Fexofed

Fexofed Uses, Dosage, Side Effects, Food Interaction and all others data.

Fexofed
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Fexofed
Generic	fexofenadine hydrochloride + pseudoephedrine hydrochloride
Weight	60mg, 120mg
Type	Caplet
Therapeutic Class
Manufacturer	Kalbe Farma PT
Available Country	Indonesia
Last Updated:	September 19, 2023 at 7:00 am

Uses

Allergic rhinitis: Fexofenadine is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, in adults and children 12 years of age and over. Symptoms treated effectively include sneezing, rhinorrhea, lacrimation, itchy, red eyes and itchy nose/palate/throat ... Read morePseudoephedrine is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa, sinuses and eustachian tube. It is indicated for the symptomatic relief of allergic rhinitis (hay fever), vasomotor rhinitis, the common cold, influenza (flu) and ear congestion caused by ear inflammation or infection. Pseudoephedrine can also be used as a bronchodilator.

Dosage

Fexofed dosage

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 mltwice 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 dailyAs a decongestant and symptomatic treatment for upper respiratory tract infections the recommended dose is:Adults: 1 tablet every 4 to 6 hours, up to maximum of 240 mg in 24 hoursChildren: 6-12 years of age: 1/2 tablet every 4 to 6 hours daily 2-5 years of age: 1/4 tablet every 4 to 6 hours daily Less than 2 years of age: This drug is not advised unless specifically recommended by a physician.

Side Effects

The following frequency rating has been used, when applicable: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo: Nervous system disorders- Common: headache, drowsiness, dizziness; Gastrointestinal disorders- Common: nausea; General disorders and administration site conditions- Uncommon: fatigue. In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from available data): Immune system disorders- hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis; Psychiatric disorders- insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria); Cardiac disorders- tachycardia, palpitations; Gastrointestinal disorders- diarrhea; Skin and subcutaneous tissue disorders- rash, urticaria, pruritusSerious adverse effects associated with the use of Pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and, rarely, hallucinations have been reported. Skin rashes, with or without irritation, have occasionally been reported.

Precaution

As with most new medicinal products there is only limited data in the older people and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups. Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.Effects on ability to drive and use machines: On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that Fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Fexofenadine has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.Although Pseudoephedrine has virtually no pressor effects in normotensive patients, it should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, Pseudoephedrine should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.

Interaction

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly. No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

Pregnancy & Breastfeeding use

There are no adequate data from the use of Fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.There are no data on the content of human milk after administering Fexofenadine hydrochloride. However, when Terfenadine was administered to nursing mothers Fexofenadine was found to cross into human breast milk. Therefore, Fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies. No human data on the effect of Fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with Fexofenadine hydrochloride treatment.Although Pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus. Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known.

Contraindication

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.Pseudoephedrine is contraindicated in- Hypersensitivity of individuals to this drug Severe hypertension and coronary artery disease Concurrent use of Mono Amine Oxidase Inhibitor (MAOI) drugs

Special Warning

Renal and hepatic impaired patient: The pharmacokinetics of fexofenadine are altered in individuals with renal impairment. Based on increases in bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. Moderate to severe hepatic disease does not affect the pharmacokinetics of fexofenadine substantially.Elderly patient: Adverse events were similar in this group compared to patients under 65 years of age. Nevertheless, the pharmacokinetics of fexofenadine is altered (increased bioavailability) in individuals over 65 years of age.

Acute Overdose

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of Fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of Fexofenadine hydrochloride has not been established. Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove Fexofenadine hydrochloride from blood.As with other sympathomimetic agents, symptoms of overdosage include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition. Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. If desired, the elimination of Pseudoephedrine can be accelerated by acid diuresis or by dialysis.