Telfor 60

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Thuốc kháng histamin, chống dị ứng
Barcode: 8935206094695
Description

TELFOR 60

COMPOSITION:

Fexofenadine HCl ......................................................................... 60 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 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.

PHARMACOKINETICS:

Fexofenadine is rapidly absorbed after oral doses. Following the administration of a 60 mg dose, the plasma peak concentration was approximately 142 ng/ml, occurring 2 - 3 hours. Food reduces the plasma peak concentration by 17%, but does not delay the time to peak plasma concentration. Fexofenadine is 60 to 70% bound to plasma proteins, primarily albumin and alpha1-acid glycoprotein. Fexofenadine does not cross the blood-brain barrier. Approximately 5% of the total dose of fexofenadine was eliminated by metabolism. Approximately 0.5 - 1.5% is metabolized in the liver by cytochrome P450 enzymes into inactive substances. About 3.5% is converted into methyl ester derivatives, mainly due to the intestinal flora.

In older subjects (≥ 65 years old), peak plasma levels of fexofenadine were 99% greater than those observed in younger subjects (< 65 years old). Mean fexofenadine elimination half-lives were similar to those observed in healthy subjects.

In subjects with mild to moderate (creatinine clearance 41 - 80 ml/min) and severe (creatinine clearance 11 - 40 ml/min) renal impairment, peak plasma concentrations of fexofenadine were 87% and 111% greater, respectively, and mean elimination half-lives were 59% and 72% longer, respectively, than observed in healthy subjects.

Hepatically impaired: The pharmacokinetics of fexofenadine in subjects with hepatic impairment did not differ substantially from that observed in healthy subjects.

Effect of gender: No significant gender-related differences were observed in the pharmacokinetics of fexofenadine.

INDICATIONS:

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.

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 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.

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:

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Coadministration of fexofenadine with erythromycin or ketoconazole is safe and causes no point torsion syndrome, an adverse effect which frequently occurs in combination of 1st generation histamine receptor antagonist with erythromycin or ketoconazole. However, erythromycin and ketoconazole increase levels and AUC of fexofenadine.

The administration of an antacid containing aluminium and magnesium hydroxide causes a reduction in fexofenadine absorption. It is advisable to leave 2 hours between administration of fexofenadine and aluminium and magnesium hydroxide containing antacids.

ADVERSE EFFECTS:

Common (ADR< 1/100)

Nervous system 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 (1/1000 < ADR < 1/100)

Nervous system disorders: fear, sleep disturbances, nightmares. Gastrointestinal disorders: dry mouth, abdominal pain.

Rare (ADR < 1/1000)

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.

OVERDOSAGE:

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.

DOSAGE & ADMINISTRATION:

Adults and children aged more than 12 years: oral dose of 1 tablet twice daily.

Adults and children aged more than 12 years suffered from renal impairment or hemodialysis: oral dose of 1 tablet once daily.

No dose adjustment is required in hepatic impairment.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information. 

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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