Description
Latin name
Thioctacid
release form
film-coated tablets
Packing
100 pcs.
Indications
Neuropathy of various origins, including diabetic and alcoholic polyneuropathies, polyneuropathies with systemic lesions of the connective tissue, lesions of the facial nerve. Cerebral infarction. Parkinson’s disease. Diabetic retinopathy and diabetic macular edema. Glaucoma. Acute viral hepatitis C mild. Acute viral hepatitis A (without hepatic coma) of severe severity. Acute viral hepatitis C of moderate severity. Lesions of the intervertebral disc and other parts of the spine with radiculopathy. Other conditions accompanied by damage to cells of tissues and organs by free radicals
Contraindications
Hypersensitivity to thioctic acid or other components of the drug. Pregnancy, the period of breastfeeding (there is no sufficient experience with the use of the drug). Clinical data on the use of the drug Thioctacid ® BV in children and adolescents are not available, in connection with this, children and adolescents under 18 years of age should not be prescribed the drug
Use during pregnancy and lactation
Use of the drug during pregnancy is contraindicated in the absence of sufficient clinical experience with thioctic acid during pregnancy. The use of the drug during breastfeeding is contraindicated in the absence of data on the penetration of thioctic acid into breast milk.
Composition
1 film-coated tablet contains:
Active ingredient: thioctic acid (? -lipoic acid) – 600 mg
Excipients: low-substituted hyprolose 157.00 mg, hyprolose 20.00 mg, magnesium stearate 24, 00 mg
Film coating: hypromellose 15.80 mg, macrogol 6000 4.70 mg, titanium dioxide 4.00 mg, talc 2.02 mg, dye-based quinoline yellow aluminum varnish 1.32 mg, indigo carmine aluminum varnish 0.16 mg
Dosage and administration of
The drug is taken orally. Strictly on an empty stomach 20-30 minutes before a meal, without chewing, washed down with water. The recommended dose is 1 tablet (600 mg) 1 time per day. In severe cases, stepwise therapy is recommended for greater effectiveness: the start of treatment is the intravenous administration of the drug Thioctacid ® 600 T, solution for intravenous administration (2 to 4 weeks), followed by transfer of the patient to taking the drug Thioctacid ® BV.
If intravenous injection is not possible, it is recommended to use the drug Thioctacid ® BV, 1 tablet (600 mg) 3 times a day (which is equivalent to the intravenous injection of the drug Thioctacid ® 600 T) on an empty stomach 30 minutes before meals for 5 days and then as directed a doctor. The type and duration of the course of therapy is determined by the attending physician
Side effects
The frequency of side effects is defined as follows:
Very often:> 1/10
Frequently: 1/100
Infrequently: 1/1000
Rarely: 1/10000
Very rarely:
From the gastrointestinal tract : Often – nausea is very rare – vomiting, pain in the stomach and intestines, diarrhea, change in taste.
Allergic reactions: Very rarely – skin rash, urticaria, itching, anaphylactic shock.
From the nervous system and sensory organs: Often – dizziness.
General: Very rare – due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia (confusion, sweating, headache, visual disturbances) may appear.
Drug Interaction
The simultaneous administration of thioctic acid and cisplatin results in a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be given at the same time as preparations containing metals (for example, iron, magnesium, calcium) and dairy products. The interval between receptions should be at least 2 hours.
Thioctic acid enhances the hypoglycemic action of insulin and oral hypoglycemic agents.
Overdose
Symptoms: In the case of receiving thioctic ( -Lipoic) acid in a single dose of 10 – 40 g (more than 16 tablets of 600 mg), signs of intoxication (generalized convulsive seizures expressed disorders of acid-base balance, leading to lactoacidosis, hypoglycemic coma seizures)).
Immediate hospitalization is required if thioctic acid intoxication is suspected.
Treatment: symptomatic, if necessary – anticonvulsant therapy, measures to maintain the functions of vital organs
Storage conditions
At a temperature not exceeding 25 ° C, out of the reach of children.
Expiration
5 years.
dosage form a
Dosage form
tablets
Meda Farma GmbH and Ko.KG, Switzerland
