Regast: instructions, indications, contraindications, side effects and reviews

The article was prepared by a specialist for informational purposes only. We urge you not to self-medicate. When the first symptoms appear, consult a doctor.

Author of the article

Volodina Svetlana Igorevna

Cardiologist, therapist. Candidate of Medical Sciences. 11 years of experience. Place of work: City Clinical Hospital No. 63, Children's Clinical Center No. 1

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Regast is an antiviral drug used in antiretroviral therapy regimens for type 1 HIV infection. It is usually prescribed along with other medications selected by a specialist. Reduces the number of viral particles in the body and prevents the progression of the disease with an unfavorable outcome. Facilitates the patient's condition. Prescribed only by an experienced doctor according to indications and taking into account the risks.

The use of some antiretroviral medications for coronavirus infection is experimental in nature, since there is no reliable data on the effectiveness and safety of such treatment yet. It is strictly forbidden to try to take any medications for coronavirus on your own. You need to see a doctor. Self-medication causes serious complications.

Compatibility of Regast and alcohol

? Drug therapy involves complete abstinence from drinking alcohol. When treating HIV infection with antiviral drugs, side effects may occur in the form of an allergic reaction and an increase in enzymes in the liver.

When using medication and alcohol at the same time, it is difficult to determine whether they arose under the influence of ethyl or the drug. With a blurred clinical picture, it is difficult to determine the correct dosage, and tracking the dynamics of changes becomes almost impossible.

After drinking alcohol during therapy, partial amnesia may occur. Over time, the side effect of memory loss goes away. With regular libations, the side effects intensify.

Drinks containing ethanol suppress CD4 immune cells, reducing the total number of cells.

Contraindications

• Age up to three years and body weight less than thirteen kilograms.
• Intolerance to any substance in the tablet.
• Severe impairment of liver activity.
• Lack of lactase enzyme, lactose intolerance.
• Impaired absorption of glucose or galactose.
• Simultaneous use with medications containing St. John's wort.
• Carrying a child, except in cases of threat to the life of the mother (negative impact on the fetus.)
• Planning pregnancy during treatment.
• Lactation.
• Concomitant use with saquinavir as a single protease inhibitor or with other non-nucleoside reverse transcriptase inhibitors.

Caution is required in the treatment of patients who have one or more of the following factors: mental disorders with an increased risk of exacerbation, mild or moderate liver dysfunction, current or history of convulsive reactions, taking anticonvulsant medications with metabolization in the liver tissue. In these cases, the patient's condition must be periodically assessed.

Additional contraindication

Brief characteristics of the drug

This is an antiviral drug of the pharmacotherapeutic group that is used to treat HIV infection. The active substance of the drug is efavirenz. Prevents the formation of new DNA chains of the virus, preventing infection of healthy cells.

The effectiveness of treatment increases when therapy is combined with other antiviral drugs.

Regat is available in tablets of various dosages. Packaged in an egg-shaped contour blister or polymer jar.

The drug is used in complex therapy with other antiretroviral drugs for HIV type 1 in adult patients and children over 3 years of age.

Conditions under which the use of Regatta is prohibited:

• lactose intolerance;
• hypersensitivity to the components of the drug;
• severe liver pathologies;
• body weight less than 13 kg and children under 3 years old;
• simultaneous use with triazole, terfenadine, midozalam, astemizole, bespridil, cisapride;
• Do not use with products that contain St. John's wort. The therapeutic effect is reduced.

Use with caution in mental disorders, as well as in the treatment of mild to moderate liver pathologies.

Regast

Efavirenz should not be used as the sole treatment for HIV infection, nor should it be added as the sole treatment to an ineffective treatment regimen.

During therapy, the risk of transmitting HIV infection to others during sexual contact or through blood cannot be excluded. In this regard, appropriate precautions should be taken.

Concomitant use of efavirenz with fixed combinations containing efavirenz, emtricitabine and tenofovir disoproxil fumarate is not recommended unless dose adjustment is required (for example, when used concomitantly with rifampicin). When prescribing drugs that should be taken concomitantly with efavirenz, the doctor should refer to the appropriate “Instructions for Medical Use” for these drugs. If any antiretroviral drug is discontinued in combination therapy due to suspected intolerance, simultaneous discontinuation of all antiretroviral drugs should be considered. All discontinued antiretroviral drugs should be resumed immediately after symptoms of intolerance have resolved. Interrupted monotherapy followed by repeated doses of antiretroviral drugs is not recommended due to the increased likelihood of selection of mutagenic viruses that are resistant to therapy.

