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 Lorinex orally disintegrating tablets:
Store Lorinex 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 Lorinex orally disintegrating tablets out of the reach of children and away from pets.
Overdose of Lorinex 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.
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Lorinex 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 Lorinex 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 Lorinex 45 mg for 10 days.
Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated Lorinex and Lorinex 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 Lorinex 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 Lorinex exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).
What should I avoid while taking Lorinex?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Lorinex.
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.
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of Lorinex. If such a reaction occurs, therapy with Lorinex 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 Lorinex?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Lorinex, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to Lorinex or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Lorinex has been tested in children 6 months of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.
Lorinex has been tested in patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients are more likely to have kidney or liver problems which may make them more sensitive to the effects of Lorinex. Your doctor may give you a different Lorinex dose if you have kidney or liver problems.
Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Lorinex. Make sure you tell your doctor if you have any other medical problems, especially:
Liver disease or
Kidney disease—Effects of Lorinex may be increased because of slower removal from the body.
Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.
Slow metabolizers of Lorinex—May increase chances of unwanted effects
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.
Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of Lorinex. If such a reaction occurs, therapy with Lorinex should be stopped and alternative treatment should be considered.
Patient Counseling Information
Information For Patients
Patients should be instructed to use Lorinex as directed.
As there are no food effects on bioavailability, patients can be instructed that Lorinex 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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
The carcinogenic potential of Lorinex was assessed using a loratadine study in rats and a Lorinex 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 Lorinex and Lorinex 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 Lorinex and Lorinex 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 Lorinex 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 Lorinex, respectively, did not show significant increases in the incidence of any tumors. The estimated Lorinex and Lorinex metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose.
In genotoxicity studies with Lorinex, 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 Lorinex doses up to 24 mg/kg/day (estimated Lorinex and Lorinex 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 Lorinex dose of 12 mg/kg in rats (estimated Lorinex and Lorinex metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Lorinex had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated Lorinex and Lorinex metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).
Use In Specific Populations
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, Lorinex should be used during pregnancy only if clearly needed.
Lorinex 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. Lorinex 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 Lorinex exposure in rabbits and the sum of Lorinex and its metabolites exposures in rats, respectively.
Lorinex passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue Lorinex, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.
The recommended dose of Lorinex
Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of Lorinex in adults and pediatric subjects. The safety of Lorinex
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 Lorinex are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. The effectiveness of Lorinex
Oral Solution in these age groups is supported by evidence from adequate and well-controlled studies of Lorinex Tablets in adults. The safety and effectiveness of Lorinex Tablets or Lorinex
Oral Solution have not been demonstrated in pediatric patients less than 6 months of age.
Clinical studies of Lorinex 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.
Dosage adjustment for patients with renal impairment is recommended.
Dosage adjustment for patients with hepatic impairment is recommended.
What happens if I miss a dose of Lorinex?
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.
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).