(la mi' vyoo deen)
P:Caution when used during pregnancy
L :Contraindicated in lactation
||See TERMINOLOGY & ABBREVIATIONS ||
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued Lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Lamivudine Tablets and Oral Solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than Lamivudine-HBV Tablets and Oral Solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.
|Indication & Dosage||
Lamivudine is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
Limitation of use: The dosage of this product is for HIV-1 and not for HBV.
|Dosage & Administration||
Adults and Adolescents >16 years of age
The recommended oral dose of Lamivudine in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen.
The recommended oral dose of Lamivudine Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.
Lamivudine is also available as a scored tablet for HIV-1-infected pediatric patients who weigh â‰¥14 kg and for whom a solid dosage form is appropriate. Before prescribing Lamivudine Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow Lamivudine Tablets, the oral solution formulation should be prescribed. The recommended oral dosage of Lamivudine Tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for Lamivudine Tablets in Pediatric Patients
May be taken with or without food.
Patients With Renal Impairment
Dosing of Lamivudine is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2.
Table 2. Adjustment of Dosage of Lamivudine in Adults and Adolescents (â‰¥30 kg) in Accordance With Creatinine Clearance
No additional dosing of Lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of Lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
|Warning & Precautions||
Lactic Acidosis/Severe Hepatomegaly With Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering Lamivudine to any patient with known risk factors for liver disease; however, cases also have been reported in patients with no known risk factors. Treatment with Lamivudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Patients With HIV-1 and Hepatitis B Virus Co-infection
Posttreatment Exacerbations of Hepatitis: In clinical trials in non-HIV-1-infected patients treated with lamivudine for chronic hepatitis B, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA. Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from postmarketing experience after changes from lamivudine-containing HIV-1 treatment regimens to non-lamivudine-containing regimens in patients infected with both HIV-1 and HBV. The causal relationship to discontinuation of lamivudine treatment is unknown. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. There is insufficient evidence to determine whether re-initiation of lamivudine alters the course of posttreatment exacerbations of hepatitis.
Important Differences Among Lamivudine-Containing Products: Lamivudine Tablets and Oral Solution contain a higher dose of the same active ingredient (lamivudine) than Lamivudine-HBV Tablets and Lamivudine-HBV Oral Solution. Lamivudine-HBV was developed for patients with chronic hepatitis B. The formulation and dosage of lamivudine in Lamivudine-HBV are not appropriate for patients co-infected with HIV-1 and HBV. Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients co-infected with HIV-1 and HBV. If treatment with Lamivudine-HBV is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely to result because of the subtherapeutic dose and the inappropriateness of monotherapy HIV-1 treatment. If a decision is made to administer lamivudine to patients co-infected with HIV-1 and HBV, Lamivudine Tablets, Lamivudine Oral Solution, COMBIVIRÂ® (lamivudine/zidovudine) Tablets, EPZICOMÂ® (abacavir sulfate and lamivudine) Tablets, or TRIZIVIRÂ® (abacavir sulfate, lamivudine, and zidovudine) Tablets should be used as part of an appropriate combination regimen.
Emergence of Lamivudine-Resistant HBV: In nonâ€“HIV-1-infected patients treated with lamivudine for chronic hepatitis B, emergence of lamivudine-resistant HBV has been detected and has been associated with diminished treatment response (see full prescribing information for Lamivudine-HBV for additional information). Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-1-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.
Use With Other Lamivudine- and Emtricitabine-Containing Products
Lamivudine should not be administered concomitantly with other lamivudine-containing products including Lamivudine-HBV Tablets, Lamivudine Oral Solution, COMBIVIR (lamivudine/zidovudine) Tablets, EPZICOM (abacavir sulfate and lamivudine) Tablets, or TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) or emtricitabine-containing products, including ATRIPLAÂ® (efavirenz, emtricitabine, and tenofovir), EMTRIVAÂ® (emtricitabine), or TRUVADAÂ® (emtricitabine and tenofovir).
Use With Interferon- and Ribavirin-Based Regimens
In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as lamivudine. Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV-1/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine in HIV-1/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and Lamivudine should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of Lamivudine should be considered as medically appropriate. Dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh >6). See the complete prescribing information for interferon and ribavirin.
In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, Lamivudine should be used with caution. Treatment with Lamivudine should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur.
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Lamivudine. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and â€œcushingoid appearanceâ€ have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.
|Adverse Drug Reactions||Abdominal pain, nausea, vomiting, diarrhoea, insomnia, cough, nasal
symptoms, arthralgia, muscle pain, headache, fever, rash, alopecia, malaise, increased creatinine phosphokinase and alanine aminotransferase, peripheral
neuropathy. Rarely rhabdomyolysis, pancreatitis, hepatitis. Neutropenia and anaemia (in combination with zidovudine), thrombocytopenia, increases in LFTs.
Paronychia. Angioedema, urticaria, and anaphylactoid reaction.
