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Argatroban: Solution for injection (1mg)

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What is this Medicine?

ARGATROBAN (ar GA troh ban) is an anticoagulant. It is used in a hospital setting to help treat and prevent blood clots.

In-Depth Information

Argatroban 50mg/50ml Solution for Injection (NOVAPLUS)

NDC: 007819314
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Heparin-induced Thrombocytopenia, Percutaneous Coronary Intervention (PCI), Deep Venous Thrombosis (DVT), Deep Venous Thrombosis (DVT) Prophylaxis, Coronary Artery Thrombosis Prophylaxis, Pulmonary Embolism Prophylaxis, Pulmonary Embolism

Sometimes used for but not FDA approved for the following conditions:
Acute Myocardial Infarction, Disseminated Intravascular Coagulation (DIC)

Storage Information
Protect from light
Discard product if it contains particulate matter, is cloudy, or discolored
Store in original container
Do not freeze
Discard unused portion. Do not store for later use.
Store at controlled room temperature (between 68 and 77 degrees F)
Argatroban 50mg/50ml Solution for Injection (NOVAPLUS)

Reported Side Effects for Argatroban 50mg/50ml Solution for Injection (NOVAPLUS)

Skin Rash Incidence:
<10.0%*
Severity: MILD
Onset: EARLY
Blistery Rash Incidence:
<10.0%*
Severity: MODERATE
Onset: EARLY
Blood Clot Incidence:
0.9-1.8%*
Severity: SEVERE
Onset: DELAYED
Coughing Up Blood Incidence:
0.9-2.9%*
Severity: MODERATE
Onset: DELAYED
Heartburn Incidence:
0.9%*
Severity: MILD
Onset: DELAYED
Chest Pain Incidence:
0.9-15.2%*
Severity: MODERATE
Onset: EARLY
Bleeding In The Abdomen Incidence:
0.9%*
Severity: SEVERE
Onset: DELAYED
Fever Incidence:
0.9-6.9%*
Severity: MILD
Onset: EARLY
Blood In The Urine Incidence:
0.9%*
Severity: SEVERE
Onset: DELAYED
Fluid In Lungs Incidence:
0.9%*
Severity: SEVERE
Onset: EARLY
Intestinal Bleeding Incidence:
0.9-14.4%*
Severity: SEVERE
Onset: DELAYED
Bleeding In The Brain Incidence:
1.0-4.3%*
Severity: SEVERE
Onset: DELAYED
Bleeding Incidence:
1.8-5.3%*
Severity: SEVERE
Onset: EARLY
Chest Pain Incidence:
1.8%*
Severity: MODERATE
Onset: EARLY
Stomach Pain Incidence:
2.6-3.6%*
Severity: MILD
Onset: EARLY
Vomiting Of Blood Incidence:
2.6%*
Severity: SEVERE
Onset: DELAYED
Irregular Heart Beat Incidence:
3.0%*
Severity: SEVERE
Onset: EARLY
Infection Incidence:
3.3-6.0%*
Severity: MILD
Onset: DELAYED
Heart Attack Incidence:
3.6%*
Severity: SEVERE
Onset: DELAYED
Bruise Incidence:
3.6-5.4%*
Severity: MODERATE
Onset: EARLY
Vomiting Incidence:
4.2-6.3%*
Severity: MILD
Onset: EARLY
Slow Heart Beat Incidence:
4.5%*
Severity: SEVERE
Onset: RAPID
Upset Stomach Incidence:
4.8-7.1%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
4.8%*
Severity: SEVERE
Onset: EARLY
Headache Incidence:
5.4%*
Severity: MILD
Onset: EARLY
Suddenly Stopped Heart Incidence:
5.8%*
Severity: SEVERE
Onset: EARLY
Loose Stools Incidence:
6.2%*
Severity: MILD
Onset: EARLY
Low Blood Pressure Incidence:
7.2-10.7%*
Severity: MODERATE
Onset: RAPID
Back Pain Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
>10.0%*
Severity: MILD
Onset: DELAYED
Shortness Of Breath Incidence:
>10.0%*
Severity: MODERATE
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


Learning More About
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  • Get answers to Frequently Asked Questions (FAQs)
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