STATEX is indicated for the symptomatic relief of severe chronic pain.
STATEX is not indicated as an as-needed (prn) analgesic.
Geriatrics (> 65 Years Of Age)
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy (see CLINICAL PHARMACOLOGY, Special Populations And Conditions, Geriatrics).
Pediatrics (< 18 Years Of Age)
The safety and efficacy of STATEX has not been studied in the pediatric population. Therefore the use of STATEX is not recommended in patients under 18 years of age.
DOSAGE AND ADMINISTRATION
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).
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
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 Tablea
||To convert to oral morphine equivalent
||To convert from oral morphine multiply by
||Daily 90 mg MEDb
||Morphine dose equivalence is not reliably established
*** 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 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 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 individualised 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 opioid-responsive.
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.
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.
Storage And Stability
Store all preparations between 15-3°C in a well closed light resistant container.
Special Handling Instructions
Dosage Forms, Composition And Packaging
Statex Oral Drops 20 mg/mL:
Each 1mL of clear unflavored and colorless liquid contains 20 mg of morphine sulfate. The non-medicinal ingredients are citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water. Calorie content: 160 KCal/100 mL.
Statex Oral Drop 50 mg/ mL:
Each 1mL of clear unflavored and colorless liquid contains 50 mg of morphine sulfate. The non-medicinal ingredients are citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water. Calorie content: 160 KCal/100 mL.
Statex Oral Syrup 1 mg/mL:
Available as unflavored (clear) and orange flavored syrup. Each mL contains 1 mg of morphine sulfate. The non-medicinal ingredients of the unflavoured syrup are citric acid anhydrous, dextrose monohydrate, glycerine, propylene glycol, sodium benzoate, sodium cyclamate, water. The non-medicinal ingredients of the orange flavoured syrup are citric acid anhydrous, glycerine, orange extract, propylene glycol, sodium benzoate, sucrose, water.
Statex Oral Syrup 5 mg/mL:
Available as unflavoured (clear) and orange flavoured syrup. Each mL contains 5 mg of morphine sulfate. The non-medicinal ingredients of the unflavoured syrup are citric acid anhydrous, dextrose monohydrate, glycerine, propylene glycol, sodium benzoate, sodium cyclamate, water. The non-medicinal ingredients of the orange flavoured syrup are citric acid anhydrous, glycerine, orange extract, propylene glycol, sodium benzoate, sucrose, water.
Statex Oral Syrup 10 mg/mL:
Available as clear unflavoured syrup. Each mL contains 10 mg of morphine sulfate. The non-medicinal ingredients are citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water.
Each white cone-shape suppository contains: morphine sulfate 5, 10, 20, or 30 mg. The non-medicinal ingredient is wecobee M (hydrogenated vegetable oil).
Statex Oral Tablets:
available as 5mg (green), 10 mg (blue), 25 mg (pink), 50 mg (orange) round, scored on one side, identified with Paladin logo on the other side tablets. The non-medicinal ingredients are FD&C Blue No.1 Lake, lactose monohydrate, lake blend yellow, magnesium stearate, microcrystalline cellulose.
Statex Oral Drops 20 mg/mL:
Available in 25 mL graduated bottles and 100 mL non-graduated bottles with calibrated dropper, filled to deliver 1 mL (20 mg of Morphine Sulfate).
Statex Oral Drops 50 mg/ mL:
Available in 50 mL non-graduated bottles with calibrated dropper, filled to deliver 1 mL (50 mg of Morphine Sulfate).
Statex Oral Syrup 1 mg/mL:
Available in 250 and 500 mL graduated bottles in Pet or Pet G bottles, and in uni-dose of 5, 10 and 15 mL (unflavoured only) in amber glass bottles.
tatex Oral Syrup 5 mg/mL:
Available in 250 and 500 mL graduated bottles in Pet G bottles, and in uni-dose of 5 and 10 mL (unflavoured only) in amber glass bottles.
Statex Oral Syrup 10 mg/mL:
Available in 250 mL graduated bottles in Pet G bottles.
Available in boxes of 10.
Statex Oral Tablets:
Available in bottles of 100 or control packs of 100 (4 x 25 tablets in blister).
1. "British National Formulary", 7th ed., British Medical Association and The Pharmaceutical Society of Great Britain, London, England, 1984, pp. 163-167.
2. "Compendium of Pharmaceuticals and Specialties". 19th ed., C.M.E. Krogh, ed., Southam Murray, Toronto, Ontario, 1984, p.403.
3. Davis. A.J.: Brompton's cocktail: Making good-byes possible. Am. J. Nurs.78:610-612, 1978.
4. "The Dispensatory of the United States of America", 24th ed., A. Osol et al, ed., J.B. Lippincott Co., Philadelphia, Pa. 1950, pp. 714-720.
5. Drug Information for the Health Care Provider, Vol. I. USPDI, 5th ed., Mack Printing Co., Easton, Pa. 1984. pp. 887-901.
6. Interagency Committee on New Therapies for Pain and Discomfort. Report to the White House:U.S. Dept. of Health, Education and Welfare, Public Health Service, National Institute of Health, May 1979.
7. Lipman, A.: Drug Therapy in Chronic Pain, J. Cont. Ed. Clin. Hosp. Phar., 1, (Feb) 1979.
8. "Martindale:The Extra Pharmacopoeia", 28th ed. J.E.F. Reynolds, ed. Pharmaceutical Press, London, England, 1982. pp. 1018-1021.
9. Melzack, R., Mount, B.M. and Gordon, J.M.: The Brompton mixture vs morphine solution given orally: effects on pain. Can. Med. Assoc. J. 120:435-438 (Feb. 17 1979).
10. "The Merck Index". 10th ed., M. Windholz, Ed., Merck & Co. Inc., Rahway, N.J., 1983, pp. 898-899.
11. Mount, B.M.: Palliative Care of the Terminally Ill. Royal College Lecture (January 27, 1978).
12. Mount, B.M., Ajemian, I., and Scott, J.F.: Use of the Brompton mixture in treating the chronic pain of malignant disease. Can. Med. Assoc. J. 115:112-124 (July 17, 1976).
13. "Physician's Desk Reference", 37th ed., Medical Economics Co. Inc., Oradell, N.J., 1983, pp. 1758-1759.
14. Twycross, R.G.: Value of cocaine in opiate containing elixirs, Br. Med. J. 2:1348 (Nov. 19)1977.
15. "The United States Pharmacopeia". 21st rev., Mack Publishing Company, Easton, Pa. 1984, p. 701.
Paladin Labs Inc.,
100 Alexis Nihon Blvd., Suite 600,
H4M 2P2. Revised: Apr 2018