Active ingredient: Lidocaine Hydrochloride Anhydrous

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Lidocaine Hydrochloride Anhydrous uses


1 INDICATIONS AND USAGE

Lidocaine Hydrochloride Anhydrous is indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3–18 years of age.

Lidocaine Hydrochloride Anhydrous is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults.


Important Limitations:

2 DOSAGE AND ADMINISTRATION

Apply one Lidocaine Hydrochloride Anhydrous to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.

Perform the procedure within 10 minutes after Lidocaine Hydrochloride Anhydrous administration. Use Lidocaine Hydrochloride Anhydrous only on intact skin.

Application of one additional Lidocaine Hydrochloride Anhydrous at a new location is acceptable after a failed attempt at venous access. Multiple administrations of Lidocaine Hydrochloride Anhydrous at the same location are not recommended.

When Lidocaine Hydrochloride Anhydrous is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities.

2.1 Instructions for Use

Prepare the T r eatment Site and Device:

Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.

Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.

Tear open the pouch using the notch provided (Figure 1a). Remove ZingoTM from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b).


Figure 1a


Figure 1b



Position Lidocaine Hydrochloride Anhydrous : Grip Lidocaine Hydrochloride Anhydrous and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.


Figure 2


Figure 3



Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Lidocaine Hydrochloride Anhydrous outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.

Avoid gaps between the skin and the Lidocaine Hydrochloride Anhydrous outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery.


Figure 4



Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Lidocaine Hydrochloride Anhydrous and the skin.

Lidocaine Hydrochloride Anhydrous is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.


Figure 5a


Zingo cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.

Figure 5b

Administer Lidocaine Hydrochloride Anhydrous : While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Lidocaine Hydrochloride Anhydrous during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.

Figure 6


Remove Lidocaine Hydrochloride Anhydrous : Remove Lidocaine Hydrochloride Anhydrous from the application site and dispose.
Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Lidocaine Hydrochloride Anhydrous administration.
Figure 1a Figure 1b Figure 2 Figure 3 Figure 4 Figure 5a Figure 5b Figure 6
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3 DOSAGE FORMS AND STRENGTHS

Lidocaine Hydrochloride Anhydrous (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate.

Lidocaine Hydrochloride Anhydrous is a sterile, single-use, powder intradermal injection system containing 0.5 mg Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate. (3)

Lidocaine Hydrochloride Anhydrous utilizes a helium-powered delivery system. (11)

4 CONTRAINDICATIONS

Lidocaine Hydrochloride Anhydrous is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type.

Lidocaine Hydrochloride Anhydrous is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type. (4)

5 WARNINGS AND PRECAUTIONS

Do not use around the eyes.

Do not use Lidocaine Hydrochloride Anhydrous on body orifices, mucous membranes, or on areas with a compromised skin barrier. Only use Lidocaine Hydrochloride Anhydrous on skin locations where an adequate seal can be maintained.

Patients with severe hepatic disease or pseudocholinesterase deficiency, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations of Lidocaine Hydrochloride Anhydrous.

Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding.

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6 ADVERSE REACTIONS

The most common adverse reactions are skin reactions at the site of administration: erythema, petechiae, edema, and pruritus (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Marathon Pharmaceuticals, LLC, at 1-866-562-4620 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 clinical practice.

The safety of Lidocaine Hydrochloride Anhydrous has been evaluated in 10 clinical trials, five in adults and five in pediatric patients.

The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open-label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of Lidocaine Hydrochloride Anhydrous, while 775 received placebo.

The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, sham- placebo controlled trials in which 1761 patients, ages 3 to 18, received either Lidocaine Hydrochloride Anhydrous or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo.

Application Site Reaction

The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae).

In adults, erythema occurred in 67.3% of Lidocaine Hydrochloride Anhydrous -treated patients, and in 25.0% of placebo- treated patients. Petechiae occurred in 46.4% of Lidocaine Hydrochloride Anhydrous -treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Lidocaine Hydrochloride Anhydrous -treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Lidocaine Hydrochloride Anhydrous -treated patients and in 6.2% of placebo-treated patients.

