Bromhexine (Kodel) hydrochloride SYRUP is contra-indicated in patients with known hypersensitivity to sympathomimetic amines or any of the other ingredients; hypertrophic obstructive cardiomyopathy; and tachyarrhythmia.
Sympathomimetics, such as orciprenaline sulphate, may interact with monoamine oxidase inhibitors (MAOI), and therefore Bromhexine (Kodel) hydrochloride SYRUP should not be given to patients receiving such treatment or within 14 days of MAOI treatment termination.
Safety in pregnancy and lactation has not been established.
See also:
What is the most important information I should know about Codeine (Kodel)?
Codeine (Kodel) Sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
Codeine (Kodel) Sulfate is contraindicated in patients with known hypersensitivity to Codeine (Kodel) or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to Codeine (Kodel).
Codeine (Kodel) Sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.
Codeine (Kodel) Sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.
Codeine (Kodel) Sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.
Bromhexine (Kodel)’s pharmacological action may lead to gastric irritation. A transient rise in serum aminotransferase values have been reported due to Bromhexine (Kodel).
Orciprenaline sulphate, as a sympathomimetic agent, may precipitate a wide range of adverse effects. Side-effects include fear; anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. A rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur. Other effects that may occur include difficulty in micturition and urinary retention; dyspnoea; weakness; headache; disturbances of glucose metabolism; sweating and hypersalivation. Muscle cramps or twitching or unpleasant taste may occur.
See also:
What are the possible side effects of Codeine (Kodel)?
Applies to Codeine (Kodel): oral solution, oral syrup, oral tablet, oral tablet extended release
In addition to its needed effects, some unwanted effects may be caused by Codeine (Kodel). In the event that any of these side effects do occur, they may require medical attention.
Major Side EffectsYou should check with your doctor immediately if any of these side effects occur when taking Codeine (Kodel):
Incidence not known:
If any of the following symptoms of overdose occur while taking Codeine (Kodel), get emergency help immediately:
Symptoms of overdose:
Some of the side effects that can occur with Codeine (Kodel) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:
Bromhexine (Kodel) hydrochloride SYRUP indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Codeine (Kodel) sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.
Codeine (Kodel) is an opioid pain medication. An opioid is sometimes called a narcotic.
Codeine (Kodel) is used to treat mild to moderately severe pain.
Codeine (Kodel) may also be used for purposes not listed in this medication guide.
Each tablet also contains lactose, maize or potato starch, gelatine and magnesium stearate as excipients.
The oral/inhalation solution also contains tartaric acid and methyl parahydroxybenzoate as excipients.
The syrup also contains tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, sorbitol solution, pharma flavor and ethanol as excipients.
Each capsule also contains lactose, cornstarch and magnesium stearate as excipients.
Bromhexine (Kodel) HCl is N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)amine hydrochloride.
An opioid analgesic related to morphine but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough. [PubChem]
Bromhexine (Kodel) is used to treat breathing difficulties caused by excessive mucus secretions in the air passages associated with respiratory tract infections.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsPain management: Management of mild- to moderately-severe pain
Limitations of use: Reserve Codeine (Kodel) for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate.
Off Label UsesCough in select patients
In a metaanalysis of trials evaluating the treatment of chronic cough, the use of Codeine (Kodel) demonstrated efficacy in patients with this condition.
Unless otherwise prescribed, the following doses are recommended:
Tablet: Adults and Children >12 years: 8 mg (1 tab) thrice daily; 6-12 years: 4 mg (½ tab) thrice daily; 2-6 years: 4 mg (½ tab) twice daily.
Oral Solution: Adults and Children >12 years:6-12 years: 2-6 years:<2 years:Inhalation Solution (with aerosol apparatus): It is generally recommended to warm inhalation solution to body temperature before inhalation. Patients with bronchial asthma may be advised to commencing inhalation after they have taken their regular bronchospasmolytic therapy.
Adults: 4 mL. Children >12 years: 2 mL; 6-12 years: 1 mL; 2-6 years: 10 drops; <2 years: 5 drops. All doses to be taken twice daily.
