NICOTINE TRANSDERMAL SYSTEM patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H-E-B

INN (International Name):

Nicotine

Composition:

Nicotine 14 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 TRANSDERMAL SYSTEM- NICOTINE TRANSDERMAL SYSTEM PATCH,
EXTENDED RELEASE
H-E-B
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NICOTINE TRANSDERMAL SYSTEM - NICOTINE PATCH, EXTENDED RELEASE
DRUG FACT
_ACTIVE INGREDIENT (IN EACH PATCH) _
Step 1 - Nicotine, 21 mg delivered over 24 hours
Step 2 - Nicotine, 14 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 have skin problems, because you are
more likely to get rashes.
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
blood stream 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
if 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, get medical help or
contact a Poison Control Center right away. Save pouch to use