Telfast BD 60mg
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Telfast BD 60mg

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INDICATIONS

Telfast BD: Relief of symptoms associated with seasonal allergic rhinitis in adults and children ≥12 years. Symptoms treated effectively were sneezing, rinorrhea, itchy nose/palate/throat, itchy/watery red eyes, nasal congestion.

Telfast HD: Relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children ≥12 years.

CONTRAINDICATIONS

Patients with known hypersensitivity to any of the ingredients of Telfast BD/HD.

OVERDOSAGE

Symptoms: Human Experience: Most reports of fexofenadine HCl overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year were studied in healthy subjects without the development of clinically significant adverse events as compared to placebo. The maximum tolerated dose of Telfast 60 mg was not established.

There has been no reported case of an acute overdose of fexofenadine HCl.

Treatment: Consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended.

Hemodialysis did not effectively remove fexofenadine from blood.

DOSAGE AND ADMINISTRATION

Telfast BD:

Adults: Seasonal Allergic Rhinitis: The recommended dose is 60 mg twice daily for patients ≥12 years.

Special Populations: Studies in special risk groups (elderly or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine HCl in these patients; a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

 

Telfast HD:

Adults and Children ≥12 years: Recommended Dose: 1 tab once daily.

Children <12 years: The efficacy and safety of fexofenadine HCl have not been studied in children <12 years.

Special Risk Groups: Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine HCl in these patients

PRECAUTIONS

As with most new drugs, there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine HCl should be administered with care in these special groups.

Effects on the Ability to Drive or Operate Machinery: On the basis of the pharmacodynamic profile and reported adverse events, it is unlikely that fexofenadine HCl tablets will produce an effect on the ability to drive or use machines. In objective tests, Telfast HD has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to drugs, it is advisable to check the individual response before driving or performing complicated tasks.

Carcinogenicity, Mutagenicity & Impairment of Fertility: The carcinogenic potential and reproductive toxicity of fexofenadine HCl were assessed using terfenadine studies with adequate fexofenadine exposure (based on plasma area-under-the-curve (AUC) values). No evidence of carcinogenicity was observed when mice and rats were given daily oral doses of 50 and 150 mg/kg of terfenadine for 18 and 24 months, respectively, these doses resulted in plasma AUC values of fexofenadine that were up to 4 times the human therapeutic value (based on a 60-mg twice-daily fexofenadine HCl dose).

In in vitro (Bacterial Reserve Mutation, CHO/HGPRT Forward Mutation and Rat Lymphocyte Chromosomal Aberration assays) and in vivo (Mouse Bone Marrow Micronucleus assay) tests, fexofenadine HCl revealed no evidence of mutagenicity.

In rat fertility studies, dose-related reductions in implants and increases in post-implantation losses were observed at oral doses ≥150 mg/kg of terfenadine; these doses produced plasma AUC values of fexofenadine that were ≥3 times the human therapeutic value (based on a 60-mg twice-daily fexofenadine HCl dose).

Use in pregnancy & lactation: No animal reproduction studies have been performed with fexofenadine HCl. Supportive pharmacokinetic studies with terfenadine have been performed and show exposure to fexofenadine at the high dose level in animal reproduction studies performed with terfenadine to be higher than is achieved at the recommended clinical fexofenadine dose. In these studies, no evidence of teratogenicity or effects on male fertility were observed. Effects on female fertility and on peri- and postnatal development were seen only at maternally toxic doses.

There is no experience with fexofenadine HCl in pregnant women. As with other medications, fexofenadine HCl should not be used during pregnancy unless the expected benefit to the patient outweighs any possible risk to the foetus.

There are no data on the content of human milk after administering fexofenadine HCl. However, when terfenadine was administered to nursing mothers, fexofenadine was found to cross into human breast milk. Therefore, fexofenadine HCl is not recommended for mothers breastfeeding their babies.

Use in children: Safety and effectiveness of Telfast BD in pediatric <12 years have not been established. Across well-controlled clinical trials in patients with allergic rhinitis, a total of 205 patients between 12-16 years, received doses ranging from 20-240 mg twice daily for up to 2 weeks. Adverse events were similar in this group compared to patients >16 years.

Use in the elderly: In placebo-controlled trials, 42 patients, 60-68 years, received doses of 20-240 mg of fexofenadine twice daily for up to 2 weeks. Adverse events were similar in this group to patients <60 years.

ADVERSE REACTIONS

In placebo-controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients, adverse events were comparable in fexofenadine- and placebo-treated patients.

In controlled clinical trials, the most commonly reported adverse events were headache, drowsiness, nausea, dizziness and fatigue. The incidence of these events observed with fexofenadine was similar to that observed with placebo.

 

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