The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your not to work correctly. These are possible, but not always occur. Your doctor or can often prevent or manage interactions by changing how you use your medications or by close monitoring. This medicine may cause some people to become drowsy or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Some antihistamines are more likely to cause drowsiness than others. Drowsiness is less likely with cetirizine, and rare with desloratadine and loratadine.
African-American patients treated for 14 days with desloratadine had peak plasma concentration and area under the curve values for desloratadine that were 18% and 32% higher, respectively, in African-Americans compared with Caucasian patients. For 3-hydroxydesloratadine there was a corresponding 10% reduction in peak plasma concentration and area under the curve values in African-Americans compared to Caucasian. This is not relevant clinically and no dosage adjustment is recommended. Adults and teenagers: 10 milligrams mg injected into a muscle, under the skin, or into a vein every eight to twelve hours.
Desloratadine, resulted in Desloratadine plasma concentrations similar to those achieved in adults administered a single 5-mg Desloratadine Tablet. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, or confusion. These side effects can increase the risk of falling. AUC in humans at the recommended daily oral dose. AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of Desloratadine is not known.
Desloratadine and Desloratadine metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose. Antihistamines are used to relieve or prevent the symptoms of your medical problem. Take them only as directed. Do not take more of them and do not take them more often than recommended on the label, unless otherwise directed by your doctor. There were no differences in adverse events for subgroups of patients as defined by gender, age, or race. Do not consider WebMD User-generated content as medical advice. Never delay or disregard seeking professional medical advice from your doctor or other qualified healthcare provider because of something you have read on WebMD. You should always speak with your doctor before you start, stop, or change any prescribed part of your care plan or treatment. WebMD understands that reading individual, real-life experiences can be a helpful resource but it is never a substitute for professional medical advice, diagnosis, or treatment from a qualified health care provider. If you think you may have a medical emergency, call your doctor or dial 911 immediately.
Neither food nor grapefruit juice had an effect on the bioavailability C max and AUC of desloratadine. If you have and your doctor has prescribed loratadine, or if you are considering using this drug to treat your own hives, tell your doctor right away if you have any of these other symptoms because they may be signs of a more serious condition: hives that are an unusual color, hives that look bruised or blistered, hives that do not itch. Red No. 33, noncrystallizing sorbitol solution 70% propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, and sucrose. HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Although certain medicines should not be used together at all, in other cases different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. NDC 51672-4159-8, 6 fl oz 177 mL NDC 51672-4159-5, 8 fl oz 237 mL NDC 51672-4159-1. Elimination: The mean plasma elimination half-life of desloratadine was approximately 27 hours. C max and AUC values increased in a dose proportional manner following single oral doses between 5 and 20 mg. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. A human mass balance study documented a recovery of approximately 87% of the 14C-desloratadine dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-hydroxydesloratadine showed similar T max and half-life values compared to desloratadine. Keep Desloratadine Tablets, and all medicines out of the reach of children. Severe allergic reactions rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; difficulty urinating; fainting; fast or irregular heartbeat; seizures; severe or persistent dizziness; shortness of breath; tremor; vision changes. CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Take this medicine at least 30 minutes or, even better, 1 to 2 hours before you begin to travel. Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Call your doctor for medical advice about side effects. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Desloratadine may affect the way other medicines work, and other medicines may affect how desloratadine works. Children 2 to 6 years of age: 2 mg every eight to twelve hours as needed. You should not take Clarinex if you are allergic to desloratadine or to loratadine Claritin.
Get emergency medical help if you have any of these signs of an allergic reaction to Clarinex: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. CLARINEX can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take CLARINEX. Commonly used brand names: Aerius; Clarinex. What is desloratadine Clarinex? Adults and teenagers: 25 milligrams mg every four to six hours as needed. CLARINEX-D 24 HOUR Extended Release Tablets with these agents. Do NOT take more than the recommended dose or take more often than you were told without checking with your doctor. Keep out of the reach of children, since overdose may be very dangerous in children. CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. Children younger than 12 years of age: Use and dose must be determined by your doctor. Clarinex is not for children younger than 6 months of age. Whitby, Ontario, L1N 5Z5, Canada.
