chloroprocaine hydrochloride
Pharmaranks rates Chloroprocaine Hydrochloride 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Chloroprocaine Hydrochloride is an ester local anesthetic used to treat Pain.
Ester Local Anesthetic · by Hikma
Generic of Iheezo
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Chloroprocaine Hydrochloride
- Drug class
- Ester Local Anesthetic
- Form
- Injectable
- Strength
- Chloroprocaine Hydrochloride 2% · Chloroprocaine Hydrochloride 3%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- pain
- Manufacturer
- Hikma
- FDA application
- ANDA040273
What is Chloroprocaine Hydrochloride?
From the FDA label:Chloroprocaine Hydrochloride Injection, USP is a sterile non-pyrogenic local anesthetic. The active ingredient is chloroprocaine HCl (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride), which is represented by the following structural formula: Molecular Formula: C 13 H 19 ClN 2 O 2 • HCl M. W. 307.22 Chloroprocaine Hydrochloride Injection, USP is available in a 2% and 3% solution for infiltration, nerve block, caudal and epidural anesthesia ( not for spinal anesthesia). Each mL of the 20 mg/mL, 2%, solution contains; 20 mg of Chloroprocaine HCl, USP, 4.7 mg of Sodium Chloride, USP, and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. The pH range is 2.7 to 4.0. Each mL of the 30 mg/mL, 3%, solution contains; 30 mg of Chloroprocaine HCl, USP, 3.3 mg of Sodium Chloride, USP, and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. The pH range is 2.7 to 4.0. Chloroprocaine HCl Injection, USP, should not be resterilized by autoclaving. structural formula
How to use
Chloroprocaine may be administered as a single injection or continuously through an indwelling catheter. As with all local anesthetics, the dose administered varies with the anesthetic procedure, the vascularity of the tissues, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be used. Dosage should be reduced for children, elderly and debilitated patients and patients with cardiac and/or liver disease. The maximum single recommended doses of chloroprocaine in adults are: without epinephrine, 11 mg/kg, not to exceed a maximum total dose of 800 mg; with epinephrine (1:200,000), 14 mg/kg, not to exceed a maximum total dose of 1000 mg. For specific techniques and procedures, refer to standard textbooks. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Chloroprocaine hydrochloride injection is not approved for this use. (See WARNINGS and DOSAGE AND ADMINISTRATION ). Caudal and Lumbar Epidural Block: In order to guard against adverse experiences sometimes noted following unintended penetration of the subarachnoid space, the following procedure modifications are recommended: Use an…
Side effects
Systemic: The most commonly encountered acute adverse experiences that demand immediate countermeasures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and may result from rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) may result in underventilation or apnea (“Total Spinal”). Factors influencing plasma protein binding, such as acidosis, systemic diseases that alter protein production, or competition of other drugs for protein binding sites, may diminish individual tolerance. Plasma cholinesterase deficiency may also account for diminished tolerance to ester-type local anesthetics. Central Nervous System Reactions: These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into…
Warnings
Important safety information
LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE REACTIONS and PRECAUTIONS .) DELAY IN PROPER MANAGEMENT OF DOSE RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH. Chloroprocaine hydrochloride injection, methylparaben free, contains no preservative; discard unused injection remaining in vial after initial use. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been postmarketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. Vasopressors should not be used in the presence of ergot-type oxytocic drugs, since a severe persistent hypertension may occur. To avoid intravascular injection, aspiration should be performed before the anesthetic solution is injected. The needle must be repositioned until no blood return can be elicited. However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Mixtures of local anesthetics are sometimes employed to compensate for the slower onset of one drug and the shorter duration of action of the second drug. Experiments in primates suggest that toxicity is probably additive when mixtures of local anesthetics are employed, but some experiments in rodents suggest synergism. Caution regarding toxic equivalence should be exercised when mixtures of local anesthetics are employed.
Who should not take Chloroprocaine Hydrochloride
Chloroprocaine hydrochloride is contraindicated in patients hypersensitive (allergic) to drugs of the PABA ester group. Lumbar and caudal epidural anesthesia should be used with extreme caution in persons with the following conditions: existing neurological disease, spinal deformities, septicemia, and severe hypertension.
Overdose — what happens if you take too much
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see ADVERSE REACTIONS , WARNINGS and PRECAUTIONS ). In mice, the intravenous LD50 of chloroprocaine HCl is 97 mg/kg and the subcutaneous LD50 of chloroprocaine HCl is 950 mg/kg. Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered. The first step in the management of convulsions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe, prolonged hypotension or hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. The para-aminobenzoic acid metabolite of chloroprocaine inhibits the action of sulfonamides. Therefore, chloroprocaine should not be used in any condition in which a sulfonamide drug is being employed.
Drug class
May treat (source: NIH RxClass)
See how Chloroprocaine Hydrochloride ranks — best-rated ester local anesthetic for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Chloroprocaine Hydrochloride treat?
- Chloroprocaine Hydrochloride (Chloroprocaine Hydrochloride) may be used to treat pain, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Chloroprocaine Hydrochloride rated?
- pharmaranks gives Chloroprocaine Hydrochloride a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Chloroprocaine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Chloroprocaine Hydrochloride. To pay less, Chloroprocaine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Chloroprocaine Hydrochloride?
- Chloroprocaine Hydrochloride is marketed by Hikma. You can see Hikma's full profile, rating, and other products on pharmaranks.
- Is Chloroprocaine Hydrochloride a brand-name or generic drug?
- Chloroprocaine Hydrochloride is a generic medication; its active ingredient is Chloroprocaine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Chloroprocaine Hydrochloride available over the counter?
- No. Chloroprocaine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Chloroprocaine Hydrochloride come in?
- Chloroprocaine Hydrochloride is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Chloroprocaine Hydrochloride?
- Chloroprocaine Hydrochloride is classified as ester local anesthetic, per the FDA's Established Pharmacologic Class.
- Is Chloroprocaine Hydrochloride FDA-registered?
- Chloroprocaine Hydrochloride is on record with the U.S. FDA under application number ANDA040273. You can verify this on its official FDA label.
- Has Chloroprocaine Hydrochloride been recalled by the FDA?
- Chloroprocaine Hydrochloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Chloroprocaine Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Chloroprocaine Hydrochloride a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Chloroprocaine Hydrochloride?
- Chloroprocaine Hydrochloride's side effects are taken directly from its FDA label. From the label: Systemic: The most commonly encountered acute adverse experiences that demand immediate countermeasures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and may result from rapid absorption from the injection site,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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chloroprocaine hydrochloride
72/100