Vesticap (Capsules) 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
Histamine preparation
Pharmacological Action
Betahistine acts mainly on histamine H1 and H3 receptors of the inner ear and vestibular nuclei of the CNS.
By direct agonistic action on H1 receptors of the inner ear vessels, as well as indirectly on H3 histamine receptors of the vestibular nuclei of the CNS; it improves microcirculation and capillary permeability, normalizes endolymph pressure in the labyrinth and cochlea. Furthermore, Betahistine increases blood flow in the basilar artery.
It accelerates the restoration of vestibular function after unilateral vestibular neurectomy, accelerating and facilitating central vestibular compensation (due to antagonism with H3 histamine receptors). It has a pronounced central effect, being an inhibitor of H3 receptors of the vestibular nerve nuclei. It dose-dependently reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei.
It alleviates symptoms in Ménière’s syndrome and vestibular vertigo. A stable therapeutic effect occurs after 14 days.
Pharmacokinetics
Absorption and Distribution
After oral administration, Betahistine is rapidly absorbed, plasma protein binding is low. Time to reach Cmax in plasma is 3 hours.
Metabolism and Excretion
It is metabolized to inactive metabolites: 2-pyridylacetic acid (main metabolite) and demethylbetahistine.
85-90% is excreted by the kidneys as 2-pyridylacetic acid within 24 hours. Renal excretion of betahistine and demethylbetahistine is insignificant. Only a small portion of betahistine and its metabolites is excreted via the intestines.
Indications
- Treatment of Ménière’s syndrome, characterized by vertigo (accompanied by nausea and vomiting), hearing loss, and tinnitus;
- Symptomatic treatment of vestibular vertigo.
ICD codes
| ICD-10 code | Indication |
| H81 | Vestibular function disorders |
| H81.0 | Ménière's disease |
| H81.3 | Other peripheral vertigo |
| ICD-11 code | Indication |
| AB31.0 | Ménière's disease |
| AB34.1 | Other peripheral vestibular vertigo |
| AB34.Z | Unspecified vestibular function disorders |
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 orally with meals to enhance tolerability.
For the 8 mg capsule, take 1 to 2 capsules three times daily.
For the 16 mg capsule, take 1 capsule three times daily.
The total daily dosage should not exceed 48 mg.
Adhere strictly to the dosage and frequency prescribed by your physician.
Initial symptomatic improvement may be observed early in the treatment course.
A stable therapeutic effect is typically achieved after two weeks of continuous therapy.
The full benefit may continue to increase over several months of treatment.
Treatment for vestibular disorders is generally long-term.
The exact duration of therapy must be determined individually based on clinical response.
Do not discontinue use or adjust the dosage without consulting your healthcare provider.
Adverse Reactions
From the digestive system nausea, vomiting, abdominal pain, bloating, dyspepsia.
From the skin angioedema, urticaria, itching, rash.
Allergic reactions hypersensitivity, including anaphylactic reactions.
Contraindications
- Hypersensitivity to any of the components of the drug;
- Pregnancy;
- Lactation period (due to lack of data);
- Childhood;
- Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
With caution gastric or duodenal ulcer (including history), pheochromocytoma, bronchial asthma. Patients in these groups should be regularly monitored during treatment.
Use in Pregnancy and Lactation
Insufficient data to assess the effect of the drug during pregnancy and lactation. In this regard, use during pregnancy is not recommended. Breastfeeding should be discontinued during treatment.
Pediatric Use
Contraindication: childhood.
Special Precautions
The therapeutic effect in some cases increases over several months from the start of treatment.
Effect on ability to drive vehicles and mechanisms
Betahistine does not have a sedative effect and does not affect the ability to drive a car or engage in activities requiring speed of psychomotor reactions.
Overdose
Symptoms nausea, abdominal pain, drowsiness (when taken in a dose up to 640 mg); convulsions, cardiovascular complications (when taken in a dose over 640 mg or in combination with other medicines).
