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Protamine Sulfate

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Overview

What is Protamine Sulfate?

Protamines are simple proteins of low molecular weight that are rich in arginine and strongly basic.  They occur in the sperm of salmon and certain other species of fish.

Protamine sulfate occurs as fine white or off-white amorphous or crystalline powder.  It is sparingly soluble in water.  The pH is between 6.0 and 7.0.  The cationic hydrogenated protamine at a pH of 6.8 to 7.1 reacts with anionic heparin at a pH of 5.0 to 7.5 to form an inactive complex.

Protamine Sulfate Injection, USP is a sterile, isotonic solution of protamine sulfate.  It acts as a heparin antagonist.  It is also a weak anticoagulant.

Each mL contains: Protamine sulfate 10 mg; sodium chloride 9 mg; Water for Injection q.s.  Sulfuric acid and/or dibasic sodium phosphate (heptahydrate) may have been added for pH adjustment.

The preparation is preservative free.

Protamine sulfate is administered intravenously.



What does Protamine Sulfate look like?



What are the available doses of Protamine Sulfate?

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What should I talk to my health care provider before I take Protamine Sulfate?

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How should I use Protamine Sulfate?

Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.

Each mg of protamine sulfate, calculated on the dried basis, neutralizes not less than 100 USP Heparin Units.

Protamine sulfate injection should be given by very slow intravenous injection over a 10-minute period in doses not to exceed 50 mg

Protamine sulfate is intended for injection without further dilution; however, if further dilution is desired, D5-W or normal saline may be used.  Diluted solutions should not be stored since they contain no preservative.

Protamine sulfate should not be mixed with other drugs without knowledge of their compatibility, because protamine sulfate has been shown to be incompatible with certain antibiotics, including several of the cephalosporins and penicillins.

Because heparin disappears rapidly from the circulation, the dose of protamine sulfate required also decreases rapidly with the time elapsed following intravenous injection of heparin.  For example, if the protamine sulfate is administered 30 minutes after the heparin, one-half the usual dose may be sufficient.

The dosage of protamine sulfate should be guided by blood coagulation studies (see ).

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.


What interacts with Protamine Sulfate?

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What are the warnings of Protamine Sulfate?

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What are the precautions of Protamine Sulfate?

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What are the side effects of Protamine Sulfate?

The intravenous administration of protamine sulfate may cause a sudden fall in blood pressure and bradycardia.  Other reactions include transitory flushing and feeling of warmth, dyspnea, nausea, vomiting and lassitude.  Back pain has been reported in conscious patients undergoing such procedures as cardiac catheterization.

Severe adverse reactions have been reported including: (1) Anaphylaxis that resulted in severe respiratory distress, circulation collapse and capillary leak (see ).  Fatal anaphylaxis has been reported in one patient with no prior history of allergies; (2) Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary edema; acute pulmonary hypertension.

Complement activation by the heparin-protamine complexes, release of lysosomal enzymes from neutrophils, and prostaglandin and thomboxane generation have been associated with the development of anaphylactoid reactions.

Severe and potentially irreversible circulatory collapse associated with myocardial failure and reduced cardiac output can also occur.  The mechanism(s) of this reaction and the role played by concurrent factors are unclear.

High-protein, noncardiogenic pulmonary edema associated with the use of protamine has been reported in patients on cardiopulmonary bypass who are undergoing cardiovascular surgery.  The etiologic role of protamine in the pathogenesis of this condition is uncertain, and multiple factors have been present in most cases.  The condition has been reported in association with administration of certain blood products, other drugs, cardiopulmonary bypass alone, and other etiologic factors.  It is difficult to treat, and it can be life-threatening.  Because fatal anaphylactic and anaphylactoid reactions have been reported after the administration of protamine sulfate, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.


What should I look out for while using Protamine Sulfate?

Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.

Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 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 the end of the operation.  It is important to keep the patient under close observation after cardiac surgery.  Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time.

