HEPTRAL 400 TABLET by ABBOTT

Name

Brand Name: Heptral 400 Tablet Common Name: Ademetionine (S-Adenosyl-L-Methionine or SAMe)

Composition

Each tablet of Heptral 400 contains Ademetionine (S-Adenosyl-L-Methionine) 400 mg. Ademetionine is a naturally occurring amino acid derivative. Inactive ingredients may include Microcrystalline Cellulose, Mannitol, Carboxymethylstarch sodium salt, Colloidal silica anhydrous, Magnesium stearate, Methacrylic acid copolymer, Titanium dioxide, Triethyl citrate, and Stearic Acid.

Uses

Heptral 400 Tablet is primarily used in the management of various liver conditions, including intrahepatic cholestasis (a condition where bile flow from the liver is reduced) in patients with or without liver disease, liver cirrhosis, hepatitis, and alcoholic liver disease. It supports the liver's natural detoxification processes, helps restore antioxidant levels like glutathione, and improves bile flow.

Additionally, it may be used to manage intrahepatic cholestasis during pregnancy and can help reduce fatigue associated with chronic liver problems. Heptral 400 Tablet is also used for managing anxiety, depression, other mental illnesses, osteoarthritis (joint pain), and fibromyalgia (severe muscle pain with memory and mood problems) due to its role in regulating mood and reducing inflammation and pain.

Dosage and Administration

Heptral 400 Tablet should be taken exactly as prescribed by your doctor. It is usually recommended to be taken before meals for better absorption. The tablets should be swallowed whole and not chewed. The exact dose and duration of treatment depend on body weight and the condition being treated, often requiring several months or longer. The usual starting dose for intrahepatic cholestasis is 800 mg/day, and the total daily dose should not exceed 1600 mg. Consistency in taking the medicine at the same time each day is important for optimal benefits. Do not stop taking it without consulting your doctor, even if symptoms improve.

Side Effects

Common side effects include nausea, abdominal discomfort, diarrhea, upset stomach, constipation, and dizziness. These effects are usually mild and temporary. Rarely, some individuals may experience headache, trouble sleeping (insomnia), or a skin rash.

Serious side effects are rare but may include signs of serotonin syndrome (agitation, hallucinations, confusion, fast heartbeat, dizziness, increased sweating, tremors), allergic reactions (skin rash, swelling of face/tongue/throat, difficulty breathing), or a worsening of depression.

Precautions

Consult your doctor before taking Heptral 400 Tablet if you are pregnant, planning a pregnancy, or breastfeeding. Information regarding its use during pregnancy and breastfeeding is not fully established, so medical supervision is essential.

Caution is advised in patients with kidney disease. Avoid consuming alcohol while on treatment, as it may increase strain on your liver and worsen side effects. Inform your doctor if you have a history of bipolar disorder or mood swings, as this medicine may trigger mania/hypomania. It is not recommended for use in children below 18 years of age due to a lack of safety and efficacy studies.

Heptral 400 Tablet may interact with other medicines, so it's essential to inform your doctor about all current medications and supplements you are taking. Your doctor may check vitamin B12 and folate levels during treatment, as these vitamins are necessary to enhance the effects of S-Adenosyl-L-Methionine. Driving or operating machinery should be done with caution if dizziness occurs.

Storage

Store Heptral 400 Tablet in a cool and dry place, below 25°C, away from light and moisture. Keep it out of the reach of children and pets. It should not be frozen.

What is Heptral 400 Tablet used for?

Heptral 400 Tablet, containing S-Adenosyl-L-Methionine (Ademetionine), is primarily used to manage various liver problems in adults. These include intrahepatic cholestasis (a condition with reduced bile flow), liver cirrhosis, hepatitis, alcoholic liver disease, and fatty liver disease. It can also be used to address intrahepatic cholestasis during pregnancy and to alleviate fatigue associated with chronic liver conditions. Beyond liver health, it may also be prescribed as an adjunctive therapy for depression, anxiety, other mental illnesses, osteoarthritis (joint pain), and fibromyalgia.

