NICOTINE patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)

Available from:

Strategic Sourcing Services LLC

INN (International Name):

NICOTINE

Composition:

NICOTINE 7 mg in 24 h

Administration route:

TRANSDERMAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stop smoking aid Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NICOTINE- NICOTINE PATCH
STRATEGIC SOURCING SERVICES LLC
----------
NICOTINE TRANSDERMAL SYSTEM
DRUG FACTS
ACTIVE INGREDIENT STEP ONE (IN EACH PATCH)
Nicotine, 21 mg delivered over 24 hours
ACTIVE INGREDIENT STEP TWO (IN EACH PATCH)
Nicotine, 14 mg delivered over 24 hours
ACTIVE INGREDIENT STEP THREE (IN EACH PATCH)
Nicotine, 7 mg delivered over 24 hours
PURPOSE
Stop smoking aid
USE
Reduces withdrawal symptoms, including nicotine craving, associated
with quitting
smoking
WARNINGS
IF YOU ARE PREGNANT OR BREAST-FEEDING, ONLY USE THIS MEDICINE ON THE
ADVICE
OF YOUR HEALTH CARE PROVIDER.Smoking can seriously harm your child.
Try to stop
smoking without using any nicotine replacement medicine. This medicine
is believed to be
safer than smoking. However, the risks to your child from this
medicine are not fully
known.
ASK A DOCTOR BEFORE USE IF YOU HAVE
Heart disease, recent heart attack, or irregular heartbeat. Nicotine
can increase your
heart rate.
High blood pressure not controlled with medication. Nicotine can
increase your blood
pressure.
An allergy to adhesive tape or skin problems because you are more
likely to get
rashes
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
Using a non-nicotine stop smoking drug
Taking a prescription medicine for depression or asthma. Your
prescription dose may
need to be adjusted.
WHEN USING THIS PRODUCT
Do not smoke even when not wearing the patch. The nicotine in your
skin will still be
entering your bloodstream for several hours after you take off the
patch.
If you have vivid dreams or other sleep disturbances, remove this
patch at bedtime
STOP USE AND ASK A DOCTOR IF
Skin redness caused by the patch does not go away after four days, or
your skin
swells, or you get a rash
Irregular heartbeat or palpitations occur
You get symptoms of nicotine overdose, such as nausea, vomiting,
dizziness,
weakness, and rapid heartbeat
KEEP OUT OF REACH OF CHILDREN AND PETS
Used patches have enough nicotine to poison children and pets. If
swallowed,