This medicine is an antiemeticantiemetic agent used to prevent and treat peripheral vertigo associated with nausea and vomiting.
Control is the name of a commercial drug brand based on a chemical compound called Diphenidol.
This drug does not have a significant sedative, tranquilizing or antihistaminic action, but it has an anticholinergic effect on the weak peripheral nervous system.
- Clorhidrato de 1,1-Difenil-4-(1-piperidil)butan-1-ol.
- Tablets: 25 mg diphenidol hydrochloride.
- Solution for injection: 2 ml ampoules with 20 mg/ml diphenidol hydrochloride.
- For vertigo: Control is indicated for labyrinthine peripheral vertigo associated with nausea and vomiting. It has been presented in the symptoms of Ménière’s disease and when surgery of the middle ear and inner ear ( labyrinthitis ) is performed.
- For nausea and vomiting: Control is indicated for nausea and vomiting, symptoms in post-operative states, malignant neoplasms, and labyrinth alterations.
- In the prevention and Control of nausea and vomiting: Control is indicated to prevent and control nausea and vomiting caused by diseases associated with the kidneys, liver, gallbladder, and gastrointestinal tract, labyrinthine disorders, malignancies, etc.
- In the prevention and Control of vertigo: Control is indicated for the prevention and Control in the case of peripheral vertigo such as that produced by Ménière’s disease, labyrinthitis, otitis media, surgery of the middle and inner ear, traumas of the vestibular apparatus.
Control is also used to control central vertigo in cases of insufficiency of the vertebral basilar artery, in inevitable cerebrovascular accidents and their sequelae, and traumas involving the central nervous system.
Mechanism of action
The mechanism of action by which Control exerts its antiemeticantiemetic, and anti-vertigo effects is unknown.
It is supposed to diminish the vestibular stimulation by regulating the sense of movement and balance by exerting a specific antivertiginous action.
It is also thought to depress labyrinthine function and act in the medullary chemoreceptive trigger zone that may be involved in the antiemeticantiemetic effect and therefore controls nausea and vomiting.
After oral administration, the maximum blood concentration of Control is reached from 1.5 to 3 hours.
Control is excreted in the urine and stool 3 to 4 days after administration.
Doses recommended for adults in cases of nausea, vomiting, and vertigo:
- In tablets: The recommended initial dose is two tablets, 50 mg, and then 1 or 2 tablets every 4 hours.
- In intramuscular injection: To rapidly control acute symptoms, applying 1 to 2 ml of 20 to 40 mg in the deep intramuscular application is recommended.
If the symptoms are persistent, they can be administered after one hour.
Subsequently, if necessary, apply 1 to 2 ml every 4 hours.
- In intravenous injection: 1 ml or 20 mg can be administered for rapid Control of symptoms. If symptoms persist, another milliliter may be applied one hour later.
After intravenous application, the route of administration to the patient should be changed orally or intramuscularly.
The total dose to be administered in 24 hours should not exceed 300 mg.
Subcutaneous administration is not recommended, so great care must be taken to avoid subcutaneous or perivenous infiltration at the time of administration.
Pediatric dose for nausea and vomiting:
In children, the dose is calculated by bodyweight of 1 mg per kilogram orally and 0.5 mg per kilogram of body weight intramuscularly.
Usually, in pediatric use, it should not be administered with a frequency of fewer than 4 hours between each dose.
However, if the symptoms persist after the first dose, a dose can be repeated orally or intramuscularly after one hour of the first application.
And from now on, the dose will be administered with a frequency of every 4 hours as necessary.
The total dose to be administered in 24 hours should not exceed 5 mg per kg of body weight orally or 3 mg per kg of body weight intramuscularly.
The Control investigations conducted in a small sample of patients subjected to this treatment have reported the occurrence of adverse effects such as the presence of auditory and visual hallucinations.
Symptoms of disorientation and mental confusion were also observed.
Control is a weak central anticholinergic. These reactions have been observed in less than 0.5% of patients or when primary anticholinergic agents, such as Atropine and Escopolamine, have been coadministered with this therapy.
These reactions usually occur three days after starting treatment and disappear spontaneously when the drug is suspended.
Therefore, its administration is not recommended in conjunction with these medications, nor in patients whose, hypersensitivity to these medications is known.
The drug should be discontinued in case these symptoms occur.
Side effects such as depression, drowsiness, overstimulation, sleep disturbances, dry mouth, gastrointestinal irritation, nausea, dyspepsia, or blurred vision were observed.
Slight dizziness, skin rashes, general malaise, headache, and heartburn or heartburn may occur on rare occasions.
Mild jaundice has also been observed, but its relation to the use of Control is still doubtful.
In a small group of patients, a slight decrease in systolic and diastolic pressure has been reported transiently and even within the normal blood pressure limits after Control administration.
Rarely abnormalities of the kidney type, dyspnoea, and increased transaminase enzymes such as alanine aminotransferase and aspartate transaminase have been observed, whose elevation can cause acute myocardial infarction, acute liver disease, myopathies, and liver damage.
Warnings and contraindications
Control should not be administered in known hypersensitivity to the medication and any formula component.
Control tablets contain the yellow number 5, an agent that can cause allergic reactions, including bronchial asthma in some patients, so its use is contraindicated in patients with allergies to this agent.
In patients suffering from anuria, the use of Control is contraindicated because approximately 90% of the drug is excreted in the urine. When the functioning of the kidneys is not normal, the drug can accumulate systemically.
Within the notable observations for the use of Control, it must be known that this drug has an antiemeticantiemetic action that may mask the signs of drug overdose or confuse the differential diagnosis in conditions such as intestinal obstruction and brain tumors.
Until now, there is limited experience in the use of Vontrol in pregnant patients.
Even when significant adverse experiences have not been reported, their use must be carefully evaluated, placing the potential benefits of the medication against the possible risks for the mother and embryonic-fetal development in a balance.
There is no information available on the use of Control during the lactation period, neither in human studies nor in animal studies.
On the other hand, the use of this medicine during pregnancy and lactation should be carefully evaluated according to the potential benefits against the possible risks for the mother and the baby.
Vontrol is not recommended in children under six months of age, nor is intravenous or subcutaneous administration recommended in children.
Its administration must be under strict medical supervision in patients suffering from glaucoma.
The intravenous administration of Control should not be indicated in those patients with a history of sinus tachycardia since this type of procedure to administer the medication may precipitate an attack in those persons.