Oraverse

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 2.
• DOSAGE AND ADMINISTRATION Amount of Local Anesthetic Administered Dose of OraVerse 1 / 4 Cartridge 1 / 4 Cartridge (0.1 mg) ½ Cartridge ½ Cartridge (0.2 mg) 1 Cartridge 1 Cartridge (0.4 mg) 2 Cartridges 2 Cartridges (0.8 mg) OraVerse is administered using the same location(s) and same technique(s) (infiltration or block injection) used for the administration of local anesthetic.
• ( 2.1 )
• 2.1 General Dosing information The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered:
• Amount of Local Anesthetic Administered Dose of OraVerse [mg] Dose of OraVerse [Cartridge(s)] 1 / 4 Cartridge 0.1 1 / 4 ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2 OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.
• Chemically disinfect the carpule cap by wiping with either isopropyl alcohol (91%) or ethyl alcohol (70%).
• Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used.
• Inspect carpules visually prior to administration and
• do not use if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed.
• Note:
• Do not administer OraVerse if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed.
• 2.2 Dosing in Special Populations In pediatric patients weighing between ≥15 kg and <30 kg, the maximum dose of OraVerse recommend is ½ cartridge (0.2 mg).
• (Note:
• Use in pediatric patients under 3years of age or weighing less than15 kg (33 lbs) is not recommended.
• A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 4 years of age.)

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and efficacy of OraVerse has not been established in patients younger than 3 years.
• The safety and effectiveness of OraVerse in pediatric patients ages 3 years and older is supported by evidence from adequate and well-controlled studies of OraVerse in
• adults, with additional adequate and well-controlled studies of OraVerse in pediatric patients ages 12-17 years old [Studies 1 (mandibular procedures) and 2 (maxillary procedures)], ages 6-11 years old [Study 3 (mandibular and maxillary procedures)], and another study in patients ages 2-5 years [Study 4].
• Study 4 assessed safety and effectiveness in patients 4 to 5 years, but was not designed to demonstrate efficacy.
• Use in patients 3 to <4 years is supported by similar pharmacokinetics and safety in these patients compared with older pediatric patients (see Clinical Pharmacology (12.3)].
• Use of OraVerse in this age group (3 to < 4 years) is also supported by the similarity in the exposure response of OraVerse for pediatric and adult patients, and the adequacy of the safety database for patients age ≥ 3.
• The safety database for patients age < 3 is limited, and therefore, use in patients age < 3 is not recommended.
• Dosages in pediatric patients may need to be limited based on body weight. [see Dosage and Administration (2) ]

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the total number of patients in clinical studies of OraVerse, 55 were 65 and over, while 21 were 75 and over.
• No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 6.
• ADVERSE REACTIONS In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain.
• The most common adverse reaction with OraVerse (incidence ≥5% and > control) is injection-site pain.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Septodont at 1-888-888-1441 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Dental patients were administered a dose of either 0.2, 0.4 or 0.8mg of OraVerse.
• The majority of adverse reactions were mild and resolved within 48 hours.
• There were no serious adverse reactions and no discontinuations due to adverse reactions.
• Table 1 lists adverse reactions where the frequency was greater than or equal to 3% in any OraVerse dose group and was equal to or exceeded that of the control group.
• Table 1:
• Adverse Reactions with Frequency Greater Than or Equal to 3% and Equal to or Exceeding Control Adverse Event OraVerse Control 0.2 mg (N = 83) 0.4 mg (N = 284) 0.8 mg (N = 51) Total (N = 418) Total (N = 359) N (%) N (%) N (%) N (%) N (%) Patients with AEs 15 (18) 82 (29) 20 (39) 117 (28) 96 (27) Tachycardia 0 (0) 17 (6) 2 (4) 19 (5) 20 (6) Bradycardia 0 (0) 5 (2) 2 (4) 7 (2) 1 (0.3) Injection site pain 5 (6) 15 (5) 2 (4) 22 (5) 14 (4) Post procedural pain 3 (4) 17 (6) 5 (10) 25 (6) 23 (6) Headache 0 (0) 10 (4) 3 (6) 13 (3) 14 (4) An examination of population subgroups did not reveal a differential adverse reaction incidence on the basis of age, gender, or race.
• Results from the pain assessments in Study 1 and Study 2, involving mandibular and maxillary procedures, respectively, indicated that the majority of dental patients in both OraVerse and control groups experienced no or mild oral pain, with less than 10% of patients in each group reporting moderate oral pain with a similar distribution between the OraVerse and control groups.
• No patient experienced severe pain in these studies.
• Study 4 included 150 pediatric patients between 2-5 years of age who received a dose of either ¼ cartridge (0.1 mg), ½ cartridge (0.2 mg) or 1 cartridge (0.4 mg) of OraVerse or sham injection (placebo).
• Safety in patients in Study 4 was similar to safety in older patients described above.
• Post-procedural revealed that oral pain was reported in the OraVerse group with a higher frequency (10.1%) than the placebo group (3.9%).
• The proportion of patients in the OraVerse and placebo groups was comparable with respect to the highest severity of pain experienced:
• 30.4% of OraVerse patients and 30% of placebo patients reported no pain; 43.1% of OraVerse patients and 45.0% of placebo patients reported mild pain; 19.0% of OraVerse subjects and 17.5% of placebo patients reported moderate pain; and 15.2% of OraVerse patients and 15.0% of placebo patients reported severe pain.
• 6.2 Adverse Reactions in Clinical Trials Adverse reactions reported by less than 3% but at least 2 dental patients receiving OraVerse and occurring at a greater incidence than those receiving control, included diarrhea, facial swelling, increased blood pressure/hypertension, injection site reactions, jaw pain, oral pain, paresthesia, pruritus, tenderness, upper abdominal pain and vomiting.
• The majority of these adverse reactions were mild and resolved within 48 hours.
• The few reports of paresthesia were mild and transient and resolved during the same time period.
• 6.3 Post Marketing Adverse Reactions Reports from Literature and Other Sources The following adverse reactions have been identified during postapproval parenteral use of phentolamine mesylate.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Acute and prolonged hypotensive episodes and cardiac arrhythmias have been reported with the use of phentolamine.
• In addition, weakness, dizziness, flushing, orthostatic hypotension, and nasal stuffiness have occurred.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

17. PATIENT COUNSELING INFORMATION Patients should be instructed not to eat or drink until normal sensation returns.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

3. DOSAGE FORMS AND STRENGTHS 0.4 mg/1.7 mL solution per cartridge 0.4 mg/1.7 mL solution per cartridge ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.
• HOW SUPPLIED/STORAGE AND HANDLING OraVerse (phentolamine mesylate) Injection 0.4 mg/1.7 mL is supplied in a dental cartridge, in cartons of 10 and 50 cartridges.
• Each cartridge is individually packaged in a separate compartment of a 10 cartridge blister pack.
• NDC 0362-0101-50 NDC 0362-0101-10
• Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature) Protect from direct heat and light.
• Do not permit to freeze.

Quoted from the official label, section “How Supplied”.

How to store it

Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature) Protect from direct heat and light. Do not permit to freeze.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 11. DESCRIPTION Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H -imidazol-2-yl)methyl](4-methyl-phenyl)amino]-,methanesulfonate (salt), a non-specific alpha adrenergic blocker. Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a molecular weight of 377.46. It is sparingly soluble in water, soluble in alcohol, and slightly soluble in chloroform. The empirical formulation is C 17 H 19 N 3 O
• CH 4 O 3 S, and the chemical structure is:
• OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate. Either acetic acid or sodium hydroxide is used as necessary to adjust the pH. Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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