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Opioid (mixture) Pregnancy: There is limited amount of data from the use of opium in pregnant women. Studies in animals have shown reproductive toxicity. Dropizol is not recommended during pregnancy unless the benefits clearly outweigh the risks to both mother and child. When morphine is used during pregnancy up to parturition, neonatal withdrawal syndrome can occur. Breastfeeding: opium is excreted in human milk; Dropizol is contraindicated during breastfeeding. Fertility: there are insufficient data to assess human risk to fertility. Animal studies have shown chromosomal damage in reproductive cells. Men and women of reproductive age should take necessary precautions. (UK SPC §4.6)

Opium tincture

Opium tincture is a concentrated opioid preparation derived from opium, historically used for the symptomatic relief of severe or refractory diarrhoea.

Adult dose

Dose: Symptomatic treatment of severe diarrhoea in adults when other anti-diarrhoea treatments have not given sufficient effect: usual starting dose 5-10 drops, 2-3 times daily (oral drops 10 mg/ml morphine; 1 drop = 0.5 mg anhydrous morphine; 1 ml = 20 drops)
Route: Oral
Frequency: 2-3 times daily
Max: Individual doses not to exceed 1 ml; total daily dose not to exceed 6 ml/day
Product is DROPIZOL 10 mg/ml oral drops, solution - an opium tincture. SPC §2: '1 ml of oral liquid contains 1 ml of tincture from Papaver somniferum L., succus siccum (Opium, raw) corresponding to 10 mg of morphine. 1 drop contains 50 mg opium tincture corresponding to 0.5 mg (10 mg/ml) anhydrous morphine; 1 ml = 20 drops; extraction solvent 33 % ethanol (V/V)'. §4.1: 'Symptomatic treatment of severe diarrhoea in adults, when use of other anti-diarrhoea treatments have not given sufficient effect.' §4.2 (verbatim): 'Usual starting dose in adults: 5-10 drops, 2-3 times daily. Individual doses should not exceed 1 ml, and the total daily dose should not exceed 6 ml. The posology should be individualized to use the lowest effective dose for the shortest duration of time taking into account the patient's general condition, the patient's age, weight, and medical history.' 'Treatment should be initiated and supervised by a specialist, i.e. oncologist or gastroenterologist. Particular caution should be exercised when prescribing this drug due to its morphine content. The treatment period should be as short as possible.' Method of administration: oral; the product can be used undiluted or mixed in a glass of water (after mixture with water it should be used immediately); if used undiluted the dose can be given with a spoon. Elderly: 'Caution should be exercised and the dosage initially reduced.' Hepatic impairment: 'Morphine may precipitate coma in hepatic impairment - avoid or reduce dose.' Renal impairment: 'Elimination is reduced and delayed in renal impairment - avoid or reduce dose.' Children: 'Dropizol should not be used in children and adolescents aged below 18 years for safety reasons' - no paediatric dose. SCOPE: this SPC covers ONLY the severe-diarrhoea indication in adults; no dose is given here for any other use of opium tincture (e.g. palliative care). Before surgery: not recommended before a surgical operation or within 24 hours after operation because of the risk of paralytic ileus (§4.4). TRUNCATION: the retrieved §4.4 and §4.8 text is cut off at the source-fetch limit; nothing beyond it is stated.

Dose adjustments

Renal

SPC §4.2: 'Elimination is reduced and delayed in renal impairment - avoid or reduce dose.' §4.3: severe renal impairment is a contraindication. §4.4: use with caution in chronic renal disease; adjustment of dose may be needed in patients with mild to moderate renal impairment. No numeric renal dose is printed.

Hepatic

SPC §4.2: 'Morphine may precipitate coma in hepatic impairment - avoid or reduce dose.' §4.3: severe hepatic impairment is a contraindication. §4.4: use with caution in chronic hepatic disease; adjustment of dose may be needed in patients with mild to moderate hepatic impairment. No numeric hepatic dose is printed.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (§4.3)
  • Opiate dependency (§4.3)
  • Glaucoma (§4.3)
  • Severe hepatic or renal impairment (§4.3)
  • Delirium tremens (§4.3)
  • Severe head trauma (§4.3)
  • Risk of paralytic ileus (§4.3)
  • Chronic obstructive pulmonary disease (§4.3)
  • Acute asthma (§4.3)
  • Severe respiratory depression with hypoxia and/or hypercapnia (§4.3)
  • Heart failure secondary to lung disease (cor pulmonale) (§4.3)
  • Breastfeeding (§4.3, §4.6)