The use of efavirenz with Gingo Biloba extracts is not recommended.

Taking efavirenz with food may increase its effect and lead to an increase in the incidence of adverse reactions. Therefore, it is recommended to use the drug before bed on an empty stomach.

Skin rash

: In clinical studies of efavirenz, mild to moderate rashes were reported, which usually resolved with continued therapy. Taking appropriate H1-receptor blockers and/or glucocorticosteroid drugs may improve tolerability and promote rapid resolution of the rash. Severe rash accompanied by blistering, desquamation, or ulceration occurred in less than 1% of patients receiving efavirenz. Multimorphic exudative erythema or Stevens-Johnson syndrome occurred in 0.14% of cases. If patients develop severe rash accompanied by blistering, desquamation involving mucous membranes, or fever, efavirenz should be stopped immediately. If efavirenz therapy is discontinued, consideration should be given to discontinuing other antiretroviral agents to avoid the emergence of treatment-resistant virus.

Rash was observed in 26 of 57 (46%) children receiving efavirenz for 48 weeks, with three patients experiencing severe rash. Prescribing H1-histamine receptor blockers before starting efavirenz therapy in children to prevent rash may be advisable.

Mental symptoms

:

There is evidence of the occurrence of adverse mental events in patients receiving efavirenz. Patients with a history of mental disorders are at increased risk of developing serious adverse mental events. There are also post-marketing data on cases of suicide, delusional ideas and psychosis-like behavior. Patients should be advised that if they develop these symptoms, they should contact their physician immediately. The physician should determine the possible relationship of these symptoms with taking efavirenz, and, if this connection is confirmed, assess the balance of risk for the patient with continued therapy and the potential benefits of taking the drug (see section "Precautions").

Nervous system symptoms:

In patients receiving efavirenz 600 mg once daily in clinical trials, the following symptoms are often observed: dizziness, insomnia, drowsiness, decreased concentration, dream pathology, and other adverse events. Symptoms from the nervous system are usually observed during the first or second day of therapy and in most cases disappear after the first 2-4 weeks. Patients should be informed that such symptoms, if they occur, usually disappear with continued therapy and are not a sign of possible mental disorders, which are less common.

Immune reconstitution syndrome

:

In HIV-infected patients with severe immunodeficiency, an inflammatory response to asymptomatic or residual opportunistic infections may develop during initiation of antiretroviral therapy, which can cause serious deterioration of the condition or aggravation of symptoms. As a rule, such reactions are observed in the first weeks or months after starting antiretroviral therapy. The most significant examples are cytomegalovirus retinitis, generalized and/or focal mycobacterial infection, and pneumonia caused by Pneumocystis jiroveci (formerly Pneumocystis carinii). Any symptoms of inflammation must be identified and treatment prescribed if necessary. Autoimmune diseases (eg, Graves' disease) have been observed in the setting of immune reconstitution, but the timing of initial manifestations varies, and the disease may occur many months after the start of therapy. Lipodystrophy and metabolic disorders

Combination antiretroviral therapy is associated with redistribution of body fat (lipodystrophy) in HIV-infected patients, including depletion of peripheral and facial subcutaneous fat, accumulation in the intraperitoneal space, viscera, posterior neck (“buffalo hump”), and mammary hypertrophy. Combination antiretroviral therapy may cause metabolic abnormalities such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactatemia. Osteonecrosis

Cases of osteonecrosis have been reported, especially in patients with common risk factors (corticosteroid use, alcohol consumption, acute immunosuppression, increased mass index), advanced HIV infection, or on long-term combination antiretroviral therapy. Patients should be advised to consult a doctor if they experience joint pain, joint stiffness, or difficulty moving.

Special patient groups

Liver diseases

: Efavirenz is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see Contraindications section) and is not recommended in patients with moderate hepatic impairment because there are insufficient data at this time to determine whether Is it possible to adjust the dose in such cases? Due to the extensive metabolism of efavirenz by the cytochrome P450 system and limited clinical experience with the use of efavirenz in patients with chronic liver disease, the drug should be administered with caution to patients with mild hepatic impairment (see section "Caution"). In this case, patients should be monitored for timely detection of dose-dependent adverse reactions, especially from the nervous system. Laboratory tests should also be performed at regular intervals to assess the condition of the liver.

