يتوفر حاليا في الأسواق السورية مركب دوائي حديث يساعد عاة إيقاف التدخين هو [vareniciline])
يتمتع هذا المركب بألفة وانتقائية عالية للارتباط بالمساقبلات العصبية النيكوتينية للأستيل كولين حيث يعمل كمشابه جزئي للنيكوتين لكن أقل فعالية من النيكوتين وله تأثير مثبط بوجود النيكوتين
يتوافر المستحضر الصيدلاني بي عيارين 0.5 ملغ و 1 ملغ
يتم العلاج بطريقة متدرجة على النحو التالي :
0.5 ملغ جرعو وحيدة يوميا في الثلاثة أيام الأولى
0.5 ملغ مرتين يوميا في الأربعة ؟أيام التالية
1 ملغ صباحا ومساء بعد الأسبوع الأول وحتى نهاية العلاج
علما بأن فترة العلاج الكاملة لا تقل عن 3 أشهر
يعتبر الغثيان من أكثر التأثيرات الجانبية شيوعا مع النفخة وعسر الهضم
ويمكن أن يترافق استخدامه مع مشاكل واضطرابات في النوم
جفاف الفم صداع صعوبة في التنفس
مع اضطرابات في الشهية العامة
هذه لمحة موجزة عن هذا المركب وهو يعتبر من المركبات الجديدة في الأسواق السورية
لكن أود الإشارة الى غلا ء ثمن مثل هذه المستحضرات بصورة تجعل المدخنين يحجمون عن استخدامه
حيث يبلغ ثمن العبوة 11 حبة من عيار 0, 5 ملغ 555 ليرة سورية
والعبوة من عيار 1 ملغ 1350 ليرة سورية
مما يجعل كلفة العلاج الممتدة ل 12 اسبوع باهظة على أغلب المدخنين
لنتعاون جميعا من أجل الدعوة للإقلاع عن التدخين

في عندي كم سؤال بتمنى الاجابة:
ما هي مدة العلاج؟؟
هل يجوز استخدامه اثناء فترة الحمل والرضاعة؟؟
في حالة نسيان اخذ جرعة من الجرعات .......شو هو الحل؟؟يا ترى برجع بعيد العلاج من بدايته ولا بكمله؟؟؟
هل من الممكن ان يترافق اخذ الدواء مع التدخين.......ام يجب قطع التدخين ومن ثم الشروع في العلاج؟؟
شكرا كتير.....

هذا ما هو مذكور عن هذا الدواء في UPTODATE 16.1


Varenicline: Drug information



Copyright 1978-2008 Lexi-Comp, Inc. All rights reserved.

