Country: United States
Language: English
Source: NLM (National Library of Medicine)
VARENICLINE TARTRATE (UNII: 82269ASB48) (VARENICLINE - UNII:W6HS99O8ZO)
A-S Medication Solutions
VARENICLINE TARTRATE
VARENICLINE 1 mg
ORAL
PRESCRIPTION DRUG
CHANTIX is indicated for use as an aid to smoking cessation treatment. CHANTIX is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX. Risk Summary Available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see Data]. Smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see Clinical Considerations) . In animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (MRHD). Additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the MRHD [see Data] . The estimated background risk of oral clefts is increased by
Product: 50090-0995 NDC: 50090-0995-0 1 TABLET, FILM COATED in a KIT
New Drug Application
A-S Medication Solutions ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised Feb 2019 MEDICATION GUIDE CHANTIX® (CHANT-iks) (varenicline) Tablets What is the most important information I should know about CHANTIX? When you try to quit smoking, with or without CHANTIX, you may have symptoms that may be due to nicotine withdrawal, including: • urge to smoke • depressed mood • trouble sleeping • irritability • frustration • anger • feeling anxious • difficulty concentrating • restlessness • decreased heart rate • increased appetite • weight gain Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking CHANTIX to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems before taking CHANTIX, than in people without a history of mental health problems. Stop taking CHANTIX and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take CHANTIX. In many people, these symptoms went away after stopping CHANTIX, but in some people symptoms continued after stopping CHANTIX. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking CHANTIX, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptom Read the complete document
CHANTIX- VARENICLINE TARTRATE TABLET, FILM COATED A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CHANTIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CHANTIX. CHANTIX (VARENICLINE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2006 RECENT MAJOR CHANGES Warnings and Precautions, Cardiovascular Events (5.5) 6/2018 INDICATIONS AND USAGE CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. (1 and 2.1) DOSAGE AND ADMINISTRATION Begin CHANTIX dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment. (2.1) Starting Week: 0.5 mg once daily on days 1–3 and 0.5 mg twice daily on days 4–7. (2.1) Continuing Weeks: 1 mg twice daily for a total of 12 weeks. (2.1) An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. (2.1) Consider a gradual approach to quitting smoking with CHANTIX for patients who are sure that they are not able or willing to quit abruptly. 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 treatment for an additional 12 weeks, for a total of 24 weeks. (2.1) Severe Renal Impairment (estimated creatinine clearance less than 30 mL/min): Begin with 0.5 mg once daily and titrate to 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum of 0.5 mg daily may be given if tolerated. (2.2) Consider dose reduction for patients who cannot tolerate adverse effects. (2.1) 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. (2.1) Provide pati Read the complete document