Vontrol: Formula, Presentation, Indications, Mechanism of Action, Dosage, Side Effects and Interactions

This medicine is an antiemetic agent used to prevent and treat peripheral vertigo, which is associated with nausea and vomiting.

Vontrol is the name of a commercial brand of a drug 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.

Chemical formula

  • C21H27NO.
  • Clorhidrato de 1,1-Difenil-4-(1-piperidil)butan-1-ol.

Presentation

  • Tablets: 25 mg diphenidol hydrochloride.
  • Solution for injection: 2 ml ampoules with 20 mg / ml diphenidol hydrochloride.

Indications

  • For vertigo: Vontrol is indicated for labyrinthine peripheral vertigo associated with nausea and vomiting, as 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: Vontrol is indicated for the control of nausea and vomiting, symptoms that appear in post-operative states, malignant neoplasms and labyrinth alterations.
  • In the prevention and control of nausea and vomiting: Vontrol 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: Vontrol 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.

Vontrol is also used for the control of central vertigo in cases of insufficiency of the basilar vertebral artery , in certain cerebrovascular accidents and their sequelae and in traumas involving the central nervous system.

Mechanism of action

The mechanism of action by which Vontrol exerts its anti-emetic and anti-vertigo effects is not known exactly.

It is supposed that it diminishes 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 anti-emetic effect and therefore controls nausea and vomiting.

After oral administration, the maximum blood concentration of Vontrol is reached from 1.5 to 3 hours.

Vontrol is excreted in the urine and stool 3 to 4 days after administration.

Dose

Doses recommended for adults in cases of nausea, vomiting and vertigo:

  • In tablets: The recommended initial dose is 2 tablets, 50 mg and then 1 or 2 tablets every 4 hours.
  • In intramuscular injection: For rapid control of acute symptoms, it is recommended to apply 1 to 2 ml of 20 to 40 mg, in deep intramuscular application.

If the symptoms are persistent, it can be administered after one hour.

Subsequently, if necessary, apply 1 to 2 ml every 4 hours.

  • In intravenous injection: For the rapid control of symptoms 1 ml or 20 mg can be administered. 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 body weight of 1 mg per kilogram of body weight orally and 0.5 mg per kilogram of body weight intramuscularly.

Normally, in pediatric use, it should not be administered with a frequency of less 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.

Side effects

The Vontrol in investigations conducted in a small sample of patients who were subjected to this treatment has been reported the occurrence of adverse effects such as the presence of auditory and visual hallucinations.

Symptoms of disorientation and mental confusion were also observed.

Vontrol is a weak central anticholinergic and these reactions have been observed in less than 0.5% of patients or when central anticholinergic agents, such as Atropine and Escopolamine, have been coadministered with this therapy.

These reactions usually occur within 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 depressions , drowsiness, overstimulation, sleep disturbances, dry mouth, gastrointestinal irritation, nausea, dyspepsia, or blurred vision were observed.

On rare occasions slight dizziness, skin rashes, general malaise, headache and heartburn or heartburn may occur.

Mild jaundice has also been observed, but its relation to the use of Vontrol 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 limits of blood pressure, after Vontrol administration.

Rarely abnormalities of the kidney type, dyspnoea, 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

Vontrol should not be administered in cases of known hypersensitivity to the medication and to any component of the formula.

Vontrol tablets contain the yellow number 5, which is an agent that can cause allergic reactions including bronchial asthma in some patients so its use is contraindicated in patients with allergy to this agent.

In patients suffering from anuria, the use of Vontrol is contraindicated, because approximately 90% of the drug is excreted in the urine and when the functioning of the kidneys is not normal, the drug can accumulate systemically.

Within the special observations for the use of Vontrol, it must be known that this drug has an antiemetic action that may mask the signs of drug overdose or may confuse in 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 for embryonic-fetal development in a balance.

There is no information available with the use of Vontrol 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 that exist against the possible risks for the mother and the baby.

Vontrol is not recommended in children under 6 months of age, nor is intravenous or subcutaneous administration recommended in children of any age.

In patients suffering from glaucoma , its administration must be under strict medical supervision.

Interactions

The intravenous administration of Vontrol 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.

Among alterations in laboratory tests have very occasionally been observed in comparative clinical studies, the presence of leukocytes in the urine, an increase in prothrombin time, an increase in hematocrits, an elevation of leukocytes and eosinophils and a increase or reduction of neutrophils.