Lamivudine (Tablets, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

J05AF05 (Lamivudine)

Active Substance

Lamivudine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral drug active against HIV

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; nucleoside and nucleotide reverse transcriptase inhibitors

Pharmacological Action

An antiviral agent, a nucleoside reverse transcriptase inhibitor. After penetrating cells, it is metabolized to the 5′-triphosphate, which inhibits HIV reverse transcriptase, leading to suppression of viral replication. It is active against strains resistant to zidovudine, and when used in combination with it, it slows the development of viral resistance to zidovudine (in previously untreated patients). It has a higher therapeutic index in vitro than zidovudine (it suppresses bone marrow progenitor cells less strongly than zidovudine and has a less pronounced cytotoxic effect on peripheral blood lymphocytes, lymphocytic, and monocyte-macrophage cell lines). It has a minor effect on the metabolism of cellular deoxynucleotides and the DNA content in the mitochondria of intact cells.

Lamivudine is highly active against the hepatitis B virus (HBV) in all studied cell lines and in all experimentally infected animals.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract. Bioavailability is 80-88%. C_max in blood plasma is reached 1 hour after administration. Lamivudine penetrates the blood-brain barrier and the placental barrier. Plasma protein binding is 36%. It is metabolized by phosphorylation to form the 5′-triphosphate. T_1/2 is 5-7 hours. 68-71% is excreted unchanged in the urine.

Indications

Treatment of HIV infection in adults and children (as part of combination therapy with other antiretroviral drugs).

Chronic viral hepatitis B with HBV replication in patients aged 16 years and older.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B18.0	Chronic viral hepatitis B with delta-agent
B18.1	Chronic viral hepatitis B without delta-agent
B24	Human immunodeficiency virus [HIV] disease, unspecified

ICD-11 code	Indication
1C62.1	HIV disease, clinical stage 2, without mention of tuberculosis or malaria
1E51.0Z	Chronic hepatitis B, unspecified
1E51.2	Chronic hepatitis D

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Determine the dosage and treatment regimen based on the indication and patient population.

For HIV infection in adults and adolescents (over 12 years and body weight ≥50 kg), administer 300 mg once daily or 150 mg twice daily.

For pediatric patients with HIV infection, base the dose on body weight. For children weighing ≥30 kg, use 150 mg twice daily. For children weighing 21-30 kg, use 75 mg twice daily. For children weighing 14-21 kg, use 75 mg once daily. For children weighing less than 14 kg, use the oral solution; the recommended dose is 4 mg/kg twice daily, up to a maximum of 150 mg twice daily.

For chronic hepatitis B in adults and adolescents (aged 16 years and older), administer 100 mg once daily.

Adjust the dosage in patients with renal impairment. If creatinine clearance is 30-49 mL/min, administer 150 mg once daily for HIV or 100 mg as the first dose then 50 mg once daily for hepatitis B. If creatinine clearance is 15-29 mL/min, administer 150 mg as the first dose then 100 mg once daily for HIV or 100 mg as the first dose then 25 mg once daily for hepatitis B. If creatinine clearance is 5-14 mL/min, administer 150 mg as the first dose then 50 mg once daily for HIV or 35 mg as the first dose then 15 mg once daily for hepatitis B. If creatinine clearance is less than 5 mL/min, administer 50 mg as the first dose then 25 mg once daily for HIV or 35 mg as the first dose then 10 mg once daily for hepatitis B.

For patients undergoing hemodialysis, administer the dose after a dialysis session. For HIV infection, give 50 mg after dialysis. For hepatitis B, give 15 mg after dialysis. No supplemental dose is needed after peritoneal dialysis.

No dosage adjustment is required for patients with hepatic impairment.

Administer tablets and oral solution without regard to meals.

Adverse Reactions

From the digestive system: pain and discomfort in the epigastric region, nausea, vomiting, diarrhea, decreased appetite, increased activity of liver transaminases. The development of autoimmune hepatitis is possible.

From the central nervous system: increased fatigue, headache.

From the respiratory system: respiratory tract infections.

Other: general malaise.

Contraindications

Hypersensitivity to lamivudine.

Use in Pregnancy and Lactation

Despite the absence of direct evidence of teratogenic effects and changes in reproductive function, Lamivudine should be used during pregnancy only after careful assessment of the expected benefits and the potential risk of side effects.

