What is Zotacet MD?
Zotacet MD 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.
Zotacet MD is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.
Zotacet MD is also used to treat itching and swelling caused by chronic urticaria (hives).
Zotacet MD may also be used for purposes not listed in this medication guide.
Zotacet MD indications
Perennial Allergic Rhinitis: Zotacet MD hydrochloride 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: Zotacet MD hydrochloride 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.
How should I use Zotacet MD?
Use Zotacet MD 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 Zotacet MD 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. Zotacet MD 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 Zotacet MD 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 Zotacet MD orally disintegrating tablets.
Uses of Zotacet MD in details
Use: Labeled Indications
Oral:
Allergic rhinitis: Relief of symptoms associated with allergic rhinitis.
Urticaria, chronic spontaneous: Treatment of uncomplicated skin manifestations of chronic spontaneous urticaria.
Injection:
Urticaria, acute: Treatment of acute urticaria.
Off Label Uses
Anaphylaxis (adjunct to epinephrine for relief of cutaneous symptoms)
Based on joint guidelines from the American Academy of Allergy, Asthma & Immunology, American College of Allergy, Asthma & Immunology, and Joint Council of Allergy, Asthma and Immunology on the diagnosis and management of anaphylaxis and guidelines from the World Allergy Organization on anaphylaxis, Zotacet MD may be used as adjunctive treatment, although should not be used as monotherapy or as first-line therapy of anaphylaxis.
Angioedema, acute allergic or recurrent idiopathic
Clinical experience suggests the utility of second-generation H receptor antagonists (eg, Zotacet MD) for the treatment of acute allergic or recurrent idiopathic angioedema.
Zotacet MD description
Zotacet MD HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H1) receptor sites. Zotacet MD HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.
Zotacet MD dosage
Zotacet MD Dosage
Applies to the following strength(s): 10 mg; 5 mg; 1 mg/mL
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
- Allergic Rhinitis
- Urticaria
Usual Pediatric Dose for:
- Allergic Rhinitis
- Urticaria
Additional dosage information:
- Renal Dose Adjustments
- Liver Dose Adjustments
- Precautions
- Dialysis
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 Zotacet MD 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 Zotacet MD in such patients.
Liver Dose Adjustments
5 mg orally or chewed once a day
Use of Zotacet MD 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 Zotacet MD 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
Zotacet MD 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.
More about Zotacet MD
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
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- Support Group
- Pricing & Coupons
- 139 Reviews - Add your own review/rating
Consumer resources
- Zotacet MD
- Zotacet MD chewable tablets
- Zotacet MD orally disintegrating tablets
- Zotacet MD solution
- Other brands: Zyrtec, Children's Zyrtec, Zyrtec Hives, Zotacet MD, More (1) »
Professional resources
- Zotacet MD Hydrochloride (AHFS Monograph)
- More (8) »
Related treatment guides
- Allergic Rhinitis
- Urticaria
Zotacet MD interactions
See also:
What other drugs will affect Zotacet MD?
Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Zotacet MD; maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Zotacet MD.
Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Zotacet MD.
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 Zotacet MD with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Zotacet MD clearance is observed when theophylline (400 mg once daily) is taken with Zotacet MD. However, disposition of theophylline was not altered by concomitant Zotacet MD administration. Concomitant administration of Zotacet MD and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Zotacet MD was increased by 40% when ritonavir is taken with Zotacet MD. Disposition of ritonavir was slightly altered further to concomitant Zotacet MD administration.
Zotacet MD side effects
See also:
What are the possible side effects of Zotacet MD?
Pediatric studies were conducted with Zotacet MD hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Zotacet MD 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 up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received Zotacet MD, 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 Zotacet MD (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 Zotacet MD (0.25 mg/kg bid).
The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Zotacet MD hydrochloride 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 Zotacet MD hydrochloride was uncommon (0.4% on Zotacet MD hydrochloride vs. 1.0% on placebo).
Table 1 lists adverse experiences which were reported for Zotacet MD 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 common with Zotacet MD hydrochloride 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 Zotacet MD and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Zotacet MD hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Zotacet MD 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 Zotacet MD compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Zotacet MD 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 Zotacet MD Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Zotacet MD Hydrochloride Group, and More Frequently Than in the Placebo Group
| Adverse Experiences | Placebo (N=309) | Zotacet MD Hydrochloride | |
| 5 mg (N=161) | 10 mg (N=215) | ||
| Headache | 12.3% | 11.0% | 14.0% |
| Pharyngitis | 2.9% | 6.2% | 2.8% |
| Abdominal pain | 1.9% | 4.4% | 5.6% |
| Coughing | 3.9% | 4.4% | 2.8% |
| Somnolence | 1.3% | 1.9% | 4.2% |
| Diarrhea | 1.3% | 3.1% | 1.9% |
| Epistaxis | 2.9% | 3.7% | 1.9% |
| Bronchospasm | 1.9% | 3.1% | 1.9% |
| Nausea | 1.9% | 1.9% | 2.8% |
| Vomiting | 1.0% | 2.5% | 2.3% |
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 Zotacet MD hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Zotacet MD hydrochloride 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 Zotacet MD therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Zotacet MD hydrochloride 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.
Zotacet MD contraindications
See also:
What is the most important information I should know about Zotacet MD?
