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 200 mg powder for oral solution.
| Pharmaceutical Form |
|---|
|
Powder for oral solution. Off-white to pale-pink, gritty powder. |
Each bottle contains 200 mg of stavudine.
The reconstituted solution contains 1 mg of stavudine per ml.
Excipients with known effect:
Each bottle contains 31.5 mg of propylhydroxybenzoate (E216).
Each bottle contains 315 mg of methylhydroxybenzoate (E218).
Each bottle contains 10.15 g of sucrose.
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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