If it is necessary to use lamivudine during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

No dose adjustment is required in patients with impaired liver function. However, it should be used with caution in patients with severe cirrhosis of the liver caused by the hepatitis B virus, given the risk of exacerbation of the disease after discontinuation of lamivudine.

Use in Renal Impairment

Use with caution in patients with impaired renal function. If creatinine clearance is less than 50 ml/min, dose adjustment is necessary.

Pediatric Use

There is no experience with the use of lamivudine in children under 3 months of age. In children with impaired renal function, dose adjustment is recommended in the same proportions as in adults.

Special Precautions

Use with caution in patients with impaired renal function. If creatinine clearance is less than 50 ml/min, dose adjustment is necessary.

Given that Lamivudine is excreted almost exclusively by the kidneys, no dose adjustment is required in patients with impaired liver function. However, it should be used with caution in patients with severe cirrhosis of the liver caused by the hepatitis B virus, given the risk of exacerbation of the disease after discontinuation of lamivudine.

Lamivudine is not used in combination with zidovudine in neutropenia (neutrophil count less than 750/µl) or anemia (hemoglobin less than 7.5 g/dl or 4.65 mmol/l).

If abdominal pain, nausea, vomiting, or an increase in plasma pancreatic enzyme levels occur, Lamivudine should be discontinued and not resumed until the diagnosis of pancreatitis is ruled out.

The use of lamivudine does not prevent the possibility of infection through sexual contact or through blood.

During treatment, the possibility of developing a secondary infection should be kept in mind.

Use in pediatrics

There is no experience with the use of lamivudine in children under 3 months of age. In children with impaired renal function, dose adjustment is recommended in the same proportions as in adults.

Drug Interactions

With simultaneous use, Lamivudine increases the duration of action of zidovudine by 13%, and its C_max in blood plasma by 28%. Zidovudine does not affect the pharmacokinetics of lamivudine.

Synergism with zidovudine and other antiviral agents used in the treatment of HIV infections has been noted regarding HIV replication in cell culture.

With simultaneous use with didanosine, sulfonamides, zalcitabine, the risk of developing pancreatitis increases.

With simultaneous use with dapsone, didanosine, isoniazid, stavudine, zalcitabine, the risk of developing peripheral neuropathy increases.

Trimethoprim increases the plasma concentration of lamivudine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Lamivudine [Aurobindo Pharma, Ltd. (India)]
Film-coated tablets, 150 mg: 60 or 100 pcs.

Marketing Authorization Holder

Aurobindo Pharma, Ltd. (India)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oblong in shape, with an engraving “C” on one side and an engraving “63” on the other side.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose 123.5 mg, sodium carboxymethyl starch 5 mg, magnesium stearate 1.5 mg.

Film coating composition: Opadry white (hypromellose, titanium dioxide, macrogol-4000, polysorbate-80) 7 mg.

10 pcs. – Al/PVC blisters (6) – cardboard packs.
10 pcs. – Al/PVC blisters (10) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Lamivudine [Hetero Labs, Limited (India)]
Oral solution 10 mg/1 ml: fl. 240 ml 1 pc.

Marketing Authorization Holder

Hetero Labs, Limited (India)

Dosage Form

Lamivudine

Oral solution 10 mg/1 ml: fl. 240 ml 1 pc.

Dosage Form, Packaging, and Composition

Oral solution clear, from colorless to light yellow with a strawberry-banana odor.

	1 ml
Lamivudine	10 mg

Excipients: sucrose – 200 mg, propylene glycol – 50 mg, methylparahydroxybenzoate – 1.8 mg, propylparahydroxybenzoate – 0.2 mg, anhydrous citric acid – 1 mg, sodium citrate dihydrate – 10 mg, strawberry flavor – 1 mg, banana flavor – 3 mg, purified water – up to 1 ml.

240 ml – polyethylene bottles with a protective cap (1) – cardboard packs.

Lamivudine [Amedart LLC (Russia)]
Oral solution 10 mg/1 ml: fl. 240 ml with dosing syringe and adapter

Marketing Authorization Holder

Amedart LLC (Russia)

Dosage Form

Lamivudine

Oral solution 10 mg/1 ml: fl. 240 ml with dosing syringe and adapter

Dosage Form, Packaging, and Composition

Oral solution clear, colorless or from slightly yellowish to yellow, with a characteristic odor.

