What happens if I overdose Desloratadine Biogaran?
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 Desloratadine Biogaran orally disintegrating tablets:
Store Desloratadine Biogaran 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 Desloratadine Biogaran orally disintegrating tablets out of the reach of children and away from pets.
Overdose of Desloratadine Biogaran in details
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine Biogaran 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 Desloratadine Biogaran 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 Desloratadine Biogaran 45 mg for 10 days.
Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated Desloratadine Biogaran and Desloratadine Biogaran 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 Desloratadine Biogaran 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 Desloratadine Biogaran exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).
What should I avoid while taking Desloratadine Biogaran?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Desloratadine Biogaran.
Desloratadine Biogaran warnings
Hypersensitivity Reactions
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of Desloratadine Biogaran. If such a reaction occurs, therapy with Desloratadine Biogaran 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 Desloratadine Biogaran?
Some medical conditions may interact with Desloratadine Biogaran 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 Desloratadine Biogaran 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 Desloratadine Biogaran 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 Desloratadine Biogaran 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.
Desloratadine Biogaran precautions
Hypersensitivity Reactions
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of Desloratadine Biogaran. If such a reaction occurs, therapy with Desloratadine Biogaran should be stopped and alternative treatment should be considered.
Patient Counseling Information
Information For Patients
- Patients should be instructed to use Desloratadine Biogaran as directed.
- As there are no food effects on bioavailability, patients can be instructed that Desloratadine Biogaran 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 Desloratadine Biogaran was assessed using a loratadine study in rats and a Desloratadine Biogaran 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 Desloratadine Biogaran and Desloratadine Biogaran 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 Desloratadine Biogaran and Desloratadine Biogaran 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 Desloratadine Biogaran 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 Desloratadine Biogaran, respectively, did not show significant increases in the incidence of any tumors. The estimated Desloratadine Biogaran and Desloratadine Biogaran 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 Desloratadine Biogaran, 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 Desloratadine Biogaran doses up to 24 mg/kg/day (estimated Desloratadine Biogaran and Desloratadine Biogaran 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 Desloratadine Biogaran dose of 12 mg/kg in rats (estimated Desloratadine Biogaran and Desloratadine Biogaran metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine Biogaran had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated Desloratadine Biogaran and Desloratadine Biogaran 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, Desloratadine Biogaran should be used during pregnancy only if clearly needed.
Desloratadine Biogaran 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. Desloratadine Biogaran 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 Desloratadine Biogaran exposure in rabbits and the sum of Desloratadine Biogaran and its metabolites exposures in rats, respectively.
Nursing Mothers
Desloratadine Biogaran passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue Desloratadine Biogaran, 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 Desloratadine Biogaran
Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of Desloratadine Biogaran in adults and pediatric subjects. The safety of Desloratadine Biogaran
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 Desloratadine Biogaran are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. The effectiveness of Desloratadine Biogaran
Oral Solution in these age groups is supported by evidence from adequate and well-controlled studies of Desloratadine Biogaran Tablets in adults. The safety and effectiveness of Desloratadine Biogaran Tablets or Desloratadine Biogaran
Oral Solution have not been demonstrated in pediatric patients less than 6 months of age.
Geriatric Use
Clinical studies of Desloratadine Biogaran 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 Desloratadine Biogaran?
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).
- DrugBank. "Desloratadine". http://www.drugbank.ca/drugs/DB00967 (accessed September 17, 2018).
- MeSH. "Cholinergic Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
