Algerica
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Algerica is an anticonvulsant drug.
Release form and composition
Dosage form of release of Algherika - capsules: opaque, black print on the lid "TEVA", the capsules contain partially compressed and granular powder of white or almost white color; 25 mg each - the lid and the body are light yellow, the inscription on the body - "7622"; 50 mg each - a lid and a body of light yellow color with a radial black stripe, the inscription on the body - "7623"; 75 mg each - pink lid, light yellow body with the inscription "7624"; 150 mg each - light yellow cap and body, inscription on the body - "7626": 300 mg each - pink cap, light yellow body inscription "7621" (7 pcs. in blisters, 2 or 8 blisters in a cardboard box).
Composition of 1 capsule:
- Active ingredient: pregabalin - 25, 50, 75, 150 or 300 mg;
- Additional components (25/50/75/150/300 mg): talc - 9/18/8/16/32 mg, mannitol - 43/86/10/20/40 mg, pregelatinized corn starch - 7/14/7 / 14/28 mg.
Capsule shell composition:
- 25 mg "7622 / TEVA": Size # 3, 48 mg; body: titanium dioxide - 2%, dye iron oxide yellow - 0.1%, gelatin - up to 100%; cap: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%;
- 50 mg "7623 / TEVA": size # 2, 61 mg; body: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%; cap: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%;
- 75 mg "7624 / TEVA": Size # 3, 48 mg; body: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%; cap: titanium dioxide - 2.1747%, red iron oxide dye - 0.6996%, gelatin - up to 100%;
- 150 mg "7626 / TEVA": Size # 2, 61 mg; body: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%; cap: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%;
- 300 mg "7621 / TEVA": Size # 0, 96 mg; body: titanium dioxide - 2%, yellow iron oxide dye - 0.1%, gelatin - up to 100%; cap: titanium dioxide - 2.1747%, red iron oxide dye - 0.6996%, gelatin - up to 100%.
Capsule ink: pharmaceutical glaze (shellac solution in ethanol) - 59.42%, isopropanol - 0.55%, propylene glycol - 1.3%, butanol - 9.75%, ethanol - 1.08%, dye black iron oxide - 24.65%, aqueous ammonia - 0.001%, purified water - 3.249%.
Indications for use
Algerica is prescribed for the treatment of the following diseases in adults:
- Fibromyalgia;
- Neuropathic pain;
- Generalized anxiety disorders;
- Epilepsy with partial seizures, proceeding with or without secondary generalization (as an additional therapy).
Contraindications
Absolute:
- Age under 18;
- Pregnancy and lactation;
- Hypersensitivity to drug components.
Relative (Algerica is prescribed with caution in the presence of the following diseases / conditions):
- Diabetes;
- Functional disorders of the kidneys;
- Heart failure;
- Encephalopathy (anamnestic data);
- Drug dependence (anamnestic data);
- Combined use with ethanol, lorazepam, oxycodone;
- Age from 65 years.
Women of reproductive age need to use effective contraceptive methods during therapy.
Method of administration and dosage
Algerica is taken orally, regardless of food intake, with sufficient water. The capsules should be swallowed whole without crushing or chewing.
The daily dose varies within 150-600 mg, the frequency of administration is 2-3 times a day. The duration of treatment is determined by the doctor individually, depending on the indications and individual characteristics of the patient.
The initial daily dose for all indications is 150 mg. After 3-7 days (determined by the response to therapy and individual tolerance), it may be doubled. After another 7 days, if necessary, it can be increased to a maximum of 600 mg.
Cancellation of treatment is carried out gradually - for at least 7 days.
In case of functional disorders of the kidneys, when selecting a dose, creatinine clearance (CC) is taken into account, calculated by the formula:
- Men: CC (ml / min) = (weight in kg) × (140 - age in years) / 72 × plasma creatinine concentration (mg / dl);
- Women: CC (ml / min) = 0.85 × CC for men.
For patients on hemodialysis, the daily dose of Algerica is selected taking into account the kidney function, while immediately after each four-hour hemodialysis session, an additional dose must be taken (CC / initial daily dose / maximum daily dose / frequency of application):
- From 60 ml / min: 150 mg / 600 mg / 2-3 times a day;
- 30-60 ml / min: 75 mg / 300 mg / 2-3 times a day;
- 15-29 ml / min: 25-50 mg / 150 mg / 1-2 times a day;
- Up to 15 ml / min: 25 mg / 75 mg / once a day.
Additional daily dose prescribed once after dialysis: initial - 25 mg, daily - 100 mg.
No dose adjustment is required for patients with liver dysfunction.
Patients over 65 years of age due to decreased renal function may be prescribed Algerica in reduced doses.
If you miss a single dose, you need to take it as soon as possible. Do not take a double dose.