The safety and effectiveness of efavirenz have not been established in patients with a history of significant liver impairment. Patients with chronic hepatitis B and C who are taking combination antiretroviral therapy (ART) are at risk of developing severe liver adverse reactions that can be fatal. Patients with a history of liver dysfunction, including chronic active hepatitis, have an increased incidence of liver dysfunction with combination ART and should be monitored according to a standard regimen. In patients with worsening liver disease or persistent elevations in serum transaminases greater than 5 times the upper limit of normal, the benefit of continued efavirenz therapy must be weighed against the potential risk of hepatotoxicity. In such patients, the advisability of interrupting or discontinuing ART should be considered.

When using other drugs with known hepatotoxicity simultaneously, it is recommended to monitor the activity of liver enzymes. Patients with hepatitis B or C should also follow the instructions for use of the prescribed drugs for the treatment of hepatitis B or C when prescribing combination antiviral therapy.

Kidney failure:

The pharmacokinetics of efavirenz in patients with renal failure have not been studied, however, due to the fact that less than 1% of the amount of efavirenz is excreted unchanged by the kidneys, impaired renal function should not have a significant effect on the elimination of efavirenz.

There is no experience of use in patients with severe renal failure, therefore, in this group of patients, when using the drug, monitoring is recommended to assess the safety of therapy.

Elderly patients:

Since a small number of elderly patients were included in clinical studies, it is not possible to assume that the effect of the drug in elderly patients differs from that in younger patients (see section Pharmacokinetics).

Children:

Efavirenz has not been studied in children younger than 3 years or weighing less than 13 kg. There is evidence that the pharmacokinetics of efavirenz may be altered in very young children.

Convulsions

: Seizures were observed extremely rarely in patients receiving efavirenz, including in patients with a history of seizures. In patients receiving concomitant anticonvulsants with predominant metabolism in the liver, such as phenytoin, carbamazepine and phenobarbital, it is necessary to periodically monitor their plasma concentrations. Caution should be exercised when prescribing the drug to patients with a history of seizures (see sections “With caution” and “Side effects”).

"Liver" enzymes

: In patients with a known or suspected history of hepatitis B and C and in patients taking drugs associated with liver toxicity, regular monitoring of liver enzyme activity is recommended. In patients with persistent increases in serum transaminase levels greater than 5 times the upper limit of normal, the benefit of continuing efavirenz therapy must be weighed against the possible risk of hepatotoxicity (see Adverse Reactions).

Cholesterol:

In patients taking efavirenz, blood cholesterol concentrations should be monitored (see section “Side Effects”).

Interaction with cannabinoid test:

Efavirenz does not bind to cannabinoid receptors, but there have been reports of false-positive urine test results for cannabinoids in uninfected volunteers receiving efavirenz. False-positive test results were observed only with the CEDIA DAU Multi-Level TIS assay, which is used for screening, and were not observed with other cannabinoid tests, including tests used to confirm positive results.

Use of the drug for alcoholism

As a rule, with alcoholism, dependent people suffer from liver dysfunction of varying degrees of severity. Use in this case is contraindicated. A person with an alcohol addiction must first undergo treatment to get rid of it.

Quitting alcohol will normalize your general condition. The liver cells will gradually recover. Only after this can the specialist decide on the prescription and dosage of the medication.

An alcoholic's body gets used to the effects of ethyl alcohol and reacts worse to medications. HIV is a serious pathology that, if you neglect your health and lack of treatment, quickly develops into AIDS. You should not overload your body with alcohol, so as not to cause undesirable consequences.

Alcohol-dependent patients, fearing side effects, do not take the drug every time they get drunk. The combination of alcohol and medication causes memory loss, causing patients to forget to take the medicine.

Therapeutic effect

Inhibits immunodeficiency virus type 1 reverse transcriptase in a non-competitive manner. At the same time, it has little effect on the analogous compound of the type 2 immunodeficiency virus and the intracellular enzyme substances of ordinary human cells. In laboratory conditions, the susceptibility of viral particles to the drug has not been determined. It is possible that the pathogen may develop immunity to the drug. For example, with a mutant change K103N. In the presence of such a mutation, sensitivity to efavirenz, nevirapine and delavirdine is lost. Cross resistance possible.

The likelihood of cross-resistance with protease-inhibiting medications is low. Various features of activity and scope.

Using the drug for a hangover

After drinking large amounts of alcohol for a long time, the patient experiences a hangover. It occurs as a result of general intoxication of the body with ethanol breakdown products.

