Is Chantix Safe During Pregnancy

Improved Sleep And Reduced Anxiety

How and When to use Varenicline? (Champix, Chantix) – Medical Doctor Explains

A explored whether CBD could help improve sleep or reduce anxiety.

In the studys first month, 79.2 percent of the participants reported reduced anxiety levels and 66.7 percent said they experienced better sleep. Sleep quality varied over the course of the study, but reduced anxiety levels held.

If youre currently pregnant, theres a good chance you may have considered trying CBD for these very reasons pain, nausea and morning sickness, insomnia, and anxiety are common pregnancy symptoms.

Yet, since very little research to date explores the use of CBD during pregnancy, experts still arent sure how it might affect fetal health and development.

What About Hemp Seeds

FDA recently completed an evaluation of some hemp seed-derived food ingredients and had no objections to the use of these ingredients in foods. THC and CBD are found mainly in hemp flowers, leaves, and stems, not in hemp seeds. Hemp seeds can pick up miniscule amounts of THC and CBD from contact with other plant parts, but these amounts are low enough to not raise concerns for any group, including pregnant or breastfeeding mothers.

Dosage In Special Populations

Patients with Impaired Renal Function

No dosage adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment , the recommended starting dose of Chantix is 0.5 mg once daily. The dose may then be titrated as needed to a maximum dose of 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum dose of 0.5 mg once daily may be administered if tolerated .

Elderly and Patients with Impaired Hepatic Function

No dosage adjustment is necessary for patients with hepatic impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function .

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Availability Of Data And Materials

The data sets were constructed with the permission of each of the source data custodians and with specific ethical approvals. The authors do not have permission to share patient-level data because of the highly confidential nature of the data. Permission to access to the data is restricted to researchers named and approved by relevant Human Research Ethics Committees.

Explore Quit Smoking Tools

Updates On Smoking Cessation

There are many ways to quit smoking you dont have to quit cold turkey. Below are free, no-judgment resources that will help you quit.

  • Try SmokefreeMOM. This text message program gives 24/7 support to pregnant women. Enter your childs due date to receive customized messages that match where you are in your pregnancy. Then, choose your goal of the program: to quit smoking or receive messages on smoking and health. You have the option to receive support even if youre not yet ready to quit permanently. or text MOM to 222888 to join now.
  • . Women who have quit, or are trying to quit, offer one another advice and inspiration.
  • Make your phone your quit buddy. Download quitSTART or QuitGuide, Smokefrees free smartphone apps. Track your cravings by time and location to help you see patterns so you can stay in control. They also have ways to see your progress and fun distractions to keep you from having a slip.
  • Speak with a quit smoking counselor. Call , or log on to LiveHelp, an online chat service. A trained specialist will give you support and quit smoking information.

Tip: It might take some time to find the quit method that works best for you. If one isnt working, try something new. Each time you try is a step closer to a smokefree life.

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Stop Smoking With Chantix

Chantix is safe and effective for people of all ages who want to quit smoking. Its also safe and effective for pregnant and breastfeeding women.

Since its a prescription drug, youll need to talk to your doctor before you buy it.

Theyll be able to determine if this drug is safe for you and if its appropriate for you. They may also be able to refer you to a support group in your area.

If you decide that this drug is right for you, youll need to call your doctors office to get a prescription.

Chantix is available by prescription only.

Chantix is not available in Canada.

Why Do Experts Consider Cbd Unsafe During Pregnancy

As noted above, CBD doesnt produce the high THC does. You might assume this makes CBD safe to use during pregnancy, but experts still recommend avoiding it entirely.

Not only is the research around CBD and pregnancy very limited, but also most existing studies involve animals. Plus, the results of these studies have prompted some concerns.

For example, an older suggests that exposure to CBD during gestation or the day after birth affected sperm count and testicular function in male rats, but there isnt any recent data to back up this claim.

A 2019 study also suggested that fetal exposure to cannabinoids could affect immune system development and possibly weaken the bodys ability to defend against cancer and infections. That said, the study referred to cannabinoids in general rather than specifically focusing on CBD.

The study authors also noted that cannabinoids mainly work by binding to CB1 and CB2 receptors in the body. They went on to explain, though, that both THC and CBD can also bind to other receptors, which could have other developmental or health consequences during pregnancy and nursing.

Future research may help shed more light on possible risks of CBD use during pregnancy or while nursing.

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What Is The Safety Information And Possible Side Effects Of Chantix

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Do not take CHANTIX if you have had a serious allergic or skin reaction to CHANTIX. Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

Use caution driving or operating machinery until you know how CHANTIX may affect you.