	1 ml
Lamivudine	10 mg

Excipients: sucrose – 200 mg, propylene glycol – 20 mg, sodium citrate – 11 mg, methylparahydroxybenzoate – 1.5 mg, citric acid – 1 mg, strawberry flavor – 0.8 mg, banana flavor – 0.6 mg, propylparahydroxybenzoate – 0.18 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.0, purified water – up to 1 ml.

240 ml – bottles (1) complete with a dosing syringe and adapter – cardboard packs.

Lamivudine [Atoll LLC (Russia)]
Film-coated tablets, 150 mg: 7, 10, 14, 20, 21, 25, 28, 30, 60, 35, 40, 42, 49, 50, 56, 60, 63, 70, 75, 80, 90, 100, 120, 125, 150, 175, 180, 200, 210, 225, 240, 250, 270, or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 7, 10, 14, 20, 21, 25, 28, 30, 60, 35, 40, 42, 49, 50, 56, 60, 63, 70, 75, 80, 90, 100, 120, 125, 150, 175, 180, 200, 210, 225, 240, 250, 270, or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score on one side; a cross-section of the tablet shows two layers: a core of almost white color and a film coating.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose – 167.4 mg, sodium carboxymethyl starch – 7 mg, hypromellose – 3.3 mg, magnesium stearate – 2.3 mg.

Film coating composition: hypromellose – 4.56 mg, macrogol-4000 – 1.2 mg, titanium dioxide – 2.24 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (6) – cardboard packs.
7 pcs. – contour cell packs (7) – cardboard packs.
7 pcs. – contour cell packs (8) – cardboard packs.
7 pcs. – contour cell packs (9) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (6) – cardboard packs.
25 pcs. – contour cell packs (7) – cardboard packs.
25 pcs. – contour cell packs (8) – cardboard packs.
25 pcs. – contour cell packs (9) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (7) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (9) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
70 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
80 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
90 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Lamivudine [Atoll LLC (Russia)]
Film-coated tablets, 300 mg: 10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 100, 105, 120, 135, 140, 150, 160, 180 or 200 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 300 mg: 10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 100, 105, 120, 135, 140, 150, 160, 180 or 200 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; a cross-section shows two layers: a core of white or almost white color and a film coating.

	1 tab.
Lamivudine	300 mg

Excipients: microcrystalline cellulose – 334.8 mg, sodium carboxymethyl starch – 14 mg, hypromellose – 6.6 mg, magnesium stearate – 4.6 mg.

Film coating composition: hypromellose – 9.12 mg, macrogol-4000 – 2.4 mg, titanium dioxide – 4.48 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (5) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (7) – cardboard packs.
15 pcs. – contour cell packs (8) – cardboard packs.
15 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (7) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (9) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
70 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Lamivudine [Atoll LLC (Russia)]
Oral solution 10 mg/ml: fl. 240 ml with adapter and dosing syringe

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Lamivudine

Oral solution 10 mg/ml: fl. 240 ml with adapter and dosing syringe

Dosage Form, Packaging, and Composition

Oral solution transparent, from colorless to light yellow with a slight characteristic odor.

	1 ml
Lamivudine	10 mg

Excipients: sucrose – 200 mg, propylene glycol – 20 mg, sodium citrate dihydrate – 11 mg, citric acid monohydrate – 1.1 mg, peach flavor – 0.3 mg, strawberry flavor – 0.3 mg, cetylpyridinium chloride – 0.11 mg, disodium edetate dihydrate – 0.11 mg, purified water – up to 1 ml.

240 ml – bottles (1) complete with adapter and dosing syringe – cardboard packs.

Lamivudine [Kirov Pharmaceutical Factory, JSC (Russia)]
Oral solution 10 mg/ml: fl. 100 ml, 200 ml or 240 ml with adapter and dosing syringe

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

Dosage Form

Lamivudine

Oral solution 10 mg/ml: fl. 100 ml, 200 ml or 240 ml with adapter and dosing syringe

Dosage Form, Packaging, and Composition

Oral solution transparent or slightly opalescent, from colorless to light yellow in color, with a characteristic odor.

