Alibra

Alibra

An indication is a term used to refer to a list of conditions, symptoms, or diseases for which a medication is prescribed or used by a patient. For example, acetaminophen or paracetamol is used by the patient for fever, or the doctor prescribes it for headaches or body aches. Now fever, headache, and body aches are all signs of paracetamol. The patient should be aware of the indications of medications used for common conditions, because they can be taken without a prescription at the pharmacy.

Permanent allergic rhinitis: Alibra hydrochloride syrup is indicated to relieve the symptoms associated with permanent allergic rhinitis due to allergens such as dust mites, animal dander, and mold in children aged 6 to 23 months. Symptoms that are effectively treated include sneezing, rhinorrhea, post-nasal discharge, itchy nose, itchy eyes, and watery eyes.

Chronic urticaria: Alibra hydrochloride syrup is indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in children aged 6 months to 5 years. It significantly reduces the occurrence, severity and duration of urticaria and significantly reduces itching.

Alibra It is an antihistamine that reduces the effect of the natural chemical histamine in the body. Histamine can cause symptoms of sneezing, itching, watery eyes, and runny nose.

Alibra is used to treat symptoms of a cold or allergy, such as sneezing, itching, watery eyes, or a runny nose.

Alibra is also used to treat itching and swelling caused by chronic urticaria (urticaria).

Alibra may also be used for purposes not listed in this medication guide.

The usual adult dose for Allergic rhinitis

5 to 10 mg orally or chew once a day

The usual adult dose for urticaria

5 to 10 mg orally or chew once a day

The usual pediatric dose for Allergic rhinitis

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

from 2 to 5 years: 2.5 mg orally once a day, can be increased to 5 mg/day in 1-2 divided doses.

6 years and older: 5 to 10 mg orally or chew once a day.

The usual pediatric dose for urticaria

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

from 2 to 5 years: 2.5 mg orally once a day, can be increased to 5 mg/day in 1-2 divided doses.

6 years and older: 5 to 10 mg orally or chew once a day.

The Kidney Dose Is Adjusted

CrCl less than 30 ml / min: 5 mg orally or chew once a day.

The use of Alibra is not recommended for children under 6 years of age with impaired renal function due to the difficulty of reliably administering doses of less than 2.5 mg (1/2 teaspoon) and the lack of pharmacokinetic information about the safety of Alibra in such patients.

Dose adjustment for the liver

5 mg orally or chew once a day

The use of Alibra is not recommended for children under 6 years of age with hepatic insufficiency due to the difficulty of reliably administering doses of less than 2.5 mg (1/2 teaspoon) and the lack of pharmacokinetic information about the safety of Alibra in such patients.

Safety precautions

In clinical studies, the occurrence of drowsiness has been reported. Therefore, due care should be taken when driving or working with potentially dangerous machinery. Concomitant use of alcohol or other CNS depressants should be avoided, as there may be an additional decrease in alertness and an additional deterioration in the CNS function.

Dialysis

Alibra is not significantly removed during hemodialysis, so no additional dosage is required after hemodialysis. The recommended dose for patients on hemodialysis is 5 mg orally or chewed once a day.

See also:
What is the most important information I need to know about Alibra?

Tablet: Alibra should not be used, except in special cases, in patients with impaired liver and kidney function.

The risk-benefit should be considered in the presence of medical problems such as bladder neck obstruction, prostatic hypertrophy, urinary retention, and glaucoma.

Syrup: Hypersensitivity to Alibra dihydrochloride, hydroxyzine, any piperazine derivatives, or to any of the Alibra excipients. Patients with severe renal insufficiency CrCl <10 ml/min. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take Alibra.

Use Alibra orally to break up the tablets as directed by your doctor. Check the label on the medicine for accurate dosage instructions.

• Do not remove the blister from the box until you are ready to take the orally disintegrating Alibra tablets. Make sure your hands are dry when you open the blister. Do not push the tablet through the foil. Remove the foil from the blister and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Alibra Tablets for oral disintegration can be taken with or without water. Take the tablet immediately after opening the blister. Do not store the extracted tablet for future use.
• If you have missed a dose of oral disintegrating Alibra tablets and are taking them regularly, take them as soon as possible. If it's almost time for the next dose, skip the missed dose and return to your normal dosing schedule. Do not take 2 doses at the same time.

Ask your healthcare provider any questions you may have about how to use the orally disintegrating Alibra tablets.

This combination drug is used to treat tension headaches. Acetaminophen helps reduce the pain of headaches. Caffeine helps to enhance the effects of acetaminophen. Butalbital is a sedative that helps reduce anxiety and cause drowsiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional label of the drug, but that may be prescribed by your healthcare professional. Use this medication for the conditions listed in this section only if it has been prescribed by your healthcare provider.

This medication can also be used to treat migraines.

How to use Alibra

Take this medicine orally with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medicine, carefully measure the dose with a special measuring device/spoon. Do not use a homemade spoon, because you may not get the right dose.

The dosage depends on your state of health, age, and response to treatment. This medication works best if it is used when the first signs of a headache appear. If you wait until the headache gets worse, the medication may not work.

This medication can cause a withdrawal reaction, especially if it is used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop taking this drug. To prevent withdrawal reactions, your doctor may gradually reduce your dose. Report any withdrawal reactions immediately.

Along with its benefits, this drug can rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medicine exactly as prescribed to reduce the risk of addiction.

Tell your doctor if you notice an increase in the use of this medication, a worsening of headaches, an increase in the number of headaches, the medication does not work as well, or the use of this medication for more than 2 episodes of headache per week. Do not take more than recommended. Your doctor may need to change your medication and / or add a separate medication to prevent headaches.

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What other drugs will affect Alibra?

