Lignospan Standard .01 mg/mL

Lidocaine Hydrochloride and Epinephrine · INJECTION, SOLUTION · Septodont, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Lignospan Standard is a injection, solution containing lidocaine hydrochloride and epinephrine at .01 mg/mL, taken submucosal. Manufactured by Septodont, Inc..

Key Facts

Brand Name: Lignospan Standard
Generic Name: Lidocaine Hydrochloride and Epinephrine
NDC Code (Product): 0362-1095
Manufacturer: Septodont, Inc.
Strength: .01 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Marketing Status
Application #: ANDA088390
Marketing Start: 11/28/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective38 reports

off label use7 reports

diarrhoea4 reports

dyspnoea4 reports

anaemia3 reports

injection site pain3 reports

burning sensation2 reports

chest pain2 reports

cytokine release syndrome2 reports

emotional disorder2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.

Dosage & Administration

DOSAGE AND ADMINISTRATION The dosage of LIGNOSPAN (lidocaine HCl and epinephrine) depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. For specific techniques and procedures of a local anesthesia in the oral cavity, refer to standard textbooks. For most routine dental procedures, LIGNOSPAN STANDARD (lidocaine HCl 2% with a 1:100,000 epinephrine concentration) is preferred. However, when greater depth and a more pronounced hemostasis are required, LIGNOSPAN FORTE (lidocaine HCl 2 % with 1:50,000 epinephrine concentration) should be used. Dosage requirements should be determined on an individual basis. In oral infiltration and / or mandibular block, initial dosages of 1.0 - 5.0 mL (½ to 2 ½ cartridges) of LIGNOSPAN (lidocaine HCl 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration) are usually effective. In children under 10 years of age, it is rarely…

Warnings

WARNINGS DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES WHICH MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE. To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided. Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection. LIGNOSPAN solutions contain potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non asthmatic people. The American Heart Associa…

Contraindications

CONTRAINDICATIONS LIGNOSPAN is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.

Drug 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 and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. As the LIGNOSPAN STANDARD and the LIGNOSPAN FORTE solutions both contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose- dependent hypertension and bradycardia with possible heart block. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: EXAMPLES OF DRUGS ASSOCIATED WITH METHEMOGLOBINEMIA Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nit…

Adverse Reactions

ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide-type local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels (which may be caused by excessive dosage, rapid absorption, unintended intravascular injection or slow metabolic degradation), injection technique, volume of injection, hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness follo…

Frequently Asked Questions

What is Lignospan Standard used for?

Lignospan Standard contains Lidocaine Hydrochloride and Epinephrine. It is a injection, solution taken submucosal. Consult your doctor for specific uses.

Is Lignospan Standard a controlled substance?

Lignospan Standard is not classified as a controlled substance by the DEA.

What is the generic name for Lignospan Standard?

The generic name for Lignospan Standard is Lidocaine Hydrochloride and Epinephrine. There are 12 other brand versions of Lidocaine Hydrochloride and Epinephrine.

What is the NDC code for Lignospan Standard .01 mg/mL?

The NDC (National Drug Code) for Lignospan Standard .01 mg/mL is 0362-1095, listed by Septodont, Inc..

Product NDC

0362-1095

Package NDC

0362-1095-60

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

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