Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: CIPLA MEDPRO MANUFACTURING (PTY) LTD., 1474 South Coast Road, Mobeni, Durban, 4052, Customer Care: 080 222 6662
TELADO Film-coated tablets.
| Pharmaceutical Form |
|---|
|
Blue coloured, capsule shaped, biconvex film-coated tablet, debossed with 'C' on one side and plain on other side. |
Each TELADO film-coated tablet contains:
Lamivudine 300 mg
Tenofovir disoproxil fumarate 300 mg
Dolutegravir 50 mg (as dolutegravir sodium)
Contains sugar: mannitol 145 mg.
For full list of excipients, see section 6.1.
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE SECTION 4.4). TELADO IS NOT INDICATED FOR TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION. THE SAFETY AND EFFICACY OF TELADO HAS NOT BEEN ESTABLISHED IN PATIENTS CO-INFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO ARE CO-INFECTED WITH HBV AND HIV AND HAVE DISCONTINUED THE COMBINATION TABLET. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE CO-INFECTED WITH HIV AND HBV AND WHO DISCONTINUED THE COMBINATION TABLET. IF APPROPRIATE, INITIATION OF ANTI-HEPTATITIS B THERAPY MAY BE WARRANTED (SEE SECTION 4.4).
| Active Ingredient |
|---|
|
Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. |
|
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription. |
|
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. |
| List of Excipients |
|---|
|
Croscarmellose sodium |
Containers of 28's: TELADO is packed in a 85 cc white HDPE bottle with 38 mm non-child resistant cap containing 28 tablets and two 2 g silica gel bags.
Containers of 30's: TELADO is packed in a 85 cc white HDPE bottle with 38 mm non-child resistant cap containing 30 tablets and two 2 g silica gel bags.
Containers of 84's: TELADO is packed in a 200 cc white HDPE bottle with 45 mm screw cap containing 84 tablets and five 2 g silica gel bags.
Containers of 90's: TELADO is packed in a 200 cc white HDPE bottle with 45 mm screw cap containing 90 tablets and five 2 g silica gel bags.
Not all pack sizes may be marketed.
CIPLA MEDPRO MANUFACTURING (PTY) LTD., 1474 South Coast Road, Mobeni, Durban, 4052, Customer Care: 080 222 6662
52/20.2.8/0450
Date of first authorisation: 31 August 2018
Renewal: 03 August 2023
| Drug | Countries | |
|---|---|---|
| TELADO | South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.