Hexocet Uses

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What is Hexocet?

Hexocet 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.

Hexocet is used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.

Hexocet is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.

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

Hexocet indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Seasonal Allergic Rhinitis

Hexocet dihydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.

Perennial Allergic Rhinitis

Hexocet dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.

Chronic Idiopathic Urticaria

Hexocet dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

How should I use Hexocet?

Use Hexocet solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Hexocet solution.

Uses of Hexocet in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Hexocet is used to treat symptoms of allergic conditions such as allergic fever (hay fever), year-round allergies like dust or pet allergies and chronic nettle rash.

Hexocet description

Hexocet is a third-generation non-sedative antihistamine indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria. It was developed from the second-generation antihistamine cetirizine. Hexocet is the R-enantiomer of the cetirizine racemate. Hexocet is an inverse agonist that decreases activity at histamine H1 receptors. This in turn prevents the release of other allergy chemicals and increased blood supply to the area, and provides relief from the typical symptoms of hay fever. It does not prevent the actual release of histamine from mast cells. Hexocet was approved by the United States Food and Drug Administration on May 25, 2007 and is marketed under the brand Hexocet® by sanofi-aventis U.S. LLC.

Hexocet dosage

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Hexocet Dosage

Generic name: Hexocet DIHYDROCHLORIDE 5mg

Dosage form: tablet, film coated, oral solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Hexocet is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Hexocet can be taken without regard to food consumption.

Adults and Children 12 Years of Age and Older

The recommended dose of Hexocet is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.

Children 6 to 11 Years of Age

The recommended dose of Hexocet is 2.5 mg (1/2 tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults.

Children 6 months to 5 Years of Age

The recommended initial dose of Hexocet is 1.25 mg (1/2 teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg.

Dose Adjustment for Renal and Hepatic Impairment

In adults and children 12 years of age and older with:

No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

More about Hexocet (Hexocet)

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Hexocet interactions

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What other drugs will affect Hexocet?

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Drug interaction studies have been performed with racemic cetirizine.

Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline and Pseudoephedrine: Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole and cimetidine. There was a small decrease (approximately 16%) in the clearance of cetirizine caused by theophylline 400 mg dose. It is possible that higher theophylline doses could have a greater effect.

Interactions with Other Medicaments: No interaction studies have been performed with Hexocet (including no studies with CYP3A4 inducers); studies with the racemate compound, cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple-dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.

The extent of absorption of Hexocet is not reduced with food, although the rate of absorption is decreased.

In sensitive patients the simultaneous administration of cetirizine or Hexocet and alcohol or other CNS depressants, may have effects on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.

Hexocet side effects

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What are the possible side effects of Hexocet?

Use of Hexocet has been associated with somnolence, fatigue, asthenia, and urinary retention.

Clinical Trials Experience

The safety data described below reflect exposure to Hexocet in 2708 patients with seasonal or perennial allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration.

The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with Hexocet 2.5, 5, or 10 mg once daily in the evening.

The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with seasonal or perennial allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with Hexocet 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with Hexocet 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with Hexocet 1.25 mg once daily for 2 weeks.

The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with Hexocet 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 Hexocet-treated subjects 12-24 months of age.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 years of Age and Older

In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian.

In these trials 43% and 42% of the subjects in the Hexocet 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group.

In placebo-controlled trials of 1-6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity. Somnolence with Hexocet showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%).

Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to Hexocet 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with Hexocet than placebo.

Table 1 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 12 Years and Older Exposed to Hexocet 2.5 mg or 5 mg Once Daily in Placebo-Controlled Clinical Trials 1-6 Weeks in Duration

Adverse Reactions Hexocet 2.5 mg

(n = 421)

Hexocet 5 mg

(n = 1070)

Placebo

(n = 912)

Somnolence 22 (5%) 61 (6%) 16 (2%)
Nasopharyngitis 25 (6%) 40 (4%) 28 (3%)
Fatigue 5 (1%) 46 (4%) 20 (2%)
Dry Mouth 12 (3%) 26 (2%) 11 (1%)
Pharyngitis 10 (2%) 12 (1%) 9 (1%)
*Rounded to the closest unit percentage

Additional adverse reactions of medical significance observed at a higher incidence than in placebo in adults and adolescents aged 12 years and older exposed to Hexocet are syncope (0.2%) and weight increased (0.5%).