Side effects
When taking Algerica, the following disorders may develop (very often (≥10%); often (≥1% and <10%); infrequently (≥0.1% and <1%); rarely (≥0.01% and < 0.1%); very rare (<0.01%, considering isolated cases)):
- Nervous system: very often - drowsiness, dizziness; often - fainting, sedation, irritability, decreased libido, euphoria, confusion, insomnia, disorientation, ataxia, lethargy, tremor, memory impairment, paresthesia, amnesia; infrequently - hallucinations, anorgasmia, depersonalization, increased insomnia, anxiety, agitation, depression, mood lability, difficulty in finding words, loss of taste, depressed mood, increased libido, nightmares, panic attacks, cognitive disorders, apathy, hypesthesia, nystagmesia myoclonic convulsions, weakening of reflexes, hyperesthesia, dyskinesia, burning sensation on the mucous membranes and skin, psychomotor agitation, postural dizziness, stupor, intentional tremor, impaired speech, coordination, balance and attention; rarely - parosmia,high spirits, disinhibition, hypokinesia, dysgraphia;
- Digestive system: often - flatulence, dryness of the oral mucosa, vomiting, bloating, constipation; infrequently - hypoesthesia of the oral mucosa, gastroesophageal reflux, increased salivation; rarely - dysphagia, ascites, pancreatitis;
- Cardiovascular system: infrequently - AV-blockade of the I degree, skin hyperemia, hot flashes, increased blood pressure, tachycardia; rarely - sinus tachycardia, arrhythmia and bradycardia;
- Hematopoietic system: rarely - leukopenia, neutropenia, thrombocytopenia;
- Infectious diseases: infrequently - nasopharyngitis;
- Urinary system: infrequently - urinary incontinence, dysuria; rarely - oliguria, renal failure;
- Respiratory system: infrequently - shortness of breath, dryness of the nasal mucosa; rarely - nosebleeds, nasal congestion, rhinitis, a feeling of tightness in the throat, snoring;
- Reproductive system: often - erection dysfunction; infrequently - delayed ejaculation, sexual dysfunction; rarely - dysmenorrhea, pain in the mammary glands, amenorrhea, discharge from the mammary glands, as well as their increase in volume;
- Musculoskeletal system: infrequently - joint swelling, muscle twitching, muscle spasms, muscle stiffness, myalgia, arthralgia, pain in the limbs and back; rarely - pain in the neck, spasm of the cervical muscles, rhabdomyolysis;
- Skin and subcutaneous tissues: infrequently - sweating, papular rash; rarely - urticaria, cold sweat;
- Hearing organ and labyrinthine disorders: often - vertigo; rarely - hyperacusis;
- Organ of vision: often - double vision, blurred vision; infrequently - narrowing of the visual fields, visual impairment, decreased visual acuity, swelling of the eyes, pain in the eyes, rapidly onset eye fatigue, increased lacrimation, dry eyes; rarely - mydriasis, eye irritation, flashing "sparks" before the eyes, oscillopsia, strabismus, impaired depth perception, increased brightness of visual perception, loss of peripheral vision;
- Metabolism and nutrition: often - weight gain and appetite; infrequently - hypoglycemia, anorexia, hyperglycemia; rarely - weight loss;
- Instrumental and laboratory data: infrequently - increased activity of creatine phosphokinase, aspartate aminotransferase, alanine aminotransferase; rarely - hypokalemia, hypercreatininemia;
- Others: often - a feeling of inebriation, fatigue, gait disturbance, edema, including peripheral; infrequently - falls, asthenia, thirst, generalized edema, chest tightness, chills, pain; rarely - hyperthermia.
Adverse reactions recorded during post-marketing surveillance:
- Nervous system: with unknown frequency - loss of consciousness, headache, cognitive impairment;
- Digestive system: rarely - nausea, swelling of the tongue, diarrhea;
- Cardiovascular system: with unknown frequency - prolongation of the QT interval, chronic heart failure;
- Respiratory system: with unknown frequency - pulmonary edema;
- Urinary system: with unknown frequency - urinary retention;
- Skin and subcutaneous tissues: rarely - itching, swelling of the face;
- Organ of vision: with unknown frequency - loss of vision;
- Allergic reactions: with unknown frequency - angioedema, hypersensitivity reaction, allergic reaction, Stevens-Johnson syndrome.
special instructions
During therapy or immediately after discontinuation of Algerica, it is possible to develop status epilepticus and the appearance of grand mal seizures.
Violations of the organ of vision (in the form of decreased visual acuity, loss of vision) usually go away on their own, both when treatment is canceled and when it is continued.
There is evidence of the development of reversible (after discontinuation of Algerica) renal failure.
After completion of treatment, withdrawal syndrome may develop (the frequency of occurrence and the severity of symptoms depend on the dose and duration of the course).
In diabetes mellitus, in case of weight gain during therapy, it may be necessary to adjust the doses of hypoglycemic drugs.
In cases where symptoms of angioedema appear, the drug is immediately canceled.
While taking the drug, dizziness and drowsiness may develop, which increases the likelihood of accidental injuries (falls) in elderly patients. Care should be taken until the patient evaluates the possible effects of the drug.
In the treatment of neuropathic pain, there have been reports of chronic heart failure in elderly patients with cardiovascular disease.
The risk of developing disorders from the central nervous system (in particular, drowsiness) increases in cases when the drug is used in the treatment of pain in spinal injuries (may be associated with interactions with other drugs, including antispasmodics).
If you have suicidal ideation or attempts, you should immediately consult a doctor.
Patients with anamnestic data on drug dependence on any drugs are prescribed Algerica with caution.
Side effects in the form of encephalopathy were observed mainly in the presence of concomitant conditions that predispose to the development of the disease.
If necessary, combined use with opioid analgesics, it is necessary to take measures to prevent intestinal obstruction and constipation, in particular in elderly patients.
During the period of taking Algerica, one should refrain from driving vehicles and potentially hazardous work, the performance of which requires an increased concentration of attention and rapid psychomotor reactions (associated with the possibility of developing side reactions in the form of dizziness, drowsiness and visual impairment).
Drug interactions
Pharmacokinetic interaction of Algerica with other substances / drugs is unlikely.
Pregabalin enhances oxycodone-induced disorders of basic motor and mnestic functions, as well as the effects of lorazepam and ethanol.
When combined with opioid analgesics, Algerica can provoke a weakening of the function of the lower gastrointestinal tract, including intestinal obstruction and constipation.
Analogs
The analogues of Algerica are: Pregabalin, Pregabalin-Canon, Lyrica, Pregabalin-Richter, Prabegin, Pregabio.
Terms and conditions of storage
Keep out of reach of children at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
