Nicabate CQ patches

May 4th, 2008 | By quitsmoking-review | Category: NRP


Use: Smoking cessation aid
Contraindications: Acute MI; nonsmokers, occasional smokers; unstable angina; severe arrhythmias; recent CVA; skin disease (if patch therapy unsuitable); pregnancy, lactation, children
Precautions: Therapy > 3 mnths; vascular disease; hepatic, severe renal impairment; endocrine disease esp diabetes; peptic ulcer; hypertension
Adverse Reactions: Local effects; GI upset; abnormal dreams, insomnia; nervousness;
Interactions: Concomitant smoking
Dose: Nicotine; 36 mg (7 mg/day), 78 mg (14 mg/day), 114 mg (21 mg/day).
Remove at bedtime (after 16 hrs) if dream, sleep disturbances occur; apply new patch upon waking.

So what is Nicabate CQ Clear patch?
It is a rate controlled nicotine transdermal patch. Nicotine is the major pharmacologically active alkaloid of tobacco, and NicabateCQ are multilayered rectangular films containing nicotine that is absorbed rapidly through the skin. The patches are made of mutiple layers. The layer furthest from the skin is an occlusive backing that holds in the next layer, which is a drug reservoir matrix containing nicotine. After that comes a rate controlling membrane made of polyethylene; a polyisobutylene adhesive; and lastly is the protective liner that covers the adhesive (which must be removed before use). Nicotine is the only active ingredient in the patches.

How fast is nicotine released?
The rate that nicotine penetrates the skin is proportional to the surface area which is about 40 microgram/cm2/hour. About 73% of the total amount of nicotine remains in the system 24 hours after application. NicabateCQ and NicabateCQ Clear are labelled by the dose actually absorbed by the patient (i.e. 7, 14 or 21 mg/day). The dose of nicotine absorbed from NicabateCQ and NicabateCQ Clear represents 68% of the amount released in 24 hours. The other 32% evaporates from the edge of the system. After putting on the patch, nicotine levels rise rapidly, stays elevated between 2 to 4 hours, and then slowly decline until the patch is removed, after which it declines faster. Nicotine is eliminated from the body mainly by the liver; the kidney and lung also metabolise nicotine. When you use it the second time the next day, the steady-state plasma nicotine concentrations are on average 30% higher compared with single dose applications.

Half-hourly smoking of cigarettes produces average plasma nicotine concentrations of approximately 44 nanogram/mL. In comparison, average plasma nicotine concentrations from NicabateCQ or NicabateCQ Clear 21 mg/day are about 17 nanogram/mL.

How does nicotine work?
Please read the article Nicotine explained

When is it appropriate to use this?
This should be used as an aid to stop smoking. It is intended to be used as part of an effective behavioural therapy program in an overall strategy for smoking cessation. Therapy should be confined to short-term use (3 months) and be initiated after consulting your doctor.

Who shouldn’t use this?
Consult your doctor before starting as this article is by no means comprehensive. This should not be used by people who do not smoke, children or occasional smokers. People with the following also need to be careful: Hypersensitivity to any component; recent stroke; heart attacks or rhythm problems; pregnancy or breast feeding; diseases of the skin that may complicate patch therapy. Occasional smokers are not expected to benefit from use. Use for more than 3 months should be discouraged because of the risk of addiction.

NicabateCQ and NicabateCQ Clear are contraindicated in pregnant women. Women of reproductive age should use an effective means of contraception while using NicabateCQ or NicabateCQ Clear. The harmful effects of cigarette smoking on maternal and fetal health are clearly established. These include low birthweight, increased risk of spontaneous abortion and increased perinatal mortality. The specific effects of NicabateCQ and NicabateCQ Clear therapy on fetal development are unknown. Therefore pregnant smokers should be encouraged to attempt cessation using educational and behavioural interventions before using pharmacological approaches. Spontaneous abortion during nicotine replacement therapy has been reported; as with smoking, nicotine as a contributing factor cannot be excluded.

What are the common side effects?
The most common side effect is skin redness, itch and/or burning at the application site, which was seen at least once in 47% of patients on NicabateCQ in clinical trials. Skin redness after patch removal was noted at least once in 14% of patients. The redness generally resolved within 24 hours. The other side effects are as follows:

  • Gastrointestinal. Diarrhoea, dyspepsia (heart burns)
  • Oral/ dental. Dry mouth
  • Musculoskeletal. Arthralgia, myalgia (bone and muscle aches)
  • Nervous system. Abnormal dreams, insomnia (23%), nervousness.
  • Dermatological. Sweating, itch
What is the recommended use?
You can overdose on nicotine, so always consult your doctor. The recommended dosing schedule for healthy patients is as follows. NicabateCQ or NicabateCQ Clear 21 mg/day should be used for the first six weeks, followed by NicabateCQ or NicabateCQ Clear 14 mg/day for the next two weeks, then NicabateCQ or NicabateCQ Clear 7 mg/day for the last two weeks. If you have any health problems at all, the schedule is different. People who have successfully abstained from smoking should have their dose of NicabateCQ or NicabateCQ Clear reduced after each two to four weeks of treatment until the 7 mg/day dose has been used for two to four weeks. The entire course of nicotine substitution and gradual withdrawal should take 8 to 12 weeks, depending on the size of the initial dose. The use of NicabateCQ or NicabateCQ Clear beyond three months has not been studied.

How is it applied?
NicabateCQ or NicabateCQ Clear should be applied only once a day to a nonhairy, clean, dry skin site on the upper body or upper outer arm. After 24 hours, the used NicabateCQ or NicabateCQ Clear patch should be removed and a new patch applied to an alternate skin site. Skin sites should not be reused for at least a week. Patients should be cautioned not to continue to use the same patch for more than 24 hours. The patch is recommended to be worn for 24 hours to minimise the chance of morning cravings. However, if the user experiences any vivid dreams or other disruptions of sleep while wearing the patch for 24 hours, the patch may be removed at bedtime (after 16 hours) and a new one put on upon waking the next day.

Conclusions
NicabateCQ has its place for people wanting to quit smoking. Use it to compliment behavioral modification techniques and it should not be used longer than 3 months. For women, they need to think of other ways of quitting if they want to get pregnant or breast feed. But of course it is safer than smoking.

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