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DRUGS & SUPPLEMENTS
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Oto Xilodase
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Oto Xilodase uses
Oto Xilodase consists of Hyaluronidase, Lidocaine Hydrochloride, Neomycin Sulfate.Hyaluronidase:
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
- Clinical pharmacology
- Nonclinical toxicology
- How supplied/storage and handling
- Patient counseling information
1 INDICATIONS AND USAGE
- Oto Xilodase is an endoglycosidase indicated as an adjuvant to increase the absorption and dispersion of other injected drugs. (1.1)
- for hypodermoclysis (1.2)
- in subcutaneous urography for improving resorption of radiopaque agents (1.3)
1.1 Absorption and Dispersion of Injected Drugs
Oto Xilodase (Hyaluronidase) (hyaluronidase injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs.
1.2 Hypodermoclysis
Oto Xilodase is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
1.3 Subcutaneous Urography
Oto Xilodase (Hyaluronidase) is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque.
2 DOSAGE AND ADMINISTRATION
- See Full Prescribing Information for all approved routes of administration.
- Absorption and Dispersion of Injected Drugs
Absorption and dispersion of other injected drugs may be enhanced by adding 50 to 300 Units, most typically 150 Units of Oto Xilodase (Hyaluronidase) , to the injection solution. (2.2)
- Hypodermoclysis
Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject Oto Xilodase (Hyaluronidase) into rubber tubing close to needle. (2.3)
- Subcutaneous Urography
The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 Units of Oto Xilodase (Hyaluronidase) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. (2.4)
2.1 Important Administration Instructions
Do not administer Oto Xilodase (Hyaluronidase) intravenously because Oto Xilodase (Hyaluronidase) is enzyme is rapidly inactivated with intravenous administration.
Oto Xilodase (Hyaluronidase) may be administered for infiltration use, interstitial use, intramuscular use, intraocular use, retrobulbar use, soft tissue use and subcutaneous use.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Always use aseptic precautions.
2.2 Absorption and Dispersion of Subcutaneously Injected Drugs
Absorption and dispersion of other injected drugs may be enhanced by adding 50 to 300 Units, most typically 150 Units of Oto Xilodase, to the injection solution.
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Oto Xilodase (Hyaluronidase) to a solution containing another drug.
2.3 Hypodermoclysis
Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject Oto Xilodase (Hyaluronidase) (hyaluronidase injection) into rubber tubing close to needle.
An alternate method is to inject Oto Xilodase (Hyaluronidase) under skin prior to clysis. 150 Units will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are given by hypodermoclysis, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.
Oto Xilodase (Hyaluronidase) may be added to small volumes of solution (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.
2.4 Subcutaneous Urography
The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 Units of Oto Xilodase (Hyaluronidase) (hyaluronidase injection) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
3 DOSAGE FORMS AND STRENGTHS
Injection: 150 USP Units/mL single dose vials.
Injection: 150 USP Units/mL in single-dose vials (3)
4 CONTRAINDICATIONS
Hypersensitivity
4.1 Hypersensitivity
Oto Xilodase (Hyaluronidase) contraindicated in patients with known hypersensitivity to Oto Xilodase (Hyaluronidase) or any other ingredient in the formulation. A preliminary skin test for hypersensitivity to Oto Xilodase (Hyaluronidase) can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution [see Dosage and Administration (2)]. A positive reaction consists of a wheal with pseudopods appearing within five minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.
Discontinue Oto Xilodase (Hyaluronidase) if sensitization occurs.
5 WARNINGS AND PRECAUTIONS
- Spread of Localized Injection
- Ocular Damage (5.2)
5.1 Spread of Localized Injection
Oto Xilodase (Hyaluronidase) should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.
Oto Xilodase (Hyaluronidase) should not be used to reduce the swelling of bites or stings.
5.2 Ocular Damage
Oto Xilodase (Hyaluronidase) should not be applied directly to the cornea.
6 ADVERSE REACTIONS
The most frequently reported adverse experiences have been local injection site reactions.
Oto Xilodase (Hyaluronidase) has been reported to enhance the adverse events associated with co-administered drug products. Edema has been reported most frequently in association with hypodermoclysis.
