Indications

Allergic rhinitis: Alanil 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. Alanil improves health-related quality of life and work/activity productivity. 
 
Chronic idiopathic urticaria: Alanil is indicated for the relief of symptoms associated with chronic idiopathic urticaria in adults and children 12 years of age and older. Alanil significantly reduces the signs and symptoms of chronic idiopathic urticaria, the number of wheals, and pruritus. Alanil improves health-related quality of life and work/activity productivity.

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Pharmacology

The H1 histamine receptor is responsible for mediating hypersensitivity and allergic reactions. Exposure to allergen results in the degranulation of mast cells and basophils, which then release histamine and other inflammatory mediators. Histamine binds to, and activates, H1 receptors, which results in the further release of pro-inflammatory cytokines, such as interleukins, from basophils and mast cells. These downstream effects of histamine binding are responsible for a wide variety of allergic symptoms, such as pruritus, rhinorrhea, and watery eyes.

Fexofenadine is considered an "inverse agonist" of the H1 receptor because it binds to and stabilizes the inactive form of the receptor, preventing its activation and subsequent downstream effects. It has a potent and selective affinity for H1 receptors, and there is no evidence that it carries antidopaminergic, antiserotonergic, anticholinergic, sedative, or adrenergic blocking activity. Fexofenadine does not cross the blood-brain barrier and thus is unlikely to cause significant CNS effects.

Dosage & Administration

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

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Interaction

Alanil does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Coadministration of Alanil 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 Alanil caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of Alanil and aluminium and magnesium hydroxide containing antacids.

Contraindications

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

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, pruritus

Pregnancy & Lactation

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.

Precautions & Warnings

As with most new medicinal products there is only limited data in the older people and renally or hepatically impaired patients. Alanil 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 Alanil tablets will produce an effect on the ability to drive or use machines. In objective tests, Alanil 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.

Use in Special Populations

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.

Overdose Effects

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of Alanil. 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 Alanil 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 Alanil from blood.

Therapeutic Class

Non-sedating antihistamines

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

Chemical Structure

Common Questions about Alanil 30 mg/5 ml Suspension

What is Alanil 30 mg/5 ml Suspension?

Alanil 30 mg/5 ml Suspension is an antihistamine. It works by blocking histamine that the body makes during an allergic reaction.

What are the uses of Alanil 30 mg/5 ml Suspension?

Alanil 30 mg/5 ml Suspension is used for the treatment of allergic rhinitis and urticaria. It relieves allergy symptoms such as runny nose, itching eyes/nose, sneezing, hives, and itching.

What are the Side Effects of Alanil 30 mg/5 ml Suspension?

Alanil 30 mg/5 ml Suspension has some reported side effects such as Vomiting, Headache, Coughing, Diarrhea, Painful menstruation, Pain in the arms and legs, Hives and redness of skin, Swelling of face, lips, eyelids, tongue, hands and feet.

What are the instructions for storage and disposal Alanil 30 mg/5 ml Suspension?

Alanil 30 mg/5 ml Suspension should be kept in a cool dry place and in its original pack. Make sure this medication remains unreachable to children and pets.

Can Alanil 30 mg/5 ml Suspension make you sleepy?

Yes, Alanil 30 mg/5 ml Suspension can make you feel sleepy, infect sleepiness is a common side effect of this medicine.

Can you overdose on Alanil 30 mg/5 ml Suspension?

Do not take an overdose of Alanil 30 mg/5 ml Suspension as this can cause adverse reactions and may increase the risk of side effects like dizziness, drowsiness, fatigue, and dry mouth.

How quickly does Alanil 30 mg/5 ml Suspension work?

Alanil 30 mg/5 ml Suspension starts working within 1 hour of consuming it. The peak benefit of Alanil 30 mg/5 ml Suspension is observed within 6 hours.

Does Alanil 30 mg/5 ml Suspension relieve symptoms of outdoor and indoor allergies?

Yes, Alanil 30 mg/5 ml Suspension can help relieve symptoms that may be caused by outdoor and indoor allergens such as upper respiratory allergies, hay fever, watery eyes, runny nose, and sneezing, or itching of the nose or throat.

How to cope with dizziness caused by Alanil 30 mg/5 ml Suspension?

Take some rest after taking Alanil 30 mg/5 ml Suspension if you feel dizzy or sleep. Do not use heavy machinery or drive and move very slowly. Exercise caution and if there is extreme dizziness, then consult a doctor as soon as possible.

Can I take antacids while taking Alanil 30 mg/5 ml Suspension?

Alanil 30 mg/5 ml Suspension should not be used in combination with antacids as the interaction between them can result in a decreased absorption of Alanil 30 mg/5 ml Suspension.

How should I take Alanil 30 mg/5 ml Suspension?

Alanil 30 mg/5 ml Suspension should be taken in dose and duration as recommended by the doctor. Do not take an overdose as this can affect your health adversely.

Is there any food or drink that I need to avoid while taking Alanil 30 mg/5 ml Suspension?

Do not consume juices like grapefruit juice, orange juice and apple juice if you are on the course of medication with Alanil 30 mg/5 ml Suspension.

Can Alanil 30 mg/5 ml Suspension cause heart problems?

Those who suffer from heart disorders should exercise caution and must look out for some other alternative of this medicine.

Quick Tips

• Alanil 30 mg/5 ml Suspension is an antihistaminic medication. It treats allergy symptoms such as itching, swelling, and rashes by blocking the effects of a chemical messenger (histamine) in the body.
• Alanil 30 mg/5 ml Suspension is less likely to make you feel sleepy than some other similar medicines.
• Do not take Alanil 30 mg/5 ml Suspension with any fruit juices (such as apple, orange, or grapefruit) as they might make the drug less effective.
• Alanil 30 mg/5 ml Suspension may cause nausea. Stick to simple meals, and do not eat rich or spicy food.
• Avoid using antacids 30 minutes before or after taking Alanil 30 mg/5 ml Suspension. It can make it harder for your body to absorb this medication.

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