Please wait while the formulary information is being retrieved.
Drug overview for CEPROTIN (protein c, human):
Generic name: PROTEIN C, HUMAN
Drug class: Protein C Replacement
Therapeutic class: Hematological Agents
Protein C, a naturally occurring precursor of a vitamin K-dependent serine protease, is an anticoagulant. Protein C (human) is a lyophilized concentrate of protein C prepared from pooled human plasma.
No enhanced Uses information available for this drug.
Generic name: PROTEIN C, HUMAN
Drug class: Protein C Replacement
Therapeutic class: Hematological Agents
Protein C, a naturally occurring precursor of a vitamin K-dependent serine protease, is an anticoagulant. Protein C (human) is a lyophilized concentrate of protein C prepared from pooled human plasma.
No enhanced Uses information available for this drug.
DRUG IMAGES
No Image Available
The following indications for CEPROTIN (protein c, human) have been approved by the FDA:
Indications:
Protein C deficiency disease
Professional Synonyms:
None.
Indications:
Protein C deficiency disease
Professional Synonyms:
None.
The following dosing information is available for CEPROTIN (protein c, human):
Potency of protein C (human) is determined by chromogenic assay and is expressed in international units (IU, units) as tested against the activity of the World Health Organization reference standard. One unit is approximately equivalent to the protein C activity (as measured by an amidolytic assay) present in 1 mL of plasma. The number of units of protein C is indicated on the label of each vial.
Dosage and duration of protein C (human) therapy is dependent on the severity of protein C deficiency, the plasma protein C concentration, and the patient's age and clinical condition. Dosage of protein C (human) should be individualized based on measured protein C activity, expressed as a percentage of normal plasma protein C concentrations, and adjusted according to the pharmacokinetic profile for each individual patient.
Plasma protein C concentrations should be determined before and during therapy with protein C (human) using a chromogenic assay to measure the level of protein C activity. During acute thrombotic episodes, protein C activity should be measured immediately before administration until the patient is stabilized; protein C concentrations should continue to be monitored after the patient is stabilized. The magnitude of increase in plasma protein C activity achieved with the drug may be substantially reduced during acute thrombotic episodes.
(See Description.) Coagulation parameters also should be monitored; however, data from clinical studies were insufficient to establish correlation between levels of protein C activity and coagulation parameters.
Dosage and duration of protein C (human) therapy is dependent on the severity of protein C deficiency, the plasma protein C concentration, and the patient's age and clinical condition. Dosage of protein C (human) should be individualized based on measured protein C activity, expressed as a percentage of normal plasma protein C concentrations, and adjusted according to the pharmacokinetic profile for each individual patient.
Plasma protein C concentrations should be determined before and during therapy with protein C (human) using a chromogenic assay to measure the level of protein C activity. During acute thrombotic episodes, protein C activity should be measured immediately before administration until the patient is stabilized; protein C concentrations should continue to be monitored after the patient is stabilized. The magnitude of increase in plasma protein C activity achieved with the drug may be substantially reduced during acute thrombotic episodes.
(See Description.) Coagulation parameters also should be monitored; however, data from clinical studies were insufficient to establish correlation between levels of protein C activity and coagulation parameters.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CEPROTIN 400-600 UNIT VIAL | Maintenance | Adults infuse 45 unit/kg at a rate not to exceed 2 mL/min by intravenous route every 12 hours |
No generic dosing information available.
The following drug interaction information is available for CEPROTIN (protein c, human):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for CEPROTIN (protein c, human):
Drug contraindication overview.
The manufacturer states that there are no known contraindications to the use of protein C (human).
The manufacturer states that there are no known contraindications to the use of protein C (human).
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Heparin-induced thrombocytopenia |
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for CEPROTIN (protein c, human):
Adverse reaction overview.
The most common adverse effects reported in clinical studies of protein C (human) are hypersensitivity or allergic reactions (e.g., itching, rash) and lightheadedness.
The most common adverse effects reported in clinical studies of protein C (human) are hypersensitivity or allergic reactions (e.g., itching, rash) and lightheadedness.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Hemorrhage Heparin-induced thrombocytopenia Hypersensitivity drug reaction Hypotension Injection site sequelae |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dizziness Pruritus of skin Skin rash |
None. |
| Rare/Very Rare |
|---|
|
Fever Hyperhidrosis Nervousness |
The following precautions are available for CEPROTIN (protein c, human):
Safety and efficacy of protein C (human) have been established in several retrospective and prospective studies in children 2 days of age and older. The pharmacokinetic profile of protein C (human) has not been established in pediatric patients. Limited data suggest that systemic exposure to protein C (human) may be reduced in very young children compared with older individuals because the protein may have a shorter half-life, a larger volume of distribution, and/or more rapid clearance in very young children; clinicians should consider this fact when selecting a dosage regimen for children, and dosage of protein C (human) should be individualized based on measured protein C activity. (See Dosage and Administration: Dosage.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) Exposure to protein C (human) during labor and delivery has been reported without adverse effects in at least one case. However, protein C (human) has not been studied for use during labor and delivery.
It is not known whether protein C (human) is distributed into milk in humans. Protein C (human) has not been studied for use in nursing women.
Experience in patients 65 years of age or older is insufficient to determine whether they respond differently than younger adults.
The following prioritized warning is available for CEPROTIN (protein c, human):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CEPROTIN (protein c, human)'s list of indications:
| Protein C deficiency disease | |
| D68.59 | Other primary thrombophilia |
Formulary Reference Tool