- 24%
NIQUITIN 14 MG/24
active ingredients
Each 15 cm2 transdermal patch contains 78 mg of nicotine, equivalent to 5,1mg/cm2 of nicotine and which releases 14 mg of nicotine in 24 hours. For the full list of excipients, see paragraph 6.1.Excellent
Active substance storage: ethylene vinyl acetate copolymer. Dorsal wall: polyethylene/aluminum/polyethylene tereftalate/ethylene acetate vinyl. Permeable member: polyethylene film. Adhesive layer and protective foil: laminate polysobutilene adhesive. Press ink: FGN-7214 NT20 Brown ink 465.Therapeutic indications
NiQuitin is indicated to alleviate symptoms from nicotine withdrawal including desire, acting as a help to stop smoking. If possible, when you are quitting smoking, NiQuitin must be used together with a behavioral support program. NiQuitin transdermal patches is indicated in adults and adolescents from 12 years on.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. NiQuitin should not be used by: • children under 12 years; • occasional smokers; • non-smoking.Population
Population Adults (from 18 years up) The patches must be used as indicated below. Before starting the therapy the candidates to use nicotine through transdermal must want to stop smoking. During an attempt to quit, it must be made every effort not to smoke in process with NiQuitin. NiQuitin’s use is recommended along with behavioral support therapy, as this association has shown benefits in the treatment to stop smoking. NiQuitin must be applied once a day, at the same time and preferably just awake and left in the application site for 24 hours continuous. The therapy with NiQuitin normally begins with the application of a 21 mg/24 hours patch and later is reduced according to the following treatment scheme:dosage | duration | |
first phase: | NiQuitin 21 mg/24 hours | for the first 6 weeks |
second phase: | NiQuitin 14 mg/24 hours | for the following 2 weeks |
third phase: | NiQuitin 7 mg /24 hours | for the last 2 weeks |
Conservation
Store at a temperature below 30°C.Warnings
The well-proven smoke-related hazards have a considerably greater relevance in all circumstances than the risks associated with the use of TNS. . Patients admitted for myocardial infarction, severe arrhythmia or cardiovascular disorders, deemed unstable from the hemodynamic point of view must be encouraged to stop smoking through non-pharmacological interventions. If you do not succeed, you can use NiQuitin, but by limiting the security data available for this group of patients, the start of the therapy should only take place under medical control. Once discharged from the hospital, patients can make use of TNS normally. In case of a clinically significant increase in cardiovascular effects or other effects attributable to nicotine, the dose of nicotine patches must be reduced or the application must be suspended. Gastrointestinal disorders: the TNS can accentuate symptoms in people suffering from active esophagitis, oral inflammation and pharyngeal, gastritis, gastric ulcer or peptic ulcer. Diabetes:blood glucose levels can be subject to increased variability when you quit smoking, with or without TNS since the release of catecholamines due to nicotine can interfere with the metabolism of carbohydrates, so it is important for patients with diabetes to monitor their blood glucose levels more closely than usual when using this drug. Allergic reactions: susceptibility to angioedema and hives. Atopic or eczematous dermatitis (due to local sensitization caused by the plaster): in the case of severe or persistent local reactions in the place of application (e.g. severe erythema, itching or edema) or generalized skin reaction (e.g. urticaria or generalized skin rash) patients should be advised to suspend therapy with NiQuitin and inform their doctor. Contact awareness: contact-sensitivity subjects should be advised that serious reactions may occur as a result of the use of other products containing nicotine or smoke. The risk-benefit ratio assessment must be done by a patient specialist who has the following conditions: • Renal and hepatic insufficiency: use with caution in patients with moderate to severe liver failure and/or severe kidney failure as clearance of nicotine or metabolites can be decreased with potential increase in unwanted effects. • Phochromocytoma and uncontrolled hyperthyroidism: use with caution in patients with uncontrolled hyperthyroidism or feochromocytoma since nicotine causes the release of catecholamines. • Convulsive crisis: use with caution in subjects taking anti-convulsive therapy or with a history of epilepsy as cases of seizures were reported in association with nicotine. Danger for small children: the amount of nicotine tolerated by adult smokers