FDA pregnancy category C. It is not known whether desloratadine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Clarinex Tablets: Embossed "C5", light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 NDC 0085-1264-01 and 500 NDC 0085-1264-02. In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. Conventional tablets, oral solution, or orally disintegrating tablets: Dosage reduction recommended. 1 See Hepatic Impairment under Dosage and Administration and also see Elimination: Special Populations, under Pharmacokinetics. Refer to adult dosing. Desloratadine, respectively, did not show significant increases in the incidence of any tumors. The estimated Desloratadine and Desloratadine metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose. Check the labels on all your medicines such as or -and-cold products, because they may contain ingredients that could affect your or cause drowsiness. Ask your pharmacist about using those products safely. What other drugs will affect desloratadine? Keep this and all medication out of the reach of children. Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Wheal and Flare: Human histamine skin wheal studies following single and repeated 5-mg doses of Desloratadine have shown that the drug exhibits an antihistaminic effect by 1 hour; this activity may persist for as long as 24 hours. There was no evidence of histamine-induced skin wheal tachyphylaxis within the Desloratadine 5-mg group over the 28-day treatment period. The clinical relevance of histamine wheal skin testing is unknown. Elderly patients are usually more sensitive to the effects of antihistamines. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients.
Race: Following 14 days of treatment with desloratadine tablets, the C max and AUC values for desloratadine were 18% and 32% higher, respectively, in Blacks compared with Caucasians. For 3-hydroxydesloratadine there was a corresponding 10% reduction in C max and AUC values in Blacks compared to Caucasians. These differences are not likely to be clinically relevant and therefore no dose adjustment is recommended. Agrawal DK. Pharmacology and clinical efficacy of desloratadine as an anti-allergic and anti-inflammatory drug. Expert Opin Investig Drugs. Schering Corporation. Clarinex-D 24-Hour desloratadine 5 mg and pseudoephedrine sulfate extended-release tablets prescribing information. Kenilworth, NJ; 2005 Mar. Conventional tablets, oral solution, or orally disintegrating tablets: Dosage reduction recommended. 1 See Renal Impairment under Dosage and Administration and also see Absorption: Special Populations, under Pharmacokinetics. Desloratadine can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take Desloratadine. Clarinex Tablets are light blue, film-coated tablets embossed with "C5" containing 5 mg desloratadine. As there are no food effects on bioavailability, patients can be instructed that Clarinex Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals. Adults: 50 to 100 milligrams mg inserted into the rectum every six to eight hours as needed. Extensively metabolized to 3-hydroxydesloratadine active metabolite which subsequently undergoes glucuronidation; enzymes responsible for metabolism of desloratadine not identified. United States. The results of these studies demonstrated the efficacy and safety of desloratadine 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis. Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist. CLARINEX can be taken with or without food. The median exposure AUC to desloratadine in the poor metabolizers was approximately 6-fold greater than in the subjects who are not poor metabolizers. Subjects who are poor metabolizers of desloratadine cannot be prospectively identified and will be exposed to higher levels of desloratadine following dosing with the recommended dose of desloratadine. Desloratadine passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the benefit of the drug to the nursing mother and the possible risk to the child. Desloratadine was administered to subjects 6 to 11 months of age and 12 to 23 months of age. Desloratadine and its main active metabolite, 3-hydroxydesloratadine, are not removed by hemodialysis.
Ask your doctor or pharmacist about using this product safely. Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Desloratadine Tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Desloratadine Tablets and that were more common with Desloratadine than placebo were rates for Desloratadine and placebo, respectively: headache 14%, 13% nausea 5%, 2% fatigue 5%, 1% dizziness 4%, 3% pharyngitis 3%, 2% dyspepsia 3%, 1% and myalgia 3%, 1%. CDC, 1982; some data suggests that benzoate displaces bilirubin from protein binding sites Ahlfors, 2001; avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. Adults: 5 mg every other day as conventional tablets, oral solution, orally disintegrating tablets, or fixed-combination tablets. Fever, diarrhea, upper respiratory tract infection, coughing. Desloratadine Tablets can be taken with or without food.
