Champix (varenicline) coated tablets №25 (0.5 mg. №11+1 mg. №14)

Description

Champix (varenicline) coated tablets №25 (0.5 mg. №11+1 mg. №14)

Composition

• 0.5 mg tablets:
  active substance: varenicline tartrate;
  1 film-coated tablet contains 0.85 mg of varenicline tartrate, equivalent to 0.5 mg of varenicline;
  Excipients: microcrystalline cellulose, calcium phosphate dibasic anhydrous, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate;
  shell Opadray white (YS-1-18202-A): hypromellose, titanium dioxide (E 171), polyethylene glycol; Opadray transparent (YS-2-19114-A): hypromellose, triacetin;
• 1 mg tablets:
  active substance: varenicline tartrate;
  1 film-coated tablet contains 1.71 mg of varenicline tartrate, equivalent to 1 mg of varenicline;
  Excipients: microcrystalline cellulose, calcium phosphate dibasic anhydrous, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate;
  shell: Opadray blue (03B90547): hypromellose, polyethylene glycol, titanium dioxide (E 171), FD & C blue № 2 / indigo carmine aluminum lacquer (E 132); Opaque transparent (YS-2-19114-A): hypromellose, triacetin.

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

• 0.5 mg tablets: film-coated tablets, white to off-white, biconvex, capsule-shaped, embossed with “Pfizer” on one side and “CHX 0.5” on the other;
• 1 mg tablets: Light blue, film-coated, biconvex, capsule-shaped tablets imprinted with “Pfizer” on one side and “CHX 1.0” on the other.

Pharmacotherapeutic group

Drugs used in nicotine addiction. Varenicline.
ATX code N07B A03.

Pharmacological properties

The effectiveness of the drug as a treatment for nicotine dependence is due to the partial agonistic effect of varenicline on α4β2-nicotinic receptors, binding to which reduces the symptoms of smoking cessation and withdrawal syndrome (agonistic effect) and at the same time prevents α2β binding which ultimately leads to a decrease in smoking pleasure (antagonistic action).

Indication

To get rid of tobacco addiction in adults.

Contraindication

Hypersensitivity to the active substance or to any of the other excipients.

Method of application and dosage

Champix tablets should be administered orally. Swallow the tablets whole with water. The drug can be taken with or without food.

The recommended dose is 1 mg of varenicline twice daily after administration in smaller doses for 1 week as follows:

• Days 1–3 – 0.5 mg once a day;
• Days 4-7 – 0.5 mg twice a day;
• Day 8 before treatment – 1 mg twice daily.

The patient must determine the date of smoking cessation. Champix tablets should usually be started 1-2 weeks before this date. Treatment with Champix tablets should be carried out within 12 weeks.

For patients who have successfully stopped smoking at the end of week 12, an additional 12-week course of treatment with Champix tablets 1 mg twice daily may be considered to relieve withdrawal symptoms.

A gradual approach to smoking cessation with the use of the drug Champix tablets is ​​recommended for patients who are unable or unwilling to quit smoking abruptly. Patients should reduce their smoking frequency during the first 12 weeks of treatment and quit smoking by the end of this treatment period. Patients should continue to take Champix tablets for another 12 weeks, for a total of 24 weeks of treatment.

Retrying smoking with Champix tablets may be successful for patients who seek to quit smoking but have not been able to do so during previous Tchempix tablets therapy or have returned to smoking after treatment.

Patients who cannot tolerate the side effects of Champix tablets can have their dose reduced to 0.5 mg twice a day, temporarily or permanently.

Treatment for tobacco cessation drugs will be more successful in patients who seek to quit smoking themselves and who receive additional counseling and support.

With the use of drugs to get rid of tobacco dependence, the risk of returning to smoking increases immediately after the end of therapy. Patients at high risk of recurrence should consider gradually reducing the dose at the end of therapy.

Children

Safety and effectiveness of the drug in children have not been established.

Overdose

No overdose has been reported in clinical trials.
In case of overdose it is necessary to carry out usual symptomatic therapy.
Varenicline has been shown to be excreted by dialysis in patients with end-stage renal disease, but there is no experience with dialysis after overdose.

Side effects:

• Infections and invasions: nasopharyngitis, bronchitis, sinusitis, fungal infections, viral infections.
• Metabolism and nutritional disorders: weight gain, decreased appetite, increased appetite, hyperglycemia.
• From the psyche: abnormal dreams, insomnia.
• From the nervous system: headache, drowsiness, dizziness, dysgeusia.
• Respiratory, thoracic and mediastinal disorders: cough, inflammation of the upper respiratory tract, accumulation of secretions in the respiratory tract, dysphonia, allergic rhinitis, throat irritation, sinus congestion, cough syndrome of the upper respiratory tract, gonorrhea, pain, rhinorrhea, pain.
• From the gastrointestinal tract: nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, bloating, abdominal pain, toothache, dyspepsia, flatulence, dry mouth, fresh blood in the stool, gastritis, changes in bowel rhythm, belching , aphthous stomatitis, gum pain.
• From the skin and subcutaneous tissue: rash, itching, erythema, acne, sweating, night sweats, severe skin reactions, including Stevens-Johnson syndrome, erythema multiforme, angioneurotic edema.
• From the musculoskeletal system and connective tissue: arthralgia, myalgia, back pain, muscle spasms, musculoskeletal pain in the chest, joint rigidity, costal chondritis.
• From the kidneys and urinary system: pollakiuria, nocturia, glucosuria, polyuria.
• From the reproductive system and mammary glands: menorrhagia, vaginal discharge, sexual dysfunction.
• General disorders and administration site conditions: chest pain, fatigue, chest discomfort, flu-like illness, pyrexia, asthenia, weakness, feeling cold, cyst.