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Morrhuate Sodium Injection

Generic Name: morrhuate sodium
Dosage Form: injection, solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Morrhuate Sodium Injection, USP

Rx Only

DESCRIPTION

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.

PHARMACOLOGY

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.

USES:

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. (see CAUTIONS.)

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.

CAUTIONS:

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.

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.

PREGNANCY: Pregnancy Category 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.

DOSAGE

Morrhuate Sodium is administered only by INTRAVENOUS injection. Care must be taken to avoid extravasation. (See CAUTIONS.) 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.

How is Morrhuate Sodium Injection 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).

IN3065
Rev. 8/13

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container

NDC 0517-3065-01

MORRHUATE SODIUM
INJECTION, USP

50 mg/mL (5%)

30 mL
MULTIPLE DOSE VIAL

FOR IV USE ONLY

CAUTION: AVOID EXTRAVASATION

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

  

Carton

NDC 0517-3065-01

30 mL MULTIPLE DOSE VIAL

MORRHUATE SODIUM
INJECTION, USP

50 mg/mL (5%)

FOR IV USE ONLY

CAUTION: AVOID EXTRAVASATION

Rx Only

AMERICAN
REGENT, INC.

SHIRLEY, NY 11967

MORRHUATE SODIUM 
Morrhuate Sodium Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-3065
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORRHUATE SODIUM (MORRHUIC ACID) MORRHUATE SODIUM 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-3065-01 1 VIAL, MULTI-DOSE in 1 CARTON
1 30 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990
Labeler - American Regent, Inc. (622781813)
Establishment
Name Address ID/FEI Operations
Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-3065), MANUFACTURE(0517-3065), STERILIZE(0517-3065)
Revised: 09/2014
 
American Regent, Inc.



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