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AMETOP is a brand name for Tetracaine, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AMETOP Gel 4% (Tetracaine Hydrochloride Gel) is indicated for: Percutaneous local anaesthetic to produce anaesthesia of the skin prior to venepuncture or venous cannulation, including intravenous injections of medications. 1.1 Pediatrics Pediatrics (older than one month and in the case of premature babies: 1 month…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Adults (including the elderly): No more than the contents of 1 tube (approximately 1g) should be applied per site of venepuncture or venous cannulation. , where cannulation is difficult). In such cases, a maximum of 5 sites may be anaesthetized at the outset of a course of treatment, if required to ensure that a series of sites are available for cannulation in the event that venous access cannot be achieved at the first site.
The maximum cumulative dose in a 24-hour period should not exceed 7 tubes. Product Monograph AMETOP GEL 4% (Tetracaine Hydrochloride Gel) Page 5 of 14 Children (over 1 month of age): The contents of no more than 1 tube (approximately 1 g) can be applied at separate sites in a single application.
The maximum cumulative dose in a 24-hour period should not exceed 2 tubes. 4 Administration Apply the contents of the tube to the skin starting from the centre of the area to be anaesthetised and cover with an occlusive dressing. The contents expellable from one tube (approximately one gram) are sufficient to cover and anaesthetise an area of up to 30 cm2 (6 x 5 cm).
Smaller areas of anaesthetised skin may be adequate in infants and small children. Each tube is intended for use on a single occasion only. Adequate anaesthesia can usually be achieved for venepuncture following a thirty-minute application time, and for venous cannulation following a forty-five-minute application time; after which the gel should be removed with a gauze swab and the site prepared with an antiseptic wipe in the normal manner.
It is not necessary to apply AMETOP Gel 4% for longer than the above recommended times and anaesthesia is maintained for 4 to 6 hours in most patients after a single application.
1 Adverse Reaction Overview Slight erythema is frequently seen at the site of application and is due to the pharmacological action of tetracaine dilating capillary vessels. This may help in delineating the anaesthetised area. Slight oedema or itching are less frequently seen at the site of application.
More severe erythema, oedema and/or itching have rarely been reported. This may be due to the local release of histamine and 5-HT. In very rare instances, blistering of the skin at the site of application may be apparent; in these cases, remove the gel immediately and treat the affected area symptomatically.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 5 Post-Market Adverse Reactions Common: Erythema (slight), Oedema (slight), Pruritus (slight) Slight erythema is frequently seen at the site of application and is due to the pharmacological action of amethocaine (tetracaine) in dilating capillary vessels.
This may help delineating the anaesthetized area. Slight oedema or itching are less frequently seen at the site of application.
Rare:
Erythema (severe) Oedema (severe) Pruritus (severe) Very rare: Blistering. In cases of blistering of the skin at the site of application, remove the gel immediately and treat the affected area symptomatically.
04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics..................................................................................................................
2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................
5 5 OVERDOSAGE............................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 5 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations .................................................................................................. 1 Pregnant Women ...............................................................................................
AMETOP
Gel 4% (Tetracaine Hydrochloride Gel) is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Patient who are hypersensitive to local anaesthetics of the ester type. Premature babies or full-term infants less than one month of age, in whom the metabolic pathway for tetracaine may not be fully developed. For premature babies use of AMETOP Gel 4% is not recommended before 1 month after the expected delivery date (44 weeks gestation).
Do not apply AMETOP Gel 4% to broken skin, mucous membranes or to the eyes or ears.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Breast-feeding .................................................................................................... 3 Pediatrics............................................................................................................
6 8 ADVERSE REACTIONS................................................................................................. 1 Adverse Reaction Overview .....................................................................................
2 Clinical Trial Adverse Reactions ............................................................................... 5 Post-Market Adverse Reactions............................................................................... 7 9 DRUG INTERACTIONS ................................................................................................
4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions ............................................................................................
6 Drug-Herb Interactions ............................................................................................ 7 Drug-Laboratory Test Interactions........................................................................... 7 Product Monograph AMETOP GEL 4% (Tetracaine Hydrochloride Gel) Page 3 of 14 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action ......................................................................................... 2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ...............................................................................................
8 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 8 12 SPECIAL HANDLING INSTRUCTIONS............................................................................ 9 PART II: SCIENTIFIC INFORMATION .......................................................................................
9 13 PHARMACEUTICAL INFORMATION ............................................................................ 9 14 CLINICAL TRIALS ........................................................................................................
9 15 MICROBIOLOGY ........................................................................................................ 9 16 NON-CLINICAL TOXICOLOGY ....................................................................................
10 PATIENT MEDICATION INFORMATION ................................................................................ 11 Product Monograph AMETOP GEL 4% (Tetracaine Hydrochloride Gel) Page 4 of 14 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AMETOP Gel 4% (Tetracaine Hydrochloride Gel) is indicated for: Percutaneous local anaesthetic to produce anaesthesia of the skin prior to venepuncture or venous cannulation, including intravenous injections of medications.
1 Pediatrics Pediatrics (older than one month and in the case of premature babies: 1 month after the expected delivery date (44 gestation weeks) – 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of AMETOP Gel 4% in pediatric patients has been established.
Therefore, Health Canada has authorized an indication for pediatric use. 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.
There is no significant difference in pseudocholinesterase activity in men between the ages of 16 – 94 years and women aged 40 – 99years. 2 CONTRAINDICATIONS AMETOP Gel 4% (Tetracaine Hydrochloride Gel) is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
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