How does Heptral 400 Tablet work?

Heptral 400 Tablet works by supplying Ademetionine, a naturally occurring compound in the body. It helps protect the liver by increasing levels of glutathione, a powerful antioxidant, thereby shielding liver cells from toxins and improving bile flow. This action supports normal liver function. Additionally, Ademetionine can increase the levels of certain neurotransmitters in the brain, such as dopamine, noradrenaline, adrenaline, serotonin, and melatonin, which can help stabilize mood and support mental well-being. It also helps reduce chemicals that cause pain and inflammation, and promotes cartilage repair, which is beneficial for joint conditions.

What is the usual dosage for Heptral 400 Tablet?

The dosage of Heptral 400 Tablet is determined by your physician based on your specific medical condition. It is generally recommended to take the tablet whole, without chewing or crushing, preferably before meals to enhance absorption. For conditions like intrahepatic cholestasis, a usual starting oral dose might be 800 mg per day, with a total daily dose not exceeding 1600 mg. Benefits are often noticeable after 7-14 days of consistent use.

What are the possible side effects of Heptral 400 Tablet?

The most common side effects reported with Heptral 400 Tablet include nausea, stomach pain or abdominal discomfort, and diarrhea. Other potential side effects can include constipation, dizziness, headache, trouble sleeping (insomnia), skin rash, and irritability. Rarely, more severe reactions such as signs of serotonin syndrome, allergic reactions, or worsening of depression have been reported. If any side effects persist or cause concern, consult your doctor.

Is Heptral 400 Tablet safe during pregnancy or breastfeeding?

Heptral 400 Tablet is generally not recommended for use during pregnancy or breastfeeding unless specifically considered necessary by a physician, and only if the potential benefits outweigh the potential risks to the infant. Medical supervision is essential if its use is considered. It is advisable to administer Ademetionine in the first three months of pregnancy only if absolutely necessary.

Can Heptral 400 Tablet be taken with other medications?

Heptral 400 Tablet can interact with certain medications. Caution is advised if you are taking other medicines for depression, such as Selective Serotonin Reuptake Inhibitors (SSRIs), tricyclic antidepressants, or Monoamine Oxidase Inhibitors (MAOIs), as this combination may increase the risk of serotonin syndrome. Interactions with levodopa (used for Parkinson's disease) and tryptophan are also possible. Always inform your doctor about all prescription and over-the-counter medications, supplements, and herbal products you are currently taking to avoid potential interactions. Your doctor may also recommend B-vitamin supplements (folic acid and vitamin B12), as these are important co-nutrients for Ademetionine's effectiveness.

What precautions should be taken while using Heptral 400 Tablet?

Several precautions should be considered. Heptral 400 Tablet is not recommended for individuals with bipolar disorder or a history of suicidal thoughts, as it may trigger manic or hypomanic episodes. Patients with kidney diseases should use this medicine with caution. It is also important to inform your doctor if you have any vitamin deficiencies (especially B12 or folic acid) or anemia. Alcohol consumption should be avoided during treatment as it can worsen liver conditions and potential side effects. Since the medicine may cause dizziness or drowsiness, exercise caution when driving or operating machinery until you are certain how it affects you. Do not stop taking the medicine without consulting your doctor, even if your symptoms improve. The safety and effectiveness of Heptral 400 Tablet have not been established in children below 18 years of age.

What happens if a dose of Heptral 400 Tablet is missed?

If you miss a dose of Heptral 400 Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one.

How should Heptral 400 Tablet be stored?

Heptral 400 Tablet should be stored in a cool and dry place, typically between 20°C to 25°C, away from direct light and moisture. It should not be frozen. Always keep the medicine out of reach of children and pets. Tablets should be removed from their blister packaging immediately before use.