What Are the Most Common Fexofenadine Side Effects?

Fexofenadine hydrochloride capsules, 1. Seasonal allergic rhinitis is intended to relieve symptoms associated with seasonal allergic rhinitis in adults and children aged 6 years and over. Such as sneezing, runny nose, itchy nose, epicondylitis, throat, itchy, wet, reddened eyes. 2. Chronic idiopathic urticaria is suitable for treating skin symptoms of chronic idiopathic urticaria in adults and children aged 6 years and over, and can reduce the number of itching and wind masses. ^[1] .

Drug Name: Fexofenadine Hydrochloride Capsules

Hanyu Pinyin: Yan Suan Fei Suo Fei Na Ding Jiao Nang
Use classification: Other H1 receptor blockers

Fexofenadine hydrochloride capsule ingredients

The main ingredient of this product is fexofenadine hydrochloride.
Chemical name: (±) 4- [1-hydroxy-4- [4- (hydroxydiphenylmethyl) -1-piperidinyl] butyl] -, -dimethylphenylacetic acid hydrochloride Structural formula:
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Molecular formula: C ₃₂ H ₃₉ NO ₄ · HCl
Molecular weight: 538.13

Characteristics of Fexofenadine Hydrochloride Capsules

The contents of this product are white or off-white particles and powder.

Indications of fexofenadine hydrochloride capsules

1. Seasonal allergic rhinitis is intended to relieve symptoms associated with seasonal allergic rhinitis in adults and children aged 6 years and over. Such as sneezing, runny nose, itchy nose, epicondylitis, throat, itchy, wet, reddened eyes.
2. Chronic idiopathic urticaria is suitable for treating skin symptoms of chronic idiopathic urticaria in adults and children aged 6 years and over, and can reduce the number of itching and wind masses.

Fexofenadine Hydrochloride Capsule Specifications

60mg

Dosage and dosage of fexofenadine hydrochloride capsules

1. For adults with seasonal allergic rhinitis, children 12 years of age and older, the recommended dose of fexofenadine hydrochloride is 60 mg twice daily or 180 mg once daily. The recommended starting dose for patients with renal insufficiency is 60 mg once a day.
For children 6 to 11 years old, the recommended dose of fexofenadine hydrochloride is 30 mg twice daily. The recommended starting dose for children with renal insufficiency is 30 mg once daily.
2. For adults with chronic idiopathic urticaria, children 12 years of age and older, the recommended dose of fexofenadine hydrochloride is 60 mg twice daily. The recommended starting dose for patients with renal insufficiency is 60 mg once a day.
For children 6 to 11 years old, the recommended dose of fexofenadine hydrochloride is 30 mg twice daily. The recommended starting dose for children with renal insufficiency is 30 mg once daily.

Adverse reactions of fexofenadine hydrochloride capsules

1. In a placebo-controlled seasonal allergic rhinitis clinical trial of seasonal allergic rhinitis, 2461 patients aged 12 years and older received treatment with fexofenadine hydrochloride 20 mg to 240 mg twice daily. Phenadin is similar to placebo.
In a placebo-controlled seasonal allergic rhinitis clinical trial, 570 patients aged 12 years and older received fexofenadine hydrochloride 120 mg or 180 mg once a day. .
The above studies show that the incidence of adverse reactions, including sleepiness, is not dose-related and is similar across age, gender, and ethnic groups.
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Chronic idiopathic urticaria
The incidence of side effects reported by patients with 12 years of age and older in the placebo-controlled chronic idiopathic urticaria study was similar to that reported by the seasonal allergic rhinitis study.
Clinical validation of placebo-controlled chronic idiopathic urticaria, including 726 patients aged 12 years and older receiving fexofenadine hydrochloride at a dose of 20 mg to 240 mg twice daily. Side effects of fexofenadine hydrochloride and The placebo is similar. The following table lists the side effects of fexofenadine hydrochloride 60 mg twice daily in the United States and Canada compared with placebo.
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Fexofenadine hydrochloride capsules contraindications

Those who are allergic to the ingredients of this product are prohibited.

Precautions for fexofenadine hydrochloride capsules

Hepatic dysfunction does not need to be reduced, and patients with renal dysfunction need to be halved.

Fexofenadine hydrochloride capsules for pregnant and lactating women

This product does not show obvious teratogenic effects in animals. A dose-related decrease in weight gain and survival in pups was observed when rats were administered orally to humans at 3 times the maximum dose.
Because adequate, well-controlled studies have not been conducted on pregnant women, fexofenadine should be used during pregnancy only if the potential benefits far outweigh the harm to the fetus.
There are no adequate, well-controlled studies of lactating women. Because many drugs can be secreted through breast milk, lactating women should be used with caution with fexofenadine hydrochloride.

Fexofenadine hydrochloride capsules for children

The safety and efficacy of fexofenadine hydrochloride in children under 6 years of age have not been established.

Fexofenadine hydrochloride capsules for elderly

It has not been determined whether there is a difference in the response between elderly patients and young patients. However, because the drug is fully excreted by the kidney, the risk of drug toxicity in patients with renal impairment may increase. Elderly patients are likely to have a decline in renal function, so the choice of dosage must be careful, and renal function monitoring needs to be performed if necessary.

