Heptral 400mg Tablet (Ademetionine 400mg)

INTRODUCTION

HEPTRAL contains S-Adenosyl L-Methionine (Ademetionine) which belongs to the class of medicines called nutraceutical agents. It is indicated for the treatment of intrahepatic cholestasis in adult patients with liver disease. Intrahepatic cholestasis is a cholestatic disorder characterized by reduced flow of bile from the liver. It can be caused due to any underlying liver conditions such as alcoholic liver disease, liver cirrhosis, hepatitis, gall stones or hepatocellular carcinoma. Symptoms includes severe itching, yellowing of skin or eyes, nausea, loss of appetite, dark urine and light-colored feces.

HEPTRAL can also be used to treat intrahepatic cholestasis of pregnancy (itching and elevated levels of serum aminotransferases and bile acid during 2nd or 3rd trimester). S-Adenosyl L-Methionine is natural substance present in the body. It is a derivative of amino acid called methionine and is responsible for various liver functions, hepatocyte growth and differentiation. Supplementation of s-adenosyl l-methionine in liver disease patients reduces oxidative stress, inflammation and offers protection against apoptotic cell death and subsequent fibrosis.

This medicine must be taken on an empty stomach for better absorption. Do not stop taking this medicine abruptly without consulting your doctor, as it may lead to lack of efficacy. During the treatment, you doctor would monitor the levels of ammonia in your blood, especially in patients with pre-cirrhotic and cirrhotic states of hyperammonemia to avoid unwanted side effects. Regular check-ups are required for pregnant, anemic and vegan patients to avoid the risk of vitamin deficiencies. The most common side effects of this medicine are nausea, vomiting, stomach pain, diarrhea and anxiety. Contact your doctor if any of these symptom bothers you.

HEPTRAL is highly contraindicated for use in patients with cystathionine beta-synthase deficiency or Vitamin B12 metabolism defects. Although it can be used during pregnancy, caution should be exercised for use during the first three months. It is not recommended for use in lactating mothers as it may pass through breast milk. It is strictly not recommended for use in children and adolescents under 18 years of age. Consult your doctor before taking.

USES OF HEPTRAL

Treats intrahepatic cholestasis in adult patients with liver disease
Treats intrahepatic cholestasis of pregnancy

HOW HEPTRAL WORKS

S-Adenosyl L-Methionine is natural substance present in the body and is a derivative of amino acid called methionine. Oral supplementation of -adenosyl l-methionine in liver disease patients acts as a hepato-protectant and reduces apoptotic cell death and its subsequent fibrosis.

It acts by enhancing the production of glutathione and other liver detoxification agents which directly counter acts the oxidative stress. It is also capable of reducing the production of various inflammatory cytokines responsible for liver damage leading to a potential therapeutic benefit in patients with liver disease.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. It should not be taken with meals. Swallow the medicine as whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF HEPTRAL

SERIOUS
Signs of allergic reactions (such as skin rash, pruritus and swelling of throat and facial muscles)
COMMON
Nausea or vomiting
Abdominal pain, diarrhea
Dizziness
Anxiety, restlessness and insomnia

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Abdominal pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid traveling, driving or operating any tools or machines while you are feeling dizzy. If the symptom still persists, contact your doctor for advice.

WARNING & PRECAUTIONS

PREGNANCY
HEPTRAL is considered safe for use during pregnancy. However, it should be used in the first three months only if it is clearly necessary. Consult your doctor before taking this medicine.

BREASTFEEDING
HEPTRAL is not recommended for use in breastfeeding women unless necessary. Discuss the risks and benefits with your doctor.

DRIVING AND USING MACHINES
Do not drive or operate any machines, because this medicine may cause dizziness.

ALCOHOL
Avoid consumption of alcohol while taking this medicine.

KIDNEY
HEPTRAL is not recommended for use in patients with kidney disease. Consult your doctor for advice before taking this medicine.

LIVER
HEPTRAL is intended for use in patients with liver disease. Your doctor will decide the suitable dose for you depending upon the severity of the disease.

ALLERGY
Do not take this medicine if you are allergic to S-adenosyl l-methionine.

OTHERS

Before taking HEPTRAL, inform your doctor if you:

Have any genetic defects affecting methionine cycle (such as cystathionine beta-synthase deficiency or Vitamin B12 metabolism defects)
Have bipolar disorder
Have depression or suicidal thoughts
Are anemic
Are vegan

INTERACTIONS

Talk to your doctor, if you are taking,

Clomipramine (a medicine used to treat obsessive-compulsive disorder)
Medicines used to treat depression (e.g. fluoxetine, sertraline, amitriptyline)
Herbal medicines containing tryptophan