ALLERWAY 5 (Film-coated tablet)
(and dosage form):
ALLERWAY 5 (Film-coated tablet)
Each film-coated tablet contains levocetirizine dihydrochloride 5 mg.
Contains lactose (sugar).
The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose and colloidal silica anhydrous. The white film-coating (Opadry™)containshypromellose, macrogol and titanium dioxide (C.I. No. 77891).
A 5.7.1 Antihistaminics
Levocetirizine, the (R) enantiomer of cetirizine, is a histamine H1 receptor antagonist.
Levocetirizine is absorbed after oral administration with peak blood levels reached 0,9 hours after oral administration. Plasma levels are linearly related between 2,5 mg and 20 mg.
The extent of absorption is not reduced by food, although the rate is decreased.
The extent of metabolism is less than 14% of the dose. The plasma half-life is approximately 8 hours in adults. The main route of excretion is via urine, accounting for approximately 85% of the dose. Approximately 13% is excreted in the faeces. Levocetirizine is 90% bound to human plasma proteins.
ALLERWAY 5 is indicated for the relief of symptoms associated with the following allergic conditions in adults:
• Seasonal allergic rhinitis
• Perennial allergic rhinitis
• Chronic idiopathic urticaria
Safety and efficacy have not been demonstrated beyond six weeks of treatment.
• Hypersensitivity to levocetirizine, to any piperazine derivative or to any of the ingredients of ALLERWAY 5
• Children, as safety and efficacy have not been demonstrated
• Pregnancy and lactation (see Pregnancy and Lactation)
• End-stage renal disease (CLcr <10 mL/min) or patients receiving dialysis
In clinical trials the occurrence of somnolence, fatigue and asthenia has been reported in some patients under therapy with levocetirizine.
Concurrent use of ALLERWAY 5 with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and impairment of central nervous system performance may occur.
The simultaneous administration of ALLERWAY 5 and alcohol or other central nervous system depressants may have depressing effects on the central nervous system. Excessive alcohol consumption is not advisable.
There are no known interactions of ALLERWAY 5 with other medicines through interactions with medicines metabolised by liver enzymes. Studies performed with the racemic cetirizine have shown no evidence of clinically relevant adverse interactions with ketoconazole, erythromycin, azithromycin, cimetidine and pseudoephedrine.
Ritonavir increases the plasma concentration of racemic cetirizine about 42%, increases the half-life by 53% and decreases the clearance 29%. The disposition of ritonavir is not altered by concomitant cetirizine administration.
PREGNANCY AND LACTATION
ALLERWAY 5 is contra-indicated in lactating women since levocetirizine dihydrochloride is excreted in breast milk.
ALLERWAY 5 is contra-indicated in pregnancy, as safety has not been demonstrated.
DOSAGE AND DIRECTIONS FOR USE
ALLERWAY 5 must be taken orally, swallowed with liquid. It may be taken with or without food. It is recommended to take the daily dose in one single intake.
Adults or children 12 years of age or older:
Take one tablet daily.
Patients with renal impairment
The total body clearance of levocetirizine is progressively reduced based on the severity of renal impairment. The dosing intervals must be individualised according to renal function. Use the table below to adjust the dose as indicated.
The patient’s creatinine clearance can be estimated from the serum creatinine determination using the modified formula of Cockroft and Gault:
(140 –age in years) x Weight in kg
Serum creatinine (micromol/L)
For females multiply the answer by 0,85.
Dosages in patients with renal impairment
Creatinine clearance (CLcr)
5 mg once daily
<80 mL/min or >50 mL/min
5 mg once daily
<50 mL/min or >30 mL/min
5 mg every second day
5 mg every third day
End stage renal disease or receiving dialysis
Patients with hepatic
No dosage adjustment is needed in patients with hepatic impairment.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
The risk of adverse reactions to ALLERWAY 5 may be greater in patients with renal impairment.
The following side effects have been reported:
Less frequent: Aggression, agitation
Frequency not known: Hallucination, depression
Nervous system disorders
Frequent: Headache, somnolence
Less frequent: Convulsion
Less frequent: Visual disturbances
Less frequent: Palpitations
Frequency not known: Tachycardia
Respiratory, thoracic and mediastinal disorders
Frequent: Pharyngitis, nasopharyngitis, dyspnoea
Frequent: Dry mouth
Less frequent:Nausea and gastro-intestinal discomfort
Less frequent: Hepatitis
Skin and subcutaneous tissue disorders
Less frequent: Hypersensitivity reactions including skin reactions, rashes, fixed drug eruptions, urticaria, pruritis, anaphylaxis and angioedema.
Musculoskeletal, connective tissue and bone disorders
Less frequent: Myalgia
General disorders and administrative site conditions
Frequent: Fatigue, weight increase
Less frequent: Asthenia, malaise
Less frequent: Abnormal liver function tests
ALLERWAY 5 tablets contain lactose. Patients who are lactose intolerant or have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take ALLERWAY 5.
Effects on ability to drive and operate machinery
Patients should be warned that ALLERWAY 5 may cause somnolence and therefore it may interfere with the patient’s daytime activities. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants. It is therefore advisable to determine individual response before driving or performing complicated tasks.
KNOWN SYMPTOMS OF OVER-DOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness followed by drowsiness in children. There is no known specific antidote to levocetirizine. Should overdose occur, symptomatic and supportive treatment is recommended. Gastric lavage should be considered following short-term ingestion.
Levocetirizine is not effectively removed by haemodialysis.
White to off white, oval, film-coated biconvex tablets debossed with ‘R 5’on one side and plain on other side.
The tablets are packed in white HDPE containers in pack sizes of 30 tablets.
The tablets are packed in Alu/Alu blister strips containing 10 tablets, which are packed in an outer carton tablet box.
Store at or below 25°C.
KEEP OUT OF REACH OF CHILDREN
The HDPE containers must be tightly closed.
The blisters must be kept in the carton until required for use.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Dr. Reddy’s Laboratories (Pty) Limited
South Wing The Place
1 Sandton Drive
Republic of South Africa
DATE OF PUBLICATION OF THE PACKAGE INSERT
August 2012 (to be confirmed)
New addition to this site: May 2014
Source: Pharmaceutical Industry
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