Asytec

Perennial Allergic Rhinitis: Asytec syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: Asytec syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

Asytec is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

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

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

Usual Adult Dose for Allergic Rhinitis

5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

5 to 10 mg orally or chewed once a day

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.

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

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

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.

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

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

Renal Dose Adjustments

CrCl less than 30 mL/min: 5 mg orally or chewed once a day.

Use of Asytec is not recommended in children under 6 years of age with renal impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Asytec in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Asytec is not recommended in children under 6 years of age with hepatic impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Asytec in such patients.

Precautions

In clinical trials, the occurrence of somnolence has been reported. Due caution should therefore be exercised when driving a car or operating potential dangerous machinery. Concurrent use of alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Dialysis

Asytec is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis. The recommended dosage for patients on hemodialysis is 5 mg orally or chewed once a day.

See also:
What is the most important information I should know about Asytec?

Tablet: Asytec should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

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

Use Asytec orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not remove the blister unit from the carton until you are ready to take Asytec orally disintegrating tablets. Make sure that your hands are dry when you open the blister unit. Do not push the tablet through the foil. Peel back the foil on the blister unit and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Asytec orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister unit. Do not store the removed tablet for future use.
• If you miss a dose of Asytec orally disintegrating tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Asytec orally disintegrating tablets.

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

How to use Asytec

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

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been 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 using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

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

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

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What other drugs will affect Asytec?

Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Asytec; maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Asytec.

Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Asytec.

Concurrent use with ototoxic medications may mask the symptoms of ototoxicity eg, tinnitus, dizziness or vertigo; photosensitizing medications may cause additive photosensitizing effects.

Syrup: No interaction is observed for Asytec with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Asytec clearance is observed when theophylline (400 mg once daily) is taken with Asytec. However, disposition of theophylline was not altered by concomitant Asytec administration. Concomitant administration of Asytec and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Asytec was increased by 40% when ritonavir is taken with Asytec. Disposition of ritonavir was slightly altered further to concomitant Asytec administration.

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What are the possible side effects of Asytec?

Pediatric studies were conducted with Asytec. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Asytec 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 up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received Asytec, the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with Asytec (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with Asytec (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Asytec were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of Asytec was uncommon (0.4% on Asytec vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Asytec 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with Asytec than placebo. Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The 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 trials with children aged 6 to 11 years.

In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the Asytec and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Asytec and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Asytec exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received Asytec compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Asytec as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

Table 1.

Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Asytec Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Asytec Group, and More Frequently Than in the Placebo Group

The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received Asytec in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Asytec administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

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

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

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

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

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

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

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Asytec therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Asytec has been reported.

Post-Marketing Experience

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

Asytec HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H₁) receptor sites. Asytec HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.