Oxymorphone Hydrochloride and Tetanus Immune Globulin

• Generic Name: oxymorphone
• Dosage Forms: n.a.
• Other Brand Names: Opana, Opana ER, Numorphan HCl

Relief of moderate to severe pain.

Symptomatic relief of moderate to moderately severe pain such as that associated with acute and some chronic medical disorders including renal or biliary colic, acute trauma, postoperative pain, and cancer.

Extended-release tablets are used orally for management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The extended-release tablets are not intended for use on an as-needed (“prn”) basis.

In symptomatic treatment of acute pain, reserve opiate analgesics for pain resulting from severe injuries, severe medical conditions, or surgical procedures, or when nonopiate alternatives for relieving pain and restoring function are expected to be ineffective or are contraindicated. Use smallest effective dosage for shortest possible duration since long-term opiate use often begins with treatment of acute pain. Optimize concomitant use of other appropriate therapies. (See Managing Opiate Therapy for Acute Pain under Dosage and Administration.)

In the management of chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.

Generally use opiates for management of chronic pain (i.e., pain lasting >3 months or past the time of normal tissue healing ) that is not associated with active cancer treatment, palliative care, or end-of-life care only if other appropriate nonpharmacologic and nonopiate pharmacologic strategies have been ineffective and expected benefits for both pain relief and functional improvement are anticipated to outweigh risks.

If used for chronic pain, opiate analgesics should be part of an integrated approach that also includes appropriate nonpharmacologic modalities (e.g., cognitive-behavioral therapy, relaxation techniques, biofeedback, functional restoration, exercise therapy, certain interventional procedures) and other appropriate pharmacologic therapies (e.g., nonopiate analgesics, analgesic adjuncts such as selected anticonvulsants and antidepressants for certain neuropathic pain conditions).

Available evidence insufficient to determine whether long-term opiate therapy for chronic pain results in sustained pain relief or improvements in function and quality of life or is superior to other pharmacologic or nonpharmacologic treatments. Use is associated with serious risks (e.g., opiate use disorder, overdose). (See Managing Opiate Therapy for Chronic Noncancer Pain under Dosage and Administration.)

Used parenterally as a supplement to anesthesia.

Used parenterally for analgesia during labor.

Used in patients with acute pulmonary edema for its cardiovascular effects and to allay anxiety. Should not be used in the treatment of pulmonary edema resulting from a chemical respiratory irritant.

• Generic Name: tetanus immune globulin
• Dosage Forms: n.a.
• Other Brand Names: HyperTET S/D

Postexposure prophylaxis of tetanus in individuals with tetanus-prone wounds who have previously received <3 doses of a preparation containing tetanus toxoid adsorbed or whose tetanus vaccination status is uncertain.

TIG provides temporary passive immunity against tetanus. It is not a substitute for active immunization with a preparation containing tetanus toxoid adsorbed and is not a substitute for adequate medical and surgical care of contaminated or potentially contaminated wounds. (See General under Dosage and Administration.)

Tetanus is a potentially fatal disease caused by a neurotoxic exotoxin produced by Clostridium tetani (tetanospasmin). C. tetani spores are ubiquitous in the environment and are found in soil and in animal (e.g., horses, sheep, cattle, dogs, cats, rats, guinea pigs, chickens) and human intestinal tracts. The spores can contaminate open wounds, especially puncture wounds or those with devitalized tissue; anaerobic wound conditions allow the spores to germinate and produce exotoxins that disseminate through the blood and lymphatic system. Neonatal tetanus occurs in infants born under nonsterile conditions to women inadequately vaccinated against tetanus; infection usually involves a contaminated umbilical stump and occurs because infant does not have passively acquired maternal antibodies against tetanus. Obstetric tetanus occurs within 6 weeks after delivery or termination of pregnancy because of contaminated wounds or abrasions or unclean deliveries or abortions. Generalized tetanus is characterized by rigidity and convulsive muscle spasms that usually involve the jaw (lockjaw) and neck and then become generalized. Tetanus occurs worldwide, almost exclusively in individuals who are unvaccinated or inadequately vaccinated against the disease. An average of 31 cases reported each year in the US from 2000 through 2007 (case fatality rate 10%); 20 cases reported in 2003. Most cases of tetanus in the US occur following acute injuries or wounds (puncture wounds, lacerations, abrasions) and usually occur in adults ≥40 years of age; however, an increase in the disease has been reported in younger adults (e.g., heroin abusers).

Tetanus-prone wounds include wounds contaminated with dirt, feces, soil, or saliva; puncture wounds; avulsions; and wounds resulting from crushing, burns, or frostbite. Tetanus also has been associated with apparently clean, superficial wounds, surgical procedures, insect bites, animal bites, dental infections, chronic sores and infections, and IV drug abuse. Tetanus is not transmitted person-to-person.

TIG is not necessary for tetanus postexposure prophylaxis in patients with clean, minor wounds (regardless of their immunization status) or for patients with tetanus-prone wounds who have previously received ≥3 doses of a preparation containing tetanus toxoid adsorbed.

In the event of injury and possible exposure to tetanus, the need for active immunization against tetanus with or without passive immunization with TIG depends on the individual’s vaccination status and the likelihood of contamination with tetanus bacilli (e.g., condition of wound, source of contamination). See Table 1 for ACIP guidelines regarding tetanus postexposure prophylaxis.

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). A dose of Tdap is preferred to a dose of Td in adolescents and adults 11 through 64 years of age who have not previously received a dose of Tdap. Use Td in individuals in this age group who previously received a dose of Tdap.

Tetanus and diphtheria toxoids adsorbed (Td). Td is used in adults, adolescents, and children ≥7 years of age. For children 6 weeks through 6 years of age, DTaP usually is indicated, but DT can be used if pertussis antigens are contraindicated. Monovalent tetanus toxoid adsorbed generally is used only when preparations containing tetanus and diphtheria antigens and preparations containing tetanus, diphtheria, and pertussis antigens are contraindicated or unavailable.

If only 3 doses of tetanus toxoid fluid (no longer commercially available in the US) have been received previously, a fourth dose should be given as a preparation containing tetanus toxoid adsorbed.

Yes, if it has been >10 years since last dose of tetanus toxoid-containing preparation.

Yes, if it has been >5 years since last dose of tetanus toxoid-containing preparation; more frequent booster doses not needed and can accentuate adverse effects.

Adapted from the Recommendations of the Immunization Practices Advisory Committee (ACIP) on prevention of diphtheria, tetanus, and pertussis published in MMWR Recomm Rep. 1991; 40(RR-10):1-28, MMWR Recomm Rep. 2006; 55(RR-3):1-43, and MMWR Recomm Rep. 2006; 55(RR-17):1-37.

Any individual whose tetanus vaccination status is unknown or uncertain should be considered to have had no previous doses of tetanus toxoid adsorbed.

Anti-infectives are not indicated for tetanus postexposure prophylaxis.

Treatment of Tetanus

Treatment of tetanus. Used in conjunction with an anti-infective active against C. tetani (e.g., metronidazole, penicillin G) and with sedatives and muscle relaxants as needed.

Treatment of neonatal tetanus in conjunction with an anti-infective active against C. tetani (e.g., penicillin G).

Evidence of effectiveness of TIG in the treatment of active tetanus infection is limited and optimum dosage not established. Although TIG can neutralize unbound exotoxin, it does not affect toxin already bound to nerve endings.

Recovery from tetanus does not result in naturally-acquired tetanus immunity. As soon as possible, initiate or complete active immunization against tetanus using a preparation containing tetanus toxoid adsorbed.