Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland.
As with other anticholinergic agents, Valoid may precipitate incipient glaucoma and it should be used with caution and appropriate monitoring in patients with glaucoma, urinary retention, obstructive disease of the gastrointestinal tract, hepatic disease, phaeochromocytoma, hypertension, epilepsy and in males with possible prostatic hypertrophy. Valoid Injection may have a hypotensive effect.
Cyclizine should be used with caution in patients with severe heart failure or acute myocardial infarction. 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. The concomitant misuse of Valoid with large amounts of alcohol is particularly dangerous, since the antiemetic effect of cyclizine may increase the toxicity of alcohol (see also Section 4.5).
Case reports of paralysis have been received in patients using intravenous cyclizine. Some of the patients mentioned in these reports had an underlying neuromuscular disorder. Thus intravenous cyclizine should be used with caution in all patients in general, and in patients with underlying neuromuscular disorders in particular.
Valoid Injection may have additive effects with alcohol, and other central nervous system depressants, e.g. hypnotics, tranquilizers, anaesthetics, antipsychotics, barbiturates.
Valoid enhances the soporific effect of pethidine.
Valoid Injection may counteract the haemodynamic benefits of opioid analgesics.
Because of its anticholinergic activity cyclizine may enhance the side-effects of other anticholinergic drugs, and may have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants (both tricyclics and MAOIs).
Valoid may mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibacterials.
In the absence of any definitive human data, the use of Valoid in pregnancy is not advised.
Cyclizine is excreted in human milk, however, the amount has not been quantified.
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 at dose levels of approximately 15 and 25 mg/kg/day. There is no experience of the effect of Valoid Injection on human fertility.
Studies designed to detect drowsiness, did not reveal sedation in healthy adults who took a single oral therapeutic dose (50 mg) of cyclizine, sedation of short duration was reported by subjects receiving intravenous 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 Valoid may have additive effects with alcohol and other central nervous system depressants, e.g. hypnotics and tranquilizers.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.
The following undesirable effects have been reported with a frequency of Not known:
| System Organ Class | Frequency | Adverse reactions |
|---|---|---|
| Blood and lymphatic system disorders | Not known | Agranulocytosis, leucopenia, Haemolytic anaemia, thrombocytopenia |
| Cardiac disorders | Not known | Tachycardia, palpitations, arrhythmias |
| Ear and labyrinth disorder | Not known | Tinnitus |
| Eye disorders | Not known | Blurred vision, oculogyration |
| Gastrointestinal disorders | Not known | Dryness of the mouth, nose and throat, |
| General disorders and administration site conditions | Not known | Asthenia, malaise |
| Hepatobiliary disorders | Not known | Hepatic dysfunction including hepatitis due to hypersensitivity. Cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine. |
| Immune system disorders | Not known | Hypersensitivity reactions, including anaphylaxis and hypersensitivity hepatitis have occurred. |
| Musculoskeletal and connective tissue disorders | Not known | Twitching, muscle spasms |
| Nervous system disorders | Not known | Effects on the central nervous system have been reported with cyclizine these include somnolence, drowsiness, incoordination headache, dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia and generalised chorea* |
| Psychiatric disorders | Not known | Disorientation, restlessness, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded |
| Renal and urinary disorders | Not known | Urinary retention |
| Respiratory, thoracic and mediastinal disorders | Not known | Bronchospasm, apnoea |
| Skin and subcutaneous tissue disorders | Not known | Urticaria, pruritus, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity |
| Vascular disorders | Not known | Hypertension, hypotension |
* There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness. The use of cyclizine has been associated with cases of paralysis following administration of the intravenous formulation of the medicine. The onset of paralysis is usually within minutes of administration, affects the limbs, and fully resolves within hours of discontinuation of the medicine (see also Section 4.4).
IV formulation only:
Blisters at the site of injection and pruritus, as well as sensation of heaviness, chills, agitation, flushing and hypotension have been reported.
Rapid IV administration can lead to symptoms similar to overdose.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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