Allergic reactions (urticaria, angioedema) have been reported in less than 0.1% of patients receiving Oto Xilodase (Hyaluronidase). Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
The most frequently reported adverse reactions have been local injections site reactions. Allergic reactions (urticarial, angioedema) anaphylactic-like reactions have been reported, rarely. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Akorn, Inc. at 1-800-932-5676, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
7 DRUG INTERACTIONS
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Oto Xilodase to a solution containing another drug.
- Furosemide, the benzodiazepines and phenytoin are incompatible with Oto Xilodase (Hyaluronidase). (7.1)
- Oto Xilodase (Hyaluronidase) should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. (7.2)
- Local Anesthetic: Oto Xilodase (Hyaluronidase) hastens the onset and shortens duration of effect, increases incidence of systemic reactions. (7.3)
- Large doses of salicylated, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hydaluronidase for equivalent dispensing effect. (7.4)
7.1 Incompatibilities
Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with Oto Xilodase (Hyaluronidase).
7.2 Drug-Specific Precautions
Oto Xilodase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
When considering the administration of any other drug with Oto Xilodase (Hyaluronidase), it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug.
7.3 Local Anesthetics
When Oto Xilodase (Hyaluronidase) is added to a local anesthetic agent, it hastens the onset of analgesia and tends to reduce the swelling caused by local infiltration, but the wider spread of the local anesthetic solution increases its absorption; this shortens its duration of action and tends to increase the incidence of systemic reaction.
7.4 Salicylates, Cortisone, ACTH, Estrogens or Antihistamines
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of Oto Xilodase (Hyaluronidase) for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of Oto Xilodase (Hyaluronidase).
8 USE IN SPECIFIC POPULATIONS
Pediatric Use: The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight, and the rate of administration should not be greater than 2 mL per minute. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion
8.1 Pregnancy
No adequate and well controlled animal studies have been conducted with Oto Xilodase (Hyaluronidase) to determine reproductive effects. Oto Xilodase (Hyaluronidase) should be used during pregnancy only if clearly needed.
8.2 Labor and Delivery
Administration of Oto Xilodase during labor was reported to cause no complications: no increase in blood loss or differences in cervical trauma were observed. It is not known whether Oto Xilodase (Hyaluronidase) has an effect on the later growth, development, and functional maturation of the infant.
8.3 Nursing Mothers
It is not known whether Oto Xilodase (Hyaluronidase) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oto Xilodase (Hyaluronidase) is administered to a nursing woman.
8.4 Pediatric Use
Oto Xilodase may be added to small volumes of solution (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. The potential for chemical or physical incompatibilities should be kept in mind [see Dosage and Administration (2)].
For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.
During hypodermoclysis, special care must be taken in pediatric patients to avoid overhydration by controlling the rate and total volume of the clysis [see Dosage and Administration (2.1)].
8.5 Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
10 OVERDOSAGE
Symptoms of toxicity consist of local edema or urticaria, erythema, chills, nausea, vomiting, dizziness, tachycardia, and hypotension. The enzyme should be discontinued and supportive measures initiated immediately.
11 DESCRIPTION
Oto Xilodase (Hyaluronidase) (hyaluronidase injection) is a preparation of purified bovine testicular Oto Xilodase (Hyaluronidase), a protein enzyme. The exact chemical structure of this enzyme is unknown.
Oto Xilodase (Hyaluronidase) (hyaluronidase injection) is supplied as sterile, colorless, odorless, ready for use solution. Each vial contains 150 USP units of Oto Xilodase (Hyaluronidase) per mL calcium chloride (0.4 mg), edetate disodium (1 mg), sodium chloride (8.5 mg), monobasic sodium phosphate buffer, sodium hydroxide to adjust the pH, and sterile water.
Oto Xilodase (Hyaluronidase) has an approximate pH of 6.9 and an osmolality of 275 to 305 mOsm.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Oto Xilodase is a spreading or diffusing substance which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Oto Xilodase (Hyaluronidase) hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and promotes diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption.
Oto Xilodase (Hyaluronidase) cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue. The activity is measured in vitro by monitoring the decrease in the amount of an insoluble serum albumin-hyaluronic acid complex as the enzyme cleaves the hyaluronic acid component.
12.2 Pharmacodynamics
When no spreading factor is present, material injected subcutaneously spreads very slowly, but Oto Xilodase (Hyaluronidase) causes rapid spreading, provided local interstitial pressure is adequate to furnish the necessary mechanical impulse. Such an impulse is normally initiated by injected solutions.
