Zonik (pregabalin) hard capsules 75 mg. №28

Description

Zonik (pregabalin) hard capsules 75 mg. №28

Composition and form of release
active substance: pregabalin

1 capsule contains 75 mg of pregabalin;

excipients: corn starch, magnesium stearate, hard gelatin capsule (gelatin, purified water, titanium dioxide (E 171)).

Release form

Hard capsules (14 capsules in a blister. 1 or 2 or 4 or 6 blisters in a carton box).
Basic physical and chemical properties
Size 2 hard gelatin capsules with a white body and an opaque white lid containing a white to off-white powder.

Pharmacological properties

The active substance is pregabalin, which is an analogue of gamma-aminobutyric acid [(S)-3-(aminomethyl)-5-methylhexanoic acid].

Clinical efficacy and safety

Neuropathic pain
Studies have demonstrated the effectiveness of the drug for the treatment of diabetic neuropathy, postherpetic neuralgia and spinal cord injury. The effectiveness of the drug in other types of neuropathic pain has not been studied.

Epilepsy
Additional treatment. Zonik (pregabalin) was studied in 3 controlled clinical trials lasting 12 weeks with a dosing regimen twice or thrice a day. In general, the safety and efficacy profiles for the twice and thrice daily dosing regimens were similar.
A decrease in the frequency of seizures was observed already in the first week.

Children
The efficacy and safety of Zonik (pregabalin) as an adjuvant for epilepsy in children under 12 years of age and in adolescents has not been established. Adverse reactions observed in a study on pharmacokinetics and tolerability, which included patients aged 3 months to 16 years (n=65) with partial seizures, were similar to adverse reactions in adults. Results of a 12-week placebo-controlled study in 295 children aged 4 to 16 years and a 14-day placebo-controlled study in 175 children aged 1 month to less than 4 years to evaluate the efficacy and safety of pregabalin as adjunctive therapy partial seizures and two 1-year open-label safety studies involving 54 and 431 children, respectively, aged 3 months to 16 years with epilepsy, indicate that adverse reactions such as pyrexia and upper respiratory tract infections are more common in children than in adults with epilepsy.

Indications for use:

• Neuropathic pain. Zonik is indicated for the treatment of neuropathic pain of peripheral or central origin in adults.
• Epilepsy. Zonik is indicated for adults as an adjunctive treatment for partial seizures with or without secondary generalization.
• Generalized anxiety disorder. Zonik is indicated for the treatment of generalized anxiety disorder in adults.
• Fibromyalgia.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the “Composition” section.

Method of administration and dosage

Take the drug Zonik regardless of food intake.
This medicinal product is intended for oral use only.
The dose range of the drug can vary from 150 to 600 mg per day. The daily dose is divided into 2 or 3 doses.
In the case of a single dose of less than 150 mg, apply in the appropriate dosage.

• Neuropathic pain
  Zonik (pregabalin) therapy can be started with a dose of 150 mg per day, divided into 2 or 3 doses. Depending on the individual response and the tolerability of the drug, the dose can be increased to 300 mg per day after 3-7 days, and, if necessary, up to a maximum dose of 600 mg per day after 7 days.
  In the case of a single dose of less than 150 mg, apply in the appropriate dosage.
• Epilepsy
  Zonik (pregabalin) therapy can be started with a dose of 150 mg per day, divided into 2 or 3 doses. Depending on the individual response and the patient’s tolerability of the drug, the dose can be increased to 300 mg per day after the first week of treatment. After one week, the dose can be increased to a maximum of 600 mg per day.
  In the case of a single dose of less than 150 mg, apply in the appropriate dosage.
• Generalized anxiety disorder
  The dose, which is divided into 2 or 3 doses, can vary in the range of 150-600 mg per day. The need for continued therapy should be reviewed periodically.
  Zonik (pregabalin) therapy can be started with a dose of 150 mg per day. Depending on the individual response and the patient’s tolerability of the drug, the dose can be increased to 300 mg per day after the first week of treatment. After another week of administration, the dose can be increased to 450 mg per day. After one week, the dose can be increased to a maximum of 600 mg per day.
  In the case of a single dose of less than 150 mg, apply in the appropriate dosage.
• Fibromyalgia
  The recommended dose for the treatment of fibromyalgia is 300 to 450 mg per day. Treatment should be started with a dose of 75 mg twice daily (150 mg daily). Depending on efficacy and tolerability, the dose can be increased to 150 mg twice a day (300 mg per day) for one week. For patients for whom the use of a dose of 300 mg per day is not effective enough, you can increase the dose to 225 mg twice a day (450 mg per day). Although there are studies on the 600 mg daily dose, there is no evidence that this dose would have an additional benefit; also such a dose should be worse tolerated. Taking into account the dose-dependent adverse reactions, the use of doses of 450 mg per day is not recommended. Since pregabalin is excreted by the kidneys, the dose should be adjusted in patients with impaired renal function.