(For additional information see "Varenicline: Patient drug information")
SPECIAL ALERTS
Varenicline: Psychiatric and central nervous system adverse events - Updated February 1, 2008
The Food and Drug Administration (FDA) has issued an update to the November, 2007 alert regarding postmarketing events reported with varenicline (Chantix™ ). After further review, the FDA feels that there is likely an association between varenicline and the neuropsychiatric events. The product labeling has been revised to include a warning concerning the neuropsychiatric symptoms, which usually occur during treatment, but have also occurred after varenicline treatment has been discontinued. Healthcare providers should monitor all patients taking varenicline for symptoms of serious neuropsychiatric events, including agitation, depression, suicidal behavior, and suicidal ideation. Inform patients to report any behavioral and/or mood changes to their healthcare provider. An FDA-approved patient medication guide is forthcoming.
Additional information is available at http://www.fda.gov/medwatch/safety/2...tm#Varenicline.
Varenicline: Psychiatric and central nervous system adverse events - November, 2007
The Food and Drug Administration (FDA) has issued preliminary information for healthcare professionals regarding postmarketing reports of suicidal thoughts and erratic/aggressive behavior in patients who have taken varenicline (Chantix™ ) to aid in smoking cessation. Many cases suggest new-onset depression, suicidal ideation, and emotion/behavioral changes within days to weeks after treatment initiation. Because smoking cessation (with or without treatment) is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness, the role of varenicline in these events is unclear. Some of the cases described above occurred in patients without a history of psychiatric disease and in patients who had not discontinued smoking. The FDA also has reports of excessive drowsiness which may impair the ability to perform tasks requiring mental alertness. The investigation by the FDA is ongoing.
Patients taking varenicline for smoking cessation should be monitored for behavioral changes and psychiatric symptoms. Patients should be informed to report any behavioral and/or mood changes to their healthcare provider and to use caution when performing tasks requiring mental alertness.
Additional information is available at http://www.fda.gov/medwatch/safety/2...07.htm#chantix
U.S. BRAND NAMES — Chantix™
PHARMACOLOGIC CATEGORY
Partial Nicotine Agonist
Smoking Cessation Aid
DOSING: ADULTS — Smoking cessation: Oral:
Initial:
Days 1-3: 0.5 mg once daily
Days 4-7: 0.5 mg twice daily
Maintenance (week 2-12): 1 mg twice daily
Note: Start 1 week before target quit date. Patients who cannot tolerate adverse events may require temporary reduction in dose. If patient successfully quits smoking during the 12 weeks, may continue for another 12 weeks to help maintain success. If not successful in first 12 weeks, then stop medication and reassess factors contributing to failure.
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT
Clcr ≥ 30 mL/minute: No adjustment required
Clcr <30 mL/minute: Initiate: 0.5 mg once daily; maximum dose: 0.5 mg twice daily
Hemodialysis: Maximum dose: 0.5 mg once daily
DOSING: HEPATIC IMPAIRMENT — Dosage adjustment not required
DOSING: ADJUSTMENT FOR TOXICITY
Lower dose for a period of time, then increase again.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, as tartrate:
Chantix™ : 0.5 mg, 1 mg
DOSAGE FORMS: CONCISE
Tablet, as tartrate:
Chantix™ : 0.5 mg, 1 mg
GENERIC EQUIVALENT AVAILABLE — No
ADMINISTRATION — Administer with food and glass of water.
USE — Treatment to aid in smoking cessation
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Insomnia (18% to 19%), headache (15% to 19%), abnormal dreams (9% to 13%)
Gastrointestinal: Nausea (16% to 40%; dose related)
1% to 10%:
Central nervous system: Sleep disorder (≤ 5%), somnolence (3%), nightmares (1% to 2%), lethargy (1% to 2%), malaise (≤ 7%)
Dermatologic: Rash (≤ 3%)
Gastrointestinal: Flatulence (6% to 9%), abdominal pain (≤ 7%), constipation (5% to 8%), abnormal taste (5% to 8%), xerostomia (≤ 6%), dyspepsia (5%), vomiting (1% to 5%), appetite increased (3% to 4%), anorexia (≤ 2%), gastroesophageal reflux (1%)
Respiratory: Dyspnea (≤ 2%), rhinorrhea (≤ 1%)
