Telfor 180
TELFOR 180
COMPOSITION:
Fexofenadine HCl ....................................................... 180 mg
Excipients q.s ............................................................ 1 tablet
(Pregelatinized starch, microcrystalline cellulose M101, croscarmellose sodium, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, talc, red ferric oxide, orange E110).
DOSAGE FORM: Film coated tablet
PRESENTATION: Box of 2 blisters x 10 tablets.
PHARMACODYNAMICS:
Telfor contains the active ingredient Fexofenadine which is a selectively peripheral H1-receptor histamine antagonist and is used to treat the allergy. At the therapeutic dose, fexofenadine causes no drowsiness or other CNS effects. Fexofenadine gives a quick and prolonged action because it slowly binds to H1-receptor, forming a stable complex and slow division.
PHARMACOKINETICS:
Fexofenadine is rapidly absorbed following oral administration. 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.
INDICATIONS:
Symptomatic treatment of unknown chronic urticaria in adults and children over 12 years old.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug.
PRECAUTIONS:
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 kidney failure patients and the elderly (over 65 years) who suffered from decreased renal function. Fexofenadine should be discontinued at least 24 to 48 hrs prior to intradermally injected antigen tests. The safety of fexofenadine 180 mg in children under 12 years of age has not been established.
PREGNANCY AND LACTATION:
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.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Although fexofenadine rarely causes drowsiness, caution should be exercised in drivers and machine users.
INTERACTIONS:
Co-administration of fexofenadine with either ketoconazole or erythromycin led to increased plasma concentrations of fexofenadine because of increased absorption and decreased elimination of fexofenadine. However, the interaction has no meaning of clinical significance.
Antacids containing aluminium and magnesium hydroxide gels cause a reduction in the bioavailability of fexofenadine, most likely due to binding in the gastrointestinal tract. Therefore, it is advisable to leave 2 hours between administration of fexofenadine and aluminium and magnesium hydroxide containing antacids.
Grapefruit juice reduces the absorption and exposure of fexofenadine.
ADVERSE EFFECTS:
Common: CNS disorders: drowsiness, fatigue, headache, insomnia, dizziness. Gastrointestinal disorders: nausea, indigestion. Others: viral infections (cold, influenza), dysmenorrhea, upper respiratory infections, itchy throat, cough, fever, otitis media, sinusitis, back pain.
Uncommon: CNS disorders: fear, sleep disturbances, nightmares. Gastrointestinal disorders: dry mouth, abdominal pain.
Rare: Skin disorders: rash, pruritus. Hypersensitivity reactions: angioedema, chest discomfort, dyspnea, flushing, anaphylactic shock.
Inform a physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Reports on acute toxicity of fexofenadine are limited; however, dizziness, drowsiness, and dry mouth have been reported.
Treatment: 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.
DOSAGE & ADMINISTRATION:
Adults and children aged more than 12 years: oral dose of 1 tablet daily.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.