Alernova 0.5mg/ml Oral Solution
Clinical Summary
Quick overview from the medicine insert
Indication
Management of allergic rhinitis and chronic urticaria.
Dosage (summary)
The usual dose for adults and children over 12 years is 5 mg once daily. For children aged 6 to 12 years, the dose is 2.5 mg once daily.
Onset of Action / Duration
Onset of action is within 1 hour, with a duration of effect lasting up to 24 hours.
Special Populations
- Elderly patients may require dose adjustment.
- Patients with renal impairment should have their dose adjusted based on severity.
Pregnancy & Breastfeeding
Levocetirizine should be used during pregnancy only if clearly needed. It is excreted in breast milk; caution is advised when administered to nursing mothers.
Key Drug Interactions
- Caution is advised when used with alcohol or other central nervous system depressants.
- May enhance the effects of other antihistamines.
Contraindications
- Hypersensitivity to levocetirizine, cetirizine, or any of the excipients.
- Severe renal impairment (creatinine clearance < 10 mL/min).
Common side effects
- Drowsiness
- Fatigue
- Dry mouth
- Headache
- Gastrointestinal disturbances
Counselling Points
- Advise patients to avoid alcohol while taking this medication.
- Inform patients about the potential for drowsiness and to avoid driving or operating machinery until they know how the medication affects them.
- Encourage patients to report any severe allergic reactions or unusual side effects.
Serious warnings
- Use with caution in patients with a history of seizures.
- May cause sedation; caution in patients with conditions that may be exacerbated by sedation.
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
ALERNOVA is indicated for the relief of symptoms associated with the following allergic conditions in adults and children:
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
- Chronic idiopathic urticaria
4.2 Posology and method of administration
Posology
Adults and adolescents 12 years of age and older
The daily recommended dose is 5 mg (10 ml) once daily.
Children aged 6 - 12 years of age
The daily recommended dose is 5 mg (10 ml) once daily.
Children aged 2 - 6 years of age
The daily recommended dose is 2,5 mg to be administered in 2 intakes of 1,25 mg (2,5 ml of oral solution twice daily).
Children aged less than 2 years of age
The administration of ALERNOVA to infants and toddlers aged less than 2 years is not recommended (see section 4.4).
Special populations
Elderly
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment.
Renal impairment
Adults:
The dosing interval must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patientu2019s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (u03bcmol/l) determination using the following formula:
Dosing adjustments for patients with impaired renal function:
| Group | Creatinine Clearance (ml/min) | Dosage and Frequency |
|---|---|---|
| Normal | u2265 80 | 5 mg once daily |
| Mild | 50 - 79 | 5 mg once daily |
| Moderate | 30 - 49 | 5 mg once every 2 days |
| Severe | < 30 | 5 mg once every 3 days |
| End-stage Renal Disease (Patient undergoing dialysis) | < 10 | Contraindicated |
Paediatric patients suffering from renal impairment: The dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his/her body weight. There are no specific data for children with renal impairment.
Hepatic impairment
No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended.
Duration of use
Intermittent allergic rhinitis (symptoms 4 days/week or during more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience with ALERNOVA is currently available for a 6-month treatment period.
Method of administration
For oral use.
4.3 Contraindications
ALERNOVA is contraindicated in:
- Hypersensitivity to levocetirizine dihydrochloride, to any piperazine derivative or to any of the excipients listed in section 6.1.
- Infants and toddlers aged less than two years, as safety and efficacy have not been demonstrated.
- Pregnancy and lactation (see section 4.6).
- Patients with end stage renal disease, at less than 10 ml/min creatinine clearance.
4.4 Special warnings and precautions for use
Alcohol
Precaution is recommended with intake of alcohol (see section 4.5). ALERNOVA lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants (see section 4.5.)
Patients with epilepsy
Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.
Risk of urinary retention
Caution should be taken in patients with predisposing factors of urinary retention (e.g., spinal cord lesion, prostatic hyperplasia) as ALERNOVA may increase the risk of urinary retention.
