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Tetracaine (United States: Not available) (topical): Drug information

Tetracaine (United States: Not available) (topical): Drug information
(For additional information see "Tetracaine (United States: Not available) (topical): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Ametop
Pharmacologic Category
  • Local Anesthetic
Dosing: Adult
Anesthesia, local

Anesthesia, local: Topical: Apply up to ~1 g (1 tube) per venipuncture or venous cannulation site; maximum of 5 sites may be anesthetized per course of treatment not to exceed a cumulative dose of ~7 g (7 tubes) in 24 hours.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Anesthesia, local

Anesthesia, local: Infants ≥1 month of age, Children, and Adolescents: Topical: Apply up to ~1 g (1 tube) per venipuncture or venous cannulation site not to exceed a cumulative dose of ~2 g (2 tubes) in 24 hours.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%, postmarketing, and/or case reports: Application site edema (severe), application site erythema (severe), application site pruritus (severe), skin blister (application site)

Contraindications

Hypersensitivity to tetracaine, other ester-type anesthetic agents, or any component of the formulation; use in premature infants and full-term infants <1 month of age; application to broken skin, mucous membranes, eyes, or ears

Warnings/Precautions

Concerns related to adverse effects:

• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, light-headedness, fatigue).

Disease-related concerns:

• Seizures: Use with caution; may lower seizure threshold.

Other warnings/precautions:

• Immunizations: Should not be used to provide anesthesia prior to immunization.

Product Availability

Not available in the United States.

Pricing: US

Solution (Pontocaine Mouth/Throat)

2% (30 mL): $19.03

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Ametop: 4% (1.5 g) [delivers ~1 g]

Administration: Adult

Topical: For external use only. Apply and cover with an occlusive dressing ~30 minutes prior to venipuncture or ~45 minutes prior to venous cannulation to achieve adequate anesthesia; after area anesthetized, remove gel with a gauze swab and prepare site as normal. Avoid contact with eyes, ears, or mucous membranes. Do not apply to open or damaged skin.

Administration: Pediatric

Topical: For external use only. Avoid contact with eyes, ears, mucous membranes, or broken skin. Apply ~30 minutes prior to venipuncture or ~45 minutes prior to venous cannulation to achieve adequate anesthesia; after area anesthetized, remove gel with a gauze swab and prepare site as normal. Do not apply to open or damaged skin. Do not use prior to immunizations.

Use: Labeled Indications

Note: Not approved in the United States.

Topical anesthetic: To produce anesthesia of the skin prior to venipuncture or venous cannulation, including intravenous injections of medications.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if tetracaine is present in breast milk. Breastfeeding is not recommended by the manufacturer.

Mechanism of Action

Ester local anesthetic blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.

Pharmacokinetics (Adult Data Unless Noted)

Metabolism: Hepatic; detoxified by plasma esterases to aminobenzoic acid

Excretion: Urine

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Amethocaine;
  • (ES) Spain: Tetracaina lainco;
  • (GB) United Kingdom: Ametop;
  • (IE) Ireland: Ametop;
  • (NO) Norway: Ametop;
  • (NZ) New Zealand: Ametop;
  • (PR) Puerto Rico: Tetravex | Viractin;
  • (PT) Portugal: Lubrificante anestesico;
  • (ZA) South Africa: Ametop
  1. Ametop gel (4%) (tetracaine topical) [product monograph]. Kirkland, Québec, Canada: Valeo Pharma Inc; April 2022.
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