STATEX Oral Drops, Suppositories, Oral Syrup, Tablets Ref.[27922] Active ingredients: Morphine

STATEX should only be used in patients for whom alternative treatment options are ineffective or not tolerated (e.g., non-opioid analgesics).

STATEX tablets must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving STATEX can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS).

For opioid products used in acute pain, a maximum of 7 days treatment is recommended at the lowest dose that provides adequate relief.

All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. For the management of chronic non-cancer, non-palliative pain, it is recommended that the daily dose of STATEX not exceed 90 mg (90 morphine milligram equivalent). Each patient should be assessed for their risk prior to prescribing STATEX, as the likelihood of experiencing serious adverse events can depend upon the type of opioid, duration of treatment, level of pain as well as the patient’s own level of tolerance. In addition, the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of STATEX (see DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage).

Dosing Considerations

STATEX (morphine sulfate drops, suppositories, syrup and tablets) should be used with caution within 12 hours pre-operatively and within the first 12-24 hours post-operatively (see WARNINGS AND PRECAUTIONS, Peri-operative Considerations).

STATEX drops, syrup and tablets are not indicated for rectal administration

STATEX may be taken with or without food.

STATEX tablets may be taken with a glass of water.

STATEX oral unflavoured drops and syrup may be diluted in a glass of fruit juice just prior to ingestion if desired, to improve the taste.

STATEX suppositories should be placed against the rectal mucosa. The drug is not absorbed if pushed into a mass of stool or if it is placed in the anal canal.

Recommended Dose and Dosage Adjustment

Adults: Individual dosing requirements vary considerably based on each patient’s age, weight, severity of pain, and medical and analgesic history.

Patients Not Receiving Opioids at the Time of Initiation of Morphine Sulfate Treatment: The usual initial adult dose is 10-30 mg q4h around the clock.

Because of the slower clearance in patients over 50 years of age, in elderly and debilitated patients, and in those with impaired respiratory function or significantly decrease renal function, an appropriate dose in those patient groups may be as low as half or less than the usual dose in the younger age group.

Patients Currently Receiving Opioids: Having determined the total daily dosage of the present analgesic, TABLE 1 can be used to calculate the approximate daily oral morphine sulfate dosage that should provide equivalent analgesia. Conversion ratios for opioids are subject to variations in kinetics governed by genetics and other factors. When switching from one opioid to another, consider reducing the calculated dose by 25-50% to minimize the risk of overdose. Subsequently, up-titrate the dose, as required, to reach the appropriate maintenance dose. It is usually appropriate to treat a patient with only one opioid at a time.

Table 1. Opioid Conversion Table^a:

^*** The maximum recommended daily dose of tramadol is 300 mg – 400 mg depending on the formulation.
^a Adapted from the 2017 Canadian guideline for opioids for chronic non-cancer pain. McMaster University; 2017
^b MED: Morphine Equivalent Dose

Patients with Hepatic Impairment: Morphine should be administered with caution and in a reduced dosage in patient with hepatic impairment.

Patients with Renal Impairment: Morphine should be administered with caution and in a reduced dosage in patient with renal impairment.

Respiratory depression has occurred in the elderly following administration of large initial doses of opioids to patients who were not opioid-tolerant or when opioids were co-administered with other agents that can depress respiration. STATEX should be initiated at a low dose and slowly titrated to effect (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY).

Use with Non-Opioid Medications: If a non-opioid analgesic is being provided, it may be continued. If the non-opioid is discontinued, consideration should be given to increasing the opioid dose to compensate for the non-opioid analgesic. STATEX can be safely used concomitantly with usual doses of other non-opioid analgesics.

Dose Titration: Dose titration is the key to success with opioid analgesic therapy. Proper optimization of doses scaled to the relief of the individual’s pain should aim at administration of the lowest dose which will achieve the overall treatment goal of satisfactory pain relief with acceptable side effects.

Dosage adjustments should be based on the patient’s clinical response.

Higher doses may be justified in some patients to cover periods of physical activity.

