Lamivudine (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING


Lamivudine Scored Tablets, 150 mg
White capsule shaped, biconvex, scored film coated tablets debossed with ‘J’ on one side and ‘16’ on the other side, 1 and 6 seperated by a score line.
NDC 50268-459-15 10 tablets per card, 5 cards per carton
Lamivudine Tablets, 300 mg
White capsule shaped, biconvex, film coated tablets debossed with ‘17’ on one side and ‘J’ on the other side.
NDC 50268-460-13 10 tablets per card, 3 cards per carton
Dispensed in blister punch material. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.

17 PATIENT COUNSELING INFORMATION

17.1 Advice for the Patient

Lactic Acidosis/Hepatomegaly: Patients should be informed that some HIV medicines, including lamivudine, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly) [see Warnings and Precautions (5.1)].

HIV-1/HBV Co-infection: Patients co-infected with HIV-1 and HBV should be informed that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Patients should be advised to discuss any changes in regimen with their physician [see Warnings and Precautions (5.2)].

Differences in Formulations of Lamivudine: Patients should be advised that lamivudine tablets contain a higher dose of the same active ingredient (lamivudine) as EPIVIR-HBV Tablets. If a decision is made to include lamivudine in the HIV-1 treatment regimen of a patient co-infected with HIV-1 and HBV, the formulation and dosage of lamivudine in EPIVIR (not EPIVIR-HBV) should be used [see Warnings and Precautions (5.2)].

Use With Other Lamivudine- and Emtricitabine-Containing Products: Lamivudine should not be coadministered with drugs containing lamivudine or emtricitabine, including COMBIVIR (lamivudine/zidovudine) Tablets, EPZICOM (abacavir sulfate and lamivudine) Tablets, TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine), ATRIPLA (efavirenz, emtricitabine, and tenofovir), EMTRIVA (emtricitabine), TRUVADA (emtricitabine and tenofovir), or COMPLERA (rilpivirine/emtricitabine/tenofovir) [see Warnings and Precautions (5.3)].

HIV-1/HCV Co-Infection: Patients with HIV-1/HCV co-infection should be informed that 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 [see Warnings and Precautions (5.4)].

Risk of Pancreatitis: Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis [see Warnings and Precautions (5.5)].

Redistribution/Accumulation of Body Fat: Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including lamivudine, and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.7)].
Information About HIV-1 Infection: Lamivudine is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using lamivudine.
Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact
with semen, vaginal secretions, or blood.
• Do not breastfeed. Lamivudine is excreted in human breast milk. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Patients should be informed to take all HIV medications exactly as prescribed.
COMBIVIR, EPZICOM and TRIZIVIR are registered trademarks of ViiV Healthcare.
The other brands listed are trademarks of their respective owners and are not trademarks of Hetero Labs Limited. The makers of these brands are not affiliated with and do not endorse Hetero Labs Limited or its products.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 12/11

AV 07/15 (P)
AvPAK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-459-15
Lamivudine Tablets 150mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026845915
NDC 50268-459-15
Lamivudine Tablets 150mg
Rx Only
50 Tablets (5 X 10) Unit Dose
5026845915

Each film coated tablet contains 150 mg of lamivudine USP.
USUAL DOSAGE: See prescribing information for Dosage and Administration.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Contact Number: 1-855-361-3993
KEEP OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE
Mfg. Lic. No. 50/MN/AP/2009/F/G AV 07/15 (P)

label 1
(click image for full-size original)

NDC 50268-460-13
Lamivudine Tablets 300mg
Rx Only
30 Tablets (3 X 10) Unit Dose
5026846013
NDC 50268-460-13
Lamivudine Tablets 300mg
Rx Only
30 Tablets (3 X 10) Unit Dose
5026846013

Each film coated tablet contains 300 mg of lamivudine USP.
USUAL DOSAGE: See prescribing information for Dosage and Administration.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Contact Number: 1-855-361-3993
KEEP OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE Mfg. Lic. No. 50/MN/AP/2009/F/G AV 07/15 (P)

label 2
(click image for full-size original)
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-459(NDC:31722-753)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSPOVIDONE
ISOMALT
ISOPROPYL ALCOHOL
MAGNESIUM STEARATE
METHYLENE CHLORIDE
HYPROMELLOSES
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE (biconvex) Size 15mm
Flavor Imprint Code J;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-459-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-459-11)
1 NDC:50268-459-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-459-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203277 07/30/2015
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-460(NDC:31722-754)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSPOVIDONE
ISOMALT
ISOPROPYL ALCOHOL
MAGNESIUM STEARATE
METHYLENE CHLORIDE
HYPROMELLOSES
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE (biconvex) Size 19mm
Flavor Imprint Code J;17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-460-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-460-11)
1 NDC:50268-460-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-460-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203277 07/30/2015
Labeler — AvPAK (832926666)

Revised: 01/2020 AvPAK

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