CYCLOSERINE Capsules Ref.[7208] Active ingredients: Cycloserine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: King Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland

Product name and form

CYCLOSERINE.

Pharmaceutical Form

Capsule, hard.

Qualitative and quantitative composition

Each capsule contains as active ingredient 250 mg of cycloserine.

Active Ingredient Description
Cycloserine

Cycloserine is an analog of the amino acid D-alanine. It interferes with an early step in bacterial cell wall synthesis in the cytoplasm by competitive inhibition of two enzymes, L-alanine racemase, which forms D-alanine from L-alanine, and D-alanylalanine synthetase, which incorporates D-alanine into the pentapeptide necessary for peptidoglycan formation and bacterial cell wall synthesis.

List of Excipients

Talc
Erythrosin E127
Carmoisine E122
Yellow FCF E110
Titanium dioxide E171
Black iron oxide E172
Gelatin

Pack sizes and marketing

Cycloserine capsules are red and grey.

HDPE bottles of 100 capsules fitted with a child resistant, HDPE/polypropylene cap with an induction heat sealed liner. 1 desiccant disc (HDPE canister containing 3g silica gel) is included in each bottle.

Marketing authorization holder

King Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland

Marketing authorization dates and numbers

PL 14385/0005

Date of first authorisation: October 1996

Date of latest renewal: 31 May 2007

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