In pediatric patients, erythema occurred in 53% of Zingo-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Zingo-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Zingo-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.

Adverse Reactions

Amongst the 742 adult patients receiving active treatment and 775 adult patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients.

Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)).

The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active- treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group.

Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.

Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group.

The most common systemic adverse reactions were nausea (2%) and vomiting (1%).

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Lidocaine Hydrochloride Anhydrous was not formally evaluated for effects on reproduction. Significant systemic exposure to Lidocaine Hydrochloride Anhydrous is not expected under recommended conditions of use of Lidocaine Hydrochloride Anhydrous as Lidocaine Hydrochloride Anhydrous levels were below the limit of detection in human studies. Lidocaine Hydrochloride Anhydrous has been previously tested for reproductive toxicity in animal studies, however. The following ratios are based on the assumption that the applied dose is completely absorbed through the skin.

Teratogenic Effects

Pregnancy Category B. Lidocaine Hydrochloride Anhydrous was not teratogenic in rats given subcutaneous doses up to 60 mg/kg [360 mg/m2 or 1200-fold the single dermal administration of 0.5 mg Lidocaine Hydrochloride Anhydrous in a 60 kg individual (0.3 mg/m2)] or in rabbits up to 15 mg/kg (180 mg/m2 or 600-fold the SDA).

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lidocaine Hydrochloride Anhydrous should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Lidocaine Hydrochloride Anhydrous, containing 1:100,000 epinephrine, at a dose of 6 mg/kg (36 mg/m or 120-fold the SDA) injected into the masseter muscle of the jaw or into the gum of the lower jaw of Long- Evans hooded pregnant rats on gestation day 11 led to developmental delays in neonatal behavior among offspring. Developmental delays were observed for negative geotaxis, static righting reflex, visual discrimination response, sensitivity and response to thermal and electrical shock stimuli, and water maze acquisition. The developmental delays of the neonatal animals were transient with responses becoming comparable to untreated animals later in life. The clinical relevance of the animal data is uncertain. No adequate and well–controlled studies have been conducted in pregnant women. Because animal studies are not always predictive of human response, Lidocaine Hydrochloride Anhydrous should be used during pregnancy only if the potential benefit justifies risk to the fetus.

8.2 Labor and Delivery

Lidocaine Hydrochloride Anhydrous is not contraindicated in labor and delivery. In humans, the use of Lidocaine Hydrochloride Anhydrous for labor conduction analgesia has not been associated with an increased incidence of adverse fetal effects either during delivery or during the neonatal period. Should Lidocaine Hydrochloride Anhydrous be used concomitantly with other products containing Lidocaine Hydrochloride Anhydrous, total doses contributed by all formulations must be considered.

8.3 Nursing Mothers

Lidocaine Hydrochloride Anhydrous is excreted into human milk; therefore, caution should be exercised when Lidocaine Hydrochloride Anhydrous is administered to a nursing mother. Because no plasma concentrations of Lidocaine Hydrochloride Anhydrous are detected after topical administration of Lidocaine Hydrochloride Anhydrous in recommended doses, the small amount of Lidocaine Hydrochloride Anhydrous that would be ingested orally by a suckling infant is unlikely to cause adverse effects.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

8.5 Geriatric Use

Of the 693 patients evaluated in a Phase 3 randomized, double blind, sham-placebo-controlled trial in adults, 17% were of 65 and over. The safety and effectiveness of Lidocaine Hydrochloride Anhydrous in geriatric patients were similar to that of Lidocaine Hydrochloride Anhydrous in adults under 65 years of age.

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9 DRUG ABUSE AND DEPENDENCE

Lidocaine Hydrochloride Anhydrous is not known to possess drug abuse or dependence potential.