During this period, the liver and other organs work harder, trying to remove toxins and other harmful substances.

The use of the drug in this situation will not bring a therapeutic effect and will only worsen the patient’s condition. Treatment with medication can be started only after the hangover has been relieved and the patient’s general condition has returned to normal.

Pharmacokinetic features

Well absorbed in the digestive tract. The maximum level of the chemical compound is reached in three to five hours. The equilibrium level occurs after about a week. If the tablet is swallowed at the same time as food, the activity is enhanced and the risk of adverse reactions increases. But at the same time, bioavailability increases. The product should be taken on an empty stomach. Almost complete combination with plasma proteins is observed. Metabolization occurs in the liver tissue with the participation of P450. CYP3A4 and CYP2B6 are involved.

Metabolized derivatives do not have a therapeutic effect. The substance is excreted from the body primarily by renal tissue. Excretion may slow down if liver function is severely impaired. Renal dysfunction does not significantly affect this indicator.

Consequences of drinking alcohol

The drug, when reacting with drinks containing ethyl alcohol, can lead to memory loss, an allergic reaction and other unpleasant consequences. Alcohol reduces the effect of the active substance, which means that the effectiveness of therapy is reduced to almost zero.

In some cases, it is allowed to drink a little red wine. It is gentle on the body and does not cause a hangover. It is better to completely avoid strong alcohol so as not to provoke the development of side effects.

Alcohol has a diuretic property, which leads to the fact that the active substance is washed out of the body before it begins to fully act.

Side effect

Dermatological reactions:

often (especially in children) - maculopapular rash; in isolated cases - a severe rash accompanied by blisters, weeping peeling and ulcers.

From the digestive system:

often - nausea; Possible diarrhea.

From the side of the central nervous system:

possible dizziness, headache, insomnia, fatigue, decreased concentration.

Allergic reactions:

in isolated cases - erythema multiforme, Stevens-Johnson syndrome.

From the laboratory parameters:

increased activity of ALT, AST, GGT, amylase, increased levels of total bilirubin, increased concentration of glucose in the blood.

When can you drink alcohol?

During the entire course of treatment, drinking alcohol is strictly contraindicated. Drinking alcohol-containing drinks after the last dose of medication is permissible no earlier than 24 hours.

Course therapy has a cumulative effect, so before drinking alcohol, you need to consult a specialist. Each medication has its own elimination period for the active substance. Only a doctor will be able to determine exactly how long you can drink alcohol so as not to reduce the effectiveness of therapy and not cause side effects.

When antiretroviral therapy is interrupted, the virus becomes resistant to the drug, and the infection progresses significantly.

In extreme cases, doctors allow you to drink a small dose of alcohol, but not more than once a week. Only low-alcohol drinks are allowed. The dose is calculated taking into account individual susceptibility. But in order for the therapy to be as effective as possible and the patient’s well-being not to worsen, complete abstinence is recommended.

Regaste and beer

Regast is used in complex therapy in the treatment of HIV infection. The therapeutic course involves a complete abstinence from beer, even non-alcoholic beer.

Combining ethanol with the drug can cause:

1. Allergies of an unexpected nature.
2. Increased concentration of liver enzymes.

The medicine has side effects on humans, the severity of which increases significantly when drinking alcohol:

• temporary amnesia appears;
• immune cells are affected, the protective function is weakened.

The consequences of the combination blur the overall picture of the course of the disease and make it difficult to determine its dynamics.

Organs affected by the toxin

The combined use of pharmacological agents and alcohol has a toxic effect on the internal organs and environments of the body. Alcohol, entering into a chemical reaction with a medicine, leads to poisoning, disrupts physiological processes, enhances or weakens the healing properties of drugs.

The liver suffers more than other organs. She gets hit twice. Many medications have a side effect - hepatotoxicity, destroy cells, and disrupt the physiology of the organ. In the liver, alcohol breaks down to ethanal, a substance 20-30 times more toxic than ethanol, which causes the death of hepatocytes.

Dangerous groups of drugs for the organ in combination with alcohol:

• anti-inflammatory;
• hormonal;
• antibacterial;
• antifungal;
• glucose control agents for diabetes mellitus;
• anti-tuberculosis;
• cytostatics (chemotherapy drugs);
• tranquilizers (anti-epileptic, psychotropic).

