Friday, December 2, 2022

Lamivudine Dose In Hepatitis B

Warnings For Other Groups

Clinically Relevant Drug Interactions with Direct Acting Antivirals (DAAs)

For pregnant women: There are no adequate and well-controlled studies of lamivudine in pregnant women. Lamivudine should be used during pregnancy only if the potential benefit outweighs potential risk to the pregnancy.

For women who are breastfeeding:

  • For women with HIV: The Centers for Disease Control and Prevention recommends that American women with HIV do not breastfeed in order to avoid transmitting HIV through breast milk.
  • For women with HBV: Lamivudine does pass through breast milk. However, there are no adequate studies that show the effects it may have on a child who is breastfed, or on a mothers milk production.

If you breastfeed your child, talk to your doctor. Discuss the benefits of breastfeeding, as well as the risks of exposing your child to lamivudine versus the risks of not having treatment for your condition.

For seniors: If you are aged 65 years or older, your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug does not build up in your body. Too much of the drug in your body can be toxic.

Important Information About All Medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

If You Experience Any Of The Following Symptoms Or Those Listed In The Important Warning Section Call Your Doctor Immediately:

  • rash
  • vomiting
  • nausea
  • ongoing pain that begins in the stomach area but may spread to the back
  • numbness, tingling, or burning in the fingers or toes
  • excessive tiredness weakness, dizziness or lightheadedness fast or irregular heartbeat muscle pain stomach pain with nausea and vomiting shortness of breath or difficulty breathing flu-like symptoms such as fever, chills, or cough or feeling cold, especially in the arms or legs
  • light-colored bowel movements yellowing of the skin or eyes loss of appetite unusual bleeding or bruising dark yellow or brown urine or pain in the upper right part of stomach

Lamivudine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .

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What Should I Know About Storage And Disposal Of This Medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture . The oral solution does not need to be refrigerated however, it should be stored in a cool place.

It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

Drugs Inhibiting Organic Cation Transporters

Borg

Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system . No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of Lamivudine.

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How To Take Lamivudine

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside your pack. It will give you more information about lamivudine, and it will also provide you with a full list of the side-effects which you could experience from taking it.
  • The usual dose is one 100 mg tablet daily. Take lamivudine exactly as your doctor tells you to – your dose will be printed on the label of the pack to remind you about what the doctor said to you.
  • It is recommended that you swallow the tablet whole . Take it with a drink of water.
  • Try to take lamivudine at the same time each day, as this will help you to remember to take it regularly. You can take the tablet either with or without food.
  • If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, leave out the missed dose. Do not take two doses together to make up for a forgotten dose.

Patients With Renal Impairment

Dosage recommendations for adult patients with reduced renal function are provided in Table 1 .Table 1. Dosage of Lamivudine Tablets in Adult Patients with Renal Impairment

Creatinine Clearance
100 mg first dose, then 50 mg once daily100 mg first dose, then 25 mg once daily35 mg first dose, then 15 mg once daily35 mg first dose, then 10 mg once daily

Following correction of the dosage for renal impairment, no additional dosage modification of Lamivudine tablets is required after routine hemodialysis or peritoneal dialysis .There are insufficient data to recommend a specific dosage of Lamivudine tablets in pediatric patients with renal impairment.

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How Should I Use This Medicine

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the hepatitis B virus resistant to this medicine and other medicines. Do not stop taking except on your doctor’s advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

Lamivudine For Chronic Hepatitis B

Safety Profile and Costs of Initial HIV Therapeutic Regimen
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
First Posted : November 4, 1999Last Update Posted : March 4, 2008
  • Study Details

Chronic hepatitis B is a disease of the liver caused by the hepatitis B virus. It affects nearly 1 million Americans. Approximately 25% of patients with chronic hepatitis B will develop liver cirrhosis and 5% of patients will develop liver cancer.

Presently, two medications have been shown effective in the treatment of hepatitis B: lamivudine and alpha interferon. Alpha interferon is given by injection once daily or three times a week for four to six months. Lamivudine is an antiviral medication given as a pill once a day for twelve months. These treatments have been known to provide long-term improvement in one third of patients receiving them.

Condition or disease
Chronic Hepatitis BChronic Hepatitis DGlomerulonephritisPolyarteritis Nodosa Drug: Lamivudine Phase 2
Layout table for study information

Study Type :
Lamivudine for Chronic Hepatitis B
Study Start Date :

EXCLUSION CRITERIA

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Dosage For Hepatitis B Virus Infection

Brand: Epivir-HBV

Adult dosage

  • Typical dosage: 100 mg once per day.

Child dosage

Dosage is based on your childs weight. For children who need less than 100 mg per day, they should take the oral solution version of this drug.

  • Typical dosage: 3 mg/kg once per day.
  • Maximum dosage: 100 mg daily.

