Label: NEXAVIR- liver derivative complex injection
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Contains inactivated NDC Code(s)
NDC Code(s): 10530-319-07 - Packager: Nexco Pharma
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 19, 2020
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DESCRIPTION:
NEXAVIR ® Injection (liver derivative complex) is a sterile solution containing 25.5mg liver derivative complex per ml in sterile water for injection.
NEXAVIR ® Injection is composed of peptides and amino acids. The product contains no protein and does not exhibit anti-anemia activity.
NEXAVIR ® Injection also contains as inactive ingredients: phenol 0.5%, sterile water for Injection, pH is adjusted with hydrochloric acid or sodium hydroxide when necessary. -
CLINICAL PHARMACOI.OGY:
The specific action of NEXAVIR ® is to enhance the resolution of inflammation and edema. In the late 1920's, it was demonstrated that liver was of benefit to patients suffering from acne vulgaris. 1 As a consequence, various techniques were employed for isolating the active "factor" from liver. Studies published in the late 1930's and early 1940's 2,3,4 showed activity in a specially purified liver fraction. During subsequent years, refinements in the isolation of the active material led to the marketing of NEXAVIR ®.
Initially it was thought that the primary action of NEXAVIR ® was on the capillaries and precapillary sphincters. However, it is now believed that this effect is a secondary one and that the primary action of NEXAVIR ® is in response to injury at the cellular level. The capillary changes observed following administration of NEXAVIR ® appear to be part of a more fundamental anti-inflammatory effect. In the normal animal, no consistent pharmacodynamic action has been demonstrated for NEXAVIR ®. In particular, there is no effect on systemic blood pressure, no action on the autonomic nervous system and no alteration in prothrombin, coagulation or bleeding times. It is concluded that the specific action of the product is only apparent when tissues have been subjected to injury and when inflammation and edema are present. -
INDICATIONS AND USAGE:
A wide range of dermatological clinical conditions benefit from NEXAVIR ® therapy. The common denominator in these varied conditions is the presence of inflammation and edema. Favourable responses to the administration of NEXAVIR ® in patients with acne vulgaris 5,6,7,8, herpes zoster, "poison ivy" dermatitis, pityriasis rosea, seborrheic dermatitis, urticaria and eczema 9,10,11, severe sunburn 12 and rosacea 13 have been reported.
- CONTRAINDICATIONS:
- WARNING:
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PRECAUTIONS:
Drug Interactions:
NEXAVIR ® contains tyramine and should not be administered to patients taking MAO inhibitors because hypertensive crisis may occur.Carcinogenesis, Mutagenesis, Impairment of Fertility:
No long-term animal studies have examined the carcinogenic or mutagenic potential of NEXAVIR ®. NEXAVIR ®s effect upon reproductive capacity is similarly unknown.
Pregnancy- Pregnancy Category C:
Animal reproduction studies have not been conducted with NEXAVIR ®. It is also not known whether NEXAVIR ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NEXAVIR ® should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NEXAVIR ® is administered to a nursing woman. - ADVERSE REACTIONS:
- DRUG ABUSE AND DEPENDENCE:
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DOSAGE AND ADMINISTRATION:
For the management of skin disorders, the usual dose of NEXAVIR ® is 2 ml administered daily or as indicated. The product is given by intramuscular or subcutaneous injection only.
As with all parenteral drug products, NEXAVIR ® should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. - HOW SUPPLIED:
- SPL UNCLASSIFIED SECTION
- Other information
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REFERENCES:
1. Sutton, R.L :. Liver Diets in Acne Vulgaris and in Furunculosis, Arch. Derm & Syph., 18:887, 1928. See also; Sutton, R.L, and Sutton, Jr, R.L.: Disease of the Skin, C.V. Mosby CO., St. Louis, 1939.
2. Marshall, V.: Further Studies on the Therapy of Acne Vulgaris with Modified Liver Extract. J . Invest. Derm.2:205, 1939.
3. Lichtenstein, M.A. and Stillians. A.W.: Liver Extract In Treatment of Acne Vulgaris in Tuberculosis Patients, Arch. Derm.& Syph.,45:959, 1942.
4. Boreen, C.A.: Boiled Liver In the Treatment of Acne Vulgaris, Minn. Med.,25:276, 1942.
5. Nierman, M.M.: Treatment of Cystic Acne Vulgaris with a Cutaneous Vasoconstrictor (Kutapressin) The Jour. of Ind. State Med. . Ass.n. 45:497,1952.
6. Knox. J.M.: Treatment of Cystic Acne with Kutapressin, U.S.N. News Letter, 20:9, 1952.
7. Lubowe, L.: Modern Treatment of Acne Vulgaris, Clin. Med. 59:8, 1952.
8. Pensky, N. and Goldber, N.: Treatment of Refractory Acne with Fractionated Type of Liver Extract, N.Y. State Jour. of Med. 53:2238, Oct. 1953
9. Burks, J.L, Jr.: The Modern Treatment of Acne Vulgaris, Jour. La. State Med. Soc. 106:92, 1954.
10. Burks,J. W and Knox, J.M.: S-Factor of Liver Extract In Acne Vulgaris, A.M.A. Archives of Derm. & Syphil., 70:508, 1954.
11. Barksdale, E. E.: The Use of S-Factor of Liver Extract (Kutapressin) in Dermatology, South. Med, Jour., 50:1524, 1957.
12. Heywood, H. W.: Use of Kutapressin in the treatment of Severe Sunburn, Clin. Med. 3:8, 1956.
13. Berrock, J.J.: Rosacea, Medical Times, 86:968, 1958 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEXAVIR
liver derivative complex injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10530-319 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 25.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color brown (brown solution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10530-319-07 20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 02/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/19/2020 Labeler - Nexco Pharma (023524538) Registrant - Nexco Pharma (023524538)