Is Chantix Safe During Pregnancy

Study: Chantix increases heart disease risk

Dr. Antonio Howell

Chantix was tested in rats and rabbits at oral doses of up to 50-times the maximum recommended dose for humans and found not to cause birth defects in rats or rabbits. Although Chantix did, cause reduced fetal weight in the offspring of pregnant rabbits.

There are no adequate and well-controlled studies in pregnant women. Therefore, the potential effects of Chantix on labor and delivery are not known.

Chantix is classified as a pregnancy category C drug.

If you asked me if I would want my mother taking Chantix, while pregnant with me. I would answer no but then again I would not want her smoking either.

Clearly, there is a knowledge gap about Chantixs use during pregnancy, so there is no way to know with total certainty whether or not one should take Chantix during pregnancy.

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How Supplied/storage And Handling

Chantix is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with “Pfizer” on one side and “CHX 0.5” on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with “Pfizer” on one side and “CHX 1.0” on the other side. Chantix is supplied in the following package configurations:

Description

Store at 25ºC excursions permitted to 1530ºC .

How Do I Take Chantix

  • Choose a Quit Date when you will stop smoking.
  • Start taking CHANTIX one week before your Quit Date. This lets CHANTIX build up in your body. You can keep smoking during this time. Make sure that you try and stop smoking on your Quit Date. If you slip up, try again. Some people need a few weeks for CHANTIX to work best.
  • Take CHANTIX after eating and with a full glass of water.
  • It is recommended to take CHANTIX for a full 12 weeks. If you have completely quit smoking by 12 weeks, ask your doctor if another 12 weeks of CHANTIX may help you stay cigarette-free.
  • CHANTIX comes as a white tablet and a blue tablet . You start with the white tablet and then usually go to the blue tablet.

    • This dosing schedule may not be right for everyone. You may need a lower dose of CHANTIX if you have kidney problems or get dialysis.
    • If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, wait. Just take your next regular dose.

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    Subjects With Chronic Obstructive Pulmonary Disease

    Chantix was evaluated in a randomized, double-blind, placebo-controlled study of subjects aged 35 years with mild-to-moderate COPD with post-bronchodilator FEV1/FVC < 70% and FEV1 50% of predicted normal value. Subjects were randomized to Chantix 1 mg twice daily or placebo for a treatment of 12 weeks and then were followed for 40 weeks post-treatment. Subjects treated with Chantix had a superior rate of CO-confirmed abstinence during weeks 9 through 12 compared to subjects treated with placebo and from week 9 through 52 compared to subjects treated with placebo .

    Table 10. Continuous Abstinence , Studies in Patients with Chronic Obstructive Pulmonary Disease

    Weeks 9 through 12

    Subjects With Cardiovascular Disease And Other Cardiovascular Analyses

    2011

    Chantix was evaluated in a randomized, double-blind, placebo-controlled study of subjects aged 35 to 75 years with stable, documented cardiovascular disease that had been diagnosed for more than 2 months. Subjects were randomized to Chantix 1 mg twice daily or placebo for a treatment period of 12 weeks and then were followed for 40 weeks post-treatment. Subjects treated with Chantix had a superior rate of CO-confirmed abstinence during weeks 9 through 12 compared to subjects treated with placebo and from week 9 through 52 compared to subjects treated with placebo .

    Table 11. Continuous Abstinence , Studies in Patients with Cardiovascular Disease

    Weeks 9 through 12
    7%

    In this study, all-cause and CV mortality was lower in patients treated with Chantix, but certain nonfatal CV events occurred more frequently in patients treated with Chantix than in patients treated with placebo . Table 12 below shows mortality and the incidence of selected nonfatal serious CV events occurring more frequently in the Chantix arm compared to the placebo arm. These events were adjudicated by an independent blinded committee. Nonfatal serious CV events not listed occurred at the same incidence or more commonly in the placebo arm. Patients with more than one CV event of the same type are counted only once per row. Some of the patients requiring coronary revascularization underwent the procedure as part of management of nonfatal MI and hospitalization for angina.

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    What You Should Know About Using Cannabis Including Cbd When Pregnant Or Breastfeeding

    FDA strongly advises against the use of cannabidiol , tetrahydrocannabinol , and marijuana in any form during pregnancy or while breastfeeding.

    Cannabis and Cannabis-derived products have become increasingly available in recent years, with new and different types of products appearing all the time. These products raise questions and concerns for many consumers. And if you are pregnant or breastfeeding, you might have even more questions about whether these products are safe for you.