<1% (Limited to important or life-threatening): Acute coronary syndrome, acute renal failure, aggression, agitation, amnesia, anemia, angina, anxiety, arrhythmia, asthma, atrial fibrillation, attention disturbance, behavioral changes, blindness (transient), blurred vision, bradycardia, bradyphrenia, cardiac flutter, cataract, cerebrovascular accident, chest pain, chills, conjunctivitis, coronary artery disease, cor pulmonale, deafness, depression, dermatitis, diabetes mellitus, diarrhea, disorientation, dissociation, dizziness, dysarthria, dysphagia, ECG abnormal, edema, emotional disorder, enterocolitis, epistaxis, erectile dysfunction, eructation, erythema, esophagitis, euphoria, facial palsy, fever, flu-like syndrome, flushing, gall bladder disorder, gastritis, gastric ulcer, gastrointestinal hemorrhage, gingivitis, hallucinations, hyperhidrosis, hyper-/hypokalemia, hyperlipidemia, hypersensitivity, hyper-/hypotension, hypoglycemia, intestinal obstruction, irritability, leukocytosis, libido decreased, liver function test abnormal, lymphadenopathy, mental impairment, MI, migraine, mood swings, mouth ulceration, muscle enzyme increased, musculoskeletal pain, multiple sclerosis, myositis, nephrolithiasis, night blindness, nocturia, nystagmus, ocular vascular disorder, palpitation, pancreatitis, parosmia, peripheral ischemia, photophobia, photosensitivity, pleurisy, polyuria, psychomotor hyperactivity, psychomotor impairment, psychotic disorder, pulmonary embolism, restless leg syndrome, restlessness, seizure, sexual dysfunction, splenomegaly, suicidal behavior, suicidal ideation, suicide, syncope, tachycardia, thinking abnormal, thrombocytopenia, thrombosis, thyroid disorder, tinnitus, transient ischemic attack, tremor, urinary retention, urticaria, ventricular extrasystoles, vertigo, visual field defect, vitreous floaters, weight gain, xerophthalmia
CONTRAINDICATIONS — There are no contraindications listed within the manufacturer's labeling.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Neuropsychiatric effects: Neuropsychiatric symptoms, including suicidal thoughts and erratic/aggressive behavior, have been reported with use as well as following withdrawal of varenicline. Smoking cessation (with or without treatment) is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness, however, some of the behavioral disturbances were reported in patients who continued to smoke. Monitor patients for behavioral changes and psychiatric symptoms (eg, agitation, depression, suicidal behavior, suicidal ideation); inform patients to report any behavioral and/or mood changes to healthcare provider. Sedation: May cause sedation, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns: Psychiatric illness: Patients with pre-existing psychiatric illness (eg, bipolar disorder, major severe depression, schizophrenia) were not studied in clinical trials; safety and efficacy has not been established in these populations. Due to rare neuropsychiatric events, caution is warranted if treatment is initiated; worsening of psychiatric illness has been reported. Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required with severe impairment.
Concurrent drug therapy issues: Nicotine: Safety and efficacy of varenicline with other smoking cessation therapies have not been established; increased adverse events when used concurrently with nicotine replacement therapy.
Special populations: Pediatrics: The manufacturer does not recommend use in patients <18 years of age.
DRUG INTERACTIONS — Successful cessation of smoking may alter pharmacokinetic properties of other medications (eg, theophylline, warfarin, insulin).
PREGNANCY RISK FACTOR — C (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies, however, decreased fertility, decreased fetal weight, and increased auditory startle response were observed in the offspring. There are no adequate or well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.
LACTATION — Excretion in breast milk unknown/not recommended
DIETARY CONSIDERATIONS — Should be given with food and a full glass of water to decrease gastric upset.
PRICING — (data from drugstore.com)
Tablets (Chantix)
0.5 mg (56): $120.91
1 mg (56): $120.91
Tablets (Chantix Continuing Month Pak)
1 mg (56): $124.12
MONITORING PARAMETERS — Monitor for behavioral changes and psychiatric symptoms (eg, agitation, depression, suicidal behavior, suicidal ideation)
CANADIAN BRAND NAMES — Champix®
INTERNATIONAL BRAND NAMES — Champix (AR, AT, BE, BG, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HN, IE, IT, MX, NL, NO, NZ, PT, RU, SE, TR)
MECHANISM OF ACTION — Partial neuronal alpha4 ß2 nicotinic receptor agonist; prevents nicotine stimulation of mesolimbic dopamine system associated with nicotine addiction. Also binds to 5 HT3 receptor (significance not determined) with moderate affinity. Varenicline stimulates dopamine activity but to a much smaller degree than nicotine does, resulting in decreased craving and withdrawal symptoms.
PHARMACODYNAMICS / KINETICS
Absorption: Well absorbed; unaffected by food
Protein binding: ≤ 20%
Metabolism: Minimal (<10% of clearance is through metabolism)
Half-life elimination: 24 hours
Time to peak, plasma: approximately 3-4 hours
Excretion: Primarily urine (92% as unchanged drug)

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