Champix (Generic Varenicline Tartrate Tablets)

Champix (Generic Varenicline Tartrate Tablets)
© The Swiss Pharmacy

Champix (Generic Varenicline Tartrate Tablets) is
a nicotinic receptor partial agonist indicated for
use as an aid to smoking cessation treatment.
This medicine is used together with behavior
modification and counseling support to help you
stop smoking.

Champix Tablets are
manufactured by Pfizer
Deutschland GmbH,
Germany in the strengths of
0.5 mg and 1 mg.

Chemical Structure

The active ingredient contained in
Champix tablets is Varenicline Tartrate.
Each Champix tablet contains
Varenicline Tartrate equivalent to 0.5 mg
or 1 mg of Varenicline.

Uses of Champix 0.5 mg and 1 mg Tablets:
Champix contains the active substance Varenicline Tartrate.
Champix is a medicine which is used in adults to help them stop
smoking. Champix can help to relieve the craving and withdrawal
symptoms associated with stopping smoking.
Champix can also reduce the enjoyment of cigarettes if you do
smoke when on treatment.
Quitting smoking can lower your chances of having lung disease,
heart disease or getting certain types of cancer that are related to
smoking.

Recommended Adult Dosage
The dose of Champix (Varenicline Tartrate Tablets) is given
below:
Begin Champix dosing one week before the date set by the
patient to stop smoking. Starting week: 0.5 mg once daily on
days 1 to 3 and 0.5 mg twice daily on days 4 to 7.
Continuing weeks: 1 mg twice daily for a total of 12 weeks.
An additional 12 weeks of treatment is recommended for
successful quitters to increase likelihood of long-term abstinence.

Recommended Adult Dosage
Renal impairment: Reduce the dose in patients with severe
renal impairment (estimated creatinine clearance less than 30
mL/min).
Consider dose reduction for patients who cannot tolerate
adverse effects. Another attempt at treatment is recommended
for those who fail to stop smoking or relapse when factors
contributing to the failed attempt have been addressed.
Champix tablets should be swallowed whole with water. Champix
can be taken with or without food.

Contraindications
➔Champix tablets are contraindicated in patients with a known
hypersensitivity or skin reactions to Varenicline Tartrate or any
component of the tablet.
➔Champix is not recommended for use in paediatric and
adolescent patients because its efficacy in this population
was not demonstrated.

Storage Instructions
Champix (Generic Varenicline Tartrate
Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

Warnings
Serious neuropsychiatric events have been reported in patients taking Champix.
Advise patients and caregivers that the patient should stop taking Champix
and contact a healthcare provider immediately if agitation, hostility, depressed
mood, or changes in behavior or thinking that are not typical for the patient
are observed, or if the patient develops suicidal ideation or suicidal
behavior while taking Champix or shortly after discontinuing Champix.
Weigh the risks of Champix against benefits of its use. Champix has been
demonstrated to increase the likelihood of abstinence from smoking for as
long as one year compared to treatment with placebo. The health benefits
of quitting smoking are immediate and substantial.

Warnings
Seizures: New or worsening seizures have been observed in patients
taking Champix. Champix should be used cautiously in patients with a
history of seizures or other factors that can lower the seizure
threshold.
Interaction with Alcohol: Increased effects of alcohol have been
reported. Instruct patients to reduce the amount of alcohol they
consume until they know whether Champix affects them.
Accidental injury: Accidental injuries (e.g., traffic accidents) have
been reported. Instruct patients to use caution driving or operating
machinery until they know how Champix may affect them.

Warnings
Cardiovascular events: A meta-analysis of 15 clinical trials, including a trial in
patients with stable cardiovascular disease, demonstrated that while
cardiovascular events were infrequent overall, some were reported more
frequently in patients treated with Champix. These events occurred
primarily in patients with known cardiovascular disease. In both the
clinical trial and meta-analysis, all-cause and cardiovascular mortality was
lower in patients treated with Champix.
Instruct patients to notify their health care providers of new or worsening
cardiovascular symptoms and to seek immediate medical attention if they
experience signs and symptoms of myocardial infarction or stroke.

Warnings
Angioedema and hypersensitivity reactions: Such reactions, including
angioedema, infrequently life threatening, have been reported. Instruct
patients to discontinue Champix and immediately seek medical care if
symptoms occur.
Serious skin reactions: Rare, potentially life-threatening skin reactions have
been reported. Instruct patients to discontinue Champix and contact a
healthcare provider immediately at first appearance of skin rash with
mucosal lesions.
Nausea: Nausea is the most common adverse reaction (up to 30%
incidence rate). Dose reduction may be helpful.

Effects On Ability To Drive And Use Machines
Varenicline Tartrate (Champix tablets) may have minor or
moderate influence on the ability to drive and use machines.
Varenicline tablets may cause dizziness, somnolence and transient
loss of consciousness, and therefore may influence the ability to
drive and use machines.
Patients are advised not to drive, operate complex machinery or
engage in other potentially hazardous activities until it is known
whether this medicinal product affects their ability to perform these
activities.

Possible Side Effects
Most common Varenicline Tartrate (Champix Tablets)
side effects with an incidence rate of greater than or
equal to 5% and twice the rate seen in placebo-treated
patients were nausea, abnormal (e.g., vivid, unusual,
or strange) dreams, constipation, flatulence, and
vomiting.

Champix Tablets Overdosage
In case of overdose, standard supportive measures should
be instituted as required.
Varenicline has been shown to be dialyzed in patients with
end stage renal disease, however, there is no experience in
dialysis following overdose.

Champix Tablets During Pregnancy
Varenicline Tartrate (Champix tablets) has been classified by the US
FDA as Pregnancy Category C.
There are no adequate and well-controlled studies of Varenicline
(Champix Tablets) use in pregnant women. In animal studies,
Varenicline caused decreased fetal weights, increased auditory
startle response, and decreased fertility in offspring.
Varenicline should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.

Champix Tablets During Pregnancy
In reproductive and developmental toxicity studies, pregnant rats and
rabbits received Varenicline Succinate during organogenesis at oral doses up
to 15 and 30 mg/kg/day, respectively. These exposures were 36 (rats) and
50 (rabbits) times the human exposure (based on AUC) at the maximum
recommended human dose (MRHD) of 1 mg twice daily.
While no fetal structural abnormalities occurred in either species,
reduced fetal weights occurred in rabbits at the highest dose (exposures 50
times the human exposure at the MRHD based on AUC).
Fetal weight reduction did not occur at animal exposures 23 times the human
exposure at the MRHD based on AUC.

Champix Tablets are manufactured by
Pfizer Deutschland GmbH, Germany.
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Champix (Generic Varenicline Tartrate Tablets)

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