Generic Name: Lamivudine Brand Name(s): .

Uses

What is Lamivudine used for?

Lamivudine is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Lamivudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTI.

Lamivudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How should I take Lamivudine?

Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor.

The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.

How do I store Lamivudine?

Lamivudine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Lamivudine in the bathroom or the freezer. There may be different brands of Lamivudine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Lamivudine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Lamivudine?

Before taking lamivudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, kidney problems, liver problems (such as hepatitis B or C, cirrhosis), alcohol use.

Avoid alcoholic beverages because they may increase your risk for liver problems and/or pancreatitis.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially the increased risk of pancreatitis.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug.

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

Lamivudine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Lamivudine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Lamivudine. According to the US Food and Drug Administration (FDA), Lamivudine is pregnancy risk category:

-Epivir-HBV(R): C

-Epivir(R): N

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Lamivudine?

Headache, dizziness, nausea, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as depression), stomach/back pain with nausea (pancreatitis).

Tell your doctor right away if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of anemia (unusual tiredness, rapid heartbeat, pale/bluish skin).

Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Lamivudine?

A product that may interact with this drug is: orlistat.

Emtricitabine is similar to lamivudine and should not be taken with this medication. Check the labels on all your HIV medicines because they may contain the same ingredients as found in this product. Taking too much of these drugs will not necessarily improve your condition, and may cause more side effects.

Lamivudine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Lamivudine?

Lamivudine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Lamivudine?

Lamivudine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Lamivudine.

What is the dose of Lamivudine for an adult?

Usual Adult Dose for HIV Infection

150 mg orally twice a day or 300 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Chronic Hepatitis B

100 mg orally once a day

Duration of therapy: The optimal duration of therapy is not known.

Use: For the treatment of chronic HBV infection associated with evidence of hepatitis B viral replication and active liver inflammation

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 150 mg orally twice a day or 300 mg orally once a day

Duration of therapy: 28 days

Comments:

-Recommended as part of preferred regimens for nonoccupational postexposure prophylaxis of HIV infection; this drug should be used with efavirenz plus (zidovudine or tenofovir) or with lopinavir-ritonavir plus zidovudine.

-Also recommended as a component in various alternative regimens (NNRTI-based, protease inhibitor-based, or triple NRTI)

-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure

US Public Health Service working group recommendations:

-Preferred dose: 300 mg orally once a day

-Alternative dose: 150 mg orally twice a day

Duration of therapy: 28 days, if tolerated

Comments:

-Recommended as a component in various alternative regimens for HIV postexposure prophylaxis

-Prophylaxis should be started as soon as possible, preferably within hours after exposure.

-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.

-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

HBV Infection:

Adults:

-CrCl 30 to 49 mL/min: 100 mg orally as first dose, then 50 mg orally once a day

-CrCl 15 to 29 mL/min: 100 mg orally as first dose, then 25 mg orally once a day

-CrCl 5 to 14 mL/min: 35 mg orally as first dose, then 15 mg orally once a day

-CrCl less than 5 mL/min: 35 mg orally as first dose, then 10 mg orally once a day

Pediatric patients: Insufficient data to recommend a specific dose

HIV Infection:

Adults and Adolescents (at least 25 kg):

-CrCl 30 to 49 mL/min: 150 mg orally once a day

-CrCl 15 to 29 mL/min: 150 mg orally as first dose, then 100 mg orally once a day

-CrCl 5 to 14 mL/min: 150 mg orally as first dose, then 50 mg orally once a day

-CrCl less than 5 mL/min: 50 mg orally as first dose, then 25 mg orally once a day

Pediatric patients: Insufficient data to recommend a specific dose; reduction in dose and/or increase in dosing interval should be considered.

Liver Dose Adjustments

No adjustment recommended.

Comments:

-Safety and efficacy have not been established in patients with decompensated liver disease.

Dialysis

Conventional 4-hour hemodialysis and peritoneal dialysis: No additional dose adjustments needed after adjustment for renal dysfunction (based on CrCl); no supplemental dose needed after dialysis.