and adolescents can cause severe toxicity in small children with possible fatal outcome. Products containing nicotine must be kept out of the reach of children in order to prevent improper or ingested use. The patches must be folded in two with the adhesive part facing the inside and carefully eliminated. Stop smoking: aromatic polycyclic hydrocarbons contained in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and perhaps by CYP 1A1). Suspension of smoking can cause slowing down metabolism resulting in increased plasma levels of such drugs.Dependency TNS: the addiction to nicotinic replacement therapy is rare and at the same time less harmful and easier to interrupt than that caused by smoking. Safety in handling: NiQuitin is potentially a skin irritant and can cause contact sensitization.Interactions
No clinically relevant interactions have been demonstrated between nicotinic replacement therapy and other drugs, but nicotine can increase the hemodynamic effect of adenosine. It reminds health care personnel that quitting smoking in themselves may require adaptation of certain drug therapies.Effects
Adverse reactions are listed below by classification for systems and organs and by frequency. The frequencies are defined as: very common (≥1/10), common (from ≥ 1/100 toOverdosing
The minimum lethal dose of nicotine in a man who did not develop tolerance was estimated between 40 and 60 mg. In children, even small amounts of nicotine can be dangerous and prove fatal. A suspected nicotine poisoning in a child must be considered a medical emergency and should be treated immediately. Synonyms It is expected that the signs and symptoms from overdose of a nicotine patch are the same as those from acute poisoning of nicotine, with pallor, cold sweating, salivation, nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and sight disorders, tremor, mental confusion and weakness. With high overdose can appear to be moved, hypotension, respiratory failure, accelerated pulse, weak or irregular, circulatory collapse and seizures (including terminal convulsions). Treatment Overdose for topical exposure Remove the transdermal patch or transdermal patches immediately in case of overdose or if the patient shows signs of overdose. The user must contact the doctor immediately. The affected skin surface should be washed with water and dried. Avoid the use of soap that can increase the absorption of nicotine. After removal of the plaster, nicotine will continue to be released in the blood for several hours, as it settles in the skin. Overdosage by ingestion Any type of nicotine intake must be immediately interrupted. The patient must immediately contact the doctor and must be treated symptomaticly. If necessary, you should practice artificial breathing with oxygen. Active carbon reduces nicotine gastrointestinal absorption.Pregnancy Pregnant smoking is associated with risks such as delay in intrauterine growth, premature birth or perinatal mortality. Smoking cessation is the only effective intervention to improve both the state of health of the smoking mother and her child. First you reach the abstinence better. Ideal would be able to stop smoking during pregnancy without the help of TNS. However, women who cannot quit alone can be recommended by health care staff to resort to TNS to help them in an attempt to stop. The risk related to the use of TNS for the fetus is less than that associated with tobacco smoke, thanks to a maximum plasma concentration of lower nicotine and the absence of exposure to polycyclic hydrocarbons and carbon monoxide. In any case, as nicotine passes to the fetus by altering the respiratory movements and has a dose-dependent effect on the placenta/feto circulation, the decision to resort to the TNS must be taken as soon as possible during pregnancy. The goal is to use the TNS only for 2-3 months. Products that provide nicotine in a discontinuous way are preferable as they generally provide a lower daily dose of nicotine than patches. However, the latter are recommended for women who suffer from nausea during pregnancy. If patches are used, they must be removed before bed. Food The nicotine that comes from smoke and TNS she finds herself in breast milk. However, nicotine concentration in the child following exposure to TNS is relatively low and less harmful than passive smoking to which the same would otherwise be exposed. The use of preparations of TNS at a discontinuous dose, compared to the patches, can minimize the concentration of nicotine in breast milk since the time between the administration of TNS and breastfeeding can be more easily prolonged. Fertility There are no relevant data available. See paragraph 5.3
Source: Farmadati
- Deductible product
- Yes