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72076 Tübingen


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Nicotine Patch

Application and dosage

Area of application
To support smoking cessation under medical supervision or as part of smoking cessation programmes.

Possible uses and recommended dosage
Nicotine patches are currently available in two different application forms, as a 16-hour patch and as a 24-hour patch. There are three different dosage options for each form of use. In the case of the 16-hour patch, the strongest patch contains 24.9 mg, the middle 16.6 mg and the weakest 8.3 mg of nicotine, which is not completely absorbed through the skin over a period of 16 hours. The 24-hour patch contains 52.5 mg, 35 mg and 17.5 mg of nicotine, respectively.

In the 1st phase of smoking cessation (i.e. during the first 4-6 weeks), a 16 or 24 hour patch with the highest dosage is used daily. In the following phase of 2-4 weeks, a patch of the medium dosage should be used daily and in the last phase, for another 2-4 weeks, a patch with the lowest dose of nicotine should be used daily.

Every day, preferably in the morning immediately after getting up, a patch is applied to a clean, dry and uninjured area of skin on the trunk, upper arm or hip after removing the protective film and pressed firmly onto the skin for 10-20 seconds.

General information

Nicotine patches should not be used in diseases and circumstances where the generally expected benefit is not in favourable proportion to any possible harm.

When using nicotine patches, this applies in particular to the following conditions: fresh heart attack, severe cardiac arrhythmia, recent stroke, worsening narrowing of the coronary arteries, hypersensitivity of the skin to nicotine, chronic generalised skin diseases such as psoriasis, chronic dermatitis and hives.

In the presence of the following diseases, nicotine patches should only be used with special caution and in consultation with the doctor: stable constriction of the coronary vessels, severely elevated blood pressure, cerebrovascular disease, circulatory disorders of the arms and legs, severe cardiac insufficiencyhyperthyroidism, diabetes mellitus requiring insulin, acute stomach and intestinal ulcers, severe and persistent skin irritations.

At the beginning of and during treatment with nicotine patches, smoking must be completely stopped and any further nicotine intake (snuff, chewing tobacco) must be avoided, as otherwise undesirable effects may increase. Among other things, severe cardiovascular reactions up to and including a heart attack may occur.

Smoking is harmful to the health of the mother and the unborn child. The consequences can be: low birth weight, increased risk of miscarriage and increased infant mortality. Nicotine also passes into breast milk and is absorbed by the infant. In general, therefore, smoking should be avoided during pregnancy and nicotine should be abstained from.

Pregnant smokers should therefore definitely try to give up smoking without the support of nicotine-containing medication. Only if this is unsuccessful and there is a risk of continued smoking should treatment with nicotine substitutes be considered in consultation with the doctor.

Basically similar nicotine side effects can occur as with smoking (headache, dizziness, nausea, palpitations, temporary slight increase in blood pressure).

The following adverse effects have been reported in clinical trials or adverse event reports:

Affected siteFrequencyAdverse reactions
Skin
frequentThe most common adverse effects of the nicotine-containing patch are skin symptoms at the stick-on site.
occasionallySkin redness, swelling at the sticker site, itching, skin rash. In isolated cases: Burning at the sticker site. These skin reactions can occur especially in the first weeks. They are usually mild and generally disappear within a day of removing the nicotine patch. If the skin reactions persist, the treatment should be discontinued. In case of known allergy to patches, special attention should be paid to the occurrence of skin reactions during the first days of treatment.
Nervous system
Occasional
Headache, anxiety, dizziness, moodiness, sleep disturbance.
Rarely
Muscle twitching, migraine, drowsiness.
Cardiovascular system
Rarely
Palpitations, chest pain, feeling of heat.
In isolated cases
Palpitations, slight increase in blood pressure.
Gastrointestinal tract
Occasionally
Constipation, nausea, diarrhoea, flatulence.
Rarely
Abdominal pain, indigestion, heartburn.
*
It should be noted that the disorders of the nervous system and gastrointestinal tract can also be withdrawal symptoms due to insufficient nicotine intake.
Skeletal Musculature
Occasionally
Muscle pain.
Rarely
Muscle cramps.
Miscellaneous
Occasional
Taste disturbances, mouth ulcers, acne, burning sensation on the tongue.
Rarely
Sweating.

The effects of some medicines may be influenced by the simultaneous use of other medicines. Interactions between nicotine patches and other medicines are not known. However, smoking may alter the effects of a number of medicines because of certain other constituents contained in smoke. In the case of the medicines listed below, it should be clarified in consultation with the doctor or pharmacist whether incompatibilities are to be expected under certain circumstances or whether special measures, such as a new dose determination, will be necessary: Caffeine, theophylline, acetaminophen, phenylbutazone, pentazocine, lidocaine, benzodiazepines, tricyclic antidepressants, warfarin, estrogen, and vitamin B12.

Other effects of smoking include a reduction in the analgesic efficacy of propoxyphene, a reduction in a diuretic effect of furosemide, an alteration in the efficacy of propranolol, and altered response rates in the treatment of gastrointestinal ulcers with H2 antagonists.

Smoking and nicotine may increase blood levels of cortisol and catecholamines (adrenaline and noradrenaline). Dosage adjustment of nifedipine and nerve receptor excitatory or inhibitory agents (adrenergic antagonists or antagonists) may be required.

The symptoms of overdoses are similar to those that occur with excessive smoking: Dizziness, faintness, nausea, cold sweats, vomiting, and diarrhea. In cases of overdose poisoning (e.g. when several patches are used at the same time) or use in children, other symptoms may include a drop in blood pressure and temperature, shortness of breath, hearing and visual disturbances, weak and irregular pulse, and convulsions. If there are signs of overdose, the nicotine patch should be removed immediately. The symptoms disappear within a few hours as the nicotine level in the blood decreases. In case of severe poisoning, emergency measures must be taken immediately and a doctor must be consulted.

Do not smoke or otherwise ingest nicotine during treatment with the nicotine patch to prevent overdoses. Nicotine is a highly toxic substance for non-smokers and children. Even a dosage that is well tolerated by adults can lead to severe symptoms of poisoning in young children, i.e. the playful application of a patch, if not noticed in time, can be fatal for children. Therefore, nicotine patches must be kept out of reach of children at all times. As the patches may still contain nicotine after use, they must be disposed of in such a way that they cannot get into the hands of a child under any circumstances.

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