Indications of Fixal 120 mg

Allergic rhinitis: In adults and children 12 years of age and older, Fixal 120 mg is recommended for the alleviation of seasonal and persistent allergic rhinitis symptoms. Sneezing, rhinorrhea, lacrimation, itchy, red eyes, and itchy nose, palate, and throat are symptoms that can be properly addressed. Both work/activity productivity and health-related quality of life are enhanced with fexofenadine. For the treatment of the symptoms of chronic idiopathic urticaria in adults and children 12 years of age and older, fexofenadine is recommended. The number of wheals and pruritus associated with chronic idiopathic urticaria are dramatically decreased by fexofenadine. Both work/activity productivity and health-related quality of life are enhanced with fexofenadine.

Theropeutic Class

Non-sedating antihistamines

Pharmacology

A selective peripheral H1-receptor antagonist, Fixal 120 mg is an antihistamine. After oral administration, it is quickly absorbed and reaches peak plasma concentration in 2 to 3 hours. The blood-brain barrier does not appear to be crossed by it.

Dosage and Administration of Fixal 120 mg

Seasonal Allergic Rhinitis-Adults and children 12 years and older: Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily

In case of impaired renal function: 60 mg once daily Children from 6 to 11 years: Tablet: 30 mg twice daily or 60 mg once daily

In case of impaired renal function: 30 mg once daily Children from 2 to 11 years Suspension: 30 mg or 5 ml twice daily

In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-Adults and children 12 years and older: Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily In case of impaired renal function: 60 mg once daily Children from 6 to 11 years: Tablet: 30 mg twice daily or 60 mg once daily

In case of impaired renal function: 30 mg once daily Children from 6 months to less than 2 years: Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily

In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily Children from 2 to 11 years: Suspension: 30 mg or 5 ml (1 tsp) twice daily

In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Dosage of Fixal 120 mg

Allergic Rhinitis-Adults and children 12 years and older: Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily In case of impaired renal function: 60 mg once daily Children from 6 to 11 years: Tablet: 30 mg twice daily or 60 mg once daily In case of impaired renal function: 30 mg once daily Children from 2 to 11 years Suspension: 30 mg or 5 ml twice daily In case of impaired renal function: 30 mg or 5 ml once daily Chronic Idiopathic Urticaria-Adults and children 12 years and older: Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily In case of impaired renal function: 60 mg once daily Children from 6 to 11 years: Tablet: 30 mg twice daily or 60 mg once daily In case of impaired renal function: 30 mg once daily Children from 6 months to less than 2 years: Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily Children from 2 to 11 years: Suspension: 30 mg or 5 ml (1 tsp) twice daily In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Interaction of Fixal 120 mg

As fexofenadine does not go through hepatic biotransformation, hepatic processes cannot be used to interact with other medications. It has been discovered that co-administration of Fixal 120 mg with erythromycin or ketoconazole causes a 2- to 3-fold increase in fexofenadine levels in plasma. When compared to the medication given separately, the adjustments had no influence on the QT interval and were not followed by an increase in unfavorable reactions. There was no evidence of a connection between fexofenadine and omeprazole. However, there was a decrease in bioavailability when Fixal 120 mg was administered 15 minutes before an antacid comprising gels of aluminum and magnesium hydroxide, most likely as a result of binding in the gastrointestinal tract. It is advised to wait two hours between the time Fixal 120 mg is administered and aluminum and magnesium hydroxide-containing antacids.

Contraindications

Those with known hypersensitivity to Fixal 120 mg or any of its components should not use it.

Side Effects of Fixal 120 mg

When appropriate, the following frequency rating has been applied: Extremely common: 1/100; Common: 1/100; Uncommon: 1/1,000; Rare: 1/10,000; Very rare: 1/10,000; and Not known: 1/1,000 (frequency cannot be estimated from the available data). Unwanted effects are listed within each frequency grouping in descending order of seriousness. Clinical trials have revealed the following negative effects in adults, with a prevalence comparable to that seen with a placebo: Common nervous system illnesses include headaches, fatigue, and vertigo. Frequent gastrointestinal issues include nausea, along with general issues and issues with the administration site. - Unusual: exhaustion. The following negative consequences have been observed in post-marketing surveillance in adults. They do not occur frequently and their frequency cannot be calculated from the data currently available. Immune system problems, including hypersensitive reactions that include angioedema, tightness in the chest, dyspnea, flushing, and systemic anaphylaxis; Mental illnesses such as anxiety, nightmares, sleeplessness, or excessive dreaming (paroniria); cardiac issues such as palpitations and tachycardia; Diarrhea as a gastrointestinal condition; Disorders of the skin and subcutaneous tissues: rash, urticaria, and pruritus.