The solution may be diluted 1:1 in physiological saline solution. In order to avoid precipitation, the solution should be inhaled immediately after mixing. The combined administration of inhalation and oral application intensifies the effect, and is especially suited for the commencement of treatment in cases where the full effect is to be reached quickly.
Syrup: Adults and Children >12 years: 5 ml (1 tsp) thrice daily.
At commencement of treatment, it may be necessary to increase the total daily dose up to 48 mg in adults.
The syrup is sugar-free and therefore suitable for diabetics and small children.
Ampoule: Severe cases, before and after surgical intervention: 1 amp SC, IM or IV (duration of injection: 2-3 min) 2-3 times daily.
Capsule: Adults: 1 cap 3 times daily.
It is recommended for the initial phase of treatment usually lasting not more than a week.
Patients being treated with Bromhexine (Kodel) should be notified of an expected increase in the flow of secretions.
Dosage FormsExcipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet,
Oral, as sulfate:Generic: 15 mg, 30 mg, 60 mg
Dosing: Adult
Pain management (analgesic):
Injection [Canadian product]:
Opioid-naive patients: IM, SubQ: 30 to 60 mg every 4 to 6 hours as needed (use the lowest effective dose for the shortest period of time necessary)
Conversion from oral Codeine (Kodel) or another opioid: IM, SubQ: Refer to product labeling for dose conversions.
Oral: Note: These are guidelines and do not represent the maximum doses that may be required in all patients. Doses should be titrated to pain relief/prevention.
Immediate release (tablet, oral solution [Canadian product]): Initial: 15 to 60 mg every 4 hours as needed; maximum total daily dose: 360 mg/day; patients with prior opioid exposure may require higher initial doses. Note: The American Pain Society recommends an initial dose of 30 to 60 mg for adults with moderate pain (American Pain Society 2016).
Controlled release: Codeine (Kodel) Contin [Canadian product]: Note: Titrate at intervals of ≥48 hours until adequate analgesia has been achieved. Daily doses >600 mg/day should not be used; patients requiring higher doses should be switched to an opioid approved for use in severe pain. In patients who receive both Codeine (Kodel) Contin and an immediate release or combination Codeine (Kodel) product for breakthrough pain, the rescue dose of immediate release Codeine (Kodel) product should be ≤12.5% of the total daily Codeine (Kodel) Contin dose.
Opioid-naive patients: Initial: 50 mg every 12 hours
Conversion from immediate release Codeine (Kodel) preparations: Immediate release Codeine (Kodel) preparations contain ~75% Codeine (Kodel) base. Therefore, patients who are switching from immediate release Codeine (Kodel) preparations may be transferred to a ~25% lower total daily dose of Codeine (Kodel) Contin, equally divided into 2 daily doses every 12 hours.
Conversion from a combination Codeine (Kodel) product (eg, Codeine (Kodel) with acetaminophen or aspirin): See table:
Conversion from another opioid analgesic: Using the patient's current opioid dose, calculate an equivalent daily dose of immediate release Codeine (Kodel). A ~25% lower dose of Codeine (Kodel) Contin should then be initiated, equally divided into 2 daily doses.
Discontinuation of therapy: When discontinuing chronic opioid therapy, the dose should be gradually tapered down. An optimal universal tapering schedule for all patients has not been established (CDC [Dowell 2016]). Proposed schedules range from slow (eg, 10% reductions per week) to rapid (eg, 25% to 50% reduction every few days) (CDC 2015). Tapering schedules should be individualized to minimize opioid withdrawal while considering patient-specific goals and concerns as well as the pharmacokinetics of the opioid being tapered. An even slower taper may be appropriate in patients who have been receiving opioids for a long duration (eg, years), particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse events (CDC [Dowell 2016]). Monitor carefully for signs/symptoms of withdrawal. If the patient displays withdrawal symptoms, consider slowing the taper schedule; alterations may include increasing the interval between dose reductions, decreasing amount of daily dose reduction, pausing the taper and restarting when the patient is ready, and/or coadministration of an alpha-2 agonist (eg, clonidine) to blunt withdrawal symptoms (Berna 2015; CDC [Dowell 2016]). Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms (eg, GI complaints, muscle spasm) as needed (Berna 2015; Sevarino 2018).