Child dosage

Dosage for children younger than 2 years has not been established.

Are There Any Other Precautions Or Warnings For This Medication

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diabetes: An adult dose of the oral solution of lamivudine 100 mg contains 4 g of sucrose. This may affect your control of blood glucose levels if you have diabetes.

Hepatitis B transmission: Treatment with lamivudine has not been proven to reduce the risk of passing on hepatitis B to other people through sexual contact and blood transfer. You should continue to take measures to prevent giving hepatitis B to other people while taking this medication.

Human immunodeficiency virus : Treatment of hepatitis B with lamivudine requires lower doses than treatment for HIV infection. If you are taking lamivudine for hepatitis B and later learn that you have HIV, tell your doctor immediately as the lower dose of lamivudine used for treating hepatitis B is not effective against HIV infection.

Lactic acidosis and enlarged liver: Lamivudine can cause a rare but serious condition called lactic acidosis together with an enlarged liver. This tends to occur more often in women, especially if they are overweight. If you experience any of the following symptoms, call your doctor immediately:

  • abdominal pain, swelling, or bloating
  • diarrhea
  • weight loss

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Chemistry Mechanism Of Action Spectrum And Resistance

Lamivudine is a nucleoside analogue that is phosphorylated to lamivudine triphosphate by cellular kinases. Lamivudine inhibits the reverse transcriptase of HBV and HIV, and it is indicated for the treatment of HIV and chronic HBV infection.

Lamivudine-resistant HBV mutants occur in up to one third of patients by the end of 1 year of therapy and in up to two thirds of them by the end of 4 years of drug exposure.218 The most common mutation affects the tyrosine-methionine-aspartate-aspartate motif in the catalytic domain of the HBV polymerase, resulting in a change from methionine to valine or isoleucine .

Leah A. Burke, Kristen M. Marks, in, 2017

See Full Prescribing Information For Complete Boxed Warning

(PDF) A Dose
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy . Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.
Lamivudine tablets contain a lower dose of the same active ingredient as EPIVIR tablets and oral solution used to treat HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV-1 infection because the lamivudine dosage in Lamivudine tablets is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with Lamivudine tablets and periodically during treatment.

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What Other Information Should I Know

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of lamivudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Where Should I Keep My Medicine

Keep out of the reach of children.

Store at a room temperature of 20 to 25 degrees C . Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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What Side Effects Are Possible With This Medication

Do not use this medication if you are allergic to lamivudine or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal or stomach pain and discomfort
  • cough
  • trouble sleeping
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • severe muscle pain or cramping
  • signs of anemia
  • signs of high lactic acid levels in the blood
  • signs of poor blood clotting
  • symptoms of ear, nose, or throat infection, such as fever, chills, cough, or sore throat
  • tingling burning numbness or pain in the hands, arms, feet, or legs

Hiv Counseling And Testing

FDA Patient Safety News (November 2002)

HIV counseling and testing should be offered to all patients before beginning treatment with Lamivudine tablets and periodically during treatment because of the risk of emergence of resistant HIV-1 and limitation of treatment options if Lamivudine tablets is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment .

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How Should This Medicine Be Used

Lamivudine comes as a tablet and oral solution to take by mouth. Lamivudine is usually taken once or twice a day with or without food. Lamivudine is usually taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lamivudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lamivudine controls HIV and hepatitis B infection and but does not cure them. Continue to take lamivudine even if you feel well. Do not stop taking lamivudine without talking to your doctor. When your supply of lamivudine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking lamivudine, your condition may become more difficult to treat.

Dosage For Human Immunodeficiency Virus Infection

Generic: Lamivudine

  • Strengths: 150 mg, 300 mg

Brand: Epivir

  • Strengths: 150 mg, 300 mg

Adult dosage

  • Typical dosage: 300 mg each day. This amount can be given as 150 mg twice a day, or 300 mg once a day.

Child dosage

Dosage is based on your childs weight.

  • Typical dosage: 4 mg/kg, twice per day, or 8 mg/kg once daily.
  • For children who weigh 14 kg to < 20 kg : 150 mg once daily, or 75 mg twice daily.
  • For children who weigh 20 to 25 kg : 225 mg once daily, or 75 mg in the morning and 150 mg in the evening.
  • For children who weigh 25 kg : 300 mg once daily, or 150 mg twice daily.

Child dosage

Dosage for children younger than 3 months has not been established.

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Drugs That Contain Sorbitol

Taking sorbitol with lamivudine can decrease the amount of lamivudine in your body. This can make it less effective. If possible, avoiding using lamivudine with any drugs that contain sorbitol. This includes prescription and over-the-counter medications. If you must take lamivudine with drugs that contain sorbitol, your doctor will likely monitor your viral load more closely.

The lamivudine dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition youre using lamivudine to treat
  • your age
  • the form of lamivudine you take
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage thats right for you. Theyll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

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