Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include drowsiness; fast or irregular heartbeat.
Proper storage of Des orally disintegrating tablets:
Store Des orally disintegrating tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Des orally disintegrating tablets out of the reach of children and away from pets.
Overdose of Des in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Des and 3-hydroxyDesloratadine are not eliminated by hemodialysis.
Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the Des product. In a dose-ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported.
In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of Des 45 mg for 10 days.
Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated Des and Des metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/kg (estimated Des exposures were approximately 290 times the human daily oral dose on a mg/m2 basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated Des exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).
What should I avoid while taking Des?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Des.
Des warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Hypersensitivity Reactions
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of Des. If such a reaction occurs, therapy with Des should be stopped and alternative treatment should be considered. This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
What should I discuss with my healthcare provider before taking Des?
Some medical conditions may interact with Des orally disintegrating tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have kidney or liver problems
if you have phenylketonuria (PKU)
Some MEDICINES MAY INTERACT with Des orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
Amiodarone because the risk of fast or irregular heartbeat may be increased
Other antihistamines (eg, diphenhydramine), azithromycin, cimetidine, erythromycin, fluoxetine, or ketoconazole because they may increase the risk of Des orally disintegrating tablets's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Des orally disintegrating tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Des precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Hypersensitivity Reactions
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of Des. If such a reaction occurs, therapy with Des should be stopped and alternative treatment should be considered.
Patient Counseling Information
Information For Patients
Patients should be instructed to use Des as directed.
As there are no food effects on bioavailability, patients can be instructed that Des Tablets or
Oral Solution may be taken without regard to meals.
Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity Studies
The carcinogenic potential of Des was assessed using a loratadine study in rats and a Des study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated Des and Des metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated Des and Des metabolite exposures in rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose. The clinical significance of these findings during long-term use of Des is not known.
In a 2-year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day Des, respectively, did not show significant increases in the incidence of any tumors. The estimated Des and Des metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose.
Genotoxicity Studies
In genotoxicity studies with Des, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).
Impairment of Fertility
There was no effect on female fertility in rats at Des doses up to 24 mg/kg/day (estimated Des and Des metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral Des dose of 12 mg/kg in rats (estimated Des and Des metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Des had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated Des and Des metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).
Use In Specific Populations
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Des should be used during pregnancy only if clearly needed.
Des was not teratogenic in rats or rabbits at approximately 210 and 230 times, respectively, the area under the concentration-time curve (AUC) in humans at the recommended daily oral dose. An increase in pre-implantation loss and a decreased number of implantations and fetuses were noted, however, in a separate study in female rats at approximately 120 times the AUC in humans at the recommended daily oral dose. Reduced body weight and slow righting reflex were reported in pups at approximately 50 times or greater than the AUC in humans at the recommended daily oral dose. Des had no effect on pup development at approximately 7 times the AUC in humans at the recommended daily oral dose. The AUCs in comparison referred to the Des exposure in rabbits and the sum of Des and its metabolites exposures in rats, respectively.
Nursing Mothers
Des passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue Des, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.
Pediatric Use
The recommended dose of Des
Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of Des in adults and pediatric subjects. The safety of Des
Oral Solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. Since the course of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria and the effects of Des are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. The effectiveness of Des
Oral Solution in these age groups is supported by evidence from adequate and well-controlled studies of Des Tablets in adults. The safety and effectiveness of Des Tablets or Des
Oral Solution have not been demonstrated in pediatric patients less than 6 months of age.
Geriatric Use
Clinical studies of Des did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Impairment
Dosage adjustment for patients with renal impairment is recommended.
Hepatic Impairment
Dosage adjustment for patients with hepatic impairment is recommended.
What happens if I miss a dose of Des?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
DailyMed. "DESLORATADINE: 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).
