protamine (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 10 mg/mL

Heparin Neutralization

1-1.5 mg per 100 USP units of heparin; not to exceed 50 mg

Monitor APTT 5-15 min after dose then in 2-8 hr

In accidental overdoses of heparin, consider t1/2 heparin 60-90 min

In setting without bleeding complications, consider observation, rather than reversal of anticoagulation with protamine (avoids ADR's)

Complex of protamine and heparin may degrade over time requiring further doses

Dalteparin or Tinzaparin Overdose

1 mg protamine for 100 units dalteparin or tinzaparin; if PTT prolonged 4hr after protamine overdose administer 0.5 mg per 100 units of dalteparin or tinzaparin

Enoxaparin Overdose

1 mg per mg enoxaparin (if enoxaparin overdose given within 8 hr); if >8 hr of overdose or bleeding continues after 4 hr after first dose, give 0.5 mg protamine per mg enoxaparin

Time Elapsed Since Heparin Dose

Dose of protamine (mg) to neutralize 100 units of heparin

  • <1/2 hr: 1-1.5 mg/100 units of heparin
  • 30-120 min: 0.5-0.75 mg/100 units of heparin
  • >2 hr: 0.25-0.375 mg/100 units of heparin

Dosage Forms & Strengths

IV solution

  • 10 mg/mL

Heparin Neutralization (Off-label)

~1 mg protamine neutralizes 100 units of heparin; not to exceed 50 mg/dose

Monagle P, et al. Chest 2008:133(6 Suppl):S887-S968

Time elapsed since heparin dose

  • Protamine dose to neutralize 100 units of heparin
  • <1/2 hr: 1 mg
  • 30-120 min: 0.5-0.75 mg
  • >2 hr: 0.25-0.375 mg
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Interactions

Interaction Checker

and protamine

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (1)

            • mifepristone

              mifepristone, protamine. Other (see comment). Contraindicated. Comment: Mifepristone may lead to excessive post abortion bleeding in pts. on anticoagulant therapy.

            Serious - Use Alternative (52)

            • abciximab

              protamine, abciximab. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • allopurinol

              allopurinol increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • amobarbital

              amobarbital decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • anagrelide

              protamine, anagrelide. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • antithrombin alfa

              antithrombin alfa and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • antithrombin III

              antithrombin III and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • argatroban

              argatroban and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • azithromycin

              azithromycin increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • bazedoxifene/conjugated estrogens

              bazedoxifene/conjugated estrogens decreases effects of protamine by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.

            • bemiparin

              bemiparin and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • bivalirudin

              bivalirudin and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • butabarbital

              butabarbital decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • butalbital

              butalbital decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • cefamandole

              cefamandole increases effects of protamine by pharmacodynamic synergism. Avoid or Use Alternate Drug.

            • cilostazol

              protamine, cilostazol. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • clarithromycin

              clarithromycin increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • clopidogrel

              protamine, clopidogrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • conjugated estrogens

              conjugated estrogens decreases effects of protamine by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.

            • dalteparin

              dalteparin and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • dipyridamole

              protamine, dipyridamole. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • enoxaparin

              enoxaparin and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • eptifibatide

              protamine, eptifibatide. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • erythromycin base

              erythromycin base increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              erythromycin lactobionate increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • erythromycin stearate

              erythromycin stearate increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • estradiol

              estradiol decreases effects of protamine by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.

            • estrogens conjugated synthetic

              estrogens conjugated synthetic decreases effects of protamine by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.

            • estropipate

              estropipate decreases effects of protamine by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.

            • fondaparinux

              fondaparinux and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • heparin

              heparin and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • levonorgestrel intrauterine

              levonorgestrel intrauterine, protamine. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

            • levonorgestrel oral

              levonorgestrel oral, protamine. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

            • levothyroxine

              levothyroxine increases effects of protamine by pharmacodynamic synergism. Avoid or Use Alternate Drug.

            • liothyronine

              liothyronine increases effects of protamine by pharmacodynamic synergism. Avoid or Use Alternate Drug.

