A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Innohep Online, Description, Chemistry, Ingredients - Tinzaparin
Innohep Online, Description, Chemistry, Ingredients - Tinzaparin
SPINAL/EPIDURAL HEMATOMAS
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal
puncture is employed, patients anticoagulated or scheduled to be
anticoagulated with low molecular weight heparins or heparinoids
for prevention of thromboembolic complications are at risk of developing
an epidural or spinal hematoma which can result in long-term or
permanent paralysis.
The risk of these events is increased by the use of indwelling
epidural catheters for administration of analgesia or by the concomitant
use of drugs affecting hemostasis such as non-steroidal anti-inflammatory
drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The
risk also appears to be increased by traumatic or repeated epidural
or spinal puncture.
Patients should be frequently monitored for signs and symptoms
of neurological impairment. If neurological compromise is noted,
urgent treatment is necessary.
The physician should consider the potential benefit versus risk
before neuraxial intervention in patients anticoagulated or to be
anticoagulated for thromboprophylaxis (see also WARNINGS
, Hemorrhage, and PRECAUTIONS
, Drug Interactions ).
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DESCRIPTION
INNOHEP is a sterile solution, containing tinzaparin sodium, a low molecular
weight heparin. It is available in a multiple dose 2 mL vial.
Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-Xa) of tinzaparin
sodium per mL, for a total of 40,000 IU, and 3.1 mg/mL sodium metabisulfite
as a stabilizer. The vial contains 10 mg/mL benzyl alcohol as a preservative.
Sodium hydroxide may be added to achieve a pH range of 5.0 to 7.5.
Table 1
Composition of 20,000 anti-Xa IU/mL INNOHEP
(tinzaparin sodium injection)
|
Component
|
Quantity per mL
|
|
Tinzaparin sodium
|
20,000 anti-Xa IU
|
|
Benzyl alcohol, USP
|
10 mg
|
|
Sodium metabisulfite, USP
|
3.106 mg 1
|
|
Sodium hydroxide, USP
|
as necessary
|
|
Water for Injection, USP
|
q.s. to 1 mL
|
|
1 Corresponding to 3.4 mg/mL sodium bisulfite
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Tinzaparin sodium is the sodium salt of a low molecular weight heparin
obtained by controlled enzymatic depolymerization of heparin from porcine
intestinal mucosa using heparinase from Flavobacterium heparinum .
The majority of the components have a 2-O-sulpho-4-enepyranosuronic acid
structure at the non-reducing end and a 2-N,6-O-disulpho-D-glucosamine
structure at the reducing end of the chain.
Potency is determined by means of a biological assay and interpreted
by the first International Low Molecular Weight Heparin Standard as units
of anti-factor Xa (anti-Xa) activity per milligram. The mean tinzaparin
sodium anti-factor Xa activity is approximately 100 IU per milligram.
The average molecular weight ranges between 5,500 and 7,500 daltons. The
molecular weight distribution is:
|
<2,000 Daltons
<10%
2,000 to 8,000 Daltons 60%
to 72%
>8,000 Daltons 22%
to 36%
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