10 OVERDOSAGE

In adults following a single administration of Lidocaine Hydrochloride Anhydrous the plasma levels of Lidocaine Hydrochloride Anhydrous were below the limit of detection (5 ng/mL). Signs of central nervous system (CNS) toxicity may start at plasma concentrations of Lidocaine Hydrochloride Anhydrous as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels. Very high levels of Lidocaine Hydrochloride Anhydrous can cause respiratory arrest, coma, decreases in cardiac output, total peripheral resistance, and mean arterial pressure, ventricular arrhythmias, and cardiac arrest. The toxicity of coadministered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of Lidocaine Hydrochloride Anhydrous or other local anesthetics should be considered. The management of overdosage includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of Lidocaine Hydrochloride Anhydrous.

11 DESCRIPTION

Lidocaine Hydrochloride Anhydrous (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate.

The chemical name is 2-diethylamino-2',6'-acetoxylidide, monohydrochloride, monohydrate. The molecular formula is C14H22N2O · HCl · H2O with a molecular weight of 288.8 Da. Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate, a local anesthetic of the amide class, has the following structural formula:

Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate is freely soluble in water, soluble in alcohol and chloroform, insoluble in ether, and melts at around 74–79°C.

Lidocaine Hydrochloride Anhydrous is a ready-to-use, sterile, single-use, disposable, needle-free delivery system. Lidocaine Hydrochloride Anhydrous consists of the following components: a drug reservoir cassette filled with 0.5 mg Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate as a powder with a nominal particle size of 40 μm, a pressurized helium gas cylinder, and a safety interlock. The safety interlock prevents inadvertent actuation of the device. Once Lidocaine Hydrochloride Anhydrous is pressed against the skin, the interlock is released, allowing the button to be depressed to actuate the device. A sound similar to that of a popping balloon is emitted at the time Lidocaine Hydrochloride Anhydrous is actuated.

Figure 7 - Lidocaine Hydrochloride Anhydrous Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Lidocaine Hydrochloride Anhydrous delivers Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate into the dermis. Lidocaine Hydrochloride Anhydrous is an amide- type local anesthetic agent that blocks sodium ion channels required for the initiation and conduction of neuronal impulses, resulting in local anesthesia.

12.2 Pharmacodynamics

Lidocaine Hydrochloride Anhydrous provides local dermal analgesia within 1–3 minutes of application. Analgesia diminishes within 10 minutes of treatment.

12.3 Pharmacokinetics

Absorption

A single dose of Lidocaine Hydrochloride Anhydrous in adults did not produce detectable plasma concentrations of Lidocaine Hydrochloride Anhydrous (limit of quantitation 5 ng/mL) in any subject tested (n = 38).

Application of Lidocaine Hydrochloride Anhydrous to broken or inflamed skin, or multiple Lidocaine Hydrochloride Anhydrous applications, could result in systemic plasma levels of Lidocaine Hydrochloride Anhydrous that could produce systemic toxicity.

Distribution

When Lidocaine Hydrochloride Anhydrous is administered intravenously to healthy volunteers, the steady-state volume of distribution is approximately 0.8 to 1.3 L/kg. At much higher plasma concentrations (1 to 4 mcg/ mL of free base) than those found following application of Lidocaine Hydrochloride Anhydrous, the plasma protein binding of Lidocaine Hydrochloride Anhydrous is concentration dependent. Lidocaine Hydrochloride Anhydrous crosses the placental and blood brain barriers, presumably by passive diffusion. CNS toxicity may typically be observed around 5000 ng/mL of Lidocaine Hydrochloride Anhydrous; however a small number of patients reportedly may show signs of toxicity at approximately 1000 ng/mL.

Metabolism

It is not known if Lidocaine Hydrochloride Anhydrous is metabolized in the skin. Lidocaine Hydrochloride Anhydrous is metabolized rapidly by the liver to a number of metabolites including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of Lidocaine Hydrochloride Anhydrous. The major metabolic pathway of Lidocaine Hydrochloride Anhydrous, sequential N-deethylation to monoethylglycinexylidide (MEGX) and glycinexylidide (GX), is primarily mediated by CYP1A2 with a minor role of CYP3A4. The metabolite, 2,6-xylidine, has unknown pharmacologic activity. Following intravenous administration of Lidocaine Hydrochloride Anhydrous, MEGX and GX concentrations in serum range from 11% to 36% and from 5% to 11% of Lidocaine Hydrochloride Anhydrous concentrations, respectively. Serum concentrations of MEGX are about one-third the serum Lidocaine Hydrochloride Anhydrous concentrations.