The rate of diffusion is proportionate to the amount of enzyme, and the extent is proportionate to the volume of solution.
12.3 Pharmacokinetics
Knowledge of the mechanisms involved in the disappearance of injected Oto Xilodase (Hyaluronidase) is limited. It is known, however, that the blood of a number of mammalian species brings about the inactivation of Oto Xilodase (Hyaluronidase). Studies have demonstrated that Oto Xilodase (Hyaluronidase) is antigenic; repeated injections of relatively large amounts of this enzyme may result in the formation of neutralizing anti-bodies. The reconstitution of the dermal barrier removed by intradermal injection of Oto Xilodase (Hyaluronidase) (20, 2, 0.2, 0.02, and 0.002 Units/mL) to adult humans indicated that at 24 hours the restoration of the barrier is incomplete and inversely related to the dosage of enzyme; at 48 hours the barrier is completely restored in all treated areas.
Results from an experimental study, in humans that evaluated the influence of Oto Xilodase (Hyaluronidase) in bone repair support the conclusion that this enzyme alone does not deter bone healing when given at the usual clinical dosage.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of Oto Xilodase (Hyaluronidase). Oto Xilodase (Hyaluronidase) is found in most tissues of the body.
Long-term animal studies have not been performed to assess whether Oto Xilodase (Hyaluronidase) impaired fertility; however, it has been reported that testicular degeneration may occur with the production of organ-specific antibodies against this enzyme following repeated injections. Human studies on the effect of intravaginal Oto Xilodase (Hyaluronidase) in sterility due to oligospermia indicated that Oto Xilodase (Hyaluronidase) may have aided conception.
16 HOW SUPPLIED/STORAGE AND HANDLING
Oto Xilodase (Hyaluronidase) (hyaluronidase injection) Bovine is supplied sterile as 150 units/mL bovine of Oto Xilodase (Hyaluronidase) in a single-dose glass vial containing 1 mL.
NDC 17478-560-01 Package of 1 vial.
NDC 17478-560-06 Package of 6 vials.
NDC 17478-560-10 Package of 10 vials.
Not recommended for IV Use.
Storage: Store in a refrigerator at 2° to 8°C (36° to 46°F).
DO NOT FREEZE.
17 PATIENT COUNSELING INFORMATION
17.1 Important Precautions Regarding Oto Xilodase
Instruct patient that Oto Xilodase (Hyaluronidase) is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.
17.2 What Patients Should Know About Adverse Reactions
The most frequently reported adverse reactions have been mild local injection site reactions such as redness, swelling, itching, or pain.
Anaphylactic-like reactions, and allergic reactions, such as hives, have been reported rarely in patients receiving hyaluronidases.
17.3 Patients Should Inform Their Doctors If Taking Other Medications
You may not receive furosemide, the benzodiazepines, phenytoin, dopamine and/or alpha agonists with Oto Xilodase (Hyaluronidase) . These medications have been found to be incompatible with Oto Xilodase (Hyaluronidase).
If you are taking salicylates (e.g., aspirin), steroids (e.g., cortisone or estrogens) or antihistamines your doctor may need to prescribe larger amounts of Oto Xilodase (Hyaluronidase) for equivalent dispersing effect.
AKORN
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
HD00N Rev. 10/15
Principal Display Panel Text for Container Label:
NDC 17478-560-01
Oto Xilodase (Hyaluronidase)
(hyaluronidase
injection) Bovine,
150 USP Units/mL
1 mL
Single-Use Vial
Rx only
Not recommended
for IV use.
Principal Display Panel Text for Carton Label:
NDC 17478-560-01
Oto Xilodase (Hyaluronidase)
(hyaluronidase
injection) Bovine,
150 USP Units/mL
1 mL
Single-Use Vial
Rx only
Akorn Logo
Lidocaine Hydrochloride:
Pharmacological action
Oto Xilodase is an antiarrhythmic agent of class IB, local anesthetic, a derivative of acetanilide. This medication has membrane stabilizing activity. Oto Xilodase (Lidocaine Hydrochloride) causes a blockade of sodium channels of excitable membranes of neurons and the membrane of cardiomyocytes.
