“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Ropivacaine Hydrochloride (Ropivacaine Hydrochloride)

Trade Name : Ropivacaine Hydrochloride

Sandoz Inc

INJECTION, SOLUTION

Strength 5 mg/mL

ROPIVACAINE HYDROCHLORIDE Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ropivacaine Hydrochloride (Ropivacaine Hydrochloride) which is also known as Ropivacaine Hydrochloride and Manufactured by Sandoz Inc. It is available in strength of 5 mg/mL per ml. Read more

Ropivacaine Hydrochloride (Ropivacaine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • No data
  • Ropivacaine Hydrochloride Injection, USP contains ropivacaine hydrochloride which is a member of the amino amide class of local anesthetics.u00a0Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride, USP for isotonicity and Water for Injection, USP.u00a0 Sodium hydroxide, NF and/or hydrochloric acid, NF may be used for pH adjustment.u00a0 It is administered parenterally.
  • Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride.u00a0 The drug substance is a white crystalline powder, with a molecular formula of CHNOu2022HCl, molecular weight of 310.87 and the following structural formula:
  • At 25u00b0C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution.u00a0 The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7).u00a0 However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine.
  • Ropivacaine Hydrochloride Injection, USP is preservative-free and is available in single dose containers in 5 mg/mL (0.5%) and 10 mg/mL (1%) concentrations.u00a0 The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25u00b0C.
  • Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S-(-)-enantiomer.u00a0 Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential.u00a0 In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers.u00a0 Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
  • No data
  • Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
  • Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration
  • Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration
  • Ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.
  • In performing ropivacaine hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest.u00a0 The potential for successful resuscitation has not been studied in humans.u00a0 There have been rare reports of cardiac arrest during the use of ropivacaine hydrochloride for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease.u00a0 In some instances, resuscitation has been difficult.u00a0 Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome.
  • Ropivacaine hydrochloride should be administered in incremental doses.u00a0 It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary.u00a0 Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously.
  • Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an IV line inserted.u00a0 All necessary precautions should be taken to avoid intravascular injection.u00a0 Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the 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 , and ).u00a0 Delay in proper management of dose-related toxicity, under ventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death.u00a0 Solutions of ropivacaine hydrochloride should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use.u00a0 Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine.
  • Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions.u00a0 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.u00a0 There is insufficient information to determine whether shorter infusion periods are not associated with these findings.u00a0 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.u00a0 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.
  • It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection.u00a0 However, a negative aspiration does not ensure against an intravascular or subarachnoid injection.
  • A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic.u00a0 Two clinical studies have been performed to verify the safety of ropivacaine hydrochloride at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected.u00a0 The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively.u00a0 Anesthesia to pinprick started in the sacral dermatomes in 2 to 3 minutes, extended to the T10 level in 10 to 13 minutes and lasted for approximately 2 hours.u00a0 The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved.
  • Ropivacaine hydrochloride should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive.
  • Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
  • No data
  • Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics.u00a0 A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation.
  • The reported adverse events are derived from clinical studies conducted in the U.S. and other countries.u00a0 The reference drug was usually bupivacaine.u00a0 The studies used a variety of premedications, sedatives, and surgical procedures of varying length.u00a0 A total of 3,988 patients have been exposed to ropivacaine hydrochloride at concentrations up to 1% in clinical trials.u00a0 Each patient was counted once for each type of adverse event.
  • Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution (see and ).
  • MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES
  • Therapy with ropivacaine hydrochloride should be discontinued at the first sign of toxicity.u00a0 No specific information is available for the treatment of toxicity with ropivacaine hydrochloride; therefore, treatment should be symptomatic and supportive.u00a0 The first consideration is prevention, best accomplished by incremental injection of ropivacaine hydrochloride, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic and during continuous infusion.u00a0 At the first sign of change in mental status, oxygen should be administered.
  • The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask.u00a0 Circulation should be assisted as necessary.u00a0 This may prevent convulsions if they have not already occurred.
  • If necessary, use drugs to control convulsions.u00a0 Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use.u00a0 Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated.u00a0 Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force).
  • Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome.
  • The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively.u00a0 These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5 mcg/mL, respectively.
  • In human volunteers given intravenous ropivacaine hydrochloride, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4 to 5.3) and 0.6 (0.3 to 0.9) mcg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted.
  • Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions.u00a0 These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest.
  • If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask.
  • The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus.u00a0 Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished.u00a0 Resuscitation of obstetrical patients may take longer than resuscitation of non-pregnant patients and closed-chest cardiac compression may be ineffective.u00a0 Rapid delivery of the fetus may improve the response to resuscitative efforts.
  • The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used.u00a0 The smallest dose and concentration required to produce the desired result should be administered.
  • There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.u00a0Ropivacaine hydrochloride injection is not approved for this use (see and ).
  • The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient.u00a0 Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients.u00a0 To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly.
  • Use an adequate test dose (3 to 5 mL of a short-acting local anesthetic solution containing epinephrine) prior to induction of complete block.u00a0 This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter.u00a0 Allow adequate time for onset of anesthesia following administration of each test dose.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.u00a0 Solutions which are discolored or which contain particulate matter should not be administered.
  • The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.u00a0 Individual variations in onset and duration occur.u00a0 The figures reflect the expected average dose range needed.u00a0 For other local anesthetic techniques standard current textbooks should be consulted.
  • When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered.u00a0 Experience to date indicates that a cumulative dose of up to 770 mg ropivacaine hydrochloride administered over 24 hours is well tolerated in adults when used for postoperative pain management: ie, 2016 mg.u00a0 Caution should be exercised when administering ropivacaine hydrochloride for prolonged periods of time, eg, >70 hours in debilitated patients.
  • For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL ropivacaine hydrochloride is induced via an epidural catheter.u00a0 Analgesia is maintained with an infusion of ropivacaine hydrochloride, 2 mg/mL (0.2%).u00a0 Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block.u00a0 With this technique a significant reduction in the need for opioids was demonstrated.u00a0 Clinical experience supports the use of ropivacaine hydrochloride epidural infusions for up to 72 hours.
  • Ropivacaine Hydrochloride Injection, USP Single Dose Vials:
  • The solubility of ropivacaine is limited at pH above 6.u00a0 Thus, care must be taken as precipitation may occur if Ropivacaine Hydrochloride Injection is mixed with alkaline solutions.
  • Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.
  • When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended.u00a0 It is recommended that chemical disinfection be accomplished by wiping the ampule or vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.u00a0Glass containers may, as an alternative, be autoclaved once.u00a0 Stability has been demonstrated using a targeted F of 7 minutes at 121u00b0C.
  • Solutions should be stored at controlled room temperature 20 to 25u00b0C (68 to 77u00b0F) [see USP]. Excursions permitted to 15 to 30u00b0C (59 to 86u00b0F).
  • These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly.u00a0
  • Manufactured by:
  • Emcure Pharmaceuticals Ltd.
  • Hinjwadi, Pune 411 057, INDIA.
  • For
  • Sandoz Inc.
  • Princeton, NJ 08540
  • PRINCIPAL DISPLAY PANEL

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.