Nicorette Invisi Transdermal Patch

Nicorette Invisi Transdermal Patch

nicotine

Manufacturer:

Johnson & Johnson

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Nicotine.
Description
Each 9.0 cm2, 13.5 cm2 and 22.5 cm2 transparent patch contains nicotine 1.75 mg/cm2.
Nicorette Invisi Transdermal Patch is a beige, semi-transparent/clear patch consisting of precoated backing layer, nicotine source layer, and a skin contact adhesive layer on a precoated aluminized and siliconized release liner.
Excipients/Inactive Ingredients: Medium chain triglycerides, basic butylated methacrylate copolymer, polyethylenterephthalate film (PET), acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate and siliconized PET release liner with aluminized single side.
Action
Pharmacotherapeutic Group: Drug used in nicotine dependence. ATC Code: N07BA01.
Pharmacology: Pharmacodynamics:
Abruptly cessation of tobacco-containing products following a prolonged period of daily use results in a characteristic withdrawal syndrome that includes ≥4 of the following: Dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, restlessness or impatience; decreased heart rate; and increased appetite or weight gain. Nicotine craving, which is recognized as a clinically relevant symptom, is also an important element in nicotine withdrawal.
Clinical studies have shown that nicotine replacement products can help smokers abstain from smoking.
Patch treatment mimics the fluctuations of nicotine over the day in smokers, with no nicotine administration during sleep. Daytime nicotine patch treatment does not give the nicotine induced sleep disturbances seen with nicotine administration during sleep.
Pharmacokinetics: All patches are labelled by the average amount of nicotine absorbed by the average patient over 16 hours.
Representative mean values of the Cmax for the patches are presented in the table as follows. (See Table 1).

Click on icon to see table/diagram/image

The calculated peak plasma levels are in the same range as true measured peak plasma concentration: 11 ng/mL for the 10 mg patch and 24.2 ng/mL for the 25 mg patch. Interpolation yields a peak plasma concentration of 15.4 ng/mL for the 15 mg patch.
The maximum level of plasma concentration after administration is reached after approximately 9 hours (tmax). The plasma peak is in the afternoon/evening when the risk of relapse is highest.
The volume of distribution of nicotine is about 2 to 3 L/kg and the half-life is approximately 3 hours. The major eliminating organ is the liver, and average plasma clearance is about 70 L/hour. The kidney and lung also metabolizes nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be less active than the parent compound.
Plasma protein-binding of nicotine is less than 5%. Therefore, changes in nicotine binding from the use of concomitant drugs or alterations of plasma proteins by disease states would not be expected to have significant effects on nicotine kinetics.
The primary metabolite of nicotine in plasma, cotinine, has a half-life of 15 to 20 hours and concentrations that exceed nicotine by 10-fold.
The primary urinary metabolites are cotinine (10-12% of the dose) and trans-3-hydroxy-cotinine (28-37% of the dose). About 10-15% of nicotine is excreted unchanged in the urine.
Progressive severity of renal impairment is associated with decreased total clearance of nicotine. Raised nicotine levels have been seen in smoking patients undergoing hemodialysis.
The pharmacokinetics of nicotine is unaffected in cirrhotic patients with mild liver impairment (Child-Pugh score 5) and nicotine clearance is decreased by about 40-50% in cirrhotic patients with moderate liver impairment (Child-Pugh score 7).
A minor reduction in total clearance of nicotine has been demonstrated in healthy elderly patients, however, not justifying adjustment of dosage.
Plasma nicotine concentrations show dose proportionality for the three patch doses.
Indications/Uses
For treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit.
Advice and support normally improve the success rate.
Dosage/Direction for Use
The patient should make every effort to stop smoking completely during treatment with Nicorette Invisi Transdermal Patch. Advice and support normally improve the success rate.
Those Adults and the Elderly:
The patch should be applied to an intact area of the skin upon waking up in the morning and removed at bedtime.
Heavy Smokers (Those Smoking 15 or more Cigarettes in a 24-hour Period) are recommended to start at Step 1 with the 25 mg/16 hours patch and use one patch daily for 8 weeks.
Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch should be used daily for 2 weeks followed by one 10 mg/16 hrs patch daily for 2 weeks.
Light Smokers (Those Smoking less than 15 Cigarettes in a 24-hour Period) are recommended to start at Step 2 with the 15 mg/16 hours patch for 8 weeks and decrease dose to Step 3 (10 mg/16 hours patch) for the final 4 weeks. (See Table 2.)