The presence of other medical problems may affect the use of antihistamines. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Overdose symptoms may include fast heart rate. What are the possible side effects of Clarinex Tablets? If you miss a dose of desloratadine syrup 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. Place each dose on the and allow to dissolve completely, then swallow it with or with water. F. Protect from excessive moisture. Protect from light. Do not crush or chew extended-release tablets or capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. There were no significant differences in the effectiveness of desloratadine tablets 5 mg across subgroups of patients defined by gender, age, or race. The mean plasma elimination half-life of Desloratadine was approximately 27 hours. C max and AUC values increased in a dose proportional manner following single oral doses between 5 and 20 mg. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. A human mass balance study documented a recovery of approximately 87% of the 14C-Desloratadine dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-hydroxyDesloratadine showed similar T max and half-life values compared to Desloratadine. In two 4-week studies of 924 patients aged 15 to 75 years with seasonal allergic rhinitis and concomitant asthma, Desloratadine Tablets 5 mg once daily improved rhinitis symptoms, with no decrease in pulmonary function. This supports the safety of administering Desloratadine Tablets to adult patients with seasonal allergic rhinitis with mild to moderate asthma. What are the ingredients in Desloratadine Tablets? Hour Extended Release Tablets can pass into your breast milk. Ask your pharmacist for a dropper or syringe if you do not have one. In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
Borge PA. Problems in allergic rhinitis. Arzneimittelforschung. Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the desloratadine product. Administer conventional tablets, oral solution, orally disintegrating tablets, and fixed-combination extended-release tablets orally once daily without regard to meals. Bazett and Fridericia methods. In subjects 6 months to 11 months of age, adverse events reported for Clarinex and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were upper respiratory tract infections 21. Dimethindene Topical: May enhance the CNS depressant effect of CNS Depressants. In subjects 6 months to 11 months of age, adverse events reported for Desloratadine and placebo in at least 2 percent of subjects receiving Desloratadine Oral Solution and at a frequency greater than placebo were upper respiratory tract infections 21. Slightly soluble in water; Very soluble in ethanol and propylene glycol.
Desloratadine and 3-hydroxydesloratadine were poorly removed by hemodialysis. Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Some of the antihistamines are also used to prevent motion sickness, nausea, vomiting, and dizziness. In patients with Parkinson's disease, diphenhydramine may be used to decrease stiffness and tremors. Also, the syrup form of diphenhydramine is used to relieve the cough due to colds or hay fever. In addition, since antihistamines may cause drowsiness as a side effect, some of them may be used to help people go to sleep. Douglas WW. Histamine and 5-hydroxytryptamine serotonin and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al, eds. Analgesics Opioid: CNS Depressants may enhance the CNS depressant effect of Analgesics Opioid. Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 'Multum' is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. If your doctor has prescribed this medication, follow your doctor's directions and the instructions on your prescription label. Clarinex-treated subjects relative to placebo. No clinically relevant adverse events were reported.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your or local waste disposal company. Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Adults: 50 milligrams mg injected into a muscle or into a vein every four hours as needed. Desloratadine or any of the ingredients in Desloratadine Tablets. See the end of this leaflet for a complete list of ingredients. C. 18 Protect from excessive moisture. Adults and teenagers: 25 to 50 milligrams mg every four to six hours as needed. Desloratadine and 3-hydroxydesloratadine are approximately 82% to 87% and 85% to 89% bound to plasma proteins, respectively. Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in subjects with impaired renal function. Desloratadine a major metabolite of loratadine is extensively metabolized to 3-hydroxyDesloratadine, an active metabolite, which is subsequently glucuronidated. The enzymes responsible for the formation of 3-hydroxyDesloratadine have not been identified. Data from clinical trials indicate that a subset of the general population has a decreased ability to form 3-hydroxyDesloratadine, and are poor metabolizers of Desloratadine. Do not store the capsule or tablet form of this medicine in the bathroom medicine cabinet, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. C. Protect Desloratadine Oral Solution from light. What are the possible side effects of desloratadine Clarinex? United States and internationally. Who should not take Clarinex? Food or grapefruit juice does not appear to affect bioavailability following administration as conventional tablets, oral solution, 1 or fixed-combination tablets; 18 water does not appear to affect bioavailability following administration as orally disintegrating tablets. AUC and Cmax of CLARINEX Oral Solution.
