Marvona SUIK 5 mg/mL

Bupivacaine Hydrochloride · INJECTION, SOLUTION · Asclemed USA, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Marvona SUIK is a injection, solution containing bupivacaine hydrochloride at 5 mg/mL, taken epidural. Manufactured by Asclemed USA, Inc..

Key Facts

Brand Name: Marvona SUIK
Generic Name: Bupivacaine Hydrochloride
NDC Code (Product): 76420-230
Manufacturer: Asclemed USA, Inc.
Strength: 5 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: EPIDURAL, INFILTRATION
Marketing Status
Marketing Start: 09/08/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective501 reports

maternal exposure during pregnancy177 reports

off label use152 reports

anaesthetic complication138 reports

hypoaesthesia124 reports

hypotension118 reports

condition aggravated114 reports

dyspnoea111 reports

hypertension103 reports

headache97 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic. Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. ( 1 , 2.2 ) Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride Injection given clinically significant risks associated with use. ( 1 , 2.2 , 4 , 5.1 , 5.5 , 5.7 , 5.9 ) Limitations of Use Not all bloc…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Not for intrathecal use. ( 2.1 ) Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. ( 2.1 ) See full prescribing information for: - Recommended concentrations and dosages of Bupivacaine Hydrochloride Injection according to type of block. ( 2.2 ) - Additional dosage and administration information pertaining to use in epidural anesthesia and use in ophthalmic surgery. ( 2.3 , 2.6 ) 2.1 Important Dosage and Administration Information Bupivacaine Hydrochloride Injection is not for intrathecal use. Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use. Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. Bupivacaine Hydrochloride Injection are clear, colorless solutions. Do not administer solutions which are discolored or contain particulate matter. Mixing or the prior or intercurrent use of any other local anesthetic with Bupivacaine Hydrochloride Injection is not recommended because of insufficient data on the clinical use of su…

Contraindications

4 CONTRAINDICATIONS Bupivacaine Hydrochloride Injection is contraindicated in: obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7) ]. patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride Injection. Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. ( 4 ) Intravenous regional anesthesia (Bier Block). ( 4 ) Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of Bupivacaine Hydrochloride Injection. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. ( 7.5 ) Potent Inhalation Anesthetics : Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are used in patients during or following the administration of potent inhalation anesthetics. ( 7.6 ) 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with Bupivacaine Hydrochloride Injection cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) ] . 7.5 Drugs Associated with Methemoglobinemia Patients who are administered Bupivacaine Hydrochloride Injection are at inc…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.1) ] Dose-Related Toxicity [see Warnings and Precautions (5.2) ] Methemoglobinemia [see Warnings and Precautions (5.3) ] Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.5) ] Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.7) ] Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9) ] Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15) ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine. Because many of these reactions were 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. Adverse reactions to Bupivacaine Hydrochloride Injection are characteristic of those associated with other amide-type l…

Frequently Asked Questions

What is Marvona SUIK used for?

Marvona SUIK contains Bupivacaine Hydrochloride. It is a injection, solution taken epidural. Consult your doctor for specific uses.

Is Marvona SUIK a controlled substance?

Marvona SUIK is not classified as a controlled substance by the DEA.

What is the generic name for Marvona SUIK?

The generic name for Marvona SUIK is Bupivacaine Hydrochloride. There are 11 other brand versions of Bupivacaine Hydrochloride.

What is the NDC code for Marvona SUIK 5 mg/mL?

The NDC (National Drug Code) for Marvona SUIK 5 mg/mL is 76420-230, listed by Asclemed USA, Inc..

Product NDC

76420-230

Package NDC

76420-230-01

Other Bupivacaine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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