This drug reduces the duration of the action potential and effective refractory period in Purkinje fibers, inhibits their automaticity. In this case, Oto Xilodase (Lidocaine Hydrochloride) inhibits electrical activity in depolarized, arrhythmogenic sites, but minimally affects the electrical activity of normal tissues. When used in the medium therapeutic doses virtually no effect on myocardial contractility and slows AV-conduction. When applied as an antiarrhythmic agent in IV injection it begin to act in 45-90 seconds, the duration of action is 10-20 minutes; for IM administration the onset of action is in 5-15 minutes, the duration - 60-90 minutes.
Oto Xilodase (Lidocaine Hydrochloride) causes all kinds of local anesthesia: a terminal, infiltration and wires.
Pharmacokinetics
After IM administration absorption of Oto Xilodase (Lidocaine Hydrochloride) is almost complete. The distribution is rapid, Vd is about 1 L/kg (in patients with heart failure it is below). The protein binding depends on the concentration of the active substance in the plasma and is 60-80%. Oto Xilodase (Lidocaine Hydrochloride) metabolized mainly in the liver with the formation of active metabolites, that may contribute to the manifestation of the therapeutic and toxic effects, especially after the infusion for 24 hours or more.
T1/2 tends to be two phases with the phase distribution of 9.7 min. In general T1/2 depends on the dose is 1-2 hours and can grow up to 3 hours or more during prolonged intravenous infusion (over 24 h). Oto Xilodase (Lidocaine Hydrochloride) excreted by the kidneys as metabolites, 10% unchanged.
Why is Oto Xilodase prescribed?
In cardiological practice: treatment and prevention of ventricular arrhythmias (extrasystoles, tachycardia, atrial flutter, atrial fibrillation), including in acute myocardial infarction, implantation of artificial pacemaker in the glycoside intoxication, narcosis.
Anaesthesia: terminal, infiltration, conduction, spinal (epidural) anesthesia in surgery, obstetrics and gynecology, urology, ophthalmology, dentistry, otolaryngology, blockade of peripheral nerves and ganglion.
Dosage and administration
As an anti-arrhythmic medicine for adult with the introduction of a loading dose by IV - 1-2 mg / kg over 3-4 minutes; the average single dose is 80 mg. Then immediately transferred to drip infusion at a rate of 20-55 mg / kg / min. Drip infusion can be carried out within 24-36 hours. If necessary, against the background of drop infusions can repeat IV jet injection of Oto Xilodase 40 mg after 10 minutes after the first loading dose.
IM is introduced to 2-4 mg / kg, if necessary, repeated administration is possible through 60-90 minutes.
For children with IV injection loading dose - 1 mg / kg, if necessary, it may be repeated administration in 5 min.
For continuous intravenous infusion (usually following the introduction of a loading dose) - 20-30 mg / kg / min.
For use in surgical and obstetric practice, dentistry, ENT practice, dosing regimen set individually, depending on the evidence, the clinical situation and used the dosage form.
Maximum dose: for adults for IV injections the loading dose is 100 mg, in a subsequent drop infusion it is 2 mg / min; when IM administration - 300 mg (about 4.5 mg / kg) for 1 h.
For children in case of reintroduction the loading dose every 5 minutes, the total dose is 3 mg / kg; by continuous intravenous infusion (usually following the introduction of a loading dose) - 50 mg / kg / min.
Oto Xilodase (Lidocaine Hydrochloride) side effects, adverse reactions
CNS and peripheral nervous system: dizziness, headache, weakness, motor restlessness, nystagmus, loss of consciousness, drowsiness, visual and auditory disturbances, tremor, trismus, seizures (risk of their development against the backdrop of increasing hypercapnia and acidosis), a syndrome of "cauda equina" (paralysis of the legs, paresthesia), paralysis of respiratory muscles, respiratory arrest, a block of motor and sensitive, respiratory paralysis (usually develops in the subarachnoid anesthesia), numb tongue (when used in dentistry).
Cardiovascular system: increased or decreased blood pressure, tachycardia if used with a vasoconstrictor, peripheral vasodilatation, collapse, chest pain.
Digestive system: nausea, vomiting, involuntary defecation.
Allergic reactions: skin rash, hives (on skin and mucous membranes), itching, angioedema, anaphylactic shock.
Local reactions: during spinal anesthesia - a pain in the back, with an epidural anesthesia - a random hit in the subarachnoid space, when applied topically in urology - urethritis.
Other: incontinent, methemoglobinemia, persistent anesthesia, decreased libido and / or potency, respiratory depression, until the stop, hypothermia; during anesthesia in dentistry: numbness and paresthesia of the lips and tongue, the lengthening of anesthesia.
