COMPOSITION
OZEN® TABLET
Each film coated tablet contains 10 mg of Cetirizine 2HCl.
OZEN® SIRUP
Each measurementspoon (5 ml) contains 5 mg of Cetirizine 2HCl.
OZEN® DROPS
Each ml drops contains 10 mg of Cetirizine 2 HCl.
MECHANISM OF ACTION
Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H1 receptors.
INDICATION
Seasonal allergic rhinitis: indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes.
Perennial allergic rhinitis: indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
Chronic urticaria: indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 2 years of age and older. It significantly reduces the occurence, severity, and duration of hives and significantly reduces pruritus.
POSOLOGY
Adults and children 12 years and older: 5 or 10 mg/day (tablet); 1 or 2 measurementspoons (syrup); and ½ or 1 ml (drops), depending on symptom severity. Most patients in clinical trials started at 10 mg. Cetirizine is given as a single daily dose, with or without food. The time of administration may be varied to suit individual patient needs.
Children 6-11 years : 5 or 10 mg (tablet); 1 or 2 measurementspoons (syrup); and ½ or 1 ml (drops) once daily depending on symptom severity. The time of administration may be varied to suit individual patient needs.
Children 2-5 years : for OZEN® syrup 2.5 mg (½ measurementspoons); or ¼ ml for OZEN® drops once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 measurementspoon (5 mg) or ½ ml (drops) once daily, or as ½ measurementspoon (2.5 mg) or ¼ ml (drops) given every 12 hours, depending on symptom severity and patient response.
Dose adjustment for renal and hepatic impairment: 12 years and older with decreased renal function (creatinine clearance 11-31 ml/min), patients on hemodialysis (creatinine clearance less than 7 ml/min), and in hepatically impaired renal or hepatic function should use the lower recommended dose. Because of the difficulty in reliably administering doses of less than 2.5 mg (½ measurementspoon of OZEN® syrup or ¼ ml of OZEN® drops and in the absence of pharmacokinetic and safety information for cetirizine in children below the age of 6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended.
PRECAUTIONS
- In clinical trials, the occurrence of somnolence has been reported in some patients taking cetirizine; due caution should therefore be excercised when driving a car or operating potentially dangerous machinery.
- Cetirizine should be used in pregnancy only if clearly needed.
- Cetirizine has been reported to be excreted in human breast milk. Because many drugs are excreted in human milk, use of cetirizine in nursing mothers is not recommended.
ADVERSE REACTIONS
- Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.
- Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.
- Central and Peripheral Nervous Systems: abnormal cocordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.
- Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.
- Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.
- Hearing and Vestibular : deafness, earache, ototoxicity, tinnitus.
- Metabolic/Nutritional : dehydration, diabetes mellitus, thirst.
- Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.
- Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.
- Respiratory system: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.
- Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.
- Reticuloendothelial: lymphadenopathy.
- Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.
- Special senses: parosmia, taste loss, taste perversion.
- Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.
- Body as a whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral ederma, rigors.
CONTRAINDICATIONS
Patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.
DRUG INTERACTION
No clinically significant drug interactions have been found with theophylline at a low dose, azithromycin, pseudoephedrin, ketoconazole, or erythromycin. There was a small decrease in the clearance of cetirizine caused by a 400 mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.
PRESENTATION
OZEN® TABLET
Box, 3 strips @ 10 film coated tablets
Reg.No.DKL0221627217A1
OZEN® SYRUP
Box, Bottle 60 ml
Reg.No.DKL0221627337A1
OZEN® DROPS
Box, Bottle 12 ml
Reg. No. DKL0221627736A1
HARUS DENGAN RESEP DOKTER
On Medical Prescription Only
Ozen tablet: Store at room temperature 15°-30° C
Ozen syrup and drops: Store at 5°-30° C
Manufactured by:
PT. PHAROS INDONESIA
Jakarta-Indonesia
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