Fexofenadine hydrochloride capsule drug interactions

1. Drug interactions with erythromycin and ketoconazole Although fexofenadine hydrochloride shows a small liver metabolic rate (about 5%), it can cause non-hydrochloric acid when used with erythromycin and ketoconazole. Sofenadine has increased plasma levels. Fexofenadine hydrochloride has no effect on the pharmacokinetics of erythromycin and ketoconazole.
In trials to study the compatibility of fexofenadine hydrochloride with erythromycin or ketoconazole, healthy volunteers (n = 24 in each research experiment) took fexofenadine hydrochloride 120 mg twice a day (yes Twice the recommended dose twice a day) with erythromycin 500mg every 8 hours or ketoconazole 400mg once daily, the results show that patients take fexofenadine hydrochloride alone or with erythromycin and ketoconazole There were no differences in side effects or QTc intervals. The results of these studies are summarized in the following table:
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The mechanisms of these interactions have been validated by adequate in situ and in vivo and in vitro animal models. Studies show that co-administration of ketoconazole or erythromycin with fexofenadine hydrochloride can promote gastrointestinal absorption of fexonadine hydrochloride. In vivo animal studies have also shown that not only can it promote absorption, ketoconazole can also reduce the gastrointestinal secretion of fexofenadine hydrochloride, and erythromycin may also reduce its biliary secretion.
2. Drug interactions with antacids
Taking 120 mg fexofenadine hydrochloride (2 × 60 mg) together with aluminum and magnesium antacids within 15 minutes will reduce the AUC of fexofenadine hydrochloride by 41% and the Cmax by 43%. Therefore, fexofenadine hydrochloride and aluminum and magnesium antacids should not be taken at the same time.

Fexofenadine hydrochloride capsule overdose

Reports of overdose of fexofenadine hydrochloride are rare and little information is available. However, dizziness, lethargy and dry mouth have been reported. Single dose of fexofenadine hydrochloride 800 mg (six healthy volunteers at this dose level), 690 mg twice daily for one month (three healthy volunteers at this dose level) or 240 mg once daily One year (234 healthy volunteers at this dose level) had no clinically significant adverse events compared to placebo.
In the case of overdose, standard measures should be considered to remove unabsorbed drugs. Symptomatic treatment and supportive treatments are recommended.
The data show that after taking terfenadine, hemodialysis therapy cannot effectively remove fexofenadine hydrochloride from the blood (only 1.7% was removed).

Pharmacology and toxicology of fexofenadine hydrochloride capsules

* Pharmacological effects:
Fexofenadine hydrochloride is an antihistamine drug with selective peripheral H1 receptor antagonism. Fexofenadine inhibits histamine release from peritoneal mast cells in rats. No anticholinergic, 1-adrenergic or -adrenergic receptor blocking effects were observed in experimental animals, and no sedation or other central nervous system effects were observed. This product cannot cross the blood-brain barrier.
* Toxicology research:
Effect on QTc: dogs take fexofenadine hydrochloride twice a day at a dose of 30mg / kg (the plasma drug concentration is equivalent to 9 times the recommended maximum oral dose for adults), and rabbits are injected intravenously with 10mg / kg (in plasma (Concentration is equivalent to 20 times of the recommended maximum oral dose for adults). There was no QTc prolongation after 1 hour of administration. For calcium channel flow, delayed potassium channel flow, guinea pig muscle cell action potential cycle, newborn rat muscle cell sodium channel flow, multiple delayed rectifying potassium channels of human heart clones (fexofenadine hydrochloride concentration reaches 1 × 10 ^[14] C]-Fexofenadine hydrochloride was recovered in feces and urine separately. Since the absolute bioavailability of fexofenadine hydrochloride has not been established, it is not yet possible to determine the composition of fexofenadine hydrochloride in feces The drug is not absorbed or is excreted from the bile duct.
About 5% of the total dose is metabolized.
Special Population Elderly Testers Among elderly subjects (65 years of age), the highest plasma levels of fexofenadine were 99% higher than those of normal subjects (<65 years of age). The mean elimination half-life was similar to healthy subjects.
Pediatric patients In a study of 7-12 year old children with allergic rhinitis and healthy adult subjects, 60 mg of this product was taken orally. The area under the curve (AUC) of child subjects was lower than that of healthy adult subjects receiving the same dose. 56% bigger. In contrast, plasma concentrations of 30 mg of fexofenadine hydrochloride in children were similar to those of 60 mg of adults.
Renal injury The highest plasma levels of fexofenadine in patients with mild to moderate (creatinine clearance 41 to 80 ml / min) and severe (creatinine clearance 11 to 40 ml / min) The levels increased by 87% and 111%, respectively, and the average elimination half-life was extended by 59% and 72%, respectively. The highest plasma levels in dialysis patients (creatinine clearance 10 ml / min) increased by 82%, and the half-life was prolonged by 31%. Based on the increase in bioavailability and half-life, a daily dose of 60 mg is recommended as the starting dose for patients with reduced renal function. (See Dosage and Administration).
Pharmacokinetics of liver injury fexofenadine in patients with liver disease is similar to healthy subjects.

Storage of fexofenadine hydrochloride capsules

Store in a sealed, dry place.

Fexofenadine hydrochloride capsules

Packed in aluminum-plastic, 7 tablets per plate, 2 plates per box.

Expiration date of fexofenadine hydrochloride capsules

12 months

Fexofenadine Hydrochloride Capsules

The State Food and Drug Administration issued the standard YBH24842006