	1 ml
Lamivudine	10 mg

Excipients: sucrose – 200 mg, propylene glycol – 20 mg, sodium citrate dihydrate – 11 mg, methylparaben – 1.5 mg, citric acid – 1 mg, propylparaben – 0.18 mg, strawberry flavor – 0.8 mg, banana flavor – 0.6 mg, 10% hydrochloric acid or 1M sodium hydroxide solution – to pH 6.00±0.5, purified water – up to 1 ml.

100 ml – bottles (1) complete with adapter and dosing syringe – cardboard packs.
100 ml – bottles (10) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
100 ml – bottles (20) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
100 ml – bottles (50) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
100 ml – bottles (100) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
200 ml – bottles (1) complete with adapter and dosing syringe – cardboard packs.
200 ml – bottles (10) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
200 ml – bottles (20) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
200 ml – bottles (50) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
200 ml – bottles (100) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
240 ml – bottles (1) complete with adapter and dosing syringe – cardboard packs.
240 ml – bottles (10) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
240 ml – bottles (20) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
240 ml – bottles (50) complete with adapter and dosing syringe – cardboard boxes (for hospitals).
240 ml – bottles (100) complete with adapter and dosing syringe – cardboard boxes (for hospitals).

Lamivudine [Promomed Rus LLC (Russia)]
Film-coated tablets, 100 mg: from 10 to 200 pcs.
Film-coated tablets, 150 mg: from 10 to 200 pcs.
Film-coated tablets, 300 mg: from 10 to 200 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

	Lamivudine	Film-coated tablets, 100 mg: from 10 to 200 pcs.
		Film-coated tablets, 150 mg: from 10 to 200 pcs.
		Film-coated tablets, 300 mg: from 10 to 200 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oval, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Lamivudine	100 mg

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), macrogol (polyethylene glycol), polysorbate or ready-made film coating Opadry^® 02F280047 white [hypromellose, titanium dioxide (E171), macrogol 4000 (polyethylene glycol 4000), polysorbate 80] or ready-made film coating of identical composition.

From 10 to 20 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
From 20 to 100 pcs. – jars (1) with first opening control – cardboard packs.

Film-coated tablets white, round, biconvex, with a score on one side; the core on the cross-section is white or almost white.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate.

From 10 to 20 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
From 20 to 100 pcs. – jars (1) with first opening control – cardboard packs.

Film-coated tablets white, oval, biconvex, with a score on one side; the core on the cross-section is white or almost white.

	1 tab.
Lamivudine	300 mg

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate.

From 10 to 20 pcs. – blister packs (from 1 to 10 pcs.) – cardboard packs.
From 20 to 100 pcs. – jars (1) with first opening control – cardboard packs.

Lamivudine [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Film-coated tablets, 150 mg: 60 pcs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose type 102 – 177.45 mg, sodium starch glycolate – 10.5 mg, colloidal silicon dioxide – 5.92 mg, sodium stearyl fumarate – 2.63 mg, calcium stearate – 3.5 mg.

Coating “Vivacoat^®” PA-1P-000 (hypromellose, titanium dioxide, polydextrose, talc, macrogol 3350) – 10.5 mg.

15 pcs. – blister packs (4) – cardboard packs.

Lamivudine [Pharmaceutical Technologies, LLC (Russia)]
Oral solution 10 mg/ml fl. 240 ml: 1 pc

Marketing Authorization Holder

Pharmaceutical Technologies, LLC (Russia)

Manufactured By

Dalkhimpharm, JSC (Russia)

Dosage Form

Lamivudine

Oral solution 10 mg/ml fl. 240 ml: 1 pc

Dosage Form, Packaging, and Composition

Oral solution transparent, colorless or from light yellow to light brown in color with a characteristic odor.

	1 ml
Lamivudine	10 mg

Excipients: sucrose (sugar) – 200 mg, propylene glycol – 20 mg, methylparaben – 1.5 mg, propylparaben – 0.18 mg, food flavor “Strawberry” or food flavor “Apple” – 1.4 mg, sodium citrate – 11 mg, citric acid – 1 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6, purified water – up to 1 ml.

240 ml – bottles (1) – cardboard packs (complete with a dosing syringe).

Lamivudine [Pharmaceutical Technologies, LLC (Russia)]
Film-coated tablets, 150 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Pharmaceutical Technologies, LLC (Russia)

Manufactured By

Dalkhimpharm, JSC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Lamivudine	150 mg

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (9) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Lamivudine [Pharmconcept, LLC (Russia)]
Film-coated tablets, 150 mg: 10, 30, 60, or 100 pcs.

