COMPOSITION :
Polarist® Tablet, each tablet contain : Dexchlorpheniramine maleate 2 mg.
INDICATIONS :
- Symptomatic treatment of perennial and seasonal allergic rhinitis.
- Vasomotor rhinitis.
- Allergic conjunctivitis.
- Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
- Allergic reactions to blood or plasma.
- Anaphylactic reaction in addition to Epinephrine administration and other standard therapies after acute manifestations can be resolved.
- Acute skin conditions such as allergic eczema, insect bites, atopic dermatitis, contact dermatitis and dermographism.
DOSAGE AND ADMINISTRATIONS :
Dose should be individualized and adjusted depending on patient’s requirement and response.
- Adults and children over 12 years
1 tablet (2 mg), 3 – 4 times daily. Maximum total dose 12 mg/day. For some patients, a total maximum daily dose of 6 mg daily is sufficient.
- Children 6 – 12 years
½ tablet (1 mg), 3 – 4 times daily. Maximum daily dose 6 mg/day.
- Children 2 – 6 years
¼ tablet (0.5 mg), 3 – 4 times daily. Maximum daily dose 3 mg/day.
CONTRAINDICATIONS :
- Treatment of lower respiratory tract symptoms.
- Patients receiving MAOI therapy.
- Hypersensitivity to any component of the product or Dexchlorpheniramine maleate.
- Newborn and premature infants.
- Breast-feeding mothers.
WARNINGS AND PRECAUTIONS :
- Use with caution in patients with narrow-angle glaucoma, urinary retention, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease including hypertension, epilepsy, renal and hepatic impairment, increased intraocular pressure or hyperthyroidism, also in patient with a history of bronchial asthma.
- Patients should be advised to avoid any activities wich requires mental alertness (such driving or operating machinery).
- Antihistamines may cause dizziness, sedation and hypotension in patients > 60 years.
- The safety use in pregnant women and children < 2 years have not been established.
- Use with caution in nursing mother as it is not known whether Dexchlorpheniramine maleateis excreted in human milk.
DRUG INTERACTIONS :
- Monoamine oxidase inhibitors (MAOIs) prolongs and enhances antihistamines effects, may cause severe hypotension.
- Concomitant use with alcohol, tricyclic antidepressants, barbiturates or other central nervous system (CNS) depressants may potentiate the sedative effects of Dexchlorpheniramine.
- Dexchlorpheniramine maleate can inhibit the action of oral anticoagulants.
ADVERSE REACTIONS :
- Exfoliative dermatitis, sedation, antimuscarinic effects, disorders and depression of central nervous system, rarely stimulates the paradoxical CNS, psychomotor impairment, headache, palpitations and arrhythmias, convulsions, sweating, myalgia, paraesthesias, extrapyramidal symptoms, tremor gastrointestinal disturbances.
- Rarely, hypersensitivity reactions and blood disorders, tinnitus, hypotension, hair loss.
- Drowsiness is the most frequent adverse effect.
- Other possible adverse effects of antihistamines include cardiovascular, hematological, neurological, gastrointestinal, genitourinary tract and respiratory tract reactions.
- General adverse effects have been reported e.g., urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, mouth, nose and throat dryness.
PRESENTATION :
Polarist® Tablet 2 mg Box, 10 strips @ 10 tablets Reg. No. DTL7802345210A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
