Avinorm Travel^® (Tablets) Instructions for Use

Marketing Authorization Holder

FPK PharmVILAR, JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

ATC Code

A04AD (Other antiemetic drugs)

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Moxastine (Rec.INN WHO Registered)

Dosage Form

Avinorm Travel®

Tablets 25 mg+30 mg: 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, flat, with a cross-shaped score on one side.

* Avinorm Travel^®, substance-granules – 245 mg (consisting of moxastine teoclate – 25 mg, caffeine – 30 mg, lactose monohydrate – 165 mg, corn starch – 25 mg).

Excipients: talc – 2.5 mg, calcium stearate – 2.5 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker used for motion sickness

Pharmacotherapeutic Group

Antiemetic agents, other antiemetic agents

Pharmacological Action

Combined medicinal product.

Moxastine is a histamine H₁-receptor blocker, possesses antihistamine and sedative properties. It has an anticholinergic effect, exerts an antiemetic action, and reduces dizziness. The action of moxastine is due to the direct reduction of the excitability of the vomiting center and the chemoreceptor trigger zone and a decrease in the body’s sensitivity to impulses that cause acute disturbances of autonomic functions in sensitive individuals, manifested as nausea and vomiting.

Caffeine is a central nervous system stimulant, a PDE inhibitor. As part of this combination, it reduces the sedative and hypnotic effects of moxastine.

Pharmacokinetics

Moxastine is well absorbed from the gastrointestinal tract. The relative bioavailability of moxastine teoclate upon oral administration is 55%. C_max in blood plasma is reached within 45-70 minutes after oral intake. It is rapidly distributed to all organs and tissues of the body, including the central nervous system. T_1/2 is 4-8 hours. It is metabolized mainly in the liver and excreted as metabolites (excreted faster in children than in adults). Very little is excreted unchanged in the urine.

Caffeine is rapidly absorbed throughout the intestine. C_max is reached 50-75 minutes after oral administration. Protein binding is 25-36%. It is rapidly distributed to all organs and tissues of the body, easily penetrates the blood-brain barrier and the placental barrier. V_d is 0.4-0.6 l/kg, in newborns – 0.78-0.92 l/kg. T_1/2 of caffeine is 3-7 hours. It is metabolized in the liver (about 80%). A number of metabolites are excreted in the urine (about 4% in the form of theophylline).

Indications

Prevention of nausea and vomiting in motion sickness occurring when using transport (car, train, airplane, ship).

Treatment and prevention of dizziness of various etiologies (including Meniere’s disease, vestibular apparatus dysfunction).

ICD codes

Dosage Regimen

Take orally with water.

For prevention of motion sickness, take the first dose 30-60 minutes before the start of the journey.

For adults and children over 12 years, the dose is 1-2 tablets up to three times daily.

The maximum daily dose for adults and children over 12 years is 6 tablets.

For children aged 6 to 12 years, the dose is 1/2-1 tablet up to three times daily.

The maximum daily dose for children aged 6 to 12 years is 3 tablets.

For children aged 3 to 6 years, the dose is 1/2 tablet up to two times daily.

The maximum daily dose for children aged 3 to 6 years is 1 tablet.

For treatment of acute nausea or vertigo, take the same age-specific dose as needed.

Maintain an interval of at least 6 hours between doses.

Do not exceed the recommended maximum daily dose.

Contraindicated in children under 3 years of age.

Adverse Reactions

Nervous system disorders: low mood, weakness, drowsiness, impaired concentration, visual disturbances (impaired accommodation).

Digestive system disorders: diarrhea, constipation, abdominal pain, dry mouth.

Cardiovascular system disorders: tachycardia, decreased blood pressure.

Allergic reactions: rash, itching, skin hyperemia.

Contraindications

Angle-closure glaucoma, prostatic hyperplasia, pregnancy, breastfeeding period, children under 3 years of age; hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated in children under 3 years of age. Used in children over 3 years of age according to indications.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

Effect on the ability to drive vehicles and machinery

The use of this combination may reduce the ability to concentrate, therefore it should be avoided when performing work requiring increased attention and rapid psychomotor reactions (including for drivers and pilots before a planned trip or flight).

Drug Interactions

It enhances the effect of hypnotics, antipsychotic drugs (neuroleptics), anxiolytics, ethanol, antispasmodics, and sympatholytics; reduces the effect of indirect anticoagulants, oral hypoglycemic drugs, phenytoin, corticosteroids, and hormonal contraceptives.

MAO inhibitors and acetylcholinesterase inhibitors increase, while barbiturates and pyrazolone derivatives reduce the effectiveness of this combination.

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

Over-the-Counter

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.