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HEPACT

Generic Name

 Ursodeoxycholic acid (UDCA)/Ursodiol

Therapeutic class

Anti-cholelithic

Pharmacological Class

Bile Acids

Composition

Hepact 150:

Each uncoated tablet contains Ursodeoxycholic acid BP 150 mg.

Hepact 300:

Each uncoated tablet contains Ursodeoxycholic acid BP 300 mg.

Pregnancy category

‘B’

Presentation

Available in the pack size as 10 tablets X 10 blisters.

What is Hepact?     

Hepact, available as 150 mg and 300 mg tablets, contain Ursodeoxycholic acid, which is a bile acid normally only found in small amounts in human bile. It is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria.

In what conditions Hepact can be used?

 

 How does Hepact work?                   

Hepact reduces elevated liver enzyme levels by facilitating bile flow through the liver and protecting liver cells. Although the exact process of ursodiol’s anticholelithic action is not completely understood, it is thought that the drug is concentrated in bile and decreases biliary cholesterol by suppressing hepatic synthesis and secretion of cholesterol and by inhibiting its intestinal absorption. The reduced cholesterol saturation permits the gradual solubilization of cholesterol from gallstones, resulting in their eventual dissolution.

 

How to take Hepact?

Hepact tablets should be administered orally and the whole tablet has to be swallowed with water (Crushing or chewing the tablet should be strictly avoided.)

The dosage regimen for various indications includes:

 

  • Primary Biliary Cirrhosis/Cholestatic liver diseases

Adults and Elderly:

10 – 15mg ursodeoxycholic acid (UDCA) per kg per day in two to four divided doses.

Children

 Dosage should be related to bodyweight.

 

 

  • Intrahepatic cholestasis of pregnancy (off-label use): 10 to 15 mg/kg/day in divided doses or 500 mg twice daily, gradually increase in increments of 500 mg/day (range: 500 mg to 2,000 mg/day in divided doses); continue until delivery.

 

Adults and Elderly:                     

The usual dose is 6 – 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary.

The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s).

ChildrenDosage should be related to bodyweight.

 

  • Take Hepact exactly as your doctor tells you to. How much you need to take will depend upon what you are being treated for.
  • Try to take Hepact at the same times each day as this will help you to remember to take it. Take each of your doses with a snack or just after eating a meal.

What to do if a dose is missed?

If you forget to take a dose, take it as soon as you remember. If you don’t remember until it’s nearly time for the next dose, skip the missed dose. Never take two doses at the same time. Never take an extra dose to make up for a forgotten one.

If you often forget doses, it setting an alarm might be helpful to remind you.

                                                   

What do you need to know before you take Hepact?

                                                                                                                

  • Tell your doctor and pharmacist if you are allergic to any component of the formulation.
  • If you have a problem with your gallbladder other than gallstones.
  • If you have a condition which affects your intestines (such as Crohn’s disease or ulcerative colitis), or if you have had surgery on your bowel.
  • If you are taking other medicines, including those available to buy without a prescription, as well as herbal or complementary medicines particularly, let your doctor know if you are taking the oral contraceptive pill or are on hormone replacement therapy.

 

Do not hesitate to provide information to your healthcare provider about the underlying health conditions that you have and also about other medicines that you are currently taking.

 

Warnings and Precautions:

  • When used for treatment of late stage of primary biliary cirrhosis, if diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
  • The liver function parameters should be monitored, particularly in patients with advanced stage primary biliary cirrhosis.
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

 Can Hepact be taken during pregnancy?                        

As a precautionary measure, Hepact is not recommended during pregnancy except in case of Intrahepatic Cholestasis of Pregnancy. However, you may consult with your healthcare provider in case of unavoidable use.

 

Can lactating mothers consume Hepact?    

It is not known whether Hepact passes into breast milk. Therefore, it should not be taken during lactation. If treatment with Hepact is necessary, breastfeeding must be discontinued.

                                                                

Possible Side effects:                          

Hepact may cause some side effects that may include fever, chills, body aches, flu symptoms, stomach pain, nausea, diarrhea, constipation, dizziness, tired feeling, back pain, runny or stuffy nose, cold symptoms and headache. Inform your healthcare provider if these symptoms are severe or persistently present.

Pharmacodynamics:

 Ursodiol (commonly known as ursodeoxycholic acid) is a product of metabolism of bacteria in the intestine. It is considered a secondary bile acid. The other type of bile acid, primary bile acids, are produced hepatically and subsequently stored in the gallbladder. When primary bile acids are secreted into the large intestine, they can be broken down into secondary bile acids by bacteria present in the intestine. Both types of bile acids assist in the metabolism of dietary fat. Ursodeoxycholic acid regulates cholesterol levels by slowing the rate at which the intestine is able to absorb cholesterol and also acts to break down micelles, which contain cholesterol. Because of this property, ursodeoxycholic acid is used to treat gall stones non-surgically.

Pharmacokinetics:             

Absorption:  Absorbed from the small bowel (about 90% of dose)

                                                                                        

Metabolism: Hepatic (first-pass hepatic clearance)      

 

Route of elimination: Primarily fecal; very small amounts are excreted into urine. Small amount of unabsorbed ursodiol passes into the colon where it undergoes bacterial degradation

 

Half-life: The half life of elimination is about 1-2 hours (in plasma).

                     

Drug Interactions:

  • Bile Acid Sequestering Agents: Reduces absorption of Hepact
  • Aluminum-based Antacids: Bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy
  • Drugs Affecting Lipid Metabolism: Increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of Hepact

                          

Contraindications:

Hepact is contraindicated in the following populations and situations with:

  • Radio-opaque calcified gall-stones
  • Acute inflammation of the gall bladder or biliary tract
  • Frequent episodes of biliary colic
  • Impaired contractibility of the gall bladder
  • Chronic liver disease, peptic ulcers or in those with inflammatory diseases of the small intestine and colon.