Tinzaparin

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|Tinzaparin

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TINZAPARIN (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Innohep

In Canada—

  • Innohep

Category

  • Anticoagulant
  • antithrombotic

Description

Tinzaparin (tin-ZA-pa-rin) is used for the prevention and/or treatment of deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. Tinzaparin is used for several days after surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. Tinzaparin also may be used for other conditions as determined by your doctor.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

  • Parenteral
  • Injection (U.S. and Canada)

Before Using This Medicine

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 tinzaparin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tinzaparin, low molecular weight heparins (LMWH), heparin, sulfites or benzyl alcohol. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, especially pork or pork products, preservatives, or dyes.

Pregnancy—Tinzaparin has not been studied in pregnant women. However, tinzaparin has not been shown to cause birth defects or other problems in animal studies. Tinzaparin should not be used to prevent blood clots in pregnant women with prosthetic heart valves. Studies on the effects in these women have not been done.

Breast-feeding— It is not known whether tinzaparin passes into breast milk. Breast-feeding is not recommended while taking this medicine. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tinzaparin in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 using tinzaparin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

  • Aspirin or
  • Inflammation or pain medicine, except narcotics or
  • Medicines that prevent platelets from sticking together (clopidogrel [e.g., Plavix], ticlopidine [e.g., Ticlid])—Using any of these medicines together with tinzaparin may increase the risk of bleeding

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

  • Prosthetic heart valve—Tinzaparin may not protect these patients from developing a blood clot
  • Blood disease or bleeding problems or
  • Eye problems caused by diabetes or high blood pressure or
  • Heart infection or
  • High blood pressure (hypertension) or
  • Kidney disease or
  • Liver disease or
  • Stomach or intestinal ulcer (active) or
  • Stroke—The risk of bleeding may be increased
  • Also, tell your doctor if you have received tinzaparin or heparin before and had a reaction to either of them called thrombocytopenia (a low platelet count in the blood), or if new blood clots formed while you were receiving the medicine.
  • In addition, tell your doctor if you have recently had surgery . This may increase the risk of serious bleeding when you are taking tinzaparin.

Proper Use of This Medicine

If you are using tinzaparin at home, your health care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional if you have any problems using the medicine .

Put used syringes in a puncture-resistant, disposable container , or dispose of them as directed by your health care professional.

Dosing—The dose of tinzaparin will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of tinzaparin. If your dose is different, do not change it unless your doctor tells you to do so.

  • For injection dosage form:
    • For prevention of deep venous thrombosis (leg clots) due to surgery:
      • Adults
      • General surgery—3500 International Units (IU) 2 hours before surgery then 3500 IU once daily for seven to ten days.
      • Hip surgery—50 International Units (IU) per kilogram (kg) of body weight 2 hours before surgery then 50 IU per kg of body weight once daily for seven to ten days, or 75 IU per kg of body weight given after surgery once daily for seven to ten days.
      • Knee surgery—75 International Units (IU) per kilogram (kg) of body weight given after surgery once daily for seven to ten days.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of deep venous thrombosis (leg clots) with or without pulmonary embolism (lung clots):
      • Adults—175 International Units (IU) per kilogram (kg) of body weight once daily for six to seven days.
      • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, discuss this with your physician.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Keep the medicine from freezing. Do not refrigerate.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Tell all your medical doctors, dentists, and other health care professionals that you are using this medicine .

This medicine may cause severe side effects in babies .

Check with your doctor immediately if you notice any of the following side effects:

  • Bruising or bleeding, especially bleeding that is hard to stop. (Bleeding inside the body sometimes appears as bloody or black, tarry stools or causes faintness.)
  • Back pain; burning, pricking, tickling, or tingling sensation; leg weakness; numbness; paralysis; or problems with bowel or bladder function.

Side Effects of This Medicine

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 immediately if any of the following side effects occur:

More common

Deep, dark purple bruise, pain, or swelling at place of injection

Less common

Bladder pain; bleeding gums; blood in urine; bloody or cloudy urine; blurred vision; chest pain; chest tightness; chills; confusion; cough; coughing up blood; difficulty in breathing or swallowing; dizziness; faintness, or lightheadedness when getting up from a lying or sitting position suddenly; fast, slow, or irregular heartbeat; fever; frequent urge to urinate; headache; increased menstrual flow or vaginal bleeding; lower back pain or side pain; nosebleeds; pain or burning while urinating; painful or difficult urination; pale skin; palpitations; paralysis; pounding in the ears; prolonged bleeding from cuts; red or dark brown urine; red or black, tarry stools; severe or continuing dull nervousness; shortness of breath; skin rash; sore throat; sores, ulcers, or white spots on lips or in mouth; sweating; swollen glands; troubled breathing, exertional; unexplained pain, swelling, or discomfort, especially in the chest, abdomen, joints, or muscles; unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood or coffee ground-like material

Rare

Blue-green to black skin discoloration; bowel/bladder dysfunction; hives; itching; leg weakness; numbness; pain, redness, or sloughing of skin at place of injection; paresthesia; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; wheezing

Incidence not known

abdominal or stomach pain; accumulation of pus; bloody or black, tarry stools; break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid; change in vision; clay-colored stools; collection of blood under the skin; dark urine; diarrhea; excessive thirst; fatigue; hoarseness; large, flat, blue or purplish patches in the skin; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of appetite; malaise; muscle cramps; numbness and tingling of face, fingers, or toes; pain in arms, legs, or lower back, especially pain in calves and/or heels upon exertion; pain, redness or swelling; painful knees and ankles; pale, bluish-colored, or cold hands or feet; problems with vision or hearing; raised, red swellings on the skin, the buttocks, legs or ankles; redness, tenderness, burning, blistering or peeling of skin (usually on the backs of arms and the fronts of legs, mouth, eyes or hands and feet; red or irritated eyes; seeing floating spots before the eyes; swollen, red, tender area of infection; unpleasant breath odor; weak or absent pulses in legs; yellow eyes or skin

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

Less common or rare

Constipation; nausea and vomiting; prolonged, painful, inappropriate erection of the penis; trouble in sleeping

Incidence not known

Hives or welts; redness of skin

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

Developed: 08/11/2000
Revised: 12/12/2002

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