Tablet: Zotacet MD 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 Zotacet MD dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Zotacet MD. 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 Zotacet MD.
Active ingredient matches for Zotacet MD:
| Unit description / dosage (Manufacturer) | Price, USD |
| Zotacet MD 10 mg Tablet | $ 0.02 |
List of Zotacet MD substitutes (brand and generic names): | |
| Zonatus DMR | |
| Zonatus DMR 100 ml Syrup (Avron Pharma) | $ 0.03 |
| Zotalase | |
| Zotalase 60 ml Syrup (Elder Pharmaceuticals Pvt Ltd) | $ 0.03 |
| Zucet Dec | |
| Zucet Dec 10+150 Tablet (Glosun Pharmaceuticals (P) Ltd.) | $ 0.03 |
| Zurtec D | |
| Zurtec D 5+120 Tablet (UCB India Pvt Ltd.) | $ 0.01 |
| Zycet | |
| Zycet 10 mg Tablet (Ascent Corporations (Pvt) Ltd) | $ 0.03 |
| ZYCET 10 MG TABLET 1 strip / 10 tablets each (Ascent Corporations (Pvt) Ltd) | $ 0.22 |
| Zycet 10mg Tablet (Ascent Corporations (Pvt) Ltd) | $ 0.02 |
| Zyllergy (Israel) | |
| Caplets; Oral; Cetirizine Dihydrochloride 10 mg (Dexcel) | |
| Zymed (Thailand) | |
| Zymed 10 mg x 10 x 10's (Millimed) | |
| Zymed 1 mg/1 mL x 60 mL (Millimed) | |
| Zymed syr 1 mg/mL 60 mL x 1's (Millimed) | |
| Zymed tab 10 mg 10 x 10's (Millimed) | |
| Zyncet (Ethiopia, Oman, Peru) | |
| Syrup; Oral; Cetirizine Hydrochloride 5 mg / 5 ml (Unichem Laboratories Ltd.) | |
| Tablet, Film-Coated; Oral; Cetirizine Hydrochloride 10 mg (Unichem Laboratories Ltd.) | |
| ZYNCET Capsule/ Tablet / 10mg / 10 units (Unichem Laboratories Ltd.) | $ 0.34 |
| ZYNCET Liquid / 5mg per 5ml / 60ml units (Unichem Laboratories Ltd.) | $ 0.31 |
| Zyncet 10mg TAB / 10 (Unichem Laboratories Ltd.) | $ 0.34 |
| Zyncet 5mg/5ml SYP / 60ml (Unichem Laboratories Ltd.) | $ 0.31 |
| 10 mg x 10's (Unichem Laboratories Ltd.) | $ 0.42 |
| 1 mg x 1 mL x 60ml (Unichem Laboratories Ltd.) | $ 0.33 |
| Zyncet 60 ml Syrup (Unichem Laboratories Ltd.) | $ 0.03 |
| Zyncet 10 mg Tablet (Unichem Laboratories Ltd.) | $ 0.05 |
| ZYNCET 10 MG SYRUP 1 bottle / 30 ML syrup each (Unichem Laboratories Ltd.) | $ 0.39 |
| ZYNCET 10 MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd.) | $ 0.19 |
| ZYNCET 5 MG/5ML SYRUP 1 bottle / 60 ML syrup each (Unichem Laboratories Ltd.) | $ 0.42 |
| ZYNCET film-coated tab 10 mg x 10's (Unichem Laboratories Ltd.) | $ 0.46 |
| ZYNCET syr 1 mg x 1 mL x 60ml (Unichem Laboratories Ltd.) | $ 0.33 |
| Zyncet 10mg Syrup (Unichem Laboratories Ltd.) | $ 0.39 |
| Zyncet 10mg Tablet (Unichem Laboratories Ltd.) | $ 0.02 |
| Zyncet 5mg/ml Syrup (Unichem Laboratories Ltd.) | $ 0.42 |
| Zyncet 10mg (Oman) | |
| Zyncet D | |
| Zyncet D 10+5 Tablet (Unichem Laboratories Ltd.) | $ 0.03 |
| ZYNCET D 5 MG/10 MG TABLET 1 strip / 10 tablets each (Unichem Laboratories Ltd.) | $ 0.49 |
| Zyncet D 5 mg/10 mg Tablet (Unichem Laboratories Ltd.) | $ 0.05 |
| Zyntra (Turkey) | |
| Zyrac (Thailand) | |
| Zyrac 10 mg x 10 x 10's (Osoth Interlab) | |
| Zyrac FC tab 10 mg 10 x 10's (Osoth Interlab) | |
| Zyrak 10 | |
| Zyrak 5 | |
| Zyral (Thailand) | |
| Zyral 10 mg x 10 x 10's | |
| Zyral 5 mg/5 mL x 100 mL | |
| Zyrazine (Thailand) | |
| Zyrazine 10 mg x 10 x 10's (British dispensary) | |
See 3022 substitutes for Zotacet MD | |
References
- DailyMed. "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "cetirizine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "cetirizine". http://www.drugbank.ca/drugs/DB00341 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Zotacet MD 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 Zotacet MD. 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.User reports
Consumer reported useful
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Information checked by Dr. Sachin Kumar, MD Pharmacology
