Please wait while the formulary information is being retrieved.
Drug overview for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
Generic name: TETRACAINE HCL/OXYMETAZOLINE HCL (TET-ra-kane/OX-i-me-TAZ-oh-leen)
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Mouth-Throat-Dental - Preparations
Tetracaine hydrochloride is a long-acting local anesthetic of the ester type.
Tetracaine hydrochloride is used mainly for spinal anesthesia. For use of tetracaine hydrochloride as a topical local anesthetic, see 52:16.
Generic name: TETRACAINE HCL/OXYMETAZOLINE HCL (TET-ra-kane/OX-i-me-TAZ-oh-leen)
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Mouth-Throat-Dental - Preparations
Tetracaine hydrochloride is a long-acting local anesthetic of the ester type.
Tetracaine hydrochloride is used mainly for spinal anesthesia. For use of tetracaine hydrochloride as a topical local anesthetic, see 52:16.
DRUG IMAGES
No Image Available
The following indications for KOVANAZE (tetracaine hcl/oxymetazoline hcl) have been approved by the FDA:
Indications:
Administration of local anesthesia
Professional Synonyms:
None.
Indications:
Administration of local anesthesia
Professional Synonyms:
None.
The following dosing information is available for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
Tetracaine hydrochloride is administered by subarachnoid injection for spinal anesthesia. Partially used solutions that do not contain preservatives should be discarded. Dosage of tetracaine hydrochloride varies with the anesthetic procedure, the degree of anesthesia required, and individual patient response.
Debilitated, geriatric, acutely ill, obstetric patients, and patients with increased intra-abdominal pressure should generally be given low doses. The drug should be administered cautiously to patients with abnormal or low plasma esterase concentrations. The smallest dose and lowest concentration required to produce the desired effect should be used.
The patient's blood pressure should be monitored during spinal anesthesia. Resuscitative equipment and drugs which may be required for treatment of adverse reactions should be immediately available when tetracaine is administered. Proper positioning of the patient is extremely important in spinal anesthesia.
For specific procedures and techniques of administration, specialized references should be consulted.
For spinal anesthesia, a 1% solution of tetracaine hydrochloride is diluted with an equal volume of CSF immediately prior to administration. Alternatively, each 5 mg of tetracaine hydrochloride powder is dissolved in 1 mL of CSF. The resulting solutions are administered slowly at a rate of approximately 1 mL/5 seconds.
When CSF is added to the powder or the 1% solution, some turbidity may result, depending on the pH of the CSF, the amount of drug and diluent, and the temperature of the solution. The cloudiness results from the release of the free base and this process (which is completed within the spinal canal) is essential for activity of the anesthetic.
For anesthesia of the perineum, the usual adult dose of tetracaine hydrochloride is 5 mg. For anesthesia of the perineum and lower extremities, the usual adult dose is 10 mg. For spinal anesthesia extending up to the costal margin, the usual adult dose is 15-20 mg.
For low spinal (saddle block) anesthesia in vaginal delivery, 2-5 mg of tetracaine hydrochloride is administered as a hyperbaric solution. Doses greater than 15 mg are rarely required and should be used only in exceptional cases.
Debilitated, geriatric, acutely ill, obstetric patients, and patients with increased intra-abdominal pressure should generally be given low doses. The drug should be administered cautiously to patients with abnormal or low plasma esterase concentrations. The smallest dose and lowest concentration required to produce the desired effect should be used.
The patient's blood pressure should be monitored during spinal anesthesia. Resuscitative equipment and drugs which may be required for treatment of adverse reactions should be immediately available when tetracaine is administered. Proper positioning of the patient is extremely important in spinal anesthesia.
For specific procedures and techniques of administration, specialized references should be consulted.
For spinal anesthesia, a 1% solution of tetracaine hydrochloride is diluted with an equal volume of CSF immediately prior to administration. Alternatively, each 5 mg of tetracaine hydrochloride powder is dissolved in 1 mL of CSF. The resulting solutions are administered slowly at a rate of approximately 1 mL/5 seconds.
When CSF is added to the powder or the 1% solution, some turbidity may result, depending on the pH of the CSF, the amount of drug and diluent, and the temperature of the solution. The cloudiness results from the release of the free base and this process (which is completed within the spinal canal) is essential for activity of the anesthetic.
For anesthesia of the perineum, the usual adult dose of tetracaine hydrochloride is 5 mg. For anesthesia of the perineum and lower extremities, the usual adult dose is 10 mg. For spinal anesthesia extending up to the costal margin, the usual adult dose is 15-20 mg.
For low spinal (saddle block) anesthesia in vaginal delivery, 2-5 mg of tetracaine hydrochloride is administered as a hyperbaric solution. Doses greater than 15 mg are rarely required and should be used only in exceptional cases.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Long-acting Bupivacaine/Local Anesthetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1) PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) |
BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Zavegepant/Intranasal Decongestants SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Intranasal decongestants may decrease the absorption of zavegepant.(1) CLINICAL EFFECTS: Concurrent administration of intranasal decongestants may result in decreased systemic exposure and effectiveness of zavegepant.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concurrent use of intranasal decongestants with zavegepant. If concurrent use is unavoidable, use the decongestant at least 1 hour after zavegepant.(1) DISCUSSION: Intranasal decongestants may lower absorption of zavegepant. This effect has not been clinically evaluated.(1) |
ZAVZPRET |
The following contraindication information is available for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Methemoglobinemia |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Angle-closure glaucoma |
| Benign prostatic hyperplasia |
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atherosclerotic cardiovascular disease |
| Coronary artery disease |
| Diabetes mellitus |
| Hypertension |
| Hyperthyroidism |
The following adverse reaction information is available for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 8 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dizziness Headache disorder Insomnia Nervousness Rebound nasal congestion Tremor |
| Rare/Very Rare |
|---|
|
Cardiac arrhythmia Hypertension |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dry nose Nasal passage irritation Rhinorrhea Sneezing |
| Rare/Very Rare |
|---|
|
Nausea Palpitations |
The following precautions are available for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for KOVANAZE (tetracaine hcl/oxymetazoline hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for KOVANAZE (tetracaine hcl/oxymetazoline hcl)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
Formulary Reference Tool