LIDOCAINE HCL 5 %

Other

Brand names: Lidotral 5 Percent and Hydrocortisone 1 Percent with Peptides and Arnica

Pregnancy: Category CTopical

Mechanism of Action

Mechanism of Action: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby affecting local anesthetic action. Hydrocortisone acetate providesrelief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Indications

INDICATIONS: The product is used for the anti-inflammatory and anesthetic relief of redness

pain

itching

and discoloration due to inflammation and skin burns. For the relief of redness

pain

itching

Contraindications

• CONTRAINDICATIONS: Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics
• which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur
• discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function
• varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

FDA Warnings

WARNINGS: CONCERNS RELATED TO ADVERSE EFFECTS: Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents
WARNINGS: For external use only
Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear
Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion

Known Side Effects

9 documented side effects by frequency

Drug Not Working

>10%

Nausea

1-10%

Fatigue

1-10%

Headache

1-10%

Shortness of Breath

1-10%

Condition Worsened

0.1-1%

Diarrhea

0.1-1%

Vomiting

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Topical