In the case of a single dose of less than 150 mg, apply in the appropriate dosage.

Cancellation of pregabalin

According to current clinical practice, it is recommended to discontinue pregabalin therapy gradually, over at least one week, regardless of the indication.

Overdose

The most common adverse reactions in pregabalin overdose have been reported to be drowsiness, confusion, agitation, and anxiety. There have also been reports of seizures.

Cases of coma have been rarely reported.

Treatment of pregabalin overdose consists of general supportive measures and, if necessary, may include hemodialysis.

Side effects:

• infections and invasions: nasopharyngitis;
• on the part of the blood and lymphatic system: neutropenia;
• from the immune system: hypersensitivity, angioedema, allergic reactions, anaphylactoid reactions;
• from the side of metabolism, metabolism: increased appetite, loss of appetite, hypoglycemia;
• from the side of the psyche: euphoria, confusion, irritability, disorientation, insomnia, decreased libido, hallucinations, panic attacks, anxiety, agitation, depression, depressed mood, high spirits, aggression, mood changes, depersonalization, difficulty finding words, pathological dreams, amplification libido, anorgasmia, apathy, disinhibition;
• from the nervous system: dizziness, drowsiness, headache, ataxia, impaired coordination, tremor, dysarthria, amnesia, memory impairment, impaired attention, paresthesia, hypesthesia, sedation, imbalance, lethargy, fainting, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, postural dizziness, intentional tremor, nystagmus;
• from the side of the organs of vision: blurred vision, diplopia, conjunctivitis, loss of peripheral vision, blurred vision, eye edema, visual field defects, decreased visual acuity, eye pain, asthenopia, photopsia, dry eyes, increased lacrimation, eye irritation, blepharitis;
• on the part of the hearing and balance organs: vertigo, hyperacusis;
• from the heart: tachycardia, first-degree block, sinus bradycardia, congestive heart failure, prolongation of the QT interval, sinus tachycardia, sinus arrhythmia;
• from the side of the vessels: arterial hypotension, arterial hypertension, hot flashes, hyperemia, feeling of coldness in the extremities;
• from the respiratory system, chest and mediastinum: pharyngolaryngeal pain, shortness of breath, epistaxis, cough, rhinitis, snoring, dry nasal mucosa, pulmonary edema, constriction in the throat, laryngospasm, apnea, atelectasis, bronchiolitis, hiccups;
• from the gastrointestinal tract: nausea, vomiting, constipation, diarrhea, flatulence, bloating, dry mouth, gastroenteritis, gastroesophageal reflux disease, salivary hypersecretion, oral hypoesthesia, cholecystitis, cholelithiasis, bleeding, gastrointestinal;
• skin and subcutaneous tissue disorders: pressure sores, papular rash, urticaria, hyperhidrosis, pruritus, alopecia, dry skin, eczema, hirsutism, skin ulcers, vesicle-bullous rash, Stevens-Johnson syndrome, cold sweat, exfoliative dermatitis;
• on the part of the musculoskeletal system and connective tissue: muscle cramps, arthralgia, back pain, pain in the extremities, neck muscle spasms, joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness, rhabdomyolysis;
• from the kidneys and urinary tract: urinary incontinence, dysuria, albuminuria, hematuria, kidney stones, nephritis, renal failure.