treatment just before or during delivery, are likely to cause respiratory depression in the newborn. Moreover, at the end of pregnancy, the chronic intake of morphine by the mother, whatever the dose, can be the cause of a withdrawal syndrome in the newborn.
Newborns whose mothers received opioid analgesics during pregnancy should be observed for signs of neonatal withdrawal (abstinence) syndrome. Treatment may include the use of an opioid and supportive care.
Consequently, subject to these precautions, morphine can be prescribed if necessary during pregnancy.
Feeding with milk
- a single dose appears to be without risk for the newborn,
- in the event of repeated administration over a few days, temporarily suspend breast-feeding,
- in case of initiation or continuation after birth of a long-term treatment, breast-feeding is contraindicated.
Fertility
Animal studies have shown that morphine may reduce fertility (see Preclinical Safety ).
| DC | DRIVING AND USING MACHINES |
Due to the reduced alertness induced by this drug, attention is drawn to the risks associated with driving a vehicle and using machinery.
| DC | OVERDOSAGE |
Symptoms
Drowsiness is an early warning sign of the onset of respiratory decompensation.
Aspiration pneumonia, extreme miosis, hypotension, hypothermia, coma are also observed. Death may occur from respiratory failure.
emergency driving
- Assisted stimulation-ventilation, before cardiopulmonary resuscitation in a specialized department.
- Specific treatment with naloxone: establishment of an approach with monitoring for the time necessary for the disappearance of symptoms.
| PP | PRECLINICAL SAFETY |
In male rats, decreased fertility and chromosomal damage in gametes have been reported.
| DP | THE DURATION OF THE CONVERSATION |
3 years.
| DP | SPECIAL STORAGE CONDITIONS |
No special storage conditions.
| DP | SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING |
No special requirements.
PRESCRIPTION/ISSUE/CARE |
Prescription limited to 28 days.
Prescription on prescription meeting the specifications set by the decree of March 31, 1999.
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