Elimination

The half-life of Lidocaine Hydrochloride Anhydrous elimination from the plasma following intravenous administration is approximately 1.8 hours. Lidocaine Hydrochloride Anhydrous and its metabolites are excreted by the kidneys. More than 98% of an absorbed dose of Lidocaine Hydrochloride Anhydrous can be recovered in the urine as metabolites or parent drug. Less than 10% of Lidocaine Hydrochloride Anhydrous is excreted unchanged in adults, and approximately 20% is excreted unchanged in neonates. The systemic clearance is approximately 8–10 mL/min/kg. During intravenous studies, the elimination half-life of Lidocaine Hydrochloride Anhydrous was statistically significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Lidocaine Hydrochloride Anhydrous.

Mutagenesis

No mutagenic potential of Lidocaine Hydrochloride Anhydrous was demonstrated in the in vitro Ames Bacterial Reverse Mutation Assay, the in vitro chromosome aberration assay using Chinese hamster ovary cells, and the in vivo mouse micronucleus assay.

Impairment of Fertility

Lidocaine Hydrochloride Anhydrous was not formally evaluated for effects on fertility. Significant systemic exposure to Lidocaine Hydrochloride Anhydrous is not expected under recommended conditions of use of Lidocaine Hydrochloride Anhydrous, as Lidocaine Hydrochloride Anhydrous levels were below the limit of detection in human studies. Lidocaine Hydrochloride Anhydrous has been previously tested in animal studies for effects on fertility, however. The following ratios are based on the assumption that the applied dose is completely absorbed through the skin.

Lidocaine Hydrochloride Anhydrous did not affect fertility in female rats when given via continuous subcutaneous infusion via osmotic minipumps up to doses of 250 mg/kg/day [1500 mg/m2 or 5000-fold higher than the SDA of 0.5 mg Lidocaine Hydrochloride Anhydrous in a 60 kg individual (0.3 mg/m2)]. Although Lidocaine Hydrochloride Anhydrous treatment of male rats increased the copulatory interval and led to a dose-related decreased homogenization resistant sperm head count, daily sperm production, and spermatogenic efficiency, the treatment did not affect overall fertility in male rats when given subcutaneous doses up to 60 mg/kg (360 mg/m2 or 1200-fold the SDA).

14 CLINICAL STUDIES

Efficacy in Adults

The efficacy of Lidocaine Hydrochloride Anhydrous in adults was evaluated in a randomized, double-blind, parallel-arm, sham-placebo controlled trial in which adult patients who required a venipuncture or peripheral venous cannulation received either Lidocaine Hydrochloride Anhydrous or a sham placebo device.

Patients were treated with Lidocaine Hydrochloride Anhydrous or a placebo device at the antecubital fossa or back of the hand, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the procedure. Efficacy was measured using a continuous 100 mm visual analogue scale ranging from 0 (“no pain”) to 100 (“worst possible pain”).

Many of the patients had chronic medical problems such as depression, hypertension, hypothyroidism, and hyperlipidemia and over one fourth of the population may have been at higher than average risk of dermal bleeding due to use of concomitant medications such as NSAIDs, aspirin, and corticosteroids.

Treatment with active drug resulted in less pain compared with placebo.

Adult Study
Active (N = 345) Placebo (N = 348)
Adjusted Mean, LSM1 11.61 16.23
Difference in LSMs (SE2) -4.62 (1.55)
95% Confidence Limits -7.67, -1.57

1 least squares mean 2 standard error

However, efficacy was primarily seen in patients undergoing venipuncture at the antecubital fossa, while patients undergoing cannulation at the back of the hand did not demonstrate a difference between active and sham administrations.