It is not known if Clarinex will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. C. 1 Protect from light. Children younger than 2 years of age: Use and dose must be determined by your doctor. Amphetamines: May diminish the sedative effect of Antihistamines. Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional. Clarinex-treated subjects relative to placebo. Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame. Call your doctor if your symptoms do not improve. What happens if I miss a dose? Slow metabolizers: Use with caution in patients known to be slow metabolizers of desloratadine incidence of side effects may be increased. Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. The mean plasma elimination half-life of desloratadine was approximately 27 hours. C max and AUC values increased in a dose proportional manner following single oral doses between 5 and 20 mg. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. A human mass balance study documented a recovery of approximately 87% of the 14C-desloratadine dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-hydroxydesloratadine showed similar T max and half-life values compared to desloratadine.
Desloratadine and Desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose. CLARINEX Tablets or CLARINEX Oral Solution. See the end of this leaflet for a complete list of ingredients. In subjects 6 months to 11 months of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving Desloratadine Oral Solution and at a frequency greater than placebo were upper respiratory tract infections 21. Pseudoephedrine is a and works by narrowing the vessels in the nose to decrease swelling and congestion. Hepatic to active metabolite, 3-hydroxydesloratadine specific enzymes not identified; subsequently undergoes glucuronidation. Decreased in slow metabolizers of desloratadine. Not expected to affect or be affected by medications metabolized by CYP with normal doses. Effects on QTc: Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist. Note: Frequency reported in children, unless otherwise noted. Discuss specific use of drug and side effects with patient as it relates to treatment. HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? What other drugs will affect desloratadine Clarinex? Discuss the risks and benefits with your doctor. Desloratadine Oral Solution was administered to 66 pediatric subjects 6 to 11 months of age. The results of these studies demonstrated the safety of Desloratadine Oral Solution in pediatric subjects 6 months to 11 years of age. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Following single- and multiple-dose administration, antihistaminic effects occur within 1 hour. 1 Symptomatic nasal and nonnasal improvement observed as early as 1 day after initiation of therapy. Serious side effects, such as convulsions seizures are more likely to occur in younger patients and would be of greater risk to infants than to older children or adults. In general, children are more sensitive to the effects of antihistamines. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
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Tmax and halflife values compared to desloratadine. Oral Solution for 15-35 days. Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Clarinex Oral Solution for 15 days in three placebo-controlled clinical trials. In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects. Lofexidine: May enhance the CNS depressant effect of CNS Depressants.
Desloratadine Oral Solution administered to 55 pediatric subjects 2 to 5 years of age. How should I take Desloratadine Tablets? Desloratadine passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue Desloratadine, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.
Bioequivalence of the Clarinex RediTabs Tablet and the previously marketed RediTabs Tablet was established in adults. If your liquid form is a suspension, shake the bottle well before each dose. Contact your doctor or health care provider right away if any of these apply to you. Desloratadine syrup should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed. Day 10 for pseudoephedrine.
Meltzer EO, Prenner BM, Nayak A for the Desloratadine Study Group. Efficacy and tolerability of once-daily 5 mg desloratadine, an H 1-receptor antagonist, in patients with seasonal allergic rhinitis assessment during the spring and fall allergy seasons. Clin Drug Invest. Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving antihistamines particularly at larger doses may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Keep Clarinex Tablets, RediTabs Tablets, and Oral Solution and all medicines out of the reach of children.