            • mestranol

              mestranol decreases effects of protamine by pharmacodynamic antagonism. Contraindicated. Risk of thromboembolic disorders.

            • pentobarbital

              pentobarbital decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • phenindione

              phenindione and protamine both increase anticoagulation. Avoid or Use Alternate Drug.

            • phenobarbital

              phenobarbital decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • prasugrel

              protamine, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • primidone

              primidone decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • quinine

              quinine increases effects of protamine by unknown mechanism. Avoid or Use Alternate Drug.

            • roxithromycin

              roxithromycin increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

            • secobarbital

              secobarbital decreases effects of protamine by increasing metabolism. Avoid or Use Alternate Drug.

            • sulfadiazine

              sulfadiazine increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

              sulfadiazine increases effects of protamine by plasma protein binding competition. Avoid or Use Alternate Drug.

            • sulfamethoxazole

              sulfamethoxazole increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

              sulfamethoxazole increases effects of protamine by plasma protein binding competition. Avoid or Use Alternate Drug.

            • sulfisoxazole

              sulfisoxazole increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.

              sulfisoxazole increases effects of protamine by plasma protein binding competition. Avoid or Use Alternate Drug.

            • thyroid desiccated

              thyroid desiccated increases effects of protamine by pharmacodynamic synergism. Avoid or Use Alternate Drug.

            • tibolone

              tibolone increases effects of protamine by pharmacodynamic synergism. Avoid or Use Alternate Drug.

            • ticlopidine

              protamine, ticlopidine. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • tirofiban

              protamine, tirofiban. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Enhanced risk of hemorrhage.

            • warfarin

              protamine and warfarin both increase anticoagulation. Avoid or Use Alternate Drug.

            Monitor Closely (89)

            • aceclofenac

              protamine and aceclofenac both increase anticoagulation. Modify Therapy/Monitor Closely.

            • acemetacin

              protamine and acemetacin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • agrimony

              protamine and agrimony both increase anticoagulation. Modify Therapy/Monitor Closely.

            • alfalfa

              protamine and alfalfa both increase anticoagulation. Modify Therapy/Monitor Closely.

            • American ginseng

              protamine and American ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.

            • anamu

              protamine and anamu both increase anticoagulation. Use Caution/Monitor.

            • aspirin

              protamine and aspirin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • aspirin rectal

              protamine and aspirin rectal both increase anticoagulation. Modify Therapy/Monitor Closely.

            • aspirin/citric acid/sodium bicarbonate

              protamine and aspirin/citric acid/sodium bicarbonate both increase anticoagulation. Modify Therapy/Monitor Closely.

            • azapropazone

              azapropazone increases effects of protamine by plasma protein binding competition. Use Caution/Monitor.

            • azathioprine

              azathioprine decreases effects of protamine by unknown mechanism. Use Caution/Monitor.

            • budesonide

              budesonide, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • capecitabine

              capecitabine increases effects of protamine by unspecified interaction mechanism. Use Caution/Monitor.

            • carbamazepine

              carbamazepine decreases levels of protamine by increasing metabolism. Use Caution/Monitor.

            • celecoxib

              protamine and celecoxib both increase anticoagulation. Modify Therapy/Monitor Closely.

            • chitosan

              chitosan increases effects of protamine by Other (see comment). Use Caution/Monitor. Comment: Chitosan can decrease GI absorption of vitamin K, enhancing anticoagulant effects.

            • choline magnesium trisalicylate

              protamine and choline magnesium trisalicylate both increase anticoagulation. Modify Therapy/Monitor Closely.

            • cinnamon

              protamine and cinnamon both increase anticoagulation. Modify Therapy/Monitor Closely.

            • conjugated estrogens, vaginal

              conjugated estrogens, vaginal decreases effects of protamine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Risk of thromboembolic disorders.

            • cordyceps

              protamine and cordyceps both increase anticoagulation. Modify Therapy/Monitor Closely.

            • cornsilk

              cornsilk decreases effects of protamine by pharmacodynamic antagonism. Use Caution/Monitor. Cornsilk contains vitamin K; consume a consistent amount daily.

