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Components:
Domperidone
Method of action:
Antiemetic, Drugs For Functional Gastrointestinal Disorders
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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 2019.12.06

Name of the medicinal product

Kineticon

Qualitative and quantitative composition

Domperidone

Therapeutic indications

The information provided in Therapeutic indications of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Kineticon Suspension is indicated in adults and children for the relief of the symptoms of nausea and vomiting.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Kineticon Oral Suspension should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.

It is recommended to take Kineticon Oral Suspension before meals. If taken after meals, absorption of the drug is somewhat delayed.

Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.

Usually, the maximum treatment duration should not exceed one week.

Adults and adolescents (12 years of age and older and weighing 35 kg or more).

10 ml (of 1mg/ml oral suspension) up to three times per day with a maximum dose of 30ml per day.

Neonates, infants and children (under 12 years of age and weighing less than 35kg)

The dose is 0.25mg/kg. This should be given up to three times per day with a maximum dose of 0.75mg/kg per day. For example, for a child weighing 10kg, the dose is 2.5mg and this can be given three times per day toa maximum dose of 7.5mg per day.

Hepatic Impairment

Kineticon Oral Suspension is contraindicated in moderate or severe hepatic impairment. Dose modification in mild hepatic impairment is however not needed.

Renal Impairment

Since the elimination half-life of Kineticon is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Kineticon Oral Suspension should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly.

Contraindications

The information provided in Contraindications of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Kineticon suspension is contraindicated in the following situations:

-

- Prolactin-releasing pituitary tumour (prolactinoma).

- When stimulation of the gastric motility could be harmful, e.g. in patients with gastro-intestinal haemorrhage, mechanical obstruction or perforation.

- In patients with moderate or severe hepatic impairment.

- In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure

- co-administration with QT-prolonging drugs, with the exception of apomorphine

- co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects)

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Precautions for use

Renal impairment:

The elimination half-life of Kineticon is prolonged in severe renal impairment. For repeated administration, the dosing frequency of Kineticon should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.

Cardiovascular effects:

Kineticon has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking Kineticon. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors.

Epidemiological studies showed that Kineticon was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30mg, and patients concurrently taking QT_prolonging drugs or CYP3A4 inhibitors.

Kineticon should be used at the lowest effective dose in adults and children.

Kineticon is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia. Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.

Treatment with Kineticon should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.

Patients should be advised to promptly report any cardiac symptoms.

Use in infants:

Although neurological side effects are rare , the risk of neurological side effects is higher in young children since metabolic functions and the blood-brain barrier are not fully developed in the first months of life. Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.

Use with Potent CYP3A4 Inhibitors:

Co-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QTc interval should be avoided.

Co-administration of levodopa:

Although no dosage adjustment of levodopa is deemed necessary, an increase of plasma levodopa concentration (max 30-40%) has been observed when Kineticon was taken concomitantly with levodopa.

Use with apomorphine:

Kineticon is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled. Please refer to the apomorphine SmPC.

Kineticon suspension contains 400mg of liquid sorbitol (non-crystallising, E420) per ml, which may have a mild laxative effect. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Kineticon suspension contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Kineticon has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Tabulated list of adverse reactions

The safety of Kineticon was evaluated in clinical trials and in postmarketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. All patients were at least 15 years old and received at least one dose of Kineticon (Kineticon base). The median total daily dose was 30 mg (range 10 to 80 mg), and median duration of exposure was 28 days (range 1 to 28 days). Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or parkinsonism were excluded.

The following terms and frequencies are applied:

Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000), where frequency can not be estimated from clinical trials data, it is recorded as “Not known”.

System Organ Class

Adverse Drug Reaction Frequency

Common

Uncommon

Not known

Immune system disorders

Anaphylactic reaction (including anaphylactic shock)

Psychiatric disorders

Loss of libido

Anxiety

Agitation

Nervousness

Nervous system disorders

Somnolence

Headache

Convulsion

Extrapyramidal disorder

Restless leg syndrome*

Eye disorders

Oculogyric crisis

Cardiac disorders

Ventricular arrhythmias

QTc prolongation

Torsades de Pointes

Sudden cardiac death

Gastrointestinal disorders

Dry mouth

Diarrhoea

Skin and subcutaneous tissue disorder

Rash

Pruritus

Urticaria

Angioedema

Renal and urinary disorders

Urinary retention

Reproductive system and breast disorders

Galactorrhoea

Breast pain

Breast tenderness

Gynaecomastia

Amenorrhoea

General disorders and administration site conditions

Asthenia

Investigations

Liver function test abnormal

Blood prolactin increased

* exacerbation of restless legs syndrome in patients with Parkinson's disease

In 45 studies where Kineticon was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher. This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed above, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.

Paediatric population

Extrapyramidal disorder occurs primarily in neonates and infants..

Other central nervous system-related effects of convulsion and agitation also are primarily reported in infants and children.

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose

The information provided in Overdose of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Symptoms

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.

Treatment

There is no specific antidote to Kineticon, but in the event of overdose, standard symptomatic treatment should be given immediately. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended.

Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Propulsives

ATC code: A03F A03

Mechanism of action

Kineticon is a dopamine antagonist with anti-emetic properties, Kineticon does not readily cross the blood-brain barrier. In Kineticon users, especially in adults, extrapyramidal side effects are very rare, but Kineticon promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Animal studies, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of Kineticon on dopamine receptors.

Studies in man have shown oral Kineticon to increase lower oesophaegeal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion.

In accordance with ICH—E14 guidelines, a thorough QT study was performed. This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 80 mg per day 10 or 20 mg administered 4 times a day of Kineticon. This study found a maximal difference of QTc between Kineticon and placebo in LS-means in the change from baseline of 3.4 msec for 20 mg Kineticon administered 4 times a day on Day 4. The 2-sided 90 % CI (1.0 to 5.9 msec) did not exceed 10 msec. No clinically relevant QTc effects were observed in this study when Kineticon was administered at up to 80 mg/day (i.e., more than twice the maximum recommended dosing).

However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when Kineticon was administered as monotherapy (10 mg 4 times a day).The largest time-matched mean difference of QTcF between Kineticon and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5 msec (95 % CI: 0.6 to 14.4), respectively.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Absorption

Kineticon is rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1hr after dosing. The Cmax and AUC values of Kineticon increased proportionately with dose in the 10mg to 20mg dose range. A 2- to 3-fold accumulation of Kineticon AUC was observed with repeated four times daily (every 5 hr) dosing of Kineticon for 4 days.

Although Kineticon's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take Kineticon 15 - 30 minutes before a meal. Reduced gastric acidity impairs the absorption of Kineticon. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate.

Distribution

Oral Kineticon does not appear to accumulate or induce its own metabolism; a peak plasma level after 90 minutes of 21 ng/ml after two weeks oral administration of 30 mg per day was almost the same as that of 18 ng/ml after the first dose. Kineticon is 91-93% bound to plasma proteins. Distribution studies with radiolabelled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of drug cross the placenta in rats.

Biotransformation

Kineticon undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that CYP3A4 is a major form of cytochrome P-450 involved in the N-dealkylation of Kineticon, whereas CYP3A4, CYP1A2 and CYP2E1 are involved in Kineticon aromatic hydroxylation.

Excretion

Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively. The proportion of the drug excreted unchanged is small (10% of faecal excretion and approximately 1% of urinary excretion). The plasma half-life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.

Hepatic impairment

In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of Kineticon is 2.9- and 1.5-fold higher, respectively, than in healthy subjects. The unbound fraction is increased by 25%, and the terminal elimination half-life is prolonged from 15 to 23 hours. Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life. Subjects with severe hepatic impairment were not studied. Kineticon should not be used in patients with moderate or severe hepatic impairment.

Renal impairment

In subjects with severe renal insufficiency (creatinine clearance<30 ml/min/1.73m2) the elimination half-life of Kineticon was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.

Since very little unchanged drug (approximately 1%) is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency.

However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.

Paediatric population

No pharmacokinetic data are available in the paediatric population.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Propulsives

Preclinical safety data

The information provided in Preclinical safety data of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of Kineticon to prolong the QTc interval in humans. In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes, exposure ratios ranged between 26-47-fold, based on IC50 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 10mg administered 3 times a day. Safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (10mg administered 3 times a day) by 45-fold. Safety margins in in vitro pro-arrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (10mg administered 3 times a day) by 9- up to 45-fold. In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for Torsades de Pointes exceeded the free plasma concentrations in humans at maximum daily dose (10mg administered 3 times a day) by more than 22-fold and 435-fold, respectively. In the anaesthetised guinea pig model following slow intravenous infurions, there were no effects on QTc at total plasma concentrations of 45.4 ng/mL, which are 3-fold higher than the total plasma levels in humans at maximum daily dose (10mg admimistered 3 times a day). The relevance of the latter study for humans following exposure to orally administered Kineticon is uncertain.

In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of Kineticon can rise up to 3-fold.

At a high, maternally toxic dose (more than 40 times the recommended human dose), teratogenic effects were seen in the rat. No teratogenicity was observed in mice and rabbits.

Incompatibilities

The information provided in Incompatibilities of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Kineticon is based on data of another medicine with exactly the same composition as the Kineticon of the medicine (Domperidone). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Kineticon directly from the package or from the pharmacist at the pharmacy.
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No special requirements.

How to use the oral syringe

1. Shake the bottle well making sure the cap is firmly on the bottle.

2. Remove the cap. Note: keep the cap nearby to close the bottle after each use.

3. Push the plastic adapter into the neck of the bottle. Note: the adapter must always stay in the bottle.

4. Take the syringe and check the plunger is fully down.

5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter.

6. Turn the whole bottle with the syringe upside down.

7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger back up completely to expel any large air bubbles that may be trapped inside the oral syringe.

8. Then pull the plunger slowly back to the volume you need for your dose.

9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle.

10. The dose of medicine can now be swallowed directly from the oral syringe. Please ensure that you are sitting upright and the plunger must be pushed slowly to allow you to swallow the dose.

11. Replace the child resistant cap after use, leaving the adapter in place.

12. To clean the oral syringe, take apart by removing the plunger completely. Pull straight out of the barrel. The barrel and plunger can be washed with soap and water, rinsed, and allowed to dry. Do not wash the oral syringe in the dishwasher.

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