Pediatric Patients 6 To 12 Years Of Age

A total of 243 pediatric patients 6 to 12 years of age received Hexocet 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were 6 to 8 years of age, and 50% were Caucasian. Table 2 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 6 to 12 years exposed to Hexocet 5 mg in placebo-controlled clinical trials and that were more common with Hexocet than placebo.

Table 2 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 6-12 Years Exposed to Hexocet 5 mg Once Daily in Placebo-Controlled Clinical Trials 4 and 6 Weeks in Duration

Adverse Reactions Hexocet 5 mg

(n = 243)

Placebo

(n = 240)

Pyrexia 10 (4%) 5 (2%)
Cough 8 (3%) 2 ( < 1%)
Somnolence 7 (3%) 1 ( < 1%)
Epistaxis 6 (2%) 1 ( < 1%)
*Rounded to the closest unit percentage

Pediatric Patients 1 To 5 Years Of Age

A total of 114 pediatric patients 1 to 5 years of age received Hexocet 1.25 mg twice daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 3.8 years, 32% were 1 to 2 years of age, 71% were Caucasian and 18% were Black. Table 3 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 1 to 5 years exposed to Hexocet 1.25 mg twice daily in the placebo-controlled safety trial and that were more common with Hexocet than placebo.

Table 3 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 1-5 Years Exposed to Hexocet 1.25 mg Twice Daily in a 2-Week Placebo-Controlled Clinical Trial

Adverse Reactions Hexocet 1.25 mg Twice Daily

(n = 114)

Placebo

(n = 59)

Pyrexia 5 (4%) 1 (2%)
Diarrhea 4 (4%) 2 (3%)
Vomiting 4 (4%) 2 (3%)
Otitis Media 3 (3%) 0 (0%)
*Rounded to the closest unit percentage

Pediatric Patients 6 To 11 Months Of Age

A total of 45 pediatric patients 6 to 11 months of age received Hexocet 1.25 mg once daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. greater than or equal to 3% of subjects) aged 6 to 11 months exposed to Hexocet 1.25 mg once daily in the placebo-controlled safety trial and that were more common with Hexocet than placebo included diarrhea and constipation which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the Hexocet and placebo-treated groups, respectively.

Long-Term Clinical Trials Experience

In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with Hexocet 5 mg once daily for 4 or 6 months. The patient characteristics and the safety profile were similar to that seen in the short-term studies. Ten (2.3%) patients treated with Hexocet discontinued because of somnolence, fatigue or asthenia compared to 2 ( < 1%) in the placebo group.

There are no long term clinical trials in children below 12 years of age with allergic rhinitis or chronic idiopathic urticaria.

Laboratory Test Abnormalities

Elevations of blood bilirubin and transaminases were reported in < 1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient.

Post-Marketing Experience

In addition to the adverse reactions reported during clinical trials and listed above, adverse reactions have also been identified during post-approval use of Hexocet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions of hypersensitivity and anaphylaxis, increased appetite, angioedema, fixed drug eruption, pruritus, rash and urticaria, convulsion, paraesthesia, dizziness, tremor, dysgeusia, vertigo, movement disorders (including dystonia and oculogyric crisis), aggression and agitation, hallucinations, depression, insomnia, suicidal ideation, visual disturbances, blurred vision, palpitations, tachycardia, dyspnea, nausea, vomiting, hepatitis, dysuria, urinary retention, myalgia, arthralgia, and edema have been reported.

Besides these reactions reported under treatment with Hexocet, other potentially severe adverse events have been reported from the post-marketing experience with cetirizine. Since Hexocet is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with Hexocet: orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, still birth, tic, myoclonus, and extrapyramidal symptoms.

Hexocet contraindications

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

You should not use this medication if you are allergic to Hexocet or cetirizine (Zyrtec).