Potentially Fatal: Lactic acidosis associated with severe hepatomegaly and hepatic steatosis.
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 (e.g., trimethoprim). No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine.
Interferon- and Ribavirin-Based Regimens
Although no evidence of a pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV-1/HCV virologic suppression) was seen when ribavirin was coadministered with lamivudine in HIV-1/HCV co-infected patients, hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.
Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of lamivudine in combination with zalcitabine is not recommended.
No change in dose of either drug is recommended. There is no information regarding the effect on lamivudine pharmacokinetics of higher doses of TMP/SMX such as those used to treat PCP.
Drugs with No Observed Interactions With EPIVIR
A drug interaction study showed no clinically significant interaction between EPIVIR and zidovudine.
|Pregnancy Category (US FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Oral: Store at 25Â°C (77Â°F).|
|Pharmacology||Lamivudine, a nucleoside analogue, is phosphorylated in the body to
the active triphosphate form. In the active form, it inhibits hepatitis B virus polymerase and HIV reverse transcriptase enzymes.
Absorption: Rapidly absorbed from the GI tract, delayed if taken with food (oral); peak plasma concentrations after 1 hr.
Distribution: Crosses the blood-brain barrier and placenta; enters breast milk. Protein-binding: Up to 36%.
Metabolism: Intracellular; low hepatic metabolism.
Excretion: Via urine (as unchanged drug); 5-7 hr (elimination half-life).
|ATC Classification||J05AF05 - lamivudine; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|AVILAM||Beximco Pharmaceuticals Ltd||Lamivudine 150 mg||Tablet||10's: 250.00 MRP|
|HEPAVIR 100||Square Pharmaceuticals Ltd.||Lamivudine 100mg||Tablet||5x4's: 503.40 MRP|
|LAMIDIN||Eskayef Bangladesh Ltd||Lamivudine INN 100mg||Film Coated Tablet||10's MRP: 253.00|
|Lamivir||Incepta Pharmaceuticals Limited||Lamivudine INN 100 mg||Tablet||4x5's:MRP 500 Tk|
|VIRADIN TAB||Healthcare Pharmacuticals Ltd.||Lamivudine INN 100 mg||Tablet||30's MRP 750 Tk|
|ZEFFIX||GlaxoSmithKline Bangladesh Limited||Lamivudine INN 100mg||Film Coated Tablet||10's: 903.40 MRP|
Lamivudine, when used alone or in combination with other antiviral medications, can cause serious damage to the liver and a condition called lactic acidosis. If you experience any of the following symptoms, call your doctor immediately: nausea, loss of appetite, excessive tiredness, weakness, dark yellow or brown urine, unusual bleeding or bruising, flu-like symptoms, yellowing of the skin or eyes, and pain in the upper right part of your stomach. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to lamivudine.
Lamivudine tablets and liquid (used to treat human immunodeficiency virus [HIV]) are not interchangeable with Lamivudine-HBV tablets and liquid (used to treat hepatitis B infection). Lamivudine contains a higher dose of lamivudine than Lamivudine-HBV. Treatment with Lamivudine-HBV in patients infected with HIV may cause the HIV virus to be less treatable with lamivudine and other medicines. If you have both HIV and hepatitis B, you should take only Lamivudine. If you are taking Lamivudine-HBV for hepatitis B infection, talk to your doctor about your risks for HIV infection.
Why is this medication prescribed?
Lamivudine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Lamivudine is used to treat hepatitis B infection. Lamivudine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and hepatitis B in the blood. Although lamivudine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.
How should this medicine be used?
Lamivudine comes as a tablet and liquid to take by mouth. Lamivudine is usually taken every 12 hours (twice a day). Lamivudine (Lamivudine-HBV) is usually taken once a day. Follow the directions on your prescription label carefully, and ask your doctorto 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.
Continue to take lamivudine even if you feel well. Do not stop taking lamivudine without talking to your doctor.
Other uses for this medicine
Lamivudine is also used sometimes in combination with zidovudine to treat healthcare workers or other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.
This medication may be prescribed for other uses; ask your doctor for more information.
What special precautions should I follow?
Before taking lamivudine,
- tell your doctor if you are allergic to lamivudine or any other drugs.
- tell your doctor what prescription and nonprescription medications you are taking, especially trimethoprim/sulfamethoxazole and vitamins.
- tell your doctor if you have or have ever had hepatitis B, kidney disease, or pancreas disease (in children only).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lamivudine, call your doctor. You should not breast-feed while taking lamivudine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Lamivudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
loss of appetite
If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
vomiting (in children)
nausea (in children)
numbness, tingling, or burning in the fingers or toes
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 (not in the bathroom). The liquid does not need to be refrigerated; however, it should be stored in a cool place. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) 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.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
| Latest mph edition: 09 Dec 2013 |
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*Trademark name & prescribing information are the property of their respective Manufacturers.