Marketing Authorization Holder

Pharmconcept, LLC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 10, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose type 102 – 165.75 mg, sodium carboxymethyl starch – 13.5 mg, colloidal silicon dioxide – 1.5 mg, magnesium stearate – 6.75 mg.

Film coating composition: ready-made white coating Aquarius Prime VAP 218010 white – 10.5 mg (hypromellose – 65%, titanium dioxide – 25%, macrogol – 10%).

10 pcs. – blister packs – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Lamivudine [FP Obolenskoe, JSC (Russia)]
Film-coated tablets, 150 mg: 20, 24, 30, 36, 40, 48, 50, 60, 75, 80, 90, 100, or 120 pcs.

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 20, 24, 30, 36, 40, 48, 50, 60, 75, 80, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; on the cross-section – the core is white or almost white.

	1 tab.
Lamivudine	150 mg

Excipients: lactose monohydrate – 45 mg, microcrystalline cellulose – 72 mg, sodium carboxymethyl starch – 24 mg, povidone – 6 mg, magnesium stearate – 3 mg.

Film coating composition: Opadry II (series 85) (polyvinyl alcohol – 3.6 mg, macrogol – 1.818 mg, talc – 1.332 mg, titanium dioxide – 2.25 mg).

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
12 pcs. – blister packs (2) – cardboard packs.
12 pcs. – blister packs (3) – cardboard packs.
12 pcs. – blister packs (4) – cardboard packs.
12 pcs. – blister packs (5) – cardboard packs.
15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (3) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.
15 pcs. – blister packs (5) – cardboard packs.
15 pcs. – blister packs (6) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
20 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (5) – cardboard packs.
20 pcs. – blister packs (6) – cardboard packs.

Lamivudine [FP Obolenskoe, JSC (Russia)]
Film-coated tablets, 150 mg: 20, 24, 30, 36, 40, 48, 50, 60, 75, 80, 90, 100, or 120 pcs.

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Manufactured By

EvoPharm, LLC (Russia)

Dosage Form

Lamivudine

Film-coated tablets, 150 mg: 20, 24, 30, 36, 40, 48, 50, 60, 75, 80, 90, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; on the cross-section – the core is white or almost white.

	1 tab.
Lamivudine	150 mg

Excipients: lactose monohydrate – 45 mg, microcrystalline cellulose – 72 mg, sodium carboxymethyl starch – 24 mg, povidone – 6 mg, magnesium stearate – 3 mg.

Film coating composition: Opadry II (series 85) (polyvinyl alcohol – 3.6 mg, macrogol – 1.818 mg, talc – 1.332 mg, titanium dioxide – 2.25 mg).

Lamivudine Avexima [Avexima JSC (Russia)]
Film-coated tablets 150 mg: 10, 20, 30, 50, 60 or 100 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Lamivudine Avexima

Film-coated tablets 150 mg: 10, 20, 30, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section – almost white.

	1 tab.
Lamivudine	150 mg

Excipients: sodium carboxymethyl starch – 12.5 mg, pregelatinized corn starch – 33 mg, magnesium stearate – 3.3 mg, povidone K30 – 5 mg, microcrystalline cellulose – 126.2 mg.

Film coating composition: Opadry II white – 10 mg, including: polyvinyl alcohol – 4.69 mg, macrogol (polyethylene glycol) – 2.36 mg, talc – 1.74 mg, titanium dioxide – 1.21 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

Lamivudine Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 300 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Canonpharma Production, CJS (Russia)

Academician V.P. Filatov Plant, LLC (Russia)

Dosage Form

Lamivudine Canon

Film-coated tablets, 300 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex, with a score; on the cross-section – almost white.

	1 tab.
Lamivudine	300 mg

Excipients: sodium starch glycolate – 25 mg, pregelatinized corn starch – 66 mg, magnesium stearate – 6.6 mg, povidone K30 – 10 mg, microcrystalline cellulose – 252.4 mg.

Film coating composition: Opadry II white – 20 mg, including: polyvinyl alcohol – 9.38 mg, macrogol (polyethylene glycol) – 4.72 mg, talc – 3.48 mg, titanium dioxide – 2.42 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.

