Scleromate ® Morrhuate Sodium Injection, U.S.P.
Prescribing Information

DESCRIPTION:

Morrhuate Sodium Injection, U.S.P. is a mixture of the sodium salts of the saturated and unsaturated fatty acids of Cod Liver Oil. SCLEROMATE Morrhuate Sodium Injection, U.S.P. is prepared by the saponification of selected Cod Liver Oils, it is overlaid with filtered Nitrogen to prevent discoloration that occurs on exposure to oxygen. Morrhuate Sodium occurs as a pale-yellowish, granular powder with a slight fishy odor and is soluable in water and in alcohol.

NOTE: Solid matter may develop a hazy appearence on standing and the injection should not be used if the solid matter does not dissolve completely on warming. The pH of the injection is adjusted to approximately 9.5

PHARMACOLOGY:

Morrhuate Sodium, when injected into the vein, causes inflamation of the intima and formation of a thrombus. This blood clot occludes the injected vein and fibrous tissue developes, 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 on in patients who have conditions which increase the risk of surgery. However, many clinicians consider sclerotherapy if not effective 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 mintues 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 reactions 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, uncontontrolled 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 severly debilitated or senile.

PREGNANCY:

Safety in use of Morrhuate Sodium during pregnancy has not been established.

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 solutions froths easily, a large bore needle should be used in 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 - 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 - 100 mg (1-2ml of the 5% Injections). For large veins, 150 - 250mg (3-5ml of the injection) is used. The drug may be given as multiple injections at one time or in single doses. Therapy may be repeated at 5 - 7 day intervals, according to the patient's response. Following injection of Morrhuate Sodium, the vein promptly becomes hard and swollen for 2 - 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 occur and last approxiamtely 48 hours.

HOW SUPPLIED:

Morrhuate Sodium Injection 5%
NDC-53159-003-01 - 30ml Multiple use Vials.

STORAGE:

Store below 40 degrees C. (104 degrees F.) preferably between 15-30 degrees C. (59-86 degrees F.)