Heptral - hepatoprotective drug with antidepressant activity.
Release form and composition
Dosage forms of Heptral - tablets for oral administration and a lyophilisate, from which a solution is prepared for IM and IV administration.
The composition of the tablets:
- 400 mg of ademetionine ion (as ademetionine 1,4-butane disulfonate);
- Excipients: sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose;
- Shell composition: polysorbate 80, macrogol 6000, copolymer of methacrylic acid and ethyl acrylate (1: 1 ratio), simethicone (emulsion 30%), talc, sodium hydroxide, water.
Tablets on 10 pieces are on sale. in blister packs packed in cartons.
1 vial of Heptral solution contains 400 mg of ademetionine ion (as ademetionine 1,4-butane disulfonate).
The composition of the accompanying solvent: injectable water, sodium hydroxide and L-lysine.
Indications for use
In accordance with the instructions to Heptral, the drug is intended for the treatment of intrahepatic cholestasis in pre-cirrhotic and cirrhotic conditions, which can be observed in such diseases as:
- Chronic hepatitis;
- Fatty degeneration of the liver;
- Chronic stoneless cholecystitis;
- Cirrhosis of the liver;
- Encephalopathy (including alcohol), including those caused by liver failure;
- Toxic lesions of the liver of different etiologies, including viral, toxic, alcoholic and medicinal (caused by taking antibiotics, anti-tuberculosis, antiviral or anticancer drugs, tricyclic antidepressants, oral contraceptives).
In addition, indications for the use of Heptral are:
- Intrahepatic cholestasis of pregnant women;
- Depressive syndromes, incl. secondary.
According to the instructions to Heptral, the use of the drug is contraindicated:
- At the age of 18 years (as experience with the use of drugs in pediatrics is limited);
- In case of hypersensitivity to the components;
- In the presence of genetic disorders that affect the methionine cycle and / or cause homocystinuria and / or hyperhomocysteinemia (this may be, for example, a violation of vitamin B12 metabolism or cystathionine beta synthase deficiency).
Prescribe the drug, but the treatment is carried out under special medical supervision:
- With bipolar disorders;
- During breastfeeding;
- In the first trimester of pregnancy;
- To old people;
- In renal failure.
Particular caution should be exercised when it is necessary to simultaneously use Heptral with tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), as well as drugs that include tryptophan.
Dosing and Administration
The Heptral solution prepared from the lyophilisate (the powder is mixed with the solvent supplied in the box just before the administration) is intended for intramuscular or very slow intravenous administration. It is possible to use a lyophilisate only if it has a white or white color with a yellowish tinge. If the shade is different (which may occur as a result of exposure to heat or a slight crack in the bottle), do not use the product.
The recommended initial dosage is 5-12 mg per kilogram of patient weight per day.
When intrahepatic cholestasis drug is prescribed in a dose of 400-800 mg (1-2 bottles) for 14 days.
In depression, Heptral is administered in the dosage of 400-800 mg. The course of treatment is from 15 to 20 days.
If necessary, the maintenance therapy of the patient is transferred to the oral drug.
Heptrall tablets, according to the instructions, should be taken between meals in the morning. Remove them from the blister should be immediately before taking. If their color is different from the original (from white to white with a yellowish tinge), which may occur as a result of leaks in aluminum foil, such tablets should not be taken.
The recommended initial dose is 10-25 mg per kilogram of patient weight per day. In the future, depending on the clinical effect and tolerability of the drug may adjust the daily dosage.
In depressive states and intrahepatic cholestasis, as a rule, 800-1600 mg per day are prescribed.
The duration of treatment in each case is determined individually.
The most common side effects of Heptral are abdominal pain, nausea and diarrhea.
In some cases, the use of the drug may be accompanied by:
- Allergic reactions;
- Edema of the larynx;
- Reactions at the injection site (very rarely with skin necrosis);
- Edema Quincke, excessive sweating, skin reactions;
- Urinary tract infections;
- Headache, anxiety, dizziness, paresthesia, insomnia, confusion;
- Phlebitis of superficial veins, flushing, cardiovascular disorders;
- Abdominal distention, dry mouth, flatulence, esophagitis, vomiting, gastrointestinal bleeding, indigestion, biliary colic, liver cirrhosis;
- Arthralgia, muscle spasms;
- General malaise, chills, asthenia, flu-like syndrome, fever, peripheral edema.
Lyophilisate is forbidden to mix with alkaline and containing calcium ions solutions.
Some patients have dizziness when taking Heptral, a side effect with potentially serious consequences. Therefore, at the beginning of treatment it is recommended to refrain from driving a car and working with complex mechanisms in order to assess the degree of adverse effects of the drug.
The active substance analogues of Heptral are Heptor and Heptor N.
Terms and conditions of storage
Heptral - a prescription drug with a shelf life of 36 months. It should be stored at a temperature of 15 to 25 ºС. Avoid exposure to heat and direct sunlight!