Do not take Hexocet if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take Hexocet.

Before taking Hexocet, tell your doctor if you have liver disease, kidney disease, or gallbladder problems.

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of Hexocet as an adult's body.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Active ingredient matches for Hexocet:

Levocetirizine


Unit description / dosage (Manufacturer)Price, USD
Hexocet 5mg TAB / 10

List of Hexocet substitutes (brand and generic names):

HG Monte Tablet (Health Guard (India) Pvt. Ltd.)$ 0.21
HHLEVO 5 MG TABLET 1 strip / 10 tablets each (Hegde and Hegde Pharmaceutical LLP)$ 0.83
Hhlevo 5mg Tablet (Hegde and Hegde Pharmaceutical LLP)$ 0.09
Hicet L 5 mg Tablet (B & B (Micro Labs Ltd.))$ 0.05
HICET L 5 MG TABLET 1 strip / 10 tablets each (B & B (Micro Labs Ltd.))$ 0.69
HICET L SYRUP 1 bottle / 30 ML syrup each (B & B (Micro Labs Ltd.))$ 0.54
Hicet L 5mg Tablet (B & B (Micro Labs Ltd.))$ 0.07
Hicet L NA Syrup (B & B (Micro Labs Ltd.))$ 0.54
Hicet-L 5mg FC-TAB / 10 (Micro Labs)$ 0.43
5 mg x 10's (Micro Labs)$ 0.43
HICET-L film-coated tab 5 mg x 10's (Micro Labs)$ 0.55
Himcet L 5 mg Tablet (Himsagar Laboratories Ltd.)$ 0.05
Himcet-L 5mg TAB / 10
His-Block 5mg Tablet (SAF Fermion Ltd)$ 0.09
Hiscorn 5 mg Tablet (Unicorn (India))$ 0.04
Hiskast LV 5 mg Tablet (Stellar Bio Labs)$ 0.04
Hista LC 5 mg Tablet (N.R.I. Vision Care)$ 0.08
HISTA LC TABLET 1 strip / 10 tablets each (N.R.I. Vision Care)$ 0.40
Hista LC NA Tablet (N.R.I. Vision Care)$ 0.04
HISTABAN 5MG TABLET 1 strip / 10 tablets each (Gracious Pharmaceuticals)$ 0.45
Histacare Tablet (N.R.I. Vision Care)$ 0.08
Histacet L 5 mg Tablet (Merril Pharma Pvt. Ltd.)$ 0.04
Histacet-L 5mg TAB / 10x10$ 3.97
Histachek 5mg TAB / 10 (Indoco Remedies Ltd)$ 0.40
5 mg x 10's (Indoco Remedies Ltd)$ 0.40
Histachek 5 mg Tablet (Indoco Remedies Ltd)$ 0.04
HISTACHEK 5MG TABLET 1 strip / 10 tablets each (Indoco Remedies Ltd)$ 0.41
Histachek 5mg Tablet (Indoco Remedies Ltd)$ 0.04
Histalev 5 mg Tablet (Altruist Pharmacia Pvt Ltd)$ 0.04
Histoliv 5mg TAB / 10 (Indus Pharma Pvt. Ltd.)$ 0.56
Histoliv 5 mg Tablet (Indus Pharma Pvt. Ltd.)$ 0.06
Hitzin L 5 mg Tablet (Hexal Pharmaceuticals)$ 0.03
Hitzin-L 5mg TAB / 10$ 0.32
Hycet LC 5 mg Tablet (Trio Remedies Pvt.Ltd)$ 0.04
Hycet-LC 5mg TAB / 10x10$ 3.97
Hyliv 5 5 mg Tablet (M.M. Pharma)$ 0.06
Hyliv-5 5mg TAB / 10$ 0.59

References

  1. PubChem. "Levocetirizine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "Levocetirizine". http://www.drugbank.ca/drugs/DB06282 (accessed September 17, 2018).
  3. MeSH. "Histamine H1 Antagonists, Non-Sedating". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Hexocet are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Hexocet. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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