Adjustment or Reduction of Dosage: During the first two or three days of effective pain relief, the patient may exhibit drowsiness or sleep for prolonged periods. This can be misinterpreted as the effect of excessive analgesic dosing rather than the first sign of relief in a pain exhausted patient. The dose, therefore, should be maintained for at least three days before reduction, provided the sedation is not excessive or associated with unsteadiness and confusional symptoms, and respiratory activity and other vital signs are adequate. If excessive sedation persists, the reason(s) for such an effect must be sought. Some of these are: concomitant sedative medications, hepatic or renal failure, exacerbated respiratory failure, higher doses than tolerated by an older patient, or the patient is actually more severely ill than realized. 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.

Physical dependence with or without psychological dependence tends to occur with chronic administration of opioids, including STATEX. Withdrawal (abstinence) symptoms may occur following abrupt discontinuation of therapy. These symptoms may include body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, palpitations, unexplained fever, weakness and yawning.

Following successful relief of severe pain, periodic attempts to reduce the opioid dose should be made. Smaller doses or complete discontinuation of the opioid analgesic may be feasible due to changes in the patient’s condition or improved mental state. Patients on prolonged therapy should be withdrawn gradually from the drug if it is no longer required for pain control. In patients who are appropriately treated with opioid analgesics and who undergo gradual withdrawal for the drug, these symptoms are usually mild (see WARNINGS AND PRECAUTIONS). Tapering should be individualized and carried out under medical supervision.

Patient should be informed that reducing and/or discontinuing opioids decreases their tolerance to these drugs. If treatment needs to be re-initiated, the patient must start at the lowest dose and titrate up to avoid overdose.

Opioid analgesics may only be partially effective in relieving dysesthetic pain, post-herpetic neuralgia, stabbing pains, activity-related pain and some forms of headache. This is not to say that patients with advanced cancer suffering from some of these forms of pain should not be given an adequate trial of opiate analgesics, but it may be necessary to refer such patients at an early time for other forms of pain therapy. Pain without nociception is usually not opioidresponsive.

Disposal

STATEX should be kept in a safe place, out of the sight and reach of children before, during and after use. STATEX should not be used in front of children, since they may copy these actions.

STATEX should never be disposed of in household trash. Disposal via a pharmacy take back program is recommended. Unused or expired STATEX should be properly disposed of as soon as it is no longer needed to prevent accidental exposure to others, including children or pets. If temporary storage is required before disposal, a sealed child-proof container, such as a biohazard waste container or a lockable medication box could be obtained from a pharmacy.

Missed Dose

If the patient forgets to take one or more doses, they should take their next dose at the next scheduled time and in the normal amount.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Symptoms: Serious morphine overdosage is characterized by respiratory depression (reduced respiratory rate and /or tidal volume: Cheyne-Stokes respiration; cyanosis), extreme somnolence progressing to stupor or coma, hypotonia, dizziness, confusion, miosis, rhabdomyolysis progression to renal failure, cold or clammy skin, and sometimes hypotension and bradycardia. Pinpoint pupils are a sign of narcotic overdose, but are not pathognomonic (e.g. pontine lesions of hemorrhagic or ischemic origin may product similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of morphine overdose. Severe over-dosage may result in apnea, circulatory collapse, cardiac arrest and death.

Treatment: Primary attention should be given to the establishment of adequate respiratory exchange through the provision of a patent airway and controlled or assisted ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression due to overdosage or as a result of unusual sensitivity to morphine. An appropriate dose of the antagonist should therefore be administered, preferably by the intravenous route. The usual initial i.v. adult dose of naloxone is 0.4 mg or higher. Concomitant efforts at respiratory resuscitation should be carried out. Since the duration of action of morphine may exceed that of the antagonist, the patient should be under continued surveillance and doses of the antagonist should be repeated as needed to maintain adequate respiration.

An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated.

In an individual physically dependent on opioids, the administration of the usual dose of opioid antagonists will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of opioid antagonists in such individuals should be avoided if possible. If an opioid antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care by using dosage titration, commencing with 10 to 20% of the usual recommended initial dose.

Evacuation of gastric contents may be useful in removing unabsorbed drug.

Store all preparations between 15-30°C in a well closed light resistant container.