Too-rapid administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions


What might happen if I take too much Protamine Sulfate?


How should I store and handle Protamine Sulfate?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.CAUTION: The total dose of protamine sulfate contained in product No. PRX22930 (250 mg in 25 mL) is 5 times greater than in product No. PRX22905 (50 mg in 5 mL).The large size 25 mL vials are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.CAUTION: The total dose of protamine sulfate contained in product No. PRX22930 (250 mg in 25 mL) is 5 times greater than in product No. PRX22905 (50 mg in 5 mL).The large size 25 mL vials are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.CAUTION: The total dose of protamine sulfate contained in product No. PRX22930 (250 mg in 25 mL) is 5 times greater than in product No. PRX22905 (50 mg in 5 mL).The large size 25 mL vials are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.CAUTION: The total dose of protamine sulfate contained in product No. PRX22930 (250 mg in 25 mL) is 5 times greater than in product No. PRX22905 (50 mg in 5 mL).The large size 25 mL vials are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

When administered alone, protamine has an anticoagulant effect.  However, when it is given in the presence of heparin (which is strongly acidic), a stable salt is formed and the anticoagulant activity of both drugs is lost.

Protamine sulfate has a rapid onset of action.  Neutralization of heparin occurs within five minutes after intravenous administration of an appropriate dose of protamine sulfate.  Although the metabolic fate of the heparin-protamine complex has not been elucidated, it has been postulated that protamine sulfate in the heparin-protamine complex may be partially metabolized or may be attacked by fibrinolysin, thus freeing heparin.

Non-Clinical Toxicology
Protamine sulfate is contraindicated in patients who have shown previous intolerance to the drug.

Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 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 the end of the operation.  It is important to keep the patient under close observation after cardiac surgery.  Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time.

Too-rapid administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions

In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see ).

It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy.

Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.

The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.

An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established.

Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.

Tolbutamide’s conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of this observation is unknown.

Chlorpropamide’s plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

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

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

Previous exposure to protamine can induce a humoral immune response and predispose susceptible individuals to the development of untoward reactions from the subsequent use of this drug.  Patients exposed to protamine through the 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 the absence of local or systemic allergic reactions to subcutaneous injection of protamine-containing insulin.  Reports of the presence of antiprotamine antibodies in the sera of infertile or vasectomized men suggest that some of these individuals may react to the use of protamine sulfate.

Fatal anaphylaxis has been reported in one patient with no prior history of allergies.

The intravenous administration of protamine sulfate may cause a sudden fall in blood pressure and bradycardia.  Other reactions include transitory flushing and feeling of warmth, dyspnea, nausea, vomiting and lassitude.  Back pain has been reported in conscious patients undergoing such procedures as cardiac catheterization.

Severe adverse reactions have been reported including: (1) Anaphylaxis that resulted in severe respiratory distress, circulation collapse and capillary leak (see ).  Fatal anaphylaxis has been reported in one patient with no prior history of allergies; (2) Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary edema; acute pulmonary hypertension.

Complement activation by the heparin-protamine complexes, release of lysosomal enzymes from neutrophils, and prostaglandin and thomboxane generation have been associated with the development of anaphylactoid reactions.

Severe and potentially irreversible circulatory collapse associated with myocardial failure and reduced cardiac output can also occur.  The mechanism(s) of this reaction and the role played by concurrent factors are unclear.

High-protein, noncardiogenic pulmonary edema associated with the use of protamine has been reported in patients on cardiopulmonary bypass who are undergoing cardiovascular surgery.  The etiologic role of protamine in the pathogenesis of this condition is uncertain, and multiple factors have been present in most cases.  The condition has been reported in association with administration of certain blood products, other drugs, cardiopulmonary bypass alone, and other etiologic factors.  It is difficult to treat, and it can be life-threatening.  Because fatal anaphylactic and anaphylactoid reactions have been reported after the administration of protamine sulfate, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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