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Varenicline

Updated on : December - 2012
Latest prescription information about Varenicline. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Varenicline
Pronunciation : var-EN-i-kleen
Therapeutic Classification : Smoking Cessation Agent
Trade Name(s): 
India- Champix , Champix ST.
International- Chantix.
Why it is prescribed (Indications) : 
This medication is a nicotinic receptor partial agonist, prescribed for smoking cessation.  It blocks the pleasant effects of nicotine (from smoking) on the brain.
When it is not to be taken (Contraindications): Hypersensitivity.

Pregnancy Category :

A B C D X
Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Dosage & When it is to be taken : 
Adult: PO- 0.5 mg once daily for 1st 3 days, followed by 0.5 mg twice daily for the next 4 days. Maintenance (week 2-12): 1 mg twice daily.
Initiate dose 1-2 week before target quit date. Usual treatment duration: 12 weeks.
May continue for another 12 weeks to reduce relapse in patients who have successfully quit after the initial treatment course.
How it should be taken : It comes as a tablet to take by mouth, with food.
Warnings and Precautions : 
* Caution should be exercised in patients with history of kidney problems or dialysis, mental or mood problems, suicidal thoughts, who are taking other medication, any allergy, elderly, during pregnancy and breastfeeding.
* It may cause dizziness or drowsiness, do not drive a car or operate machinery while taking this medication.
* Patient may develop with elevated mood or changes in behavior and Suicidality; if it so consult with your doctor.
Side Effects : 
Gastrointestinal - Nausea, vomiting, abdominal pain, flatulence, indigestion, gastrointestinal motility/defecation conditions, constipation, acid reflux disease, salivary gland conditions and dry mouth.
Central Nervous System - Sleep disorder/disturbances, sleeplessness, abnormal dreams, negative emotional state, headache, nerve disorders, drowsiness and abnormal taste.
General - Fatigue/uneasiness/weakness.
Respiratory - Runny nose, difficulty in breathing and upper respiratory tract disorder.
Skin - Rash and itching.
Metabolic - Increased and decreased appetite.
Heart- Chest pain, peripheral vascular disease (PVD).
Other Precautions : 
* Monitor kidney and liver functions regularly while taking this medication.
Storage Conditions : 
Store it at room temperature and in an airtight container. Keep away from children.
♦ Safety Labeling Changes Approved By FDA

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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