In second place among the internal organs exposed to the harmful effects of alcohol together with medications are the heart and vascular system. Strong drinks during drug therapy constrict blood vessels and increase blood pressure. The simultaneous intake of alcohol and chemical substances leads to failure of the myocardium and increases the risk of developing an attack of angina pectoris and a heart attack.

A mixture of ethanol and pharmaceuticals disrupts the quality of the blood and reduces clotting. This is dangerous due to internal bleeding and strokes.

Rules for taking medications and alcohol

Drinking alcohol during treatment minimizes the clinical effect of therapy and creates a risk of developing complications of the disease.

If this cannot be avoided, follow the rules of behavior that will reduce the occurrence of negative consequences:

1. Do not drink strong drinks (vodka, cognac, whiskey), choose dry wine (100-150 ml), beer (no more than 300 ml). Don't drink alcohol on an empty stomach.
2. The interval between taking the medicine and alcohol should be at least 2 hours.
3. To reduce the toxic effect, take medications that protect the liver (hepatoprotectors), pancreas (pancreatin), and stomach (antacids ─ Rennie, Almagel).

If a person takes antiviral medications for colds, anti-inflammatory drugs, alcohol in moderation does not pose a threat to the body.

Alcoholic drinks during treatment are strictly contraindicated in cases of liver cirrhosis, severe infectious diseases, and during a course of chemotherapy.

Release form, packaging and composition of the drug Regast

Film-coated tablets

from light brown to brown, round, biconvex, with a notch on one side.

Excipients

: betadex (betacyclodextrin) - 2 mg, calcium stearate - 1 mg, crospovidone - 12 mg, sodium lauryl sulfate - 3.5 mg, lactose monohydrate - 62 mg, povidone K-25 - 4 mg, polysorbate 80 - 1.5 mg, microcrystalline cellulose - 9 mg.

Film shell composition:

ready-made water-soluble film shell - 5 mg, including hypromellose - 74.2%, Macrogol 6000 - 14.3%, titanium dioxide - 3.5%, talc - 2.3%, red iron oxide dye - 1.4%, yellow iron oxide dye - 4.3% .

10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (6) — cardboard packs. 10 pieces. — contour cell packaging (9) — cardboard packs. 30 pcs. — polymer jars (1) — cardboard packs. 60 pcs. — polymer jars (1) — cardboard packs. 90 pcs. — polymer jars (1) — cardboard packs.

Medicines, alcohol and chronic diseases

If a person has chronic diseases, simultaneous use of alcohol and medications is potentially dangerous for the functioning of vital organs. Since patients systematically take prescribed medications, the influence of alcohol can lead to negative consequences.

People with chronic heart disease (angina pectoris, heart defects) develop arrhythmias of varying severity. Heart attacks with severe pain syndrome develop, which is not relieved by Nitroglycerin, and the risk of developing myocardial infarction increases significantly.

In case of chronic liver diseases (viral hepatitis, hepatosis), alcohol during treatment can become a trigger in the development of cirrhosis and hepatocellular carcinoma (cancer).

Drinking alcohol during cirrhosis leads to the following consequences:

• bleeding into the abdominal cavity;
• liver decomposition, infection, peritonitis;
• hepatic coma;
• death.

If a person is on long-term treatment with sedatives, psychotropic drugs, tranquilizers, he is contraindicated in drinking alcohol. This leads to severe depression and the appearance of obsessive states (hallucinations, phobias). Suicidal feelings develop. Such a patient needs constant monitoring and assistance from a psychiatrist.

Drug interactions

When efavirenz is used concomitantly with terfenadine, astemizole, cisapride, midazolam or trizolam, there is a competitive drug interaction for the CYP3A4 isoenzyme, which can lead to inhibition of the metabolism of these drugs and create the possibility of serious and/or life-threatening consequences - severe arrhythmias, prolonged sedation or depression breathing. Under the influence of efavirenz, it is possible to reduce the plasma concentration of drugs that are substrates of the CYP3A4 isoenzyme.

The most dangerous combinations and consequences

The combination of alcohol and chemical-based drugs can lead to serious disorders in the body, and in some cases to fatal consequences.

List of medications and their side effects in combination with alcohol:

Regast's analogues

There are other brands that make efavirenz-based medications. Doses and additional substances may differ, so you need to choose a similar remedy with your doctor.

Known analogues:

• Stokrin tablets.
• Efavirenz tablets.
• Efavirenz-TL tablets.

Analogue