Medicinal opium preparations


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Diarrhoea As opium tincture containing anhydrous morphine 10 mg/mL: 0.6 mL 4 times/day. As camphorated tincture of opium containing anhydrous morphine 2 mg/5 mL: 5-10 mL 1-4 times/day. Cough As a 5-mL solution containing 0.083 mL opium tincture with 1.667 mL squill oxymel: 5 mL, repeated at 4-hour intervals if required. Max: 4 doses/day. Rectal Moderate to severe pain due to ureteral spasm Each supp contains belladonna 16.2 mg and opium 30 mg or belladonna 16.2 mg and opium 60 mg: 1 supp 1-2 times/day. Max: 4 doses/day.
Dosage Details
Oral
Diarrhoea
Adult: As opium tincture containing anhydrous morphine 10 mg/mL: 0.6 mL 4 times daily. As camphorated tincture of opium containing anhydrous morphine 2 mg/5 mL: 5-10 mL 1-4 times daily.
Child: As camphorated tincture of opium containing anhydrous morphine 2 mg/5 mL: 0.25-0.5 mL/kg 1-4 times daily.

Oral
Cough
Adult: As a 5-mL solution containing 0.083 mL opium tincture with 1.667 mL squill oxymel: 5 mL repeated at 4-hour intervals if required. Max: 4 doses daily.
Child: ≥12 years Same as adult dose.

Rectal
Analgesia
Adult: Available preparations:
Belladonna 16.2 mg and opium 30 mg suppository
Belladonna 16.2 mg and opium 60 mg suppository

For moderate to severe pain due to ureteral spasm: 1 suppository 1-2 times daily. Max: 4 doses daily.
Renal Impairment
Oral:
Dosage reduction may be necessary.
Hepatic Impairment
Oral:
Dosage reduction may be necessary.
Contraindications
Hypersensitivity. Convulsion (e.g. status epilepticus, tetanus, strychnine poisoning), diarrhoea caused by poisoning. Concomitant or within 14 days of MAOI use.
Special Precautions
Patient with history and risk factors for drug dependence; morbid obesity, alcoholism, hypovolaemia, CV disease (e.g. MI), acute abdominal conditions, hypoxia, glaucoma, CNS or respiratory depression, cerebral injury or arteriosclerosis, intracranial lesions, high intracranial pressure, delirium tremens, asthma, emphysema, gastrointestinal haemorrhage, biliary tract dysfunction (e.g. acute pancreatitis), urethral stricture (e.g. prostatic hypertrophy), Addison’s disease, hypothyroidism. Hepatic and renal impairment. Children. Pregnancy and lactation. Surgery. Avoid abrupt withdrawal.
Adverse Reactions
Significant: Drug dependence, apnoea, hypotension.
Eye disorders:Miosis.
Gastrointestinal disorders: Nausea, vomiting, constipation, dry mouth.
General disorders and administration site conditions: Asthenia.
Immune system disorders: Urticaria.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Lightheadedness, dizziness, drowsiness, sedation.
Psychiatric disorders:Confusion, euphoria, dysphoria.
Renal and urinary disorders:Urinary retention.
Respiratory, thoracic and mediastinal disorders: Bronchospasms.
Skin and subcutaneous tissue disorders: Pruritus.
Vascular disorders: Flushing.
Potentially Fatal:Severe respiratory depression; increased intracranial pressure.
Patient Counseling Information
This drug may impair mental and/or physical abilities, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood pressure. Assess for signs and symptoms of drug dependence, CNS or respiratory depression.
Overdosage
Symptoms: CNS or respiratory depression, miosis, nausea, vomiting, bradycardia, hypotension, noncardiogenic pulmonary oedema, skeletal muscle flaccidity; if severe, cardiac arrest, circulatory collapse, apnoea. In combination with squill, supraventricular or ventricular arrhythmias. Management: Establish airway via assisted or controlled respiration and oxygen, if required. Maintain vital signs (e.g. serum electrolytes, blood gases) within acceptable limits. Decrease absorption from the gastrointestinal tract via activated charcoal. Naloxone may be given as an antidote against respiratory depression. Supportive treatment.
Drug Interactions
May cause increased CNS or respiratory depression with other narcotic analgesics, general anaesthetics, sedative/hypnotics, antihistamines, phenothiazines, or other CNS depressants. May cause decreased effect or increased withdrawal symptoms with other morphine agonists/antagonist (e.g. buprenorphine, nalbuphine, pentazocine). Decreased effect with CYP3A4 inducer (e.g. rifampicin). Increased toxicity of squill with concomitant diuretics.
Potentially Fatal: May cause serotonin syndrome if used with MAOIs.
Food Interaction
May cause increased CNS depression with alcohol. Avoid alcohol.
Lab Interference
May interfere with the diagnosis of acute abdominal conditions.
Action
Description: Opium, obtained from dried latex of unripe Papaver somniferum capsules, contains morphine, codeine, thebaine and other alkaloids (e.g. noscapine, papaverine). The pharmacologic effect of opium is mainly due to the morphine content. As an antidiarrhoeal, morphine increases gastrointestinal muscle tone and decreases peristalsis, thereby decreasing gastrointestinal propulsion. Morphine is used in combination with belladonna in suppositories for its analgesic effect. It is also used in combination with squill in cough preparations as it directly depresses the cough reflex.
Duration: Antidiarrhoeal effect: 3-4 hours.
Pharmacokinetics:
Absorption: Variably absorbed from the gastrointestinal tract.
Distribution: Crosses the placenta and enters breast milk.
Metabolism: Morphine is metabolised in the liver via glucuronidation at the 3-hydroxyl group; further metabolised via glucuronidation at the 6-hydroxyl group into morphine-3,6-diglucuronide.
Excretion: Via urine (approx 75%; mainly as morphine-3-glucuronide, morphine-3,6-diglucuronide and unchanged drug).
Storage
Store between 20-25°C. Protect from light.
References
Anon. Opium Preparations. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/08/2018.

Anon. Opium Tincture. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/08/2018.

Anon. Opium. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/08/2018.

Atropa Belladonna and Opium Suppository (Paddock Laboratories, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 23/08/2018.

Buckingham R (ed). Belladonna. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/08/2018.

Buckingham R (ed). Hydrochlorides of Mixed Opium Alkaloids. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/08/2018.

Buckingham R (ed). Opium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/08/2018.

Buckingham R (ed). Squill. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/08/2018.

Dropizol 10 mg/mL Oral Drops, Solution (Pharmanovia A/S). MHRA. https://products.mhra.gov.uk/. Accessed 08/08/2018.

Gee’s Linctus BP (L.C.M. Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 08/08/2018.

Opium Tincture Deodorized (Edenbridge Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/08/2018.

Paregoric Liquid (Hi-Tech Pharmacal Co., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/08/2018.

Disclaimer: This information is independently developed by MIMS based on Medicinal opium preparations from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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