For Patients

Description

Nitof 21 mg is the starting strength for individuals who smoke more than 10 cigarettes a day. As a nicotine transdermal patch, it delivers a steady dose of nicotine for 72 hours, helping manage cravings and withdrawal symptoms as you begin your journey to quit smoking.

Ingredients

Active: Nicotine USP - 21 mg

Inactive: Acrylic adhesive, release liner, polyester backing

Storage & Precautions

Site of Application

Apply on clean, dry, hairless skin (upper arm, chest, or back). Rotate the site with each new patch to avoid skin irritation.

Dosage & Administration

• Apply 1 patch every 72 hours (3 days)
• Use Nitof 21 mg for the first 4 weeks of the 12-week quitting program

Benefits

• Consistent nicotine delivery
• No need to chew, inhale, or take oral meds
• Water-resistant - can be worn in the shower
• Easy to apply and discreet
• Reduces strong cravings and withdrawal symptoms

Clinical Overview

Nitof 21 mg is a nicotine transdermal patch designed for adult patients smoking more than 10 cigarettes per day. It delivers a controlled dose of nicotine over 72 hours, reducing physical dependence and withdrawal symptoms. Nitof is indicated as part of a 12-week step-down nicotine replacement therapy (NRT) regimen.

Ingredients & Composition

Active Ingredient: Nicotine USP – 21 mg delivered over 72 hours

Other Excipients: Pressure-sensitive acrylic adhesive, release liner, polyester backing

Mechanism of Action

The patch provides sustained systemic absorption of nicotine via dermal microcapillaries, replacing nicotine from cigarettes. It binds to central nicotinic acetylcholine receptors, reducing withdrawal symptoms, craving intensity, and reward reinforcement from smoking.

Indications

• Tobacco dependence in adults (≥18 years)
• Motivated patients in structured cessation programs
• Smokers of >10 cigarettes/day

Dosage & Administration

• Apply one Nitof 21 mg patch every 72 hours (once every 3 days)
• Duration: 4 weeks (first stage of a 12-week tapering regimen)
• Follow with Nitof 14 mg (weeks 5–8) and Nitof 7 mg (weeks 9–12)

Site of Application

• Clean, dry, non-hairy, intact skin (upper arm, chest, or back)
• Rotate sites between applications to avoid local irritation

Pharmacokinetics

• Absorption: Transdermal systemic uptake begins within 1 hour
• Peak plasma concentration: 6–8 hours post-application
• Half-life: 2–3 hours
• Steady-state achieved with repeat dosing
• No hepatic first-pass metabolism

Contraindications & Warnings

• Recent MI (within 2 weeks), serious arrhythmias, or unstable angina
• Hypersensitivity to nicotine or adhesive materials
• Use with caution in patients with skin disorders, uncontrolled hypertension, or pregnancy 
• May cause vivid dreams or local dermatitis (rare)

Use with caution in 

• Pregnant/lactating patients
• Patients with dermatologic disorders 
• Concurrent use of other nicotine-containing products

Patient Suitability

Ideal for:

• Adults smoking >10 cigarettes/day
• Patients seeking non-oral NRT options
• Those who benefit from consistent 24h support and lower trigger exposure

Clinical Evidence

• Randomized controlled trials show 60–70% increased cessation success with NRT compared to placebo
• Comparable or better adherence than daily patches (due to 3-day cycle)
• WHO and ICMR endorse transdermal NRT as first-line therapy for moderate to heavy smokers

Storage & Handling

• Store below 25°C in original pouch
• Single-use only – fold and discard safely after use
• Keep out of reach of children and pets

Supporting Tools & Resources

• Printable dosage calendar (PDF)
• "How to Use Nitof" visual poster (clinic display)
• Bilingual patient education leaflets
• Optional training module for nurses and counselors
• Integration with MantraBot for in-clinic AI support