Pregnancy and Lactation

Fixal 120 mg is under category C by the US FDA for pregnancy. Therefore, it is advised to avoid using Fixal 120 mg during pregnancy and lactation unless the advantages to one outweigh the hazards to the fetus.

Precautions and Warnings

There is little information on elderly persons and patients with renal or hepatic impairment, as is the case with the majority of new medications. In these particular categories, Fixal 120 mg administration needs to be done carefully. Antihistamines as a class of medication have been linked to adverse responses such as tachycardia and palpitations, so patients with a history of active cardiovascular disease should be informed of this. Impacts on the capacity to operate machinery and drive: Fexofenadine hydrochloride tablets are unlikely to have an impact on one's ability to drive or operate machinery based on the pharmacodynamic profile and recorded adverse events. Fexofenadine has not been found to significantly affect the central nervous system's ability to function in objective testing. This entails that patients can operate a vehicle or complete other demanding jobs. Therefore, it is advisable to examine the individual response before driving or undertaking difficult duties in order to recognize sensitive individuals who have an unusual reaction to the medication.

Overdose Effects of Fixal 120 mg

Overdoses of Fixal 120 mg have been associated with symptoms such as dry mouth, sleepiness, weariness, and dizziness. Healthy participants have received single doses of up to 800 mg, doses of up to 690 mg twice daily for one month, or doses of up to 240 mg once daily for one year without experiencing clinically significant adverse responses in comparison to placebo. Fexofenadine hydrochloride has no known upper limit of tolerable dosage. To get rid of any unabsorbed medication, standard procedures should be taken into account. Treatment for symptoms and psychological assistance is advised. Fexofenadine hydrochloride cannot be efficiently removed from the blood by hemodialysate.

Storage Conditions

Keep dry and away from heat and light. Keep out of children's reach.

Drug Classes

Non-sedating antihistamines

Mode Of Action

The H1 histamine receptor is responsible for mediating hypersensitivity and allergic reactions. Hypersensitivity and allergic responses are mediated by the H1 histamine receptor. Mast cells and basophils degranulate in response to allergen exposure, releasing histamine and other inflammatory mediators as a result. Histamine binds to and activates H1 receptors, which causes basophils and mast cells to further release pro-inflammatory cytokines such as interleukins. Many allergy symptoms, including pruritus, rhinorrhea, and watery eyes, are caused by these histamine binding's downstream effects. Because it binds to and stabilizes the inactive version of the receptor, fexofenadine is referred to as an "inverse agonist" of the H1 receptor because it prevents the receptor's activation and consequent downstream effects. There is no proof that it has antidopaminergic, antiserotonergic, anticholinergic, sedative, or adrenergic blocking effects, despite having a strong and specific affinity for H1 receptors. As fexofenadine cannot cross the blood-brain barrier, it is unlikely to have a substantial impact on the central nervous system.

Pregnancy

The use of Fixal 120 mg in pregnant women is not supported by enough data. There aren't any direct or indirect negative effects on pregnancy, embryonal/fetal development, parturition, or postnatal development, according to the few available animal studies. If not absolutely required, Fixal 120 mg shouldn't be taken while pregnant. Data about the composition of human milk following the administration of Fixal 120 mg are lacking. Fexofenadine was discovered to pass into human breast milk when Terfenadine was given to nursing mothers. Fexofenadine hydrochloride is therefore not advised for moms who are nursing their infants. Fexofenadine hydrochloride's effect on fertility has not been studied in humans. The medication with Fixal 120 mg had no impact on fertility in mice.

Pediatric Uses

Patient with renal and hepatic impairment: People with renal impairment have different fexofenadine pharmacokinetics. In patients with impaired renal function, a dose of 60 mg once daily is advised as the initial dose due to increases in bioavailability and half-life. The pharmacokinetics of fexofenadine are not significantly impacted by moderate to severe hepatic disease. The patient over 65: Adverse effects in this group were comparable to those in patients under 65. Yet in people over 65, fexofenadine's pharmacokinetics are changed (its bioavailability is enhanced).