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Components:
Cyclizine
Method of action:
Antiemetic
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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 2019.11.17

Name of the medicinal product

Aculoid

Qualitative and quantitative composition

Cyclizine

Therapeutic indications

The information provided in Therapeutic indications of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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Aculoid is indicated for the prevention and treatment of nausea and vomiting including:-

 

- Motion sickness.

- Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period.

- Vomiting associated with radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels.

Aculoid may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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Route of administration: oral

Adults and Children over 12 Years:

50 mg orally, which may be repeated up to three times a day.

Children 6 - 12 Years:

25 mg orally, which may be repeated up to three times a day.

Children less than 6 years of age:

Aculoid tablets are not recommended for children less than 6 years of age.

Use in the Elderly:

There have been no specific studies of Aculoid in the elderly. Experience has indicated that normal adult dosage is appropriate.

To prevent motion sickness Aculoid should be taken about one to two hours before departure.

Contraindications

The information provided in Contraindications of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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Aculoid should not be given to individuals with known hypersensitivity to cyclizine.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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As with other anticholinergic agents, Aculoid may precipitate incipient glaucoma and it should be used with caution and appropriate monitoring in patients with glaucoma, obstructive disease of the gastrointestinal tract, hepatic disease, epilepsy and in males with possible prostatic hypertrophy.

Cyclizine should be used with caution in patients with severe heart failure. In such patients, cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure.

Cyclizine should be avoided in porphyria.

There have been reports of abuse of cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects.).

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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Studies designed to detect drowsiness did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine.

Patients should not drive or operate machinery until they have determined their own response.

Although there are no data available, patients should be cautioned that Aculoid may have additive effects with alcohol and other central nervous system depressants, e.g. hypnotics and tranquillisers.

Undesirable effects

The information provided in Undesirable effects of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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Blood and lymphatic system disorders

Agranulocytosis

Cardiac disorders

Tachycardia

Eye disorders

Blurred vision, oculogyric crisis

Gastrointestinal system disorders

Dryness of the mouth, nose and throat, constipation

General disorders and administration site conditions

Asthenia

Hepatobiliary disorders

Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine.

Immune system disorders

Hypersensitivity reactions, including anaphylaxis have occurred

Musculoskeletal and connective tissue disorders

Twitching, muscle spasms

Nervous system disorders

Effects on the central nervous system have been reported with cyclizine these include somnolence, headache, dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia and generalised chorea.

Psychiatric disorders

Disorientation, restlessness, nervousness, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.

Renal and urinary disorders

Urinary retention

Respiratory, thoracic and mediastinal disorders

Bronchospasm, apnoea

Skin and subcutaneous tissue disorders

Urticaria, drug rash, angioedema, allergic skin reactions, fixed drug eruption

Vascular disorders

Hypertension

Overdose

The information provided in Overdose of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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Symptoms:

Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic effects and effects on the central nervous system.

Peripheral anticholinergic symptoms include dry mouth, nose and throat, blurred vision, tachycardia and urinary retention. Central nervous system effects include drowsiness, dizziness, incoordination, ataxia, weakness, hyperexcitability, disorientation, impaired judgement, hallucinations, hyperkinesia, extrapyramidal motor disturbances, convulsions, hyperpyrexia and respiratory depression.

An oral dose of 5 mg/kg is likely to be associated with at least one of the clinical symptoms stated above. Younger children are more susceptible to convulsions. The incidence of convulsions, in children less than 5 years, is about 60% when the oral dose ingested exceeds 40 mg/kg.

Treatment:

In the management of acute overdosage with Aculoid, gastric lavage and supportive measures for respiration and circulation should be performed if necessary. Convulsions should be controlled in the usual way with parenteral anticonvulsant therapy.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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ATC Code: R60AE03

Pharmacotherapeutic Group: Piperazine derivatives

Mode of Action:

Cyclizine is a histamine H1 receptor antagonist of the piperazine class which is characterised by a low incidence of drowsiness. It possesses anticholinergic and antiemetic properties. The exact mechanism by which cyclizine can prevent or suppress both nausea and vomiting from various causes is unknown. Cyclizine increases lower oesophageal sphincter tone and reduces the sensitivity of the labyrinthine apparatus. It may inhibit the part of the midbrain known collectively as the emetic centre.

Pharmacodynamics:

Cyclizine produces its antiemetic effect within two hours and last approximately four hours.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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H1-blockers are well absorbed from the GI tract. Following oral administration effects develop within 30 minutes, are maximal within 1-2 hours and last, for cyclizine, for 4-6 hours.

In healthy adult volunteers the administration of a single oral dose of 50 mg cyclizine resulted in a peak plasma concentration of approximately 70 ng/mL occurring at about two hours after drug administration. The plasma elimination half-life was approximately 20 hours.

The N-demethylated derivative, norcyclizine, has been identified as a metabolite of cyclizine. Norcyclizine has little antihistaminic (H1) activity compared to cyclizine. It is widely distributed throughout the tissues and has a plasma elimination half-life of approximately 20 hours.

After a single dose of 50 mg cyclizine given to a single adult male volunteer, urine collected over the following 24 hours contained less than 1% of the total dose administered.

Preclinical safety data

The information provided in Preclinical safety data of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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A. Mutagenicity:

Cyclizine was not mutagenic in a full Ames test, including use of S9-microsomes but can nitrosate in vitro to form mutagenic products.

B. Carcinogenicity:

No long term studies have been conducted in animals to determine whether cyclizine has a potential for carcinogenesis. However, long-term studies with cyclizine administered with nitrate have indicated no carcinogenicity.

C. Teratogenicity:

Some animal studies are interpreted as indicating that Cyclizine may be teratogenic. The relevance of these studies to the human situation is not known.

D. Fertility:

In a study involving prolonged administration of cyclizine to male and female rats there was no evidence of impaired fertility after continuous treatment for 90-100 days. There is no experience of the effect of Aculoid on human fertility.

Incompatibilities

The information provided in Incompatibilities of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Aculoid is based on data of another medicine with exactly the same composition as the Aculoid of the medicine (Cyclizine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Aculoid directly from the package or from the pharmacist at the pharmacy.
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No special instructions.

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