            • cortisone

              cortisone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • danshen

              protamine and danshen both increase anticoagulation. Use Caution/Monitor.

            • deflazacort

              deflazacort, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • devil's claw

              protamine and devil's claw both increase anticoagulation. Use Caution/Monitor.

            • dexamethasone

              dexamethasone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • diclofenac

              protamine and diclofenac both increase anticoagulation. Modify Therapy/Monitor Closely.

            • diflunisal

              protamine and diflunisal both increase anticoagulation. Modify Therapy/Monitor Closely.

              diflunisal increases effects of protamine by plasma protein binding competition. Use Caution/Monitor.

            • dong quai

              protamine and dong quai both increase anticoagulation. Modify Therapy/Monitor Closely.

            • epoprostenol

              protamine and epoprostenol both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ethanol

              ethanol increases effects of protamine by unknown mechanism. Use Caution/Monitor. Acute EtOH intoxication.

            • ethotoin

              protamine increases levels of ethotoin by unknown mechanism. Use Caution/Monitor.

              ethotoin, protamine. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time.

            • etodolac

              protamine and etodolac both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fenbufen

              protamine and fenbufen both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fennel

              protamine and fennel both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fenoprofen

              protamine and fenoprofen both increase anticoagulation. Modify Therapy/Monitor Closely.

            • feverfew

              protamine and feverfew both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fludrocortisone

              fludrocortisone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • flurbiprofen

              protamine and flurbiprofen both increase anticoagulation. Modify Therapy/Monitor Closely.

            • forskolin

              protamine and forskolin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fosphenytoin

              protamine increases levels of fosphenytoin by unknown mechanism. Use Caution/Monitor.

              fosphenytoin, protamine. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time.

            • garlic

              protamine and garlic both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ginger

              protamine and ginger both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ginkgo biloba

              protamine and ginkgo biloba both increase anticoagulation. Modify Therapy/Monitor Closely.

            • glucagon intranasal

              glucagon intranasal increases effects of protamine by unknown mechanism. Use Caution/Monitor.

            • horse chestnut seed

              protamine and horse chestnut seed both increase anticoagulation. Modify Therapy/Monitor Closely.

            • hydrocortisone

              hydrocortisone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • ibuprofen

              protamine and ibuprofen both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ibuprofen IV

              protamine and ibuprofen IV both increase anticoagulation. Modify Therapy/Monitor Closely.

            • indomethacin

              protamine and indomethacin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • iodine (radioactive)

              iodine (radioactive) decreases effects of protamine by pharmacodynamic antagonism. Use Caution/Monitor.

            • ketoprofen

              protamine and ketoprofen both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ketorolac

              protamine and ketorolac both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ketorolac intranasal

              protamine and ketorolac intranasal both increase anticoagulation. Modify Therapy/Monitor Closely.

            • lofepramine

              lofepramine increases levels of protamine by decreasing metabolism. Use Caution/Monitor.

            • lornoxicam

              protamine and lornoxicam both increase anticoagulation. Modify Therapy/Monitor Closely.

            • meclofenamate

              protamine and meclofenamate both increase anticoagulation. Modify Therapy/Monitor Closely.

            • mefenamic acid

              protamine and mefenamic acid both increase anticoagulation. Modify Therapy/Monitor Closely.

            • meloxicam

              protamine and meloxicam both increase anticoagulation. Modify Therapy/Monitor Closely.

            • methimazole

              methimazole decreases effects of protamine by pharmacodynamic antagonism. Use Caution/Monitor.

            • methylprednisolone

              methylprednisolone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • mistletoe

              protamine increases and mistletoe decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

            • nabumetone

              protamine and nabumetone both increase anticoagulation. Modify Therapy/Monitor Closely.

            • naproxen

              protamine and naproxen both increase anticoagulation. Modify Therapy/Monitor Closely.

            • nettle

              protamine increases and nettle decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

            • oxaprozin

              protamine and oxaprozin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • panax ginseng

              protamine and panax ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.