Click on icon to see table/diagram/image

Combination Therapy: Highly dependent smokers, smokers who experience "breakthrough" cravings or those who have failed with single NRT treatment, can use a flexible smoking cessation format in combination with the patch for fast relief of cravings.
Children and Adolescents: Nicorette Invisi Transdermal Patch should not be administered to persons under 18 years of age without recommendation from a healthcare professional. There is limited experience of treating this age group with Nicorette Invisi Transdermal Patch.
Use of patch beyond 6 months is generally not recommended.
Some ex-smokers may need longer treatment to avoid returning to smoking.
Overdosage
Excessive use of nicotine from either nicotine replacement products and/or smoking might cause symptoms of an overdose.
Overdosage with nicotine can occur if many patches are used simultaneously or if the user has very low nicotine dependence or uses other forms of nicotine concomitantly, including smoking.
Symptoms of overdosage are those of acute nicotine poisoning and include nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, exhaustion, circulatory collapse and general convulsions.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Management: Administration of nicotine must be stopped immediately and the patient must be treated symptomatically. Remove patch and rinse application site with water. If excessive amount of nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine.
Contraindications
Hypersensitivity to nicotine or to any of the components of the patch.
Special Precautions
Certain cardiovascular patient groups should only use Nicorette Invisi Transdermal Patch after consulting a physician. These patients include those who have experienced a serious cardiovascular event, or hospitalization for a cardiovascular complaint, in the previous 4 weeks (eg, stroke, myocardial infarction, unstable angina, cardiac arrhythmia, coronary artery bypass graft and angioplasty) or those who suffer from uncontrolled hypertension.
Nicorette Invisi Transdermal Patch should be used with caution in patients with severe/moderate hepatic impairment, severe renal impairment, active duodenal and gastric ulcers. The risk of using nicotine replacement therapy should be weighed against the risk of continued smoking.
Nicotine, both from nicotine replacement products and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette Invisi Transdermal Patch should also be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma.
Patients with diabetes mellitus may require lower doses of insulin as a result of smoking cessation.
Nicorette Invisi Transdermal Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns.
Use In Pregnancy & Lactation
Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Therefore, the pregnant smoker should always be advised to stop smoking completely without the use of nicotine replacement therapy. The risk of continued smoking may pose greater hazard to the foetus as compared with the use of nicotine replacement products in a supervised smoking cessation program. Use of Nicorette Invisi Transdermal Patch by the pregnant smoker should only be initiated after advice from a healthcare professional.
Nicorette passes freely into breast milk in quantities that may affect the infant, even at therapeutic doses. The use of Nicorette Invisi Transdermal Patch should therefore be avoided when breastfeeding. Should smoking cessation not be achieved, use of the Nicorette Invisi Transdermal Patch by breastfeeding smokers should only be initiated after advice from a healthcare professional.
Side Effects
Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose-dependent. Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette Invisi Transdermal Patch. About 20% of users experienced mild local skin reactions during the 1st weeks of treatment. As would be expected, the types of adverse reactions seen for the Nicorette Invisi Transdermal Patch in clinical trials are similar to those associated with nicotine administered by other means.
Clinical Trial Data: The safety of nicotine from clinical trial data is based on data on a meta-analysis of randomized clinical trials (RCTs) for the treatment of smoking cessation. ADRs with patch formulations identified from clinical trials are presented in Table 3. (See Table 3).

Click on icon to see table/diagram/image

Post-Marketing Data: Adverse drug reactions first identified during post-marketing experience with nicotine are presented in Table 4. Frequencies are provided according to the following convention: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1,000 and <1/100; rare ≥1/10,000 and <1/1,000; very rare <1/10,000; not known (cannot be estimated from the available data). (See Table 4).

Click on icon to see table/diagram/image
Drug Interactions
Smoking (but not nicotine) is associated with increased activity of CYP1A2. After giving up smoking, clearance of certain medications which are metabolized via CYP1A2 may be reduced. This may lead to increased plasma levels of certain medications. The increase may be of clinical significance for products with narrow therapeutic windows e.g. theophylline, tacrine, clozapine or ropinirole.
Plasma level of other medications which are in part metabolized via CYP1A2 e.g. imipramine, olanzapine, clomipramine and fluvoxamine, might also rise after stop smoking. There are no data supporting this however, and the possible clinical significance of this effect on these medications is unknown.
Limited data indicates that the metabolism of flecainide and pentazocine might also be capable of being induced by smoking.
Caution For Usage
Nicorette Invisi Transdermal Patch should be applied to clean, dry intact areas of hairless skin for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days.
Wash hands before applying the patch.
Cut open the pouch with scissors along the side, as indicated. Select a clean, dry, hairless intact area of skin, for example the hip, upper arm or chest.
Peel one part of the silvery aluminium backing away as far as possible. Avoid touching the sticky surface of the patch with fingers as much as possible.
Apply the sticky part of the patch carefully onto the skin and peel off the remaining half of the silvery aluminium backing.
Press the patch firmly onto the skin with the palm or fingertips.
Rub fingers firmly round the edge to ensure that the patch sticks firmly.
After removal, used patches should be disposed of carefully.
Storage
Do not store above 30°C.
ATC Classification
N07BA01 - nicotine ; Belongs to the class of drugs used in the management of nicotine dependence.
Presentation/Packing
Patch 10 mg x 7's. 15 mg x 7's. 25 mg x 7's.
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