    FDA strongly advises against the use of cannabidiol , tetrahydrocannabinol , and marijuana in any form during pregnancy or while breastfeeding.

    Can I Use Medications To Help Me Quit While I Am Pregnant

    You should always check with your health care provider before starting any new medication. There is some evidence that nicotine replacement therapy, like patches, gum and lozenges, may have negative effects on a developing fetus. However, the risks of smoking are certainly greater than the risks from NRT. NRT may be the extra help you need to quit, especially if you are a heavy smoker. You will need to discuss the risks and benefits with your health care provider to make the best decision for you.

    There are two non-nicotine medications that improve smoking cessation: bupropion and varenicline . In animal studies of bupropion scientists have found some evidence of impact on fetal development, but no evidence of harm in studies of humans. There are no studies about fetal effects from Chantix. If you are interested in using either of these medications while youre pregnant, talk to your health care provider.

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    Usual Dosage For Adults

    Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt.

    The patient should set a date to stop smoking. Begin Chantix dosing one week before this date. Alternatively, the patient can begin Chantix dosing and then quit smoking between days 8 and 35 of treatment.

    Chantix should be taken orally after eating and with a full glass of water.

    The recommended dose of Chantix is 1 mg twice daily following a 1-week titration as follows:

    Days 1 3:
    Day 8 end of treatment: 1 mg twice daily

    Patients should be treated with Chantix for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with Chantix is recommended to further increase the likelihood of long-term abstinence.

    For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with Chantix. Patients should begin Chantix dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue Chantix treatment for an additional 12 weeks, for a total of 24 weeks of treatment. Encourage patients to attempt quitting sooner if they feel ready .

    Carcinogenesis Mutagenesis Impairment Of Fertility

    Varenicline for Smoking Cessation Through Smoking Reduction

    Carcinogenesis

    Lifetime carcinogenicity studies were performed in CD-1 mice and Sprague-Dawley rats. There was no evidence of a carcinogenic effect in mice administered varenicline by oral gavage for 2 years at doses up to 20 mg/kg/day exposure based on AUC). Rats were administered varenicline by oral gavage for 2 years. In male rats , incidences of hibernoma were increased at the mid dose and maximum dose . The clinical relevance of this finding to humans has not been established. There was no evidence of carcinogenicity in female rats.

    Mutagenesis

    Varenicline was not genotoxic, with or without metabolic activation, in the following assays: Ames bacterial mutation assay mammalian CHO/HGPRT assay and tests for cytogenetic aberrations in vivo in rat bone marrow and in vitro in human lymphocytes.

    Impairment of Fertility

    There was no evidence of impairment of fertility in either male or female Sprague-Dawley rats administered varenicline succinate up to 15 mg/kg/day . Maternal toxicity, characterized by a decrease in body weight gain, was observed at 15 mg/kg/day. However, a decrease in fertility was noted in the offspring of pregnant rats who were administered varenicline succinate at an oral dose of 15 mg/kg/day. This decrease in fertility in the offspring of treated female rats was not evident at an oral dose of 3 mg/kg/day .

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    What Do We Know About The Effects Of Marijuana Use During Pregnancy And While Breastfeeding

    There are many potential negative health effects from using marijuana and other products containing THC during pregnancy and while breastfeeding. In fact, the U.S. Surgeon General recently advised consumers that marijuana use during pregnancy may affect fetal brain development, because THC can enter the fetal brain from the mothers bloodstream. The Surgeon General also advised that marijuana may increase the risk of a newborn with low birth weight. Research also suggests increased risk for premature birth and potentially stillbirth1.

    While breastfeeding, it is important to know that breastmilk can contain THC for up to six days after use. This THC may affect a newborns brain development and result in hyperactivity, poor cognitive function, and other long-term consequences.

    Additionally, marijuana smoke contains many of the same harmful components as tobacco smoke. Neither marijuana nor tobacco products should be smoked around a baby or children.

    Secondhand Smoke Harms Your Baby

    If your partner or anyone else who lives with you smokes, their smoke can affect you and your baby before and after their birth. You may also find it more difficult to stop if someone around you smokes.

    Secondhand smoke can also reduce your baby’s birthweight and increase the risk of sudden infant death syndrome , also known as “cot death”. Babies whose parents smoke are more likely to be admitted to hospital for bronchitis and pneumonia during their first year.

    To find out more about quitting and to get support, your partner can call the NHS Smokefree helpline on from 9am to 8pm Monday to Friday, and 11am to 4pm Saturday and Sunday.

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