Morrhuate

Morrhuate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Morrhuate is a sclerosing agent that is FDA approved for the treatment of primary varicosed veins that consist of simple dilation with competent valves. Common adverse reactions include burning or cramping sensations and urticaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Morrhuate Sodium Injection is used for the obliteration of primary varicosed veins that consist of simple dilation with competent valves.
• Sclerotherapy should not be used in patients with significant valvular or deep vein incompetence.
• Although Morrhuate Sodium has been used as a sclerosing agent for the treatment of internal hemorrhoids, there is no substantial evidence that the drug is useful for this purpose.
• Most patients with symptomatic primary varicosed veins should be treated initially with compression stockings. If this treatment is inadequate, surgery may be required. Sclerosing agents may be useful as a supplement to venous ligation to obliterate residual varicosed veins or in patients who have conditions which increase the risk of surgery. However, many clinicians consider if sclerotherapy is not effective it may decrease the potential success of later surgery, should this be required.

Dosing Information

• Morrhuate Sodium is administered only by INTRAVENOUS injection. Care must be taken to avoid extravasation. Specialized references should be consulted for specific procedures and techniques of administration. When small veins are injected, or the injection solution is cold, or if solid matter has separated in the solution, the vial should be warmed by immersing in hot water. The solution should become clear on warming. Only a clear solution should be used. Because the solution froths easily, a large bore needle should be used to fill the syringe. However, a small bore needle should be used for the injection.

• To determine possible sensitivity to the drug, some clinicians recommend injection of 0.25 to 1 mL of 5% Morrhuate Sodium Injection into a varicosity 24 hours before administration of a large dose.

• Dosage of Morrhuate Sodium depends on the size and degree of varicosity. The usual adult dose for obliteration of small or medium veins is 50 to 100 mg (1 to 2 mL of the 5% injection). For large veins, 150 to 250 mg (3 to 5 mL of the injection) is used. The drug may be given as multiple injections at one time or in single doses. Therapy may be repeated 5 to 7 day intervals, according to the patient's response. Following injection of Morrhuate Sodium, the vein promptly becomes hard and swollen for 2 to 4 inches, depending on the size and response of the vein. After 24 hours, the vein is hard and slightly tender to the touch (with little or no periphlebitis). The skin around the injection becomes light-bronze. This color usually disappears shortly. An aching sensation and feeling of stiffness usually occurs and lasts approximately 48 hours.

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Morrhuate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Morrhuate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Morrhuate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Morrhuate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Morrhuate in pediatric patients.

Contraindications

• Morrhuate Sodium is contraindicated in patients who have shown a previous hypersensitivity reaction to the drug or to the fatty acids of cod liver oil. Continued administration of the drug is contraindicated when an unusual local reaction at the injection site or a systemic reaction occurs.

• Thrombosis induced by Morrhuate Sodium may extend into the deep venous system in patients with significant valvular incompetence, therefore, valvular competency, deep vein patency, and deep vein competency should be determined by angiography and/or by tests such as the Trendelenberg and Perthes before injection of sclerosing agents. The drug is contraindicated for obliterations of superficial veins in patients with persistent occlusion of the deep veins. Morrhuate Sodium is also contraindicated in patients with acute superficial thrombophlebitis; underlying arterial disease; varicosities caused by abdominal and pelvic tumors, uncontrolled diabetes mellitus, thyrotoxicosis, tuberculosis, neoplasms, asthma, sepsis, blood dyscrasias, acute respiratory or skin disease; and in bedridden patients. Treatment with Morrhuate Sodium should be delayed in patients with acute local or systemic infections (including infected ulcers). Extensive therapy with the drug is inadvisable in patients who are severely debilitated or senile.

Warnings

• Burning or cramping sensations indicate local reactions. Urticaria may result. Sloughing and necrosis of tissue may occur with extravasation of the drug. Technique development is essential for optimal success in sclerotherapy, therefore the drug should be administered only by a physician familiar with proper injection technique. Drowsiness and headache may occur rarely. Pulmonary embolism has been reported.

Rarely, patients may have, or may develop hypersensitivity to Morrhuate Sodium, characterized by dizziness, weakness, vascular collapse, asthma, respiratory depression, gastrointestinal disturbances (i.e., nausea, vomiting), and urticaria. Anaphylactic reactions may occur within a few minutes after injection of the drug and are most likely to occur when therapy is reinstituted after an interval of several weeks. Morrhuate Sodium should only be administered when adequate facilities, drugs (i.e., epinephrine, antihistamines, corticosteroids), and personnel are available for the treatment of anaphylactic reactions.

Adverse Reactions

Clinical Trials Experience

• Burning or cramping sensations indicate local reactions. Urticaria may result. Sloughing and necrosis of tissue may occur with extravasation of the drug. Technique development is essential for optimal success in sclerotherapy, therefore the drug should be administered only by a physician familiar with proper injection technique. Drowsiness and headache may occur rarely. Pulmonary embolism has been reported.

• Rarely, patients may have, or may develop hypersensitivity to Morrhuate Sodium, characterized by dizziness, weakness, vascular collapse, asthma, respiratory depression, gastrointestinal disturbances (i.e., nausea, vomiting), and urticaria. Anaphylactic reactions may occur within a few minutes after injection of the drug and are most likely to occur when therapy is reinstituted after an interval of several weeks. Morrhuate Sodium should only be administered when adequate facilities, drugs (i.e., epinephrine, antihistamines, corticosteroids), and personnel are available for the treatment of anaphylactic reactions.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Morrhuate in the drug label.

Drug Interactions

There is limited information regarding Morrhuate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproduction studies have not been performed. It is not known whether Morrhuate Sodium Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Use of Morrhuate Sodium in women of childbearing potential requires that anticipated benefits be weighed against the possible hazards.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Morrhuate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Morrhuate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Morrhuate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Morrhuate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Morrhuate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Morrhuate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Morrhuate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Morrhuate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Morrhuate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Morrhuate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Morrhuate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Morrhuate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Morrhuate in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Morrhuate in the drug label.

Pharmacology

There is limited information regarding Morrhuate Pharmacology in the drug label.

Mechanism of Action

• Morrhuate Sodium, when injected into the vein, causes inflammation of the intima and formation of a thrombus. This blood clot occludes the injected vein and fibrous tissue develops, resulting in the obliteration of the vein.

Structure

• Morrhuate Sodium Injection, USP, is a mixture of the sodium salts of the saturated and unsaturated fatty acids of Cod Liver Oil. Morrhuate Sodium Injection, USP is prepared by the saponification of selected Cod Liver Oils. Morrhuate Sodium occurs as a pale-yellowish, granular powder with a slight fishy odor and is soluble in water and in alcohol.

Each mL contains: Morrhuate Sodium 50 mg, Benzyl Alcohol 2% (as a local anesthetic), Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide.

• The pH of the injection is adjusted to approximately 9.5.

NOTE: PRODUCT MAY SHOW A SEPARATION OF A SOLID MATTER ON STANDING. DO NOT USE IF SUCH SOLID DOES NOT DISSOLVE COMPLETELY UPON WARMING.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Morrhuate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Morrhuate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Morrhuate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Morrhuate in the drug label.

How Supplied

• Morrhuate Sodium Injection, USP 50 mg/mL

• NDC 0517-3065-01 30 mL Multiple Dose Vial Individually Packaged

• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Storage

There is limited information regarding Morrhuate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Morrhuate in the drug label.

Precautions with Alcohol

• Alcohol-Morrhuate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Morrhuate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Morrhuate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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