Prolonged or continuous hemodialysis: Data not available

Other Comments

Administration advice:

-May administer without regard to food

-If patient is unable to reliably swallow a tablet, use the oral solution.

-Only use products appropriate for treatment of HIV-1 in patients with HIV-1 infection; use in combination with other antiretroviral agents.

-Use the formulation and dose recommended for HIV-1 therapy (as part of an appropriate combination regimen) in patients coinfected with HIV-1 and HBV.

-Consult the manufacturer product information regarding missed doses.

Storage requirements:

-Oral solutions: Store in tightly closed bottles at 20C to 25C (68F to 77F)

-Tablets: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

General:

-Due to development of high resistance rates in treated patients, starting this drug for treatment of chronic HBV should only be considered when an alternative antiviral with a higher genetic barrier to resistance is not available or appropriate.

-During HBV therapy, combinations of events (e.g., persistently elevated ALT recurring, HBV DNA levels increasing over time after initial decline below assay limit, clinical signs/symptoms of hepatic disease progression, and/or hepatic necroinflammatory findings worsen) may indicate loss of therapeutic response; such events should be considered when deciding whether to continue this drug.

-The durability of hepatitis B e antigen (HBeAg) seroconversions occurring during HBV therapy and the relationship between treatment response and long-term outcomes (e.g., hepatocellular carcinoma, decompensated cirrhosis) have not been established.

-The oral solutions contain sucrose; Epivir(R) contains 3 g sucrose per 15 mL dose and Epivir-HBV(R) contains 4 g sucrose per 20 mL dose.

Monitoring:

-Gastrointestinal: For signs/symptoms of pancreatitis in pediatric patients

-General: HIV testing (before starting and periodically during HBV therapy)

-Hepatic: ALT and HBV DNA levels (during HBV therapy); hepatic function of HBV-infected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)

-Renal: Renal function in elderly patients

What is the dose of Lamivudine for a child?

Usual Pediatric Dose for HIV Infection

3 months or older:

Oral solution: 4 mg/kg orally twice a day or 8 mg/kg orally once a day

-Maximum dose: 300 mg/day

Tablets:

14 to less than 20 kg: 75 mg orally twice a day or 150 mg orally once a day

20 to less than 25 kg: 75 mg orally in the morning and 150 mg in the evening, or 225 mg orally once a day

25 kg or more: 150 mg orally twice a day or 300 mg orally once a day

Comments:

-For patients starting therapy with the oral solution, HIV-1 viral load and CD4+ cell count/percentage should be considered when selecting dosing interval.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children Recommendations:

Oral solution:

Less than 4 weeks (for prevention of transmission or treatment): 2 mg/kg orally twice a day

4 weeks to less than 3 years: 4 mg/kg orally twice a day

-Maximum dose: 150 mg/dose

3 years to less than 16 years: 4 mg/kg orally twice a day or 8 to 10 mg/kg orally once a day

-Maximum dose: 300 mg/day

Tablets:

14 to 21 kg: 75 mg orally twice a day

Greater than 21 to less than 30 kg: 75 mg orally in the morning and 150 mg in the evening

30 kg or more: 150 mg orally twice a day

16 years or older:

Less than 50 kg: 4 mg/kg orally twice a day

-Maximum dose: 150 mg/dose

50 kg or more: 150 mg orally twice a day or 300 mg orally once a day

Comments:

-May consider switching from twice-daily dosing to once-daily dosing of this drug in clinically stable patients 3 years or older with a reasonable once-daily regimen, an undetectable viral load, and stable CD4 count; a dose of 8 to 10 mg/kg/dose (up to 300 mg/day) is recommended for such patients.

Usual Pediatric Dose for Chronic Hepatitis B

2 years or older: 3 mg/kg orally once a day

Maximum dose: 100 mg/day

Duration of therapy: The optimal duration of therapy is not known.

Use: For the treatment of chronic HBV infection associated with evidence of hepatitis B viral replication and active liver inflammation

How is Lamivudine available?

Lamivudine is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Lamivudine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 13, 2018 | Last Modified: March 13, 2018

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