Oto Xilodase contraindications
Severe bleeding, shock, hypotension, infection of the proposed injection site, marked bradycardia, cardiogenic shock, severe forms of chronic heart failure, SSS in elderly patients, AV-block II and III degree (except in cases when the probe was introduced to stimulate the ventricles), severe liver function abnormalities.
For subarachnoid anesthesia - complete heart block, bleeding, hypotension, shock, infection of the venue lumbar puncture, septicemia.
Increased sensitivity to Oto Xilodase (Lidocaine Hydrochloride) and other amide type local anesthetics.
Using during pregnancy and breastfeeding
During pregnancy and lactation be used only for health reasons. Oto Xilodase is excreted in breast milk.
In obstetric practice used with caution in paracervical for violations of fetal development, placental insufficiency, prematurity, postmaturity, gestosis.
Category effects on the fetus by FDA - B.
Special instructions
Use with caution in liver disease and kidney failure, hypovolemia, severe heart failure, in violation of the contractility of genetic susceptibility to malignant hyperthermia. In children, debilitated patients, elderly patients are required in dosage adjustment in accordance with the age and physical status. When injected into vascularized tissue it is recommended an aspiration test.
Oto Xilodase drug interactions
Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of Oto Xilodase (Lidocaine Hydrochloride). Cimetidine increases the plasma concentration of Oto Xilodase (Lidocaine Hydrochloride) (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Oto Xilodase (Lidocaine Hydrochloride) and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of Oto Xilodase (Lidocaine Hydrochloride). Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Oto Xilodase (Lidocaine Hydrochloride) strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.
Oto Xilodase in case of emergency / overdose
Symptoms: psychomotor agitation, dizziness, weakness, decreased blood pressure, tremors, tonic-clonic convulsions, coma, collapse, possible AV blockade, CNS depression, respiratory arrest.
Treatment: discontinuation, pulmonary ventilation, oxygen therapy, anticonvulsants, vasoconstrictors (norepinephrine, mezaton), when bradycardia - anticholinergics (atropine). It is possible to carry out intubation, mechanical ventilation, resuscitation. Dialysis is ineffective.
Neomycin Sulfate:
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oto Xilodase (Neomycin Sulfate) tablets and other antibacterial drugs, Oto Xilodase (Neomycin Sulfate) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Suppression of Intestinal Bacteria
Oto Xilodase (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).
Hepatic Coma (Portal-Systemic Encephalopathy)
Oto Xilodase (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
CONTRAINDICATIONS
Oto Xilodase (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.
Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Oto Xilodase (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
WARNINGS
Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
PRECAUTIONS
General
Prescribing Oto Xilodase tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.
Cross-allergenicity among aminoglycosides has been demonstrated.
Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.
Information for The Patient
Patients should be counseled that antibacterial drugs including Oto Xilodase (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Oto Xilodase (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Oto Xilodase (Neomycin Sulfate) tablets or other antibacterial drugs in the future.
Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Laboratory Tests
Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.
Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.
Drug Interactions
Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).
Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.
Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral Oto Xilodase (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed with Oto Xilodase to evaluate carcinogenic or mutagenic potential or impairment of fertility.
Pregnancy Category D
See WARNINGS section.
Nursing Mothers
It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and efficacy of oral Oto Xilodase (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
ADVERSE REACTIONS
The most common adverse reactions to oral Oto Xilodase (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).
OVERDOSAGE
Because of low absorption, it is unlikely that acute overdosage would occur with oral Oto Xilodase (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Oto Xilodase (Neomycin Sulfate) from the blood.
DOSAGE AND ADMINISTRATION
To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic Coma
For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
- Withdraw protein from diet. Avoid use of diuretic agents.
- Give supportive therapy, including blood products, as indicated.
- Give Oto Xilodase (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Oto Xilodase (Neomycin Sulfate) per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
- If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.
Preoperative Prophylaxis for Elective Colorectal Surgery
Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.
Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.
Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.
Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Oto Xilodase (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.
Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.
HOW SUPPLIED
Oto Xilodase (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:
Bottles of 100 (NDC 0527-1210-01)
Store at 20° to 25°C (68° to 77°F).
Dispense in tight containers as defined in the USP/NF.
Distributed By:
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
Rev. 01/17
CIB71710A
Oto Xilodase pharmaceutical active ingredients containing related brand and generic drugs:
Oto Xilodase available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.