Lamivudine Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 150 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Lamivudine Canon

Film-coated tablets, 150 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section – almost white.

	1 tab.
Lamivudine	150 mg

Excipients: sodium starch glycolate – 12.5 mg, pregelatinized potato starch – 33 mg, magnesium stearate – 3.3 mg, povidone K30 – 5 mg, microcrystalline cellulose – 126.2 mg.

Film coating composition: Opadry II white – 10 mg, including: polyvinyl alcohol – 4.69 mg, macrogol (polyethylene glycol) – 2.36 mg, talc – 1.74 mg, titanium dioxide – 1.21 mg.

10 pcs. – contour cell packs (aluminum/PVC) (3) – polymer jars – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (6) – polymer jars – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (9) – polymer jars – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.

Lamivudine Velpharm [Velpharm, LLC (Russia)]
Film-coated tablets, 150 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 pcs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Lamivudine Velpharm

Film-coated tablets, 150 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on the cross-section – a core of white or almost white color.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose MS-102, sodium starch glycolate (sodium carboxymethyl starch, primogel), colloidal silicon dioxide (aerosil), magnesium stearate.

Film coating composition: [a ready dry mixture for film coating, containing hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000) (Opadry 03F180011 white) or hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000)].

Lamivudine-3TC [Technology Lekarstv LLC (Russia)]
Film-coated tablets, 150 mg: 60 pcs.

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Dosage Form

Lamivudine-3TC

Film-coated tablets, 150 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Lamivudine	150 mg

60 pcs. – polymer jars (1) – cardboard packs.

Lamivudine-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Film-coated tablets, 150 mg: 60 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

Dosage Form

Lamivudine-Teva

Film-coated tablets, 150 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light gray, biconvex, diamond-shaped; with a score on both sides and an engraving "L 150" on one side.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose (50 µm) – 45 mg, microcrystalline cellulose (90 µm) – 87 mg, sodium starch glycolate (type A) – 15 mg, magnesium stearate – 3 mg.

Coating composition opadry gray 15B27516, including hypromellose 3cP (E464) – 2.8539 mg, hypromellose 6cP (E464) – 2.8539 mg, titanium dioxide (E171) – 2.4516 mg, macrogol-400 – 0.72 mg, polysorbate-80 (E433) – 0.09 mg, iron oxide yellow (E172) – 0.0108 mg, iron oxide black (E172) – 0.0198 mg.

10 pcs. – blisters (6) – cardboard packs.

Lamivudine-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Film-coated tablets, 300 mg: 30 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

Dosage Form

Lamivudine-Teva

Film-coated tablets, 300 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets gray, biconvex, diamond-shaped; with an engraving "L 300" on one side.

	1 tab.
Lamivudine	300 mg

Excipients: microcrystalline cellulose (50 µm) – 90 mg, microcrystalline cellulose (90 µm) – 174 mg, sodium starch glycolate (type A) – 30 mg, magnesium stearate – 6 mg.

Coating composition opadry gray 15B27517, including hypromellose 3cP (E464) – 5.7078 mg, hypromellose 6cP (E464) – 5.7078 mg, titanium dioxide (E171) – 4.6206 mg, macrogol-400 – 1.44 mg, polysorbate-80 (E433) – 0.18 mg, iron oxide yellow (E172) – 0.0882 mg, iron oxide black (E172) – 0.2556 mg.

10 pcs. – blisters (3) – cardboard packs.

Lamivudine-Vial [Vial, LLC (Russia)]
Film-coated tablets, 150 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Dosage Form

Lamivudine-Vial

Film-coated tablets, 150 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, capsule-shaped; on one side the dosage "150" is engraved, on the other side a score, on one side of which "V" is engraved, on the other "C"; on the break – the film coating and a core of white or almost white color.

	1 tab.
Lamivudine	150 mg

Excipients: microcrystalline cellulose – 153 mg, sodium starch glycolate – 23.1 mg, hypromellose – 2.25 mg, magnesium stearate – 1.65 mg.

Coating composition hypromellose – 2.25 mg, povidone – 0.75 mg, macrogol (polyethylene glycol) – 0.4 mg, talc – 0.25 mg, titanium dioxide – 1.35 mg.

30 pcs. – polymer containers (1) – cardboard packs.
60 pcs. – polymer containers (1) – cardboard packs.

Medixlife (Author)

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