Cough in select patients (off-label use):
Oral: Reported doses vary with a range of 7.5 to 120 mg/day as a single dose or in divided doses; however, evidence is of low quality (ACCP [Bolser 2006]; Smith 2010). Some experts recommend 30 to 60 mg 4 times daily in specific patient populations (eg, lung cancer) (ACCP [Molassiotis 2017]). Additional data may be necessary to further define the role of Codeine (Kodel) in this condition.
Diarrhea (persistent) (palliative care) (off-label use):
Oral: 15 to 30 mg every 4 hours as needed (von Gunten 2013). Additional data may be necessary to further define the role of Codeine (Kodel) in this condition.
Restless leg syndrome (off-label use):
Oral: Initial: 30 mg once daily at bedtime or during the night; may increase to 60 mg if needed; maximum dose: 180 mg in 2 to 3 divided doses. May be used alone or in combination with other medications used to treat RLS (Earley 2003; Sandyk 1987; Silbers 2013; Walters 2001).
Dosing: Geriatric
Refer to adult dosing. Use with caution and consider initiation at the low end of the dosing range; reduced initial dosages may be necessary.
Dosing: Pediatric
Note: Codeine (Kodel) 30 mg/5 mL oral solution has been discontinued in the US for more than 1 year. Doses should be titrated to appropriate analgesic effect; use the lowest effective dose for the shortest period of time:
Pain management; analgesia: Limited data available: Note: Use is contraindicated in pediatric patients <12 years of age and for postoperative management in pediatric patients 12 to 18 years of age who have undergone tonsillectomy and/or adenoidectomy. Avoid Codeine (Kodel) use in all pediatric patient populations in which it is contraindicated and in pediatric patients 12 to 18 years of age who have other risk factors that increase risk for respiratory depression associated with Codeine (Kodel) (eg, conditions associated with hypoventilation like postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, use of other medications known to depress respiratory drive); in rare cases in which Codeine (Kodel)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects. Codeine (Kodel) has been associated with reports of life-threatening or fatal respiratory depression in children and adolescents; multifactorial causes have been identified; of primary concern are unrecognized ultrarapid metabolizers of CYP2D6 who may have extensive conversion of Codeine (Kodel) (prodrug) to morphine and thus increased opioid-mediated effects. Avoid Codeine (Kodel) use in pediatric patient populations in which it is contraindicated; in rare cases in which Codeine (Kodel)-containing product is the only option, consider genotype testing prior to use; use extra precaution; monitor closely for adverse effects (AAP [Tobias 2016]; Dancel 2017; Gammal 2016; Goldschneider 2017; Poonai 2015).
Children and Adolescents:
Oral: 0.5 to 1 mg/kg/dose every 4 to 6 hours as needed; maximum single dose: 60 mg/dose (APS 2016)
A reduction in dose of cardiac glycosides (e.g. digitalis) and quinidine might become necessary in patients suffering from congestive cardiac failure because of the positive inotropic effect of orciprenaline sulphate.
Bromhexine (Kodel) hydrochloride SYRUP should not be administered concomitantly with beta-blocking agents, due to orciprenaline’s reversal of anti-hypertensive action.
The concomitant use of other sympathomimetic agents should be carefully controlled to avoid potentiation of effects.
See also:
What other drugs will affect Codeine (Kodel)?
When this drug applied simultaneously with:
- drugs have a depressing effect on the central nervous system (including those with opioid analgesics, barbiturates, benzodiazepines, clonidine) it is possible an increase the action of Codeine (Kodel).
- derivatives of morphine it may increased the inhibitory action on the respiratory center; ibuprofen - analgesic effect is enhanced; carbamazepine - it may increased the analgesic effect is apparently due to increased formation of Codeine (Kodel) metabolite normorphine, which has a stronger effect.
- quinidine the analgesic effect of Codeine (Kodel) decreased or almost disappeared.
- Codeine (Kodel) increases the effect of ethanol on psychomotor function.
