Heparin and sodium chloride (intravenous route)


    Description

    Heparin and sodium chloride combination injection is used to prevent and treat blood clotting problems (eg, venous thromboembolism, pulmonary embolism, peripheral arterial embolism, disseminated intravascular coagulation). It is also used to prevent clots in the blood vessels before or after surgery or during certain medical procedures. This medicine is a blood thinner.

    This medicine is to be given only by or under the supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of heparin and sodium chloride combination injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of heparin and sodium chloride combination injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, bleeding) which may require caution in patients receiving this medicine.

    Breastfeeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Defibrotide
    • Oritavancin
    • Telavancin

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Alipogene Tiparvovec
    • Alprostadil
    • Alteplase, Recombinant
    • Amtolmetin Guacil
    • Anagrelide
    • Anistreplase
    • Antithrombin, Recombinant
    • Apixaban
    • Argatroban
    • Aspirin
    • Bemiparin
    • Betrixaban
    • Bivalirudin
    • Bromfenac
    • Bufexamac
    • Cangrelor
    • Caplacizumab-yhdp
    • Cefamandole
    • Cefoperazone
    • Celecoxib
    • Chamomile
    • Choline Salicylate
    • Cilostazol
    • Citalopram
    • Clonixin
    • Clopidogrel
    • Collagenase, Clostridium histolyticum
    • Curcumin
    • Dabigatran Etexilate
    • Dalteparin
    • Danaparoid
    • Desvenlafaxine
    • Dexibuprofen
    • Dexketoprofen
    • Dextran
    • Diclofenac
    • Diflunisal

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Chondroitin
    • Coenzyme Q10
    • Dong Quai
    • Ginger
    • Palifermin
    • Vitamin A

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Avocado

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Allergy to heparin or pork products or
    • Bleeding problems, uncontrolled or
    • Blood clotting problems, heparin-induced, history of or
    • Thrombocytopenia (low number of platelets), heparin-induced, history of—Should not be used in patients with these conditions.
    • Heart disease (eg, subacute bacterial endocarditis) or
    • Hemophilia (bleeding disorder) or
    • Hypertension (high blood pressure) or
    • Liver disease or
    • Menstruation or
    • Stomach or bowel problems (eg, ulceration) or
    • Surgery or
    • Thrombocytopenia (low number of platelets)—Use with caution. May increased risk of bleeding.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.


    Precautions

    It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

    This medicine may cause bleeding problems. Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, red or dark brown urine, or red or black, tarry stools.

    Check with your doctor right away if you have anxiety, chest pain or discomfort, confusion, constipation, cough, diarrhea, difficulty in speaking, dizziness or lightheadedness, double vision, fainting, fast heartbeat, headache, inability to move the arms, legs, or facial muscle, nausea, pain, redness, or swelling in the arm or leg, pain or discomfort in the arms, jaw, back, or neck, slow speech, stomach pain, usually after eating a meal, sudden trouble breathing, sweating, vomiting. These may be symptoms of blood clotting problems (eg, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke).

    Check with your doctor right away if you have blue-green to black skin discoloration, pain, redness, or sloughing of the skin at the injection site. These maybe symptoms of serious skin or tissue damage (eg, skin necrosis, gangrene).

    This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a cough, difficulty with swallowing, dizziness, a fast heartbeat, lightheadedness or fainting, trouble breathing, chest tightness, swelling in your face, hands, tongue, or throat after you receive the medicine.

    Make sure any doctor or dentist who treats you knows that you are using this medicine before you have surgery.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Anxiety
    • back pain
    • bleeding gums
    • blood in the urine or stools
    • bloody or black, starry stools
    • blue-green to black skin discoloration
    • chest pain, discomfort, or tightness
    • confusion
    • constipation
    • coughing up blood
    • darkening of the skin
    • decrease in height
    • diarrhea
    • difficulty in breathing or swallowing
    • difficulty in speaking
    • dizziness or lightheadedness
    • double vision
    • fainting
    • fast heartbeat
    • headache
    • hives, itching, skin rash
    • inability to move the arms, legs, or facial muscles
    • inability to speak
    • increased menstrual flow or vaginal bleeding
    • large amount of fat in the blood
    • loss of appetite
    • mental depression
    • nausea
    • nosebleeds
    • pain, redness, or sloughing of skin at the injection site
    • pain, redness, or swelling in the arm or leg
    • pain in the back, ribs, arms, or legs
    • pain or discomfort in the arms, jaw, back, or neck
    • paralysis
    • pinpoint red spots on the skin
    • prolonged bleeding from cuts
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red or dark brown urine
    • slow speech
    • stomach pain or swelling
    • sweating
    • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting
    • vomiting of blood or material that looks like coffee grounds

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Loss of thinning of the hair
    • painful or prolonged erection of the penis

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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






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