HEP-LOCK U/P

DRUG DESCRIPTION

Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) ?-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-?-D-glucose 6-sulfate, (3) ?-D-glucuronic acid, (4) 2-acetamido-2-deoxy-?-D-glucose and (5) ?-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.

Structural formula of Heparin Sodium (representative sub-units):

HEP-LOCK U/P (Heparin Sodium) Structural Formula Illustration

HEP-LOCK U/P (Preservative-Free Heparin Lock Flush Solution, USP) is a sterile solution for intravenous flush only. It is not to be used for anticoagulant therapy. HEP-LOCK U/P (preservative-free heparin lock flush solution) is specially formulated for use in situations where the use of preservatives is not advisable. Each mL contains heparin sodium 10 or 100 USP units, derived from porcine intestines and standardized for use as an anticoagulant, sodium chloride 8 mg, monobasic sodium phosphate monohydrate 2.3 mg, and dibasic sodium phosphate anhydrous 0.5 mg in Water for Injection. pH 5.0-7.5. The potency is determined by biological assay using a USP reference standard based on units of heparin activity per milligram.

What are the precautions when taking preservative-free heparin lock flush solution (HEP-LOCK U/P)?

Before using heparin, tell your doctor or pharmacist if you are allergic to it; or to pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrollable bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe high blood pressure (hypertension), infection of the heart, recent surgery/procedure, bleeding/clotting disorders (e.g., hemophilia, antithrombin III deficiency, thrombocytopenia), stomach/intestinal ulcers or tube...

Read All Potential Precautions of HEP-LOCK U/P


HEP-LOCK U/P Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although very unlikely, this medication can cause bleeding if it has too much effect on your blood. Tell your doctor immediately if you develop any signs of serious bleeding, including unusual pain/swelling/discomfort, prolonged bleeding from cuts or gums, persistent nosebleeds, unusually heavy/prolonged menstrual periods, unusual/easy bruising, dark urine, black stools, severe headache, unusual dizziness.

Some patients can have certain bad reactions to heparin (heparin-induced thrombocytopenia-HIT or heparin-induced thrombocytopenia and thrombosis-HITT). This can occur during treatment and up to several weeks after treatment with heparin has stopped.

Get medical help right away if any of these rare but very serious side effects occur: pain/loss of feeling in the arms/legs, change in color of the arms/legs, chest pain, trouble breathing, confusion, weakness on one side of the body, slurred speech, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using heparin, tell your doctor or pharmacist if you are allergic to it; or to pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrollable bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe high blood pressure (hypertension), infection of the heart, recent surgery/procedure, bleeding/clotting disorders (e.g., hemophilia, antithrombin III deficiency, thrombocytopenia), stomach/intestinal ulcers or tube drainage, liver disease, kidney disease, current/recent bleeding (e.g., from wounds, menstrual period).

Adults over 60 years of age, especially women, may be at greater risk for bleeding while using this drug.

Newborns and infants may be at greater risk for bleeding while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication does not pass into breast milk. However, consult your doctor before breast-feeding.



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