            • parecoxib

              protamine and parecoxib both increase anticoagulation. Modify Therapy/Monitor Closely.

            • pau d'arco

              protamine and pau d'arco both increase anticoagulation. Modify Therapy/Monitor Closely.

            • pegaspargase

              pegaspargase increases effects of protamine by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

            • phenytoin

              protamine increases levels of phenytoin by unknown mechanism. Use Caution/Monitor.

              phenytoin, protamine. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time.

            • phytoestrogens

              protamine and phytoestrogens both increase anticoagulation. Modify Therapy/Monitor Closely.

            • piroxicam

              protamine and piroxicam both increase anticoagulation. Modify Therapy/Monitor Closely.

            • prednisolone

              prednisolone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • prednisone

              prednisone, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • propafenone

              propafenone increases effects of protamine by decreasing metabolism. Use Caution/Monitor.

            • propylthiouracil

              propylthiouracil decreases effects of protamine by pharmacodynamic antagonism. Use Caution/Monitor.

            • reishi

              protamine and reishi both increase anticoagulation. Modify Therapy/Monitor Closely.

            • rifabutin

              rifabutin decreases levels of protamine by increasing metabolism. Use Caution/Monitor.

            • salicylates (non-asa)

              protamine and salicylates (non-asa) both increase anticoagulation. Modify Therapy/Monitor Closely.

            • salsalate

              protamine and salsalate both increase anticoagulation. Modify Therapy/Monitor Closely.

            • Siberian ginseng

              protamine and Siberian ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.

            • sulfasalazine

              protamine and sulfasalazine both increase anticoagulation. Modify Therapy/Monitor Closely.

            • sulindac

              protamine and sulindac both increase anticoagulation. Modify Therapy/Monitor Closely.

            • tipranavir

              tipranavir increases effects of protamine by pharmacodynamic synergism. Use Caution/Monitor. Tipranavir has mild antiplatelet activity that may incr bleeding risk.

            • tolfenamic acid

              protamine and tolfenamic acid both increase anticoagulation. Modify Therapy/Monitor Closely.

            • tolmetin

              protamine and tolmetin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • triclofos

              triclofos increases effects of protamine by unspecified interaction mechanism. Use Caution/Monitor.

            Minor (17)

            • acetaminophen

              acetaminophen increases effects of protamine by unknown mechanism. Minor/Significance Unknown.

            • acetaminophen IV

              acetaminophen IV increases effects of protamine by unknown mechanism. Minor/Significance Unknown.

            • acetaminophen rectal

              acetaminophen rectal increases effects of protamine by unknown mechanism. Minor/Significance Unknown.

            • alprostadil intracavernous/urethral

              alprostadil intracavernous/urethral increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

            • chlorella

              chlorella decreases effects of protamine by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical, due to vitamin K content.

            • demeclocycline

              demeclocycline increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

            • dexmethylphenidate

              dexmethylphenidate increases effects of protamine by decreasing metabolism. Minor/Significance Unknown.

            • doxycycline

              doxycycline increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

            • glyburide

              glyburide increases effects of protamine by unspecified interaction mechanism. Minor/Significance Unknown.

            • heparin

              protamine decreases effects of heparin by Other (see comment). Minor/Significance Unknown. Comment: This combination produces an insoluble salt.

            • mineral oil

              mineral oil decreases levels of protamine by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • minocycline

              minocycline increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

            • oxytetracycline

              oxytetracycline increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

            • quinidine

              quinidine increases effects of protamine by decreasing metabolism. Minor/Significance Unknown.

            • tetracycline

              tetracycline increases effects of protamine by pharmacodynamic synergism. Minor/Significance Unknown.

            • verteporfin

              protamine decreases effects of verteporfin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • vitamin E

              vitamin E, protamine. Mechanism: pharmacodynamic antagonism. Minor/Significance Unknown. Vitamin E at RDA does not change INR in pts. on chronic warfarin therapy; megadoses (~10x RDA) may enhance anticoagulant effects in vitamin K deficient pts.