Tablet: Concomitant use with alcohol may potentiate the CNS-depressing effects of Alibra, maprotilin, or tricyclic antidepressants may potentiate the anticholinergic effects of either these drugs or Alibra.

Monoamine oxidase inhibitors (MAO) are not recommended, since their use can prolong and enhance the anticholinergic and depressive effects of Alibra on the central nervous system.

Concomitant use with ototoxic drugs may mask symptoms of ototoxicity, such as tinnitus, dizziness or dizziness, photosensitizing drugs may cause additive photosensitizing effects.

Syrup: For Alibra, there is no interaction with pseudoephedrine, cimetidine, ketoconazole, erythromycin, and azithromycin. A slight decrease in the clearance of Alibra is observed when taking theophylline (400 mg once a day) together with Alibra. However, the disposition of theophylline did not change with the simultaneous administration of Alibra. Concomitant use of Alibra and macrolides or ketoconazole has never resulted in clinically significant changes in EGG cells. The degree of exposure to Alibra was increased by 40% when taking ritonavir with Alibra. The location of ritonavir was slightly altered in the subsequent concurrent administration of Alibra.

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What are the possible side effects of Alibra?

Pediatric studies were conducted using Alibra hydrochloride. More than 1,300 pediatric patients aged 6 to 11 years with more than 900 treated with Alibra hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials lasting up to 4 weeks included 168 pediatric patients aged 2 to 5 years who received Alibra, most of whom received a single daily dose of 5 mg. An 18-month placebo-controlled trial included 399 patients aged 12 to 24 months treated with Alibra (0.25 mg / kg bid), and another 7-day placebo-controlled trial included 42 patients aged 6 to 11 months receiving Alibra (0.the rate is 25 mg / kg)

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years treated with Alibra hydrochloride were mild or moderate. In placebo-controlled studies, the frequency of interruptions due to adverse reactions in pediatric patients treated with up to 10 mg of Alibra hydrochloride was rare (0.4% on Alibra hydrochloride versus 1.0% on placebo).

Table 1 lists the side effects that have been reported with the use of Alibra hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more frequent with the use of Alibra hydrochloride than placebo. Of these, abdominal pain was considered treatment-related, and drowsiness appeared to be dose-related: 1.3% in placebo, 1.9% in 5 mg, and 4.2% in 10 mg. Adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in studies with children aged 6 to 11 years

In placebo-controlled studies in pediatric patients aged 6 to 24 months, the incidence of adverse events was the same in the Alibra and placebo treatment groups in each study. Drowsiness was observed with almost the same frequency in patients treated with Alibra hydrochloride and in patients treated with placebo. In a 1-week study in children aged 6 to 11 months, patients treated with Alibra showed greater irritability / fussiness than patients treated with placebo. In an 18-month study of patients 12 months and older, insomnia was more common in patients treated with Alibra compared to patients treated with placebo (9.0% in. 5.3%). Those patients who received 5 mg or more of Alibra per day compared to those who received a placebo experienced fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) met more often

Table 1.

Side effects reported in pediatric patients aged 6 to 11 years in placebo-controlled trials of Alibra hydrochloride in the United States (dose 5 or 10 mg) Which occurred with a frequency of ≥2% in either the 5 mg or 10 mg Alibra hydrochloride group, and more frequently than in the placebo group

The following events were observed infrequently (less than 2%) in either 3,982 adults and children 12 years and older, or in 659 pediatric patients aged 6 to 11 years treated with Alibra hydrochloride in American studies, including an open-label study for adults lasting six months. The causal relationship of these infrequent events with the intake of Alibra hydrochloride has not been established.

Autonomic nervous system: anorexia, redness, increased salivation, urinary retention.

Cardiovascular: heart failure, hypertension, palpitations, tachycardia.

Central and peripheral nervous systems: impaired coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertension, hypesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, fainting, tremor, convulsions, dizziness, visual field defect.

Gastrointestinal tract: impaired liver function, exacerbation of dental caries, constipation, dyspepsia, belching, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal bleeding, stomatitis, including ulcerative stomatitis, discoloration of the tongue, swelling of the tongue.

Urogenital: cystitis, dysuria, hematuria, frequency of urination, polyuria, urinary incontinence, urinary tract infection.

Hearing and vestibular apparatus: deafness, ear pain, ototoxicity, tinnitus.

Metabolism/Nutrition: dehydration, diabetes, thirst.

Musculoskeletal system: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paronyria, sleep disorder.

Respiratory system: bronchitis, shortness of breath, hyperventilation, increased sputum production, pneumonia, respiratory disorders, rhinitis, sinusitis, upper respiratory tract infections.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leucorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous rash, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, toxic photosensitivity reaction, itching, purpura, rash, seborrhea, skin diseases, skin nodules, urticaria.

Special sensations: parosmia, loss of taste, perversion of taste.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmos.

Body as a whole: accidental injury, asthenia, back pain, chest pain, abdominal enlargement, facial edema, fever, generalized edema, hot flushes, weight gain, leg swelling, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigor mortis.

Rare cases of transient, reversible increases in hepatic transaminases have been observed during Alibra therapy. Hepatitis has been reported with a significant increase in transaminase levels and an increase in bilirubin levels due to the use of Alibra hydrochloride.

Post-Marketing Experience

In the post-marketing period, the following additional rare but potentially severe adverse events were reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, oral dyskinesia, severe hypotension, stillbirth, suicidal thoughts, suicide, and thrombocytopenia.

Alibra HCl is a piperazine derivative and a hydroxyzine metabolite. It reversibly competes with histamine by blocking histamine (H₁) receptor sites. Alibra HCl is considered a non-sedative long-acting antihistamine and has some stabilizing activity against mast cells.