Stugesin (Tablets) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

N07CA02 (Cinnarizine)

Active Substance

Cinnarizine (Rec.INN registered by WHO)

Dosage Form

Stugesin

Tablets 25 mg: 40 pcs.

Dosage Form, Packaging, and Composition

20 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Calcium channel blocker with a predominant effect on cerebral vessels

Pharmacotherapeutic Group

BMCC (Bone Mineral Crystal Complex)

Pharmacological Action

Class IV calcium channel blocker with a predominant effect on cerebral vessels, a piperazine derivative. It improves cerebral, as well as coronary and peripheral circulation. It disrupts the entry of calcium ions into vascular smooth muscle cells. It reduces the tone of arteriolar smooth muscle and diminishes responses to biogenic vasoconstrictive substances (adrenaline, noradrenaline, bradykinin).

In patients with impaired peripheral circulation, it improves blood supply and potentiates post-ischemic hyperemia. It increases tissue resistance to hypoxia. Cinnarizine inhibits stimulation of the vestibular apparatus, which results in the suppression of nystagmus and other autonomic disorders. It prevents the occurrence or reduces the severity of acute vertigo episodes.

Pharmacokinetics

After oral administration, Cinnarizine is absorbed from the gastrointestinal tract, with C_max in plasma reached within 1-3 hours. Plasma protein binding is 91%. It is metabolized in the liver via glucuronidation. T_1/2 is 3-6 hours.

It is excreted through the intestine mainly unchanged, and in urine – predominantly as metabolites.

Indications

Adults

Maintenance therapy for symptoms of labyrinthine origin in Ménière’s disease, including vertigo, nausea, vomiting, tinnitus, and nystagmus; prevention of motion sickness; prevention of migraine attacks.

Maintenance therapy for symptoms of cerebrovascular origin, including vertigo, tinnitus, headache, irritability, withdrawal, memory impairment, and concentration difficulties.

Maintenance therapy for symptoms of peripheral circulatory disorders, including Raynaud’s disease, acrocyanosis, intermittent claudication, microcirculation disorders, trophic venous ulcers, paresthesia, night cramps, cold extremities.

Children

Prevention of motion sickness in children from 5 years of age.

ICD codes

Dosage Regimen

Establish the dosage individually based on indication and patient age.

Administer orally with water after a meal.

For adults, the total daily dose is 75 mg to 225 mg.

Divide the total daily dose into three equal administrations.

For cerebrovascular disorders, initiate with 25 mg (one tablet) three times daily.

For peripheral vascular disorders and vertigo of labyrinthine origin, use 25 mg to 75 mg three times daily.

For migraine prophylaxis, administer 25 mg to 75 mg three times daily.

For motion sickness prevention, take 25 mg (one tablet) 30 minutes before travel.

Repeat the 25 mg dose every 8 hours during prolonged travel if necessary.

Do not exceed the maximum daily dose of 225 mg.

For children aged 5 years and older for motion sickness, use half the adult dose.

Calculate the pediatric dose based on body weight at 1.5 mg/kg per day, divided into three doses.

Do not administer to children under 5 years of age.

For elderly patients, consider a lower initial dose due to potential for increased sensitivity.

Monitor for adverse effects, particularly drowsiness, especially at the beginning of therapy.

Adjust the dose gradually based on therapeutic response and tolerability.

Adverse Reactions

Nervous system disorders drowsiness, lethargy, dyskinesia, extrapyramidal disorders, parkinsonism, tremor.

Gastrointestinal disorders dry mouth, vomiting, epigastric pain, dyspepsia.

Skin and subcutaneous tissue disorders lichenoid keratosis, lichen planus, subacute cutaneous lupus erythematosus.

Musculoskeletal and connective tissue disorders muscle rigidity.

Other hyperhidrosis, increased fatigue.

Contraindications

Hypersensitivity to cinnarizine; pregnancy, breastfeeding period; children under 5 years of age.

With caution

In Parkinson’s disease.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy. If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

Contraindicated for use in children under 5 years of age.

Special Precautions

Cinnarizine should be prescribed to patients with Parkinson’s disease only if the benefits of its use outweigh the possible risk of worsening the condition.

Cinnarizine may cause drowsiness, especially at the beginning of treatment. Caution should be exercised when used concomitantly with agents that have a depressant effect on the central nervous system, or with tricyclic antidepressants, and with alcohol.

With long-term use, it is recommended to conduct monitoring examinations of liver function, kidney function, and peripheral blood picture.

Due to the antihistamine effect, taking cinnarizine less than 4 days before skin diagnostic tests may interfere with the detection of reactions that are positive in the absence of cinnarizine.

Effect on ability to drive vehicles and operate machinery

During the use of cinnarizine, patients should exercise caution when driving vehicles and operating machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with agents that have a depressant effect on the central nervous system (tricyclic antidepressants, hypnotics, sedatives, ethanol, ethanol-containing preparations), this effect is enhanced.

With simultaneous use with antihypertensive agents, the hypotensive effect is enhanced; with nootropic agents, vasodilators – the effect of nootropic and vasodilator agents is enhanced.

Concomitant administration of phenylpropanolamine reduces the sedative effect of cinnarizine.

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.