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DROPIZOL is a brand name for Opium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symptomatic treatment of severe diarrhoea in adults, when use of other anti- diarrhoea treatments have not given sufficient effect.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Usual starting dose in adults: 5–10 drops, 2–3 times daily. 4). 1. 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.
Elderly Caution should be exercised and the dosage initially reduced in treatment of elderly subjects. Hepatic impairment Morphine may precipitate coma in hepatic impairment – avoid or reduce dose. 3 and
The adverse events reported for Dropizol drops are derived from literature and post- marketing experience with other morphine products. Endocrine disorders Very rare /<1/10,000) Syndrome of inadequate ADH-secretion (SIADH), Amenorrhoea Not known (cannot be estimated from the available data) Adrenal insufficiency Psychiatric disorders Not known (cannot be estimated from the available data) Addiction, dysphoric mood, restlessness, decreased libido or potency, hallucinations.
Nervous system disorders Very common (1/10) Common (1/100 to <1/10) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Drowsiness Dizziness, headache Muscle cramps, seizures, allodynia and hyperalgesia Euphoria Eye disorders Common (1/100 to <1/10) Very rare (<1/10,000) Miosis Blurred vision, diplopia, nystagmus Cardiac disorders Uncommon (1/1,000 to <1/100) Tachycardia, bradycardia, palpitations, facial flushing Vascular disorders Rare (1/10,000 to <1/1,000) Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Bronchospasms, cough decreased Respiratory depression Dyspnoea Central sleep apnoea syndrome Gastrointestinal disorders Very common (1/10) Common (1/100 to <1/10) Rare (≥1/10,000 to <1/1,000) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Constipation, dry mouth Nausea, vomiting, loss of appetite, dyspepsia, dysgeusia Pancreatic enzymes increase and pancreatitis Ileus, abdominal pain Pancreatitis Hepatobiliary disorder Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000) Hepatic enzymes increased Biliary colic Not known (cannot be estimated from the available data) Spasm of sphincter of Oddi Skin and subcutaneous tissue disorders Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Urticaria, sweating Pruritus Exanthema, peripheral oedema Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Not known (cannot be estimated from the available data) Involuntary muscle contractions Renal and urinary disorders Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Urinary retention Urethral spasm Renal colic General disorders and administration site conditions Common (1/100 to <1/10) Rare (1/10,000 to <1/1,000) Very rare /<1/10,000) Not known (cannot be estimated from the available data) Asthenia Withdrawal symptoms Feeling unwell, shivering Hyperthermia, vertigo Description of selected adverse reactions Drug Dependence Repeated use of Dropizol can lead to drug dependence, even at therapeutic doses.
4. Renal impairment Elimination is reduced and delayed in renal impairment - avoid or reduce dose. 4. Method of administration Oral use. The product can be used undiluted or mixed in a glass of water. After mixture with water, it should be used immediately.
If the product is used undiluted the correct dosage can be administered with a spoon. 1. • Opiate dependency. • Glaucoma. • Severe hepatic or renal impairment. • Delirium tremens. • Severe head trauma. • Risk of paralytic ileus. 4 Special warnings and precautions for use Dropizol should only be used following investigations of the etiology causing the symptoms and when first-line treatment has not given adequate results.
Dropizol drops should be used with caution in the following conditions / for the following patients: • The elderly • Chronic renal disease and/or hepatic disease. • Alcoholism. 5. • Convulsive disorders • Gastrointestinal haemorrhage A health care professional should be contacted in case of difficulty to urinate.
3). Avoid use in older adults with a history of falls or fractures as ataxia, impaired psychomotor function, syncope, and additional falls may occur. If use is necessary, consider reducing use of other CNS-active agents that increase risk of falls and fractures and implement other strategies to reduce risk of falls.
Anti-diarrheals inhibiting peristalsis should be used with caution in patients with infection or inflammatory bowel diseases due to the increased risk of absorption of toxins, and of developing toxic megacolon and intestinal perforation.
Due to the risk of paralytic ileus, Dropizol is not recommended before a surgical operation or within 24 hours after operation. If paralytic ileus is suspected during the use of Dropizol, the treatment must be stopped immediately. Repeated administration may cause dependence and tolerance and the use of opium may lead to addiction to the substance.
1. • Opiate dependency. • Glaucoma. • Severe hepatic or renal impairment. • Delirium tremens. • Severe head trauma. • Risk of paralytic ileus. 6
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Particular caution should be exercised in individuals predisposed to addiction to narcotics and alcohol. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Dropizol and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Dropizol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 2). 5). Sleep related breathing disorders. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Severe cutaneous adverse reactions (SCARs) Acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, has been reported in association with morphine treatment.
Most of these reactions occurred within the first 10 days of treatment. Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment considered.
Hepatobiliary disorders Morphine may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Dropizol.
Repeated use of Dropizol can lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of Dropizol may result in overdose and/or death.
The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal […]