Indications:
Agimfast 120 is indicated for the treatment of symptoms associated with seasonal allergic rhinitis, such as sneezing, runny nose, itchy nose, palate and throat, itchy and red eye and watery eyes in adults and children over 12 years of age.
Administration, dosage:
Administration:
Agimfast 120 tablets should be orally taken with a glass of water.
Dosage:
Adults and children ³ 12 years of age: 1 tablet once a day, before the meal.
Patients with kidney failure: The recommended initial dose is 60 mg once in 24 hours, dose is adjusted according to renal function. Because Agimfast contains 120 mg of fexofenadine, patients should use other product with appropriate strength (containing 30 mg or 60 mg or taking ½ tablet of Agimfast 120 mg) to be able to adjust the dose.
Dose adjustment in patients with impaired hepatic function is not required.
Contraindications:
Hypersensitivity to any of the excipients of the drug.
Children under 12 years of age.
Warnings and precautions for use:
The elderly, patients with hepatic or renal impairment.
Patients who are driving and operating machinery.
Patients with a history of cardiovascular risk or with pre-existing prolonged QT interval should be monitored cautiously when using fexofenadine.
Do not use concurrently any other antihistamines while taking fexofenadine.
Fexofenadine should be discontinued at least 24-48 hours prior to antigen skin tests.
Fexofenadine may exacerbate psoriasis.
This medicine contains lactose. Patients with rare genetic problems with galactose intolerance, Lapp lactase enzyme deficiency or glucose-galactose malabsorption should not take this medicine.
Pregnancy and lactation:
Pregnancy:
There are no adequate data on fexofenadine use during pregnancy. Fexofenadine should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
Lactation:
It is not known if Agimfast 120 is excreted in human milk; therefore, fexofenadine should be used cautiously in nursing mothers.
Effects on ability to drive, use machines:
Although fexofenadine rarely causes drowsiness, caution should be exercised when driving or operating machinery.
Interactions, incompatibilities of medicine:
Interactions:
Erythromycin and ketoconazole increases the level of fexofenadine in plasma but does not change QT interval.
Fexofenadine concentrations may be increased by concomitant use of erythromycin, ketoconazole, verapamil, p – glycoprotein inhibitors.
Fexofenadine should not be taken with antacids containing aluminum, magnesium because they decrease the absorption of fexofenadine.
Fexofenadine can increase the concentrations of alcohol, CNS sedative, anticholinergics agents.
Fexofenadine may reduce the concentrations of acetylcholinesterase inhibitors (in the CNS), betahistine.
Fexofenadine levels may be reduced by the acetylcholinesterase inhibitors (in the CNS), amphetamine, antacids, grapefruit juice, rifampin.
Incompatibilities:
Because there are no studies of drug incompatibility, do not mix this drug with other drugs.
Undesirable effects:
The undesirable effects of Agimfast 120 are not affected by the dose, age, sex and race of patients.
Undesirable effects are classified according to frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR < 1/10), uncommon (1/1,000 ≤ ADR < 1/100), rare (1/10,000 ≤ ADR < 1/1,000), and very rare (ADR < 1/10,000).
Common
Nervous system disorders: Drowsiness, fatigue, headache, insomnia, dizziness.
Gastrointestinal disorders: Nausea, indigestion.
Others: Viral infection (cold, flu), dysmenorrhoea, upper respiratory tract infections, itchy throat, cough, fever, otitis media, sinusitis, back pain.
Uncommon
Nervous system disorders: Nervousness, sleep disorders, nightmares.
Gastrointestinal disorders: Dry mouth, abdominal pain.
Rare
Skin: Rash, urticaria, pruritus.
Hypersensitivity: Angioedema, chest tightness, dyspnoea, flushing, systemic anaphylaxis.
Overdose and management:
Overdose: Information on acute toxicity of fexofenadine is limited. However, drowsiness, dizziness and dry mouth have been reported.
Management: Standard measures should be considered to remove the unabsorbed medicines from the gastrointestinal tract. Symptomatic and supportive treatment is recommended. Hemodialysis reduces blood drug concentrations insignificantly (1.7%). There is no specific antidote.
Pharmacodynamics:
Pharmacological group: Antihistamines and anti-allergy drugs
ATC code: R06A X26
Fexofenadine is a second-generation antihistamine with specific, selective peripheral H1-receptor antagonist activity. Fexofenadine is an active metabolite of terfenadine without the cardiotoxic effects of terfenadine because it does not block potassium channel involved in repolarization of cardiac cells. Fexofenadine has no significant acetylcholine and dopamine antagonist activity and exhibits no alpha1-adrenergic or beta-adrenergic-receptor blocking effects.
At therapeutic doses, no sedative or other central nervous system effects are observed.
Agimfast 120 has fast and prolonged effects because fexofenadine slowly binds to H1 receptor to form a stable complex from which it subsequently slowly dissociates.
Pharmacokinetics:
Absorption: The medicine is well absorbed following oral administration. Peak plasma concentration was achieved after 2-3 hours. The mean Cmax value was approximately 427 ng/ml following the administration of a 120 mg dose once daily. The administration of fexofenadine with meal decreased plasma peak concentration by 17%, but, the time to reach peak concentration was not slowed down.
Distribution: Fexofenadine is 60-70% bound to plasma proteins, principally albumin and alpha1-acid glycoprotein. Volume of distribution is 5.4 to 5.8 liters/kg. It is unknown whether fexofenadine crosses the placenta or is excreted in breast milk. However, when terfenadine was used, fexofenadine, a terfenadine metabolites, was found in breast milk. Fexofenadine does not cross the blood-brain barrier.
Metabolism: Approximately 5% of oral dose is metabolized. Approximately 0.5 to 1.5% of dose is metabolized in the liver by the cytochrome P450 microsomal enzyme system to an inactive metabolite. About 3.5% of a fexofenadine dose is metabolized to methyl ester derivative, mainly due to intestinal microbial flora.
Elimination: The elimination half-life of fexofenadine is about 14.4 hours, it is longer in patients with renal impairment. Fexofenadine is primarily excreted in the feces (approximately 80%), 11-12% of the dose is excreted unchanged in the urine.
Packing: 2-blister box x 10 tablets.
Storage conditions, shelf life, quality specification of the medicine:
Storage conditions: Protect from humidity and light, below 300C.
Shelf life: 36 months from the manufacture date. Do not use expired medicine.
Quality specification: In house.
D1402002401