Treatment symptomatic.
Drug Interactions
Cases of interaction or incompatibility with other medicines are unknown.
Storage Conditions
The drug should be stored in a dry, light-protected place, out of reach of children, at a temperature not exceeding 25°C (77°F).
Shelf Life
Shelf life – 3 years. Do not use after the expiration date.
Dispensing Status
The drug is dispensed by prescription.
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
Capsules 8 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 180 pcs.
Capsules 16 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 180 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Contact Information
OZON LLC (Russia)
Dosage Forms
 |
Vesticap® | Capsules 8 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 180 pcs. |
| Capsules 16 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, or 180 pcs. |
Dosage Form, Packaging, and Composition
Capsules No. 2: body light blue, opaque, cap blue opaque; capsule contents – a mixture of powder and granules white or white with a creamy tint; compaction of the capsule contents according to the capsule shape is allowed, disintegrating upon pressure.
| 1 tab. | |
| Betahistine dihydrochloride | 8 mg |
Excipients : lactose monohydrate (milk sugar) 43 mg, microcrystalline cellulose 23.5 mg, potato starch 10 mg, copovidone 9 mg, sodium carboxymethyl starch 5 mg, colloidal silicon dioxide 0.5 mg, magnesium stearate 1 mg.
Capsule composition: dye indigo carmine, titanium dioxide, gelatin.
10 pcs. – polymer containers (1) – cardboard packs.
30 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (1) – cardboard packs.
50 pcs. – polymer containers (1) – cardboard packs.
100 pcs. – polymer containers (1) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
Capsules No. 2: body dark blue, opaque, cap blue opaque; capsule contents – a mixture of powder and granules white or white with a creamy tint; compaction of the capsule contents according to the capsule shape is allowed, disintegrating upon pressure.
| 1 tab. | |
| Betahistine dihydrochloride | 16 mg |
Excipients : lactose monohydrate (milk sugar) 86 mg, microcrystalline cellulose 47 mg, potato starch 20 mg, copovidone 18 mg, sodium carboxymethyl starch 10 mg, colloidal silicon dioxide 1 mg, magnesium stearate 2 mg.
Capsule composition: dye azorubine, dye indigo carmine, titanium dioxide, gelatin.
10 pcs. – polymer containers (1) – cardboard packs.
30 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (1) – cardboard packs.
50 pcs. – polymer containers (1) – cardboard packs.
100 pcs. – polymer containers (1) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
Capsules 24 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, or 180 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Contact Information
OZON LLC (Russia)
Dosage Form
|
Vesticap® | Capsules 24 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, or 180 pcs. |
Dosage Form, Packaging, and Composition
Capsules No. 0, body light blue, opaque, cap light blue, opaque; capsule contents – a mixture of powder and granules white or white with a creamy tint; compaction of the capsule contents according to the capsule shape is allowed, disintegrating upon pressure.
| 1 caps. | |
| Betahistine dihydrochloride | 24 mg |
Excipients : lactose monohydrate (milk sugar) 129 mg, microcrystalline cellulose 70.5 mg, potato starch 30 mg, copovidone 27 mg, sodium carboxymethyl starch 15 mg, colloidal silicon dioxide 1.5 mg, magnesium stearate 3 mg.
Capsule composition: cap – indigo carmine 0.0312 %, titanium dioxide 4 %, gelatin up to 100 %; body – indigo carmine 0.0312 %, titanium dioxide 4 %, gelatin up to 100 %.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – polymer containers (1) – cardboard packs.
20 pcs. – polymer containers (1) – cardboard packs.
30 pcs. – polymer containers (1) – cardboard packs.
40 pcs. – polymer containers (1) – cardboard packs.
50 pcs. – polymer containers (1) – cardboard packs.
100 pcs. – polymer containers (1) – cardboard packs.
![Vesticap [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Vesticap [Capsules] 2")