Efficacy in Pediatric Patients

The efficacy of Lidocaine Hydrochloride Anhydrous in patients 3–18 years of age was evaluated in two randomized, double-blind, parallel-arm, sham-placebo controlled trials in which pediatric patients received either Lidocaine Hydrochloride Anhydrous or a sham placebo device.

The overall patient population consisted of healthy pediatric patients as well as those with acute and chronic medical conditions (i.e., diabetes, asthma, seizure disorder, juvenile rheumatoid arthritis and renal or hepatic transplantation) ages 3–18 years. All patients required peripheral venipuncture or intravenous cannulation as part of their clinical care.

Two efficacy trials (Studies 1 and 2) were conducted during which patients were treated with Lidocaine Hydrochloride Anhydrous or a placebo device at the back of hand or antecubital fossa, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the venous procedure. Efficacy was measured using a modified version of the Wong-Baker FACES pain rating scale [a categorical 6-point scale containing 6 faces ranging from 0 (“no hurt”) to 5 (“hurts worst”)].

In both studies, treatment with active drug resulted in less pain, from venipuncture or peripheral IV cannulation, compared with placebo.

Study 1 Study 2
Active

(N = 292)

Placebo

(N = 287)

Active

(N = 269)

Placebo

(N = 266)

Adjusted Mean, LSM1 1.77 2.10 1.38 1.77
Difference in LSMs (SE2) -0.33 (0.13) -0.39 (0.13)
95% Confidence Limits -0.58, -0.08 -0.65, -0.13

1 least squares mean 2 standard error

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC 61388-001-48 Lidocaine Hydrochloride Anhydrous (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile Lidocaine Hydrochloride Anhydrous hydrochloride monohydrate. Lidocaine Hydrochloride Anhydrous is a single-use device packaged in an individual clear pouch. Twelve pouched devices are placed in labeled cartons.

Cartons are stored at controlled room temperature (15–30°C, 59–86°F).

17 PATIENT COUNSELING INFORMATION

Patients should be made aware that a sound similar to that of a popping balloon is emitted at the time Lidocaine Hydrochloride Anhydrous is actuated.

Patients should be informed that skin reactions including erythema, petechiae, pruritus and edema may occur.

Manufactured by:

Powder Pharmaceuticals, Inc.

Hong Kong, China

Lidocaine Hydrochloride Anhydrous is a trademark of Powder

Pharmaceuticals, Incorporated.

Distributed by:

[Medline Logo]

Medline Industries, Inc.,

Mundelein, IL 60060, USA (RA14)

REF: 53329-200-57

Under license by Marathon Pharmaceuticals, LLC.

NDC 61388-001-48

Lidocaine Hydrochloride Anhydrous

(lidocaine hydrochloride monohydrate)

powder intradermal injection system

0.5mg

RX only.

Manufactured by:

Powder Pharmaaceuticals, Inc.

Hong Kong, China

NDC 61388-001-48 Lidocaine Hydrochloride Anhydrous (lidocaine hydrochloride monohydrate) powder intradermal injection system 0.5mg RX only. Manufactured by: Powder Pharmaceuticals, Inc. Hong Kong, China

Lidocaine Hydrochloride Anhydrous available forms, composition, doses:


Indications and Usages:

ATC codes:


ICD-10 codes:


Lidocaine Hydrochloride Anhydrous destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."LIDOCAINE; TETRACAINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "lidocaine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "lidocaine". http://www.drugbank.ca/drugs/DB0028... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lidocaine Hydrochloride Anhydrous?

Depending on the reaction of the Lidocaine Hydrochloride Anhydrous after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lidocaine Hydrochloride Anhydrous not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Lidocaine Hydrochloride Anhydrous addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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sdrugs.com conducted a study on Lidocaine Hydrochloride Anhydrous, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Lidocaine Hydrochloride Anhydrous consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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