Dazit M Overdose

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Consists of Desloratadine, Montelukast

What happens if I overdose Desloratadine (Dazit M)?

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 (Dazit M):

Store Desloratadine (Dazit M) 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 (Dazit M) out of the reach of children and away from pets.

Overdose of Desloratadine (Dazit M) 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. Desloratadine (Dazit M) 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 (Dazit M) 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 (Dazit M) 45 mg for 10 days.

Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated Desloratadine (Dazit M) and Desloratadine (Dazit M) 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 (Dazit M) 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 (Dazit M) exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).

What should I avoid while taking Desloratadine (Dazit M)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Desloratadine (Dazit M).

Desloratadine (Dazit M) 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 Desloratadine (Dazit M). If such a reaction occurs, therapy with Desloratadine (Dazit M) 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 (Dazit M)?

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 Desloratadine (Dazit M), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Desloratadine (Dazit M) 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.

Pediatric

Desloratadine (Dazit M) 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.

Geriatric

Desloratadine (Dazit M) 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 Desloratadine (Dazit M). Your doctor may give you a different Desloratadine (Dazit M) dose if you have kidney or liver problems.

Pregnancy

Pregnancy Category Explanation
All Trimesters C 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.

Breast Feeding

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 Desloratadine (Dazit M). Make sure you tell your doctor if you have any other medical problems, especially:

Desloratadine (Dazit M) 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 Desloratadine (Dazit M). If such a reaction occurs, therapy with Desloratadine (Dazit M) should be stopped and alternative treatment should be considered.

Patient Counseling Information

Information For Patients

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity Studies

The carcinogenic potential of Desloratadine (Dazit M) was assessed using a loratadine study in rats and a Desloratadine (Dazit M) 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 (Dazit M) and Desloratadine (Dazit M) 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 (Dazit M) and Desloratadine (Dazit M) 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 (Dazit M) 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 (Dazit M), respectively, did not show significant increases in the incidence of any tumors. The estimated Desloratadine (Dazit M) and Desloratadine (Dazit M) 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 (Dazit M), 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 (Dazit M) doses up to 24 mg/kg/day (estimated Desloratadine (Dazit M) and Desloratadine (Dazit M) 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 (Dazit M) dose of 12 mg/kg in rats (estimated Desloratadine (Dazit M) and Desloratadine (Dazit M) metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine (Dazit M) had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated Desloratadine (Dazit M) and Desloratadine (Dazit M) 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 (Dazit M) should be used during pregnancy only if clearly needed.

Desloratadine (Dazit M) 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 (Dazit M) 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 (Dazit M) exposure in rabbits and the sum of Desloratadine (Dazit M) and its metabolites exposures in rats, respectively.

Nursing Mothers

Desloratadine (Dazit M) passes into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue Desloratadine (Dazit M), 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 (Dazit M)

Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of Desloratadine (Dazit M) in adults and pediatric subjects. The safety of Desloratadine (Dazit M)

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 (Dazit M) are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. The effectiveness of Desloratadine (Dazit M)

Oral Solution in these age groups is supported by evidence from adequate and well-controlled studies of Desloratadine (Dazit M) Tablets in adults. The safety and effectiveness of Desloratadine (Dazit M) Tablets or Desloratadine (Dazit M)

Oral Solution have not been demonstrated in pediatric patients less than 6 months of age.

Geriatric Use

Clinical studies of Desloratadine (Dazit M) 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 (Dazit M)?

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.

What happens if I overdose Montelukast (Dazit M)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include hyperactivity; severe or persistent headache; stomach pain; unusual drowsiness or restlessness; unusual thirst; vomiting.

Proper storage of Montelukast (Dazit M):

Store Montelukast (Dazit M) at room temperature, between at 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store in original packaging until just before use. Keep Montelukast (Dazit M) out of the reach of children and away from pets.

Overdose of Montelukast (Dazit M) 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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No specific information is available on the treatment of overdosage with Montelukast (Dazit M). In chronic asthma studies, Montelukast (Dazit M) has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.

There have been reports of acute overdosage in postmarketing experience and clinical studies with Montelukast (Dazit M). These include reports in adults and children with a dose as high as 1000 mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients. There were no adverse experiences reported in the majority of overdosage reports. The most frequent occurring adverse experiences were consistent with the safety profile of Montelukast (Dazit M) and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.

It is not known whether Montelukast (Dazit M) is dialyzable by peritoneal- or hemodialysis.

What should I avoid while taking Montelukast (Dazit M)?

Avoid situations or activities that may trigger an asthma attack.

If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) while you are taking Montelukast (Dazit M). NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

Montelukast (Dazit M) 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.

Acute Asthma

Montelukast (Dazit M) is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast (Dazit M) can be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist.

Concomitant Corticosteroid Use

While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast (Dazit M) should not be abruptly substituted for inhaled or oral corticosteroids.

Aspirin Sensitivity

Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast (Dazit M). Although Montelukast (Dazit M) is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.

Neuropsychiatric Events

Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking Montelukast (Dazit M). Post-marketing reports with Montelukast (Dazit M) use include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving Montelukast (Dazit M) appear consistent with a drug-induced effect.

Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Montelukast (Dazit M) if such events occur.

Eosinophilic Conditions

Patients with asthma on therapy with Montelukast (Dazit M) may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast (Dazit M) and these underlying conditions has not been established.

Phenylketonuria

Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine (a component of aspartame), 0.674 and 0.842 mg per 4-mg and 5-mg chewable tablet, respectively.

What should I discuss with my healthcare provider before taking Montelukast (Dazit M)?

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 Montelukast (Dazit M), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Montelukast (Dazit M) 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Montelukast (Dazit M) in children 1 year of age and older with asthma, children 6 years of age and older with exercise-induced bronchoconstriction, children 2 years of age and older with seasonal allergies, or children 6 months of age and older with perennial allergies. Safety and efficacy have not been established in children below these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Montelukast (Dazit M) in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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. When you are taking Montelukast (Dazit M), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Montelukast (Dazit M) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using Montelukast (Dazit M) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Montelukast (Dazit M) with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use Montelukast (Dazit M), or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Montelukast (Dazit M). Make sure you tell your doctor if you have any other medical problems, especially:

Montelukast (Dazit M) 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.

The efficacy of oral Montelukast (Dazit M) for the treatment of acute asthma attacks has not been established. Therefore, oral tablets of Montelukast (Dazit M) should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.

While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast (Dazit M) should not be abruptly substituted for inhaled or oral corticosteroids.

Neuropsychiatric events have been reported in patients taking Montelukast (Dazit M). Since other factors may have contributed to these events, it is not known if they are related to Montelukast (Dazit M). Physicians should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these changes occur.

In rare cases patients receiving anti-asthma agents including leukotriene receptor antagonists, have experienced one or more of the following: eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended in patients receiving Montelukast (Dazit M).

Use in Children: Montelukast (Dazit M) has been studied in pediatric patients 6 months to 14 years of age. Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. Two controlled clinical studies have demonstrated that Montelukast (Dazit M) did not affect the growth rate of prepubertal pediatric patients with asthma.

Use in

Elderly: In clinical studies, there were no age-related differences in the efficacy or safety profiles of Montelukast (Dazit M).

What happens if I miss a dose of Montelukast (Dazit M)?

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

  1. 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).
  2. DrugBank. "Desloratadine". http://www.drugbank.ca/drugs/DB00967 (accessed September 17, 2018).
  3. DrugBank. "montelukast". http://www.drugbank.ca/drugs/DB00471 (accessed September 17, 2018).

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