Fexofenadine HCl ......................................................... 120 mg
Excipients q.s .............................................................. 1 tablet
Film coated tablet
Box of 2 blisters x 10 tablets.
Telfor containing fexofenadine is an antihistamine with selective peripheral H1-receptor antagonist activity and is used to treat the allergy. At the therapeutic dose, no sedative or other central nervous system effects were observed. Fexofenadine gives a quick and prolonged action because it slowly binds to H1-receptor, forming a stable complex and slow division.
Fexofenadine is rapidly absorbed after oral doses. The plasma peak concentrations occur at 2 - 3 hours post-dose. Food reduces the plasma peak concentration by 17%. Fexofenadine is 60 to 70% bound to plasma proteins, primarily albumin and alpha1-acid glycoprotein. The mean elimination half-life of fexofenadine was 14.4 hours. Approximately 11% of an oral dose of fexofenadine is excreted in the urine, primarily as unchanged drug and 80% is excreted in faeces.
Although fexofenadine rarely causes drowsiness, caution shouldbe exercised in drivers and machine users.
Patients with a history of or ongoing cardiovascular disease or previous prolonged QT interval should be warned. Avoid concurrently administrating fexofenadine with other antihistamine agents.
Caution and dose adjustment should be exercised in renal impairment patients and the elderly (over 65 years) who suffered from decreased renal function. The safety and efficacy of fexofenadine in children under 6 years of age have not been established. Fexofenadine should be discontinued at least 24 to 48 hrs before carrying out skin test antigens.
There are no adequate data from the use of fexofenadine in pregnant women. Therefore, fexofenadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Data for content in human milk after administration of fexofenadine is not available; therefore, caution should be taken in breast-feeding mothers.
Co-administration of fexofenadine with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine because it increases absorption of and decrease elimination of fexofenadine. However, the interaction has no meaning of clinical significance.
Antacids containing aluminium hydroxide gel and magnesium hydroxide cause a reduction in the bioavailability of fexofenadine due to binding in the gastrointestinal tract. Therefore, it is advisable to leave 2 hours between administration of fexofenadine and antacids containing aluminium hydroxide gel and magnesium hydroxide.
Grapefruit juice reduces the absorption and exposure of fexofenadine.
Common: Nervous system disorders: drowsiness, fatigue, headache, insomnia. Gastrointestinal disorders: nausea, indigestion. Others: viral infections (cold, influenza), dysmenorrhea, upper respiratory infections, itchy throat, cough, fever, otitis media, sinusitis, back pain.
Uncommon: Nervous system disorders: fear, sleep disturbances, nightmares. Gastrointestinal disorders: dry mouth, abdominal pain.
Rare: Skin disorders: rash, urticaria, pruritus. Hypersensitivity reactions: angioedema, chest discomfort, dyspnea, flushing, anaphylactic shock.
Inform your physician about any adverse effects occur during the treatment.
Reports on acute toxicity of fexofenadine are limited; however, dizziness, drowsiness, and dry mouth have been reported.
Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended.
Hemodialysis did not effectively remove fexofenadine, from blood (up to 1.7% removed). There is no specific antidote.
Store in dry places, not exceeding 30oC, protect from light.
Treatment of symptoms associated with allergic rhinitis e.g sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.
Treatment of symptoms associated with chronic idiopathic urticaria: pruritus, skin rash.
Hypersensitivity to any components of the drug.
Adults and children aged more than 12 years: oral dose of 1 tablet once daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
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