Side effects, which are often noted when using various therapeutic regimens with the use of the drug Zerit: Peripheral neuropathy, lactic acidosis, pancreatitis, hepatitis, hepatic insufficiency, lipoatrophy / lipodystrophy.
Peripheral Neuropathy /peripheral neurological
symptoms: when applying the scheme stavudine + lamivudine + efavirenz the incidence of peripheral neurologic symptoms was 19%.
Pancreatitis: pancreatitis, sometimes with lethal outcome, was observed in more than 1% of patients who received Zerit as part of a combination therapy.
Lactic acidosis: cases of lactic acidosis, sometimes with a lethal outcome, were observed in nThe use of nucleoside analogues.
Muscle weakness was noted in rare cases with the use of Zerit as a combination antirtrovirus therapy.
Hepatitis or liver failure, sometimes with a fatal outcome, were observed with the use of Zerit and others nucleoside analogues.
Lipoatrophy / lipodystrophy: cases lipoatrophy / lipodystrophy were observed with Zerit and other
nucleoside analogues.
Below is the incidence of adverse reactions with Zerit® in the form of combined therapy in accordance with the generally accepted
classification: Very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); rarely (<1/10000).
Stavudine + lamivudine + Efavirenz:
From the endocrine system: infrequently - gynecomastia;
On the part of the digestive system: often - diarrhea, abdominal pain, nausea, dyspepsia;
infrequently - pancreatitis, vomiting, hepatitis, jaundice;
Metabolic disorders: often - lipoatrophy, lipodystrophy; infrequently, lactic acidosis (sometimes with muscle weakness), andnoorexia;
From the side of the locomotor system apparatus: infrequently - arthralgia, myalgia;
From the nervous system: often - depression, peripheral neuropathy, paresthesia, peripheral neuritis, dizziness, "unusual" dreams, headache, insomnia, drowsiness, "unusual" thoughts, anxiety, emotional lability;
From the skin and subcutaneous tissue:
often - a rash, itching; infrequently urticaria.
Organism as a whole: often fatigue; infrequently - asthenia, allergic reactions.
Stavudine + lamivudine + indinavir:
On the part of the digestive system: highly often - diarrhea, nausea, vomiting;
From the nervous system: Often - peripheral neuropathy, paresthesia, peripheral neuritis, headache.
From the skin and subcutaneous tissue: very often - a rash.
Stavudine + didanosine + indinavir:
On the part of the digestive system: highly often - diarrhea, nausea, vomiting;
From the nervous system: Often - peripheral neuropathy, paresthesia, peripheral neuritis.
From the skin and subcutaneous tissue:
very often - a rash.
The following are adverse reactions of any severity that were noted in clinical studies for various pdyshma therapy with stavudine with a frequency of at least 1%.
Organism as a whole: asthenia, sweating;
On the part of the digestive system: flatulence, dry mouth, increased appetite, gastritis, constipation;
From the nervous system: confusion, emotional lability, nervous excitement, dizziness, euphoria, anxiety, stupor, decreased libido, impaired coordination, hallucinations;
Metabolic disorders: hypertriglyceridemia, weight loss;
From the musculoskeletal system: arthralgia, pain in the limbs;
From the sense organs: perversion of the Taste.
Lactic acidosis, pancreatitis, hepatitis and jaundice were noted in these studies in less than 1% of patients.
Postmarketing data on the side effects reported with stavudine
On the part of the blood system and hemopoiesis: frequency unknown - macrocytosis, anemia, neutropenia, thrombocytopenia;
Metabolic disorders: often - asymptomatic hyperlactatemia; frequency unknown - lactic acidosis, lipoatrophy,lipodystrophy.
fromabout the endocrine system: frequency unknown - diabetes, hyperglycemia;
From the side of the liver: frequency unknown - steatosis of the liver, hepatitis and liver failure;
From the nervous system: frequency
unknown - severe muscle weakness (most often with hyperlactatemia or lactic acidosis);
Changes in laboratory parameters recorded when combining Zerit with other drugs:
Combination Therapy stavudine + lamivudine + indinavir: bilirubin >2.6 x VGN (upper limit of the norm) (7%); ACT > 5 x VGN (5%); ALT> 5 x VGN (6%); lipase> 2 x VGN (6%), GGT> 5 x VGN (2%); amylase> 2 x VGN (4%);
Combination Therapy stavudine + didanosine + indinavir: bilirubin> 2.6 x VGN (16%), ACT > 5 X VGN (7%), ALT> 5 x VHN (8%), lipase> 2 x VGN (5%), GGT> 5 x VHN (5%), amylase> 2 x VHN (8%). Changes in laboratory indicators recorded in patients receiving antiretroviral therapy for the first time:
Combination Therapy stavudine + lamivudine + Efavirenz: ACT > 5 x VGN
(3%), ALT> 5 x VGN (3%), lipase> 2 x VHN (3%), neutropenia (ANC <750 / mm3) (5%), andneemia (hemoglobin <80 g / l) (less than 1%), thrombocytopenia (platelets <50,000 / mm3) (2%).
Children: In clinical trials side effects of the drug in children (with birth to puberty period) and adult patients were similar.
Development of peripheral neuropathy in children were observed less often than in adults, however, its symptoms are more complex in children are detectable.