Vertran (Tablets) Instructions for Use
ATC Code
N07CA01 (Betahistine)
Active Substance
Betahistine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Drug improving microcirculation of the labyrinth, used for pathology of the vestibular apparatus
Pharmacotherapeutic Group
Other agents for the treatment of nervous system diseases; medications for the treatment of dizziness
Pharmacological Action
Synthetic analogue of histamine. It acts similarly to histamine, mainly on histamine H1 receptors.
It causes dilation of precapillaries, in particular, facilitates microcirculation in the labyrinth.
Furthermore, Betahistine regulates endolymph pressure in the labyrinth and cochlea, leading to clinical improvement in vertigo of various etiologies.
It reduces the frequency and intensity of dizziness, decreases tinnitus, and contributes to hearing improvement in cases of its reduction.
It increases the tone of the smooth muscles of the bronchi and gastrointestinal tract.
It may cause increased secretion of gastric juice.
Pharmacokinetics
After oral administration, betahistine dihydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract.
Plasma protein binding is low.
It is almost completely eliminated from the body with urine within 24 hours.
T1/2 is 3-4 hours.
Indications
Ménière’s disease; syndromes characterized by dizziness, tinnitus and/or progressive hearing loss, including labyrinthine hydrops of the inner ear, vestibular and labyrinthine disorders (including dizziness, tinnitus and ear pain, headache, nausea, vomiting, hearing loss), vestibular neuritis, labyrinthitis, benign positional vertigo (including after neurosurgical operations); vertebrobasilar insufficiency, post-traumatic encephalopathy, cerebral vascular atherosclerosis (as part of complex therapy).
ICD codes
| ICD-10 code | Indication |
| G45.0 | Vertebro-basilar artery syndrome |
| H81 | Vestibular function disorders |
| H81.0 | Ménière's disease |
| H81.1 | Benign paroxysmal vertigo |
| H81.2 | Vestibular neuronitis |
| H81.3 | Other peripheral vertigo |
| H83.0 | Labyrinthitis |
| H83.8 | Other specified diseases of inner ear |
| H90 | Conductive and sensorineural hearing loss |
| H93.0 | Degenerative and vascular disorders of ear |
| H93.1 | Tinnitus (subjective) |
| I67.2 | Cerebral atherosclerosis |
| T90 | Sequelae of injuries of head |
| ICD-11 code | Indication |
| 8B10.Y | Other specified transient ischaemic attack |
| AB30.0 | Vestibular neuronitis |
| AB30.1 | Labyrinthitis |
| AB31.0 | Ménière's disease |
| AB31.2 | Benign paroxysmal positional vertigo |
| AB34.1 | Other peripheral vestibular vertigo |
| AB34.Z | Unspecified vestibular function disorders |
| AB3Z | Diseases of inner ear, unspecified |
| AB51.Z | Acquired hearing loss, unspecified |
| AB71 | Degenerative or vascular disorders of the ear |
| BD55 | Asymptomatic stenosis of intracranial or extracranial artery |
| MC41 | Tinnitus |
| NA0Z | Head injury, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer Vertran tablets orally with water.
The standard adult dosage is 8 mg to 16 mg taken three times daily.
Initiate therapy at the lower end of the dosage range.
Titrate the dose based on individual patient response and tolerability.
For optimal efficacy, maintain a consistent dosing schedule throughout the day.
Administer the tablets during or immediately after meals to minimize potential gastrointestinal discomfort.
Continue treatment long-term as directed by a physician.
The desired therapeutic effect on vertigo and tinnitus may require several weeks to months of continuous therapy.
Do not exceed the maximum recommended daily dose of 48 mg.
Do not abruptly discontinue treatment without consulting a healthcare professional.
The dosage for pediatric patients must be determined by a physician; use with caution in this population.
For patients with hepatic or renal impairment, no specific dosage adjustment is routinely recommended; however, clinical monitoring is advised.
Adverse Reactions
From the digestive system, mildly expressed nausea, feeling of heaviness in the epigastrium are possible.
Allergic reactions in individual cases – skin rash, itching, urticaria.
Contraindications
Hypersensitivity to betahistine, pheochromocytoma, gastric and duodenal ulcer in the acute phase, bronchial asthma, first trimester of pregnancy.
With caution second and third trimesters of pregnancy, period of breastfeeding; childhood.
Use in Pregnancy and Lactation
Use is contraindicated in the first trimester of pregnancy.
It should be used with caution in the second and third trimesters of pregnancy.
Use is not recommended during breastfeeding.
Pediatric Use
It should be used with caution in children.
Special Precautions
It should be used with caution in patients with a history of gastric or duodenal ulcer, in the second and third trimesters of pregnancy, and also in children.
It is necessary to consider that the desired clinical effect is achieved after several months of treatment.
In case of dyspeptic symptoms, Betahistine is recommended to be taken during or after meals.
Drug Interactions
Antihistamine drugs with simultaneous administration reduce the effect of betahistine.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 8 mg: 30 or 60 pcs.
Marketing Authorization Holder
Belupo, Pharmaceuticals & Cosmetics d.d. (Croatia)
Dosage Form
 |
Vertran | Tablets 8 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets are white or almost white, round, flat, with beveled edges, with a score on one side.
| 1 tab. | |
| Betahistine dihydrochloride | 8 mg |
Excipients: microcrystalline cellulose 151.81 mg, mannitol 54.04 mg, citric acid monohydrate 4.7 mg, colloidal silicon dioxide 4.7 mg, talc 11.75 mg.
30 pcs. – dark glass bottles (1) – cardboard packs.
60 pcs. – dark glass bottles (1) – cardboard packs.
Tablets 16 mg: 30 or 60 pcs.
Marketing Authorization Holder
Belupo, Pharmaceuticals & Cosmetics d.d. (Croatia)
Dosage Form
|
Vertran | Tablets 16 mg: 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets are white or almost white, round, flat, with beveled edges, with a score on one side.
| 1 tab. | |
| Betahistine dihydrochloride | 16 mg |
Excipients: microcrystalline cellulose 303.619 mg, mannitol 108.081 mg, citric acid monohydrate 9.4 mg, colloidal silicon dioxide 9.4 mg, talc 23.5 mg.
15 pcs. – PVC/PVdC/aluminum foil blisters (2) – cardboard packs.
15 pcs. – PVC/PVdC/aluminum foil blisters (4) – cardboard packs.
Tablets 24 mg: 20, 30, 50, or 60 pcs.
Marketing Authorization Holder
Belupo, Pharmaceuticals & Cosmetics d.d. (Croatia)
Dosage Form
|
Vertran | Tablets 24 mg: 20, 30, 50, or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets are white or almost white, round, flat, with beveled edges.
| 1 tab. | |
| Betahistine dihydrochloride | 24 mg |
Excipients: microcrystalline cellulose 455.43 mg, mannitol 162.12 mg, citric acid monohydrate 14.1 mg, colloidal silicon dioxide 14.1 mg, talc 35.25 mg.
10 pcs. – PVC/PVdC/aluminum foil blisters (2) – cardboard packs.
10 pcs. – PVC/PVdC/aluminum foil blisters (3) – cardboard packs.
10 pcs. – PVC/PVdC/aluminum foil blisters (5) – cardboard packs.
10 pcs. – PVC/PVdC/aluminum foil blisters (6) – cardboard packs.
![Vertran [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Vertran [Tablets] 2")