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            Adverse Effects

            Frequency Not Defined

            Anaphylaxis

            Hypotension

            N/V

            Decreased O2 consumption

            Flushing

            Pulmonary hypertension

            Uncontrollable bleeding

            Circulatory collapse

            Pulmonary edema

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            Warnings

            Black Box Warnings

            Protamine sulfate can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension

            Risk factors include high dose or overdose, rapid administration, repeated doses, previous administration of protamine, and current or previous use of protamine-containing drugs (NPH insulin, protamine zinc insulin, and certain beta-blockers).

            Allergy to fish, previous vasectomy, severe left ventricular dysfunction, and abnormal preoperative pulmonary hemodynamics also may be risk factors. In patients with any of these risk factors, the risk to benefit of administration of protamine sulfate should be carefully considered. Vasopressors and resuscitation equipment should be immediately available in case of a severe reaction to protamine.

            Protamine should not be given when bleeding occurs without prior heparin use

            Contraindications

            Hypersensitivity

            Previous intolerance to drug

            Cautions

            Heparin rebound causing bleeding may occur 8-9 hr after protamine administration

            May be ineffective in cardiac surgery patients despite adequate dose

            Rapid infusion reactions can cause severe hypotensive reactions

            Because of anticoagulant effect of the drug, it is unwise to give more than 50 mg over a short period unless a larger dose is clearly needed

            Patients with history of allergy to fish may develop hypersensitivity reactions to drug, although no relationship established to date between allergic reactions to protamine and fish allergy

            Prior exposure

            • Previous exposure to protamine can induce a humoral immune response and predispose susceptible individuals to development of untoward reactions from subsequent use of drug
            • Patients exposed to protamine through use of protamine-containing insulin or during heparin neutralization may experience life-threatening reactions and fatal anaphylaxis upon receiving large doses of protamine intravenously
            • Severe reactions to intravenous protamine can occur in absence of local or systemic allergic reactions to subcutaneous injection of protamine-containing insulin
            • Reports of presence of antiprotamine antibodies in sera of infertile or vasectomized men suggest that some of these individuals may react to use of protamine sulfate
            • Fatal anaphylaxis has been reported in one patient with no prior history of allergies

            Bleeding risk

            • Hyperheparinemia or bleeding reported 30 minutes to 18 hours after cardiac surgery (under cardiopulmonary bypass) in spite of complete neutralization of heparin by adequate doses of protamine sulfate at end of operation
            • Important to keep patient under close observation after cardiac surgery; administer additional doses of protamine sulfate if indicated by coagulation studies, such as heparin titration test with protamine and determination of plasma thrombin time
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Protamine that is strongly basic combines with acidic heparin forming a stable complex and neutralizes the anticoagulant activity of both drugs

            Pharmacokinetics

            Half-life elimination: 7 min

            Onset: 5 min

            Duration: 2 hr

            Vd: 5.4 L

            Metabolism: Unknown

            Clearance: 1.4 L/min

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            Administration

            IV Incompatibilities

            Additive: cephalosporins, penicillins

            Syringe: diatrizoate meglumine 52%, diatrizoate sodium, ioxaglate meglumine 39.3%, ioxaglate sodium 19.6%

            IV Preparation

            Reconstitute with 5 mL sterile water

            Resulting solution equals 10 mg/mL

            IV Administration

            Inject without further dilution over 1-3 min; maximum of 50 mg in any 10 min period

            For IV use only

            Administer slow IVP (50 mg over 10 min)

            Rapid IV infusion causes hypotension

            Storage

            Refrigerate

            Avoid freezing

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            protamine intravenous
            -
            10 mg/mL vial
            protamine intravenous
            -
            10 mg/mL vial

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            protamine intravenous

            NO MONOGRAPH AVAILABLE AT THIS TIME

            USES: Consult your pharmacist.

            HOW TO USE: Consult your pharmacist.

            SIDE EFFECTS: Consult your 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 or at www.fda.gov/medwatch.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: Consult your pharmacist.

            DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: No monograph available at this time.

            MISSED DOSE: Consult your pharmacist.

            STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised July 2016. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.