Side effects

  • Drowsiness, dizziness, headache, euphoria; muscle cramps, seizures, allodynia and hyperalgesia (§4.8)
  • Constipation and dry mouth; nausea, vomiting, loss of appetite, dyspepsia, dysgeusia; ileus, abdominal pain (§4.8)
  • Respiratory depression, dyspnoea, bronchospasm, decreased cough; central sleep apnoea syndrome (§4.8)
  • Miosis, blurred vision, diplopia, nystagmus (§4.8)
  • Urinary retention, urethral spasm, renal colic; biliary colic, spasm of the sphincter of Oddi, pancreatitis, raised pancreatic and hepatic enzymes (§4.8)
  • Tachycardia, bradycardia, palpitations, facial flushing, orthostatic hypotension (§4.8)
  • Urticaria, sweating, pruritus, exanthema, peripheral oedema, acute generalised exanthematous pustulosis (AGEP) (§4.8, §4.4)
  • Drug dependence: repeated use can lead to dependence even at therapeutic doses; addiction, dysphoric mood, restlessness, hallucinations, decreased libido or potency; withdrawal symptoms; SIADH, amenorrhoea, adrenal insufficiency (§4.8)
  • NOTE: the retrieved §4.8 text is truncated and the frequency columns are flattened by PDF extraction; frequencies are not asserted here

Interactions

  • Additive CNS depression (sedation, respiratory depression, coma, death) with ethanol, hypnotics, general anaesthetics, MAO inhibitors, tricyclic antidepressants, sedative psychotropics (e.g. phenothiazines), gabapentin or pregabalin, antiemetics, antihistamines and other opioids; limit dose and duration of concomitant use (§4.5, §4.4)
  • Do not use with other morphine agonists/antagonists (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine): competitive receptor binding may aggravate withdrawal symptoms and reduce therapeutic effect (§4.5)
  • Ethanol content: do not use concomitantly with disulfiram or metronidazole (disulfiram-like reactions) (§4.5)
  • Rifampicin induces CYP 3A4, increasing metabolism of morphine, codeine and methadone and decreasing their effect (§4.5)
  • Morphine delays and decreases exposure to oral P2Y12 inhibitor antiplatelets in acute coronary syndrome; a parenteral P2Y12 inhibitor may be considered (§4.5)
  • Antihypertensives and other hypotensive agents: increased hypotensive effect (§4.5)
  • MAO inhibitors (including moclobemide) or within two weeks of withdrawal: use with caution (§4.4)
  • Morphine inhibits glucuronidation of zidovudine in vitro; its duration of action may be reduced after fluoxetine; opioids can increase plasma concentrations of desmopressin and sertraline; amphetamine and analogues can reduce, and loxapine and periciazine can increase, the sedative effect of opioids (§4.5)

Monitoring

  • Use only after investigating the aetiology of the symptoms and when first-line treatment has not given adequate results; treatment to be initiated and supervised by a specialist (§4.2, §4.4)
  • Use the lowest effective dose for the shortest possible duration; reduce the initial dose in the elderly (§4.2)
  • Caution in the elderly, chronic renal/hepatic disease, alcoholism, biliary disease, head injury or raised intracranial pressure, hypothyroidism, adrenocortical deficiency, prostatic hyperplasia/urinary retention, convulsive disorders and GI haemorrhage (§4.4)
  • Anti-diarrhoeals that inhibit peristalsis: caution in infection or inflammatory bowel disease because of the risk of toxic megacolon and intestinal perforation (§4.4)
  • Stop immediately if paralytic ileus is suspected (§4.4)
  • Monitor for signs of opioid use disorder and drug-seeking behaviour (e.g. too early requests for refills); follow closely for respiratory depression and sedation if given with sedative medicines (§4.4)
  • Avoid in older adults with a history of falls or fractures (§4.4)
  • A health care professional should be contacted in case of difficulty urinating (§4.4)

Clinical monograph

How it works

Its opioid alkaloids, chiefly morphine, act on gut opioid receptors to reduce intestinal motility and secretions, decreasing stool frequency.

Prescribing in practice

  • It is a potent controlled opioid with a high risk of confusion with the much weaker camphorated opium tincture and with opioid toxicity and dependence, so the exact preparation and strength must be verified to avoid serious dosing errors.
  • Avoid antimotility opioid use in conditions where reduced motility is harmful, such as acute inflammatory or infective colitis.
  • Standard opioid precautions apply, including respiratory depression and interactions with other CNS depressants.

Monitoring

Monitor for opioid effects including sedation and respiratory depression, as well as bowel response and hydration.

Counselling the patient

  • Maintain hydration with rehydration solutions during diarrhoea.
  • It can cause drowsiness; avoid alcohol and do not take more than prescribed.

Evidence & guidelines

Rehydration is the cornerstone of diarrhoea management per NICE and gastroenterology guidance, with opioid antimotility preparations reserved for selected refractory cases.

Reference: Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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