DESCRIPTION
Oral
Ciprofloxacin hydrochloride tablets and oral suspension
are synthetic broad spectrum antimicrobial agents for
oral administration. Ciprofloxacin hydrochloride, a fluoroquinolone
is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluora-1,
4-dihydro-4-oxa-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. It is a faintly yellowish to light yellow crystalline
substance with a molecular weight of 385.8. Its empirical
formula is C17H18FN3O3·HCl·H2O.
Ciprofloxacin is 1-cyclopropyl-6-fluoro-1, 4-drhydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. Its empirical formula is C17H18FN3O3 and its molecular
weight is 331.4 It is a faintly yellowish to light yellow
crystalline substance.
Ciprofloxacin differs from other quinolones in that it
has a fluorine atom at the 6-position, a piperazine moiety
at the 7-position, and a cyclopropyl ring at the 1-position.
Cipro film-coated tablets are available in 100-mg, 250-mg,
500-mg and 750-mg (ciprofloxacin equivalent) strengths.
The inactive ingredients are starch, microcrystalline
cellulose, silicon dioxide, crospovidone, magnesium stearate,
hydroxypropyl methylcellulose, titanium dioxide, polyethylene
glycol and water.
Ciprofloxacin HCl oral suspension is available in 5%
(5 g ciprofloxacin in 100 ml) and 10% (10 g ciprofloxacin
in 100 ml) strengths. Ciprofloxacin HCl oral suspension
is a white to slightly yellowish suspension with strawberry
flavor which may contain yellow-orange droplets. It is
composed of ciprofloxacin microcapsules and diluent which
are mixed prior to dispensing (See PATIENT PACKAGE INSERT).
The components of the suspension have the following compositions:
Microcapsules: Ciprofloxacin, polyvinylpyrrolidone,
methacrylic acid copolymer, hydroxypropyl methylcellulose,
magnesium stearate and Polysorbate 20.
Diluent: Medium-chain triglycerides,
sucrose, lecithin, water, and strawberry flavor.
I.V.
Ciprofloxacin is a synthetic broad-spectrum antimicrobial
agent for intravenous (I.V.) administration. Ciprofloxacin,
a fluoroquinolone, is 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid, its empirical formula is C17H18FN3O3.
Ciprofloxacin is a faint to light yellow crystalline
powder with a molecular weight of 331.4. It is soluble
in dilute (0 1N) hydrochloric acid and is practically
insoluble in water and ethanol. Ciprofloxacin differs
from other quinolones in that it has a fluorine atom at
the 6-position, a piperazine moiety at the 7-position,
and a cyclopropyl ring at the 1-position. Cipro I.V. solutions
are available as sterile 1.0% aqueous concentrates, which
are intended for dilution prior to administration, and
as 0.2% ready-for-use infusion solutions in 5% Dextrose
injection. All formulas contain lactic acid as a solubilizing
agent and hydrochloric acid for pH adjustment. The pH
range for the 1.0% aqueous concentrates in vials is 3.3
to 3.9. The pH range for the 0.2% ready-for-use infusion
solutions is 3.5 to 4.6.
The plastic container is fabricated from a specially
formulated polyvinyl chloride. Solutions in contact with
the plastic container can leach out certain of its chemical
components in very small amounts within the expiration
period, e.g., di(2-ethylhexyl) phthalate (DEHP), up to
5 parts per million. The suitability of the plastic has
been confirmed in tests in animals according to USP biological
tests for plastic containers as well as by tissue culture
toxicity studies.
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