Nalitik Overdose

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What happens if I overdose Nalitik?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Nalitik solution:

Store unopened vials of Nalitik solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Nalitik solution may be contaminated once opened. Store opened vials of undiluted medicine in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) for up to 4 days. Do not store in the bathroom. Keep Nalitik solution out of the reach of children and away from pets.

Overdose of Nalitik 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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Single intravenous doses of Nalitik at 1,000 mg/kg in mice, 2,445 mg/kg in rats, 1,500 mg/kg in guinea pigs, 1,200 mg/kg in rabbits and 500 mg/kg in dogs were lethal. Symptoms of acute toxicity were ataxia, hypoactivity, labored respiration, cyanosis, loss of righting reflex and convulsions.

What should I avoid while taking Nalitik?

Do not mix other medicines in a nebulizer with Nalitik inhalation, unless your doctor has told you to.

Nalitik 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.

Anaphylactoid Reactions

Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered Nalitik intravenously.

Acute flushing and erythema of the skin may occur in patients receiving Nalitik intravenously. These reactions usually occur 30 to 60 minutes after initiating the infusion and often resolve spontaneously despite continued infusion of Nalitik. Anaphylactoid reactions (defined as the occurrence of an acute hypersensitivity reaction during Nalitik administration including rash, hypotension, wheezing, and/or shortness of breath), have been observed in patients receiving intravenous Nalitik for acetaminophen overdose and occurred soon after initiation of the infusion. If a reaction to Nalitik involves more than simply flushing and erythema of the skin, it should be treated as an anaphylactoid reaction. This usually entails administering antihistaminic drugs and in severe cases may require administration of epinephrine. In addition, the Nalitik infusion may be interrupted until treatment of the anaphylactoid symptoms has been initiated and then carefully restarted. If the anaphylactoid reaction returns upon reinitiation of treatment or increases in severity, intravenous Nalitik should be discontinued and alternative patient management should be considered.

Monitoring Patients with Asthma

Nalitik should be used with caution in patients with asthma, or where there is a history of bronchospasm.

Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted fluid overload can occur, potentially resulting in hyponatremia, seizure and death.

For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

What should I discuss with my healthcare provider before taking Nalitik?

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 Nalitik, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Nalitik 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 on the relationship of age to the effects of Nalitik have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.

Geriatric

Although appropriate studies on the relationship of age to the effects of Nalitik have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving Nalitik.

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 receiving Nalitik, 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 Nalitik 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. 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 Nalitik. Make sure you tell your doctor if you have any other medical problems, especially:

Nalitik 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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Nalitik AS A MUCOLYTIC AGENT

General

With the administration of Nalitik, the patient may observe initially a slight disagreeable odor that is soon not noticeable. With a face mask there may be stickiness on the face after nebulization. This is easily removed by washing with water.

Under certain conditions, a color change may occur in Nalitik in the opened bottle. The light purple color is the result of a chemical reaction which does not significantly affect safety or mucolytic efficacy of Nalitik.

Continued nebulization of Nalitik solution (n-acetyl-l-cysteine) with a dry gas will result in an increased concentration of the drug in the nebulizer because of evaporation of the solvent. Extreme concentration may impede nebulization and efficient delivery of the drug. Dilution of the nebulizing solution with appropriate amounts of Sterile Water for Injection, USP, as concentration occurs, will obviate this problem.

Nalitik AS AN ANTIDOTE FOR ACETAMINOPHEN OVERDOSAGE

Occasionally severe and persistent vomiting occurs as a symptom of acute acetaminophen overdose. Treatment with oral Nalitik may aggravate the vomiting. Patients at risk of gastric hemorrhage (e.g., esophageal varices, peptic ulcers, etc.) should be evaluated concerning the risk of upper gastrointestinal hemorrhage versus the risk of developing hepatic toxicity, and treatment with Nalitik given accordingly. Dilution of the Nalitik for

Oral Administration

) minimizes the propensity of oral Nalitik to aggravate vomiting.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Carcinogenesis: Carcinogenicity studies in laboratory animals have not been performed with Nalitik alone, nor with Nalitik in combination with isoproterenol.

Long-term oral studies of Nalitik alone in rats (12 months of treatment followed by 6 months of observation) at doses up to 1,000 mg/kg/day (5.2 times the human mucolytic dose) provided no evidence of oncogenic activity.

Mutagenesis: Published data1 indicate that Nalitik is not mutagenic in the Ames test, both with and without metabolic activation.

Impairment of Fertility: A reproductive toxicity test to assess potential impairment of fertility was performed with Nalitik (10%) combined with isoproterenol (0.05%) and administered as an aerosol into a chamber of 12.43 cubic meters. The combination was administered for 25, 30, or 35 minutes twice a day for 68 days before mating, to 200 male and 150 female rats; no adverse effects were noted in dams or pups. Females after mating were continued on treatment for the next 42 days.

Reproductive toxicity studies of Nalitik in the rat given oral doses of Nalitik up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature.1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study.

Pregnancy: Teratogenic Effects: Pregnancy Category B

Teratology: In a teratology study of Nalitik in the rabbit, oral doses of 500 mg/kg/day (2.6 times the human mucolytic dose) were administered to pregnant does by intubation on days 6 through 16 of gestation. Nalitik was found to be nonteratogenic under the conditions of the study.

In the rabbit, two groups (one of 14 and one of 16 pregnant females) were exposed to an aerosol of 10% Nalitik and 0.05% isoproterenol hydrochloride for 30 or 35 minutes twice a day from the 16th through the 18th day of pregnancy. No teratogenic effects were observed among the offspring.

Teratology and a perinatal and postnatal toxicity study in rats were performed with a combination of Nalitik and isoproterenol administered by the inhalation route. In the rat, two groups of 25 pregnant females each were exposed to the aerosol for 30 and 35 minutes, respectively, twice a day from the 6th through the 15th day of gestation. No teratogenic effects were observed among the offspring.

In the pregnant rat (30 rats per group), twice-daily exposure to an aerosol of Nalitik and isoproterenol for 30 or 35 minutes from the 15th day of gestation through the 21st day postpartum was without adverse effect on dams or newborns.

Reproduction studies of Nalitik with isoproterenol have been performed in rats and of Nalitik alone in rabbits at doses up to 2.6 times the human dose. These have revealed no evidence of impaired fertility or harm to the fetus due to Nalitik. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies may not always be predictive of human responses, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nalitik is administered to a nursing woman.

What happens if I miss a dose of Nalitik?

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.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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