NICOTINE TRANSDERMAL SYSTEM patch, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Apotex Corp

INN (Nome Internazionale):

Nicotine

Composizione:

Nicotine 14 mg in 24 h

Via di somministrazione:

TRANSDERMAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

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

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NICOTINE TRANSDERMAL SYSTEM- NICOTINE TRANSDERMAL SYSTEM PATCH,
EXTENDED RELEASE
APOTEX CORP
----------
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
Step 3 - 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 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 P