Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Zerit 15 mg hard capsules.
Zerit 20 mg hard capsules.
Zerit 30 mg hard capsules.
Zerit 40 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Zerit 15 mg hard capsules: The hard capsule is red and yellow, opaque and imprinted with “BMS” over a BMS code “1964” on one side and “15” on the other side. Zerit 20 mg hard capsules: The hard capsule is brown, opaque and imprinted with “BMS” over a BMS code “1965” on one side and “20” on the other side. Zerit 30 mg hard capsules: The hard capsule is light and dark orange, opaque and imprinted with “BMS” over a BMS code “1966” on one side and “30” on the other side. Zerit 40 mg hard capsules: The hard capsule is dark orange, opaque and imprinted with “BMS” over a BMS code “1967” on one side and “40” on the other side. |
Zerit 15 mg hard capsules: Each hard capsule contains 15 mg of stavudine.
Excipients with known effect:
Each hard capsule contains 80.84 mg of lactose anhydrous.
Each hard capsule contains 40.42 mg of lactose monohydrate.
Zerit 20 mg hard capsules: Each hard capsule contains 20 mg of stavudine.
Excipients with known effect:
Each hard capsule contains 121.30 mg of lactose anhydrous.
Each hard capsule contains 60.66 mg of lactose monohydrate.
Zerit 30 mg hard capsules: Each hard capsule contains 30 mg of stavudine.
Excipients with known effect:
Each hard capsule contains 121.09 mg of lactose anhydrous.
Each hard capsule contains 60.54 mg of lactose monohydrate.
Zerit 40 mg hard capsules: Each hard capsule contains 40 mg of stavudine.
Excipients with known effect:
Each hard capsule contains 159.06 mg of lactose anhydrous.
Each hard capsule contains 79.53 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Stavudine |
Stavudine, a thymidine analogue, is phosphorylated by cellular kinases to stavudine triphosphate which inhibits HIV reverse transcriptase by competing with the natural substrate, thymidine triphosphate. It also inhibits viral DNA synthesis by causing DNA chain termination due to a lack of the 3'-hydroxyl group necessary for DNA elongation. Cellular DNA polymerase γ is also sensitive to inhibition by stavudine triphosphate, while cellular polymerases α and β are inhibited at concentrations 4,000-fold and 40-fold higher, respectively, than that needed to inhibit HIV reverse transcriptase. |
| List of Excipients |
|---|
|
Capsule contents: Lactose Capsule shell: Gelatin Black ink containing: Shellac |
HDPE bottles with child resistant screw cap (60 hard capsules per bottle).
Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/96/009/001-008
Date of first authorisation: 08 May 1996
Date of last renewal: 20 April 2011
| Drug | Countries | |
|---|---|---|
| ZERIT | Estonia, Ireland, Lithuania, Netherlands, Poland, Romania |
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