Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Less common
Wheezing, tightness in chest, or difficulty in breathing (especially in asthma patients)
Rare
Skin rash or other irritation
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Clammy skin
fever
increase in amount of mucus in lungs
irritation or soreness of mouth, throat, or lungs
nausea or vomiting
runny nose
For patients using a face mask for inhalation of Nalitik: the mask may leave a stickiness on your face. This can be removed with water.
When you use Nalitik, you may notice that the medicine has an unpleasant odor at first. However, this smell will go away soon after you use the medicine.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.
Side effects of Nalitik in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the literature the most frequently reported adverse reactions attributed to intravenous Nalitik administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of Nalitik.
Loading Dose/Infusion Rate Study
The incidence of drug-related adverse reactions occurring within the first 2 hours following Nalitik administration reported in a randomized study in patients with acetaminophen poisoning is presented in Table 5 by preferred term. In this study patients were randomized to a 15-minute or a 60-minute loading dose regimen.
Within the first 2 hours following intravenous Nalitik administration, 17% developed an anaphylactoid reaction (18% in the 15-minute treatment group; 14% in the 60-minute treatment group) in this randomized, open-label, multi-center clinical study conducted in Australia to compare the rates of anaphylactoid reactions between two rates of infusion for the intravenous Nalitik loading dose.
Table 5: Incidence of Drug-Related Adverse Reactions Occurring Within the First 2 Hours Following Study Drug Administration by Preferred Term: Loading Dose/Infusion Rate Study
Treatment Group
15-min
60-min
Number of Patients
n=109
n=71
Cardiac disorders
5 (5%)
2 (3%)
Severity:
Unkn
Mild
Moderate
Severe
Unkn
Mild
Moderate
Severe
Tachycardia NOS
4 (4%)
1 (1%)
2 (3%)
Gastrointestinal disorders
16 (15%)
7 (10%)
Severity:
Unkn
Mild
Moderate
Severe
Unkn
Mild
Moderate
Severe
Nausea Vomiting
1 (1%)
6 (6%)
1 (1%)
1 (1%)
NOS
2 (2%)
11 (10%)
2 (3%)
4 (6%)
Immune System Disorders
20 (18%)
10 (14%)
Severity:
Unkn
Mild
Moderate
Severe
Unkn
Mild
Moderate
Severe
Anaphylactoid reaction
2 (2%)
6 (6%)
11 (10%)
1 (1%)
4 (6%)
5 (7%)
1 (1%)
Respiratory, thoracic and mediastinal disorders
2 (2%)
2 (3%)
Severity:
Unkn
Mild
Moderate
Severe
Unkn
Mild
Moderate
Severe
Pharyngitis
1 (1%)
Rhinorrhoea
1(1%)
Rhonchi
1 (1%)
Throat tightness
1 (1%)
Skin & subcutaneous tissue disorders
6 (6%)
5 (7%)
Severity:
Unkn
Mild
Moderate
Severe
Unkn
Mild
Moderate
Severe
Pruritus
1 (1%)
2 (3%)
Rash NOS
3 (3%)
2 (2%)
3 (4%)
Vascular disorders
2 (2%)
3 (4%)
Severity:
Unkn
Mild
Moderate
Severe
Unkn
Mild
Moderate
Severe
Flushing
1 (1%)
1 (1%)
2 (3%)
1 (1%)
Unkn=Unknown
Postmarketing Safety Study
A large multi-center study was performed in Canada where data were collected from patients who were treated with intravenous Nalitik for acetaminophen overdose between 1980 and 2005. This study evaluated 4709 adult cases and 1905 pediatric cases. The incidence of anaphylactoid reactions in adult (overall incidence 7.9%) and pediatric (overall incidence 9.5%) patients is presented in Tables 6 and 7.
Table 6: Distribution of reported reactions in adult patients receiving intravenous Nalitik
Incidence (%)
Reaction
% of Patients (n=4709)
Urticaria/Facial Flushing
6.1%
Pruritus
4.3%
Respiratory Symptoms*
1.9%
Edema
1.6%
Hypotension
0.1%
Anaphylaxis
0.1%
Table 7: Distribution of reported reactions in pediatric patients receiving intravenous Nalitik
Incidence (%)
Reaction
% of Patients (n=1905)
Urticaria/Facial Flushing
7.6%
Pruritus
4.1%
Respiratory Symptoms*
2.2%
Edema
1.2%
Anaphylaxis
0.2%
Hypotension
0.1%
*Respiratory symptoms are defined as presence of any of the following: cough, wheezing, stridor, shortness of breath, chest tightness, respiratory distress, or bronchospasm.
What is the most important information I should know about Nalitik?
A slightly unpleasant odor may be noticeable while using Nalitik solution.
Nalitik solution may change color in the opened bottle. This is harmless.
If your breathing does not get better or if it gets worse, check with your doctor.
Lab tests may be performed while you use Nalitik solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nalitik solution while you are pregnant. It is not known if Nalitik solution is found in breast milk. If you are or will be breast-feeding while you use Nalitik solution, check with your doctor. Discuss any possible risks to your baby.
Nalitik contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Nalitik AS A MUCOLYTIC AGENT
Nalitik is contraindicated in those patients who are sensitive to it.
Nalitik AS AN ANTIDOTE FOR ACETAMINOPHEN OVERDOSAGE
There are no contraindications to oral administration of Nalitik in the treatment of acetaminophen overdose.
Reviews
The results of a survey conducted on ndrugs.com for Nalitik are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Nalitik. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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