Skin allergy tests
Response to allergy skin tests is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
Discontinuation of treatment
Pruritus may occur when ALERNOVA is stopped, even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
Infants and children under 2 years of age
Data are not sufficient to support administration of ALERNOVA to infants and toddlers aged less than 2 years of age. Therefore, administration of ALERNOVA to infants and toddlers aged less than 2 years of age is not recommended.
Children aged less than 6 years
ALERNOVA is recommended for use in children aged less than 6 years.
Excipients
Maltitol ALERNOVA contains maltitol. Patients with the rare hereditary condition of fructose intolerance should not take ALERNOVA.
Sodium benzoate
The presence of the preservative, sodium benzoate, may cause allergic reactions (see section 4.3).
4.5 Interaction with other medicines and other forms of interaction
No interaction studies have been performed with ALERNOVA (including CYP3A4 inducers). Studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with ketoconazole, erythromycin, azithromycin, cimetidine, pseudoephedrine, glipizide and diazepam).
Theophylline
A decrease in the clearance of cetirizine (16 %) was observed in a multiple dose study with theophylline (400 mg once a day), while the disposition of theophylline was not altered by concomitant cetirizine administration.
Ritonavir
In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by approximately 40 % while the disposition of ritonavir was decreased by (-11 %).
Food
The extent of absorption of ALERNOVA is not reduced with food, although the rate of absorption is decreased.
Alcohol
In sensitive patients the simultaneous administration of ALERNOVA and alcohol or other central nervous system (CNS) depressants may have effects on the central nervous system. It is advisable to avoid excessive alcohol consumption while using ALERNOVA.
4.6 Fertility, pregnancy and lactation
Pregnancy
ALERNOVA is contraindicated during pregnancy.
Breastfeeding
ALERNOVA is contraindicated in women who are breastfeeding their babies.
Fertility
No fertility data is available for ALERNOVA.
4.7 Effects on ability to drive and use machines
Some patients could experience somnolence, fatigue and asthenia during therapy with ALERNOVA. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to ALERNOVA into account.
4.8 Undesirable effects
a. Tabulated summary of adverse reactions
| System Organ Class | Frequency | Undesirable effect |
|---|---|---|
| Immune system disorders | Frequency unknown | Angioedema, hypersensitivity including anaphylaxis |
| Nervous system disorders | Frequent | Headache, somnolence |
| Nervous system disorders | Frequency unknown | Convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia |
| Gastrointestinal disorders | Frequent | Dry mouth, diarrhoea, constipation |
| Gastrointestinal disorders | Less frequent | Nausea, gastrointestinal discomfort, abdominal pain, vomiting |
| General disorders and administrative site conditions | Frequent | Fatigue |
| General disorders and administrative site conditions | Less frequent | Asthenia, malaise |
| General disorders and administrative site conditions | Frequency unknown | Oedema |
| Skin and subcutaneous tissue disorders | Frequency unknown | Hypersensitivity reactions including skin reactions, urticaria and pruritus, angioedema, fixed drug eruption, rash |
| Psychiatric disorders | Frequent | Sleep disorders |
| Psychiatric disorders | Frequency unknown | Aggression, agitation, hallucination, depression, insomnia, suicidal ideation |
| Metabolism and nutrition disorders | Frequency unknown | Increased weight, increased appetite |
| Eye disorders | Frequency unknown | Visual disturbance, blurred vision |
| Ear and labyrinth disorders | Frequency unknown | Vertigo |
| Cardiac disorders | Frequency unknown | Palpitations, tachycardia |
| Respiratory, thoracic and mediastinal disorders | Frequency unknown | Dyspnoea |
| Hepatobiliary disorders | Frequency unknown | Hepatitis, abnormal liver function test |
| Musculoskeletal, connective tissues, and bone disorders | Frequency unknown | Myalgia, arthralgia |
| Renal and urinary disorders | Frequency unknown | Dysuria, urinary retention |
| Investigations | Frequency unknown | Abnormal liver function |
b. Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8
4.9 Overdose
Symptoms of overdose may include drowsiness in adults. In children, agitation and restlessness may initially occur, followed by drowsiness. There is no known specific antidote to ALERNOVA. Should overdose occur, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.
