Telfast/Telfast-D Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Telfast Fexofenadine HCl. Telfast-D Fexofenadine HCl 60 mg, pseudoephedrine HCl 120 mg

Indications/Uses

Telfast FC tab Symptomatic relief of chronic idiopathic urticaria & allergic rhinitis including symptoms eg, sneezing, rhinorrhoea, itchy nose/palate/throat & watery red eyes. Telfast oral susp Symptomatic relief of seasonal allergic rhinitis in childn 2-11 yr. Uncomplicated skin manifestations of chronic idiopathic urticaria in childn 6 mth-11 yr. Telfast-D Symptomatic relief of seasonal allergic rhinitis eg, sneezing, rhinorrhea, itchy nose/palate &/or throat, itchy/watery/red eyes & nasal congestion.

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Dosage/Direction for Use

Telfast FC tab Adult & childn ≥12 yr 1 tab once daily. Telfast oral susp Childn 2-11 yr Seasonal allergic rhinitis 30 mg (5 mL) bd. Paed patient w/ decreased renal function Starting dose: 30 mg (5 mL) once daily. Chronic idiopathic urticaria 30 mg (5 mL) bd. Paed patient w/ decreased renal function Starting dose: 30 mg (5 mL) once daily. 6 mth to <2 yr 15 mg (2.5 mL) bd. Paed patient w/ decreased renal function Starting dose: 15 mg (2.5 mL) once daily. Telfast-D Adult & childn ≥12 yr 1 tab bd.

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Overdosage

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Administration

Should be taken on an empty stomach: Telfast: Do not take w/ fruit juice. Telfast-D: Swallow whole, do not chew/crush/break.

Contraindications

Hypersensitivity. Telfast FC tab Childn <12 yr. Telfast-D Hypersensitivity to pseudoephedrine, adrenergic agents. Narrow-angle glaucoma, urinary retention, severe HTN & CAD. Concomitant MAOIs therapy w/in 14 days.

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Special Precautions

Renal & hepatic impairment. Not to be used during pregnancy. Not recommended during lactation. Elderly ≥65 yr. Telfast FC tab History of CV disease. May affect ability to drive & use machines. Telfast oral susp Childn <2 yr (w/ seasonal allergic rhinitis) & <6 mth (w/ chronic idiopathic urticaria). Telfast-D Hypersensitivity. HTN, DM, ischemic heart disease, increased IOP, hyperthyroidism, prostatic hypertrophy; CNS stimulation w/ convulsions or CV collapse. Concomitant use w/ other antihistamines & decongestants. Not recommended in ped patients <12 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, drowsiness, dizziness; nausea. Telfast-D Insomnia, dry mouth, dyspepsia, throat irritation, agitation, back pain, palpitation, nervousness, anxiety, upper resp infection, abdominal pain.

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Drug Interactions

Increased plasma conc w/ ketoconazole or erythromycin. Decreased fexofenadine AUC & C_maxw/ Al- & Mg-containing antacids. Reduced bioavailability & exposure w/ fruit juices eg, grapefruit, orange, apple. Telfast-D Reduced antihypertensive effect of drugs interfering w/ sympathetic activity eg, methyldopa, mecamylamine, reserpine. Increased bioavailability w/ P-gp. Increased ectopic pacemaker activity w/ digitalis. Combined CV effects w/ other sympathomimetic amines.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Telfast/Telfast-D detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Antihistamines & Antiallergics

ATC Classification

R06AX26 - fexofenadine ; Belongs to the class of other antihistamines for systemic use.
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Telfast FC tab 180 mg

Packing/Price

50's

Form

Telfast oral susp 6 mg/mL

Packing/Price

60 mL x 1's

Form

Telfast-D XR tab

Packing/Price

50's

Telfast/Telfast-D

fexofenadine + pseudoephedrine

fexofenadine

Manufacturer:

sanofi-aventis

Distributor:

DKSH