Anacaine HC30 gm

Anacaine HC is a topical combination product indicated for the temporary relief of pain, itching, burning, soreness, and inflammation associated with:

• Hemorrhoids (internal and external)
• Anal fissures
• Pruritus ani (anal itching)
• Other inflamed, itchy, and painful anorectal and perianal skin conditions

It combines a topical corticosteroid (hydrocortisone) that reduces local inflammation with a local anesthetic (lidocaine) that provides rapid, temporary numbing of pain and itching. This is a symptomatic, established topical use; Anacaine HC is not an antibiotic and does not treat the underlying cause of infections or structural anorectal disease (e.g., it will not treat an abscess, fistula, or fungal/viral infection).

Hydrocortisone + Lidocaine is a fixed-dose topical combination typically formulated as a cream, ointment, or gel containing:

• Hydrocortisone (as hydrocortisone or hydrocortisone acetate) - a low-to-mid potency topical corticosteroid, commonly 0.5% to 1% w/w
• Lidocaine (as lidocaine or lidocaine hydrochloride) - an amide-type local anesthetic, commonly 2% to 3% w/w

Exact strengths and inactive ingredients vary by brand and dosage form; refer to the specific product label for the marketed formulation.

Anacaine HC is a combination topical medicine that pairs an anti-inflammatory corticosteroid with a local anesthetic in a single preparation. It is applied directly to the skin or perianal/anal area to relieve the discomfort of inflamed, itchy, and painful conditions, most commonly hemorrhoids and related anorectal disorders.

By combining two complementary mechanisms in one product, Anacaine HC offers both anti-inflammatory action and fast symptomatic pain/itch relief, reducing the need to apply two separate products.

Anacaine HC belongs to the therapeutic class of topical corticosteroid and local anesthetic combinations, used for dermatological and anorectal anti-inflammatory/analgesic therapy.

Hydrocortisone + Lidocaine works through two complementary mechanisms:

• Hydrocortisone is a corticosteroid that diffuses across cell membranes and binds to glucocorticoid receptors, reducing the synthesis and release of inflammatory mediators (prostaglandins, cytokines). This decreases local inflammation, redness, swelling, and itching.
• Lidocaine is an amide local anesthetic that stabilizes neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, primarily by blocking voltage-gated sodium channels. This produces temporary loss of sensation (numbing) in the treated area, relieving pain, burning, and itching.

Together, Hydrocortisone + Lidocaine provides both anti-inflammatory and analgesic/anesthetic effects at the site of application.

Anacaine HC is for topical (external and/or intra-anal) use only. It is not for oral, ophthalmic, or intravaginal use. See Dosage and Administration for step-by-step application instructions.

Anacaine HC has a limited but clinically relevant interaction profile because it is applied topically with generally low systemic absorption under normal use:

• Class I antiarrhythmic drugs (e.g., tocainide, mexiletine): Concomitant use with the lidocaine component should be approached with caution, as effects may be additive; toxicity from lidocaine used with these agents has been reported when systemic absorption is significant (e.g., with extensive application or use on broken/large skin areas).
• Other topical or systemic corticosteroids: Concurrent extensive use may increase the risk of systemic corticosteroid effects (see Precautions and Warnings).

Since systemic absorption of both components is normally minimal with proper topical use, clinically significant interactions are uncommon but become more likely with prolonged use, application to large areas, or use on broken skin. Inform your physician of all medicines you are using.

Most side effects of Anacaine HC are local and mild, occurring at the site of application:

• Transient stinging, burning, or tingling sensation on application
• Skin blanching (whitening) or redness (erythema)
• Itching or irritation at the application site
• Dryness, thinning, or atrophy of the skin with prolonged or excessive use
• Rarely, allergic contact dermatitis or hypersensitivity reactions

With prolonged use, use over large areas, or use on broken skin, systemic absorption may increase, raising the risk of corticosteroid-related systemic effects (e.g., HPA-axis suppression) or lidocaine-related systemic effects (e.g., dizziness, irregular heartbeat) — see Precautions and Warnings. Contact a physician if irritation, signs of infection, or unusual symptoms develop.

Pregnancy: There are no adequate and well-controlled studies of Anacaine HC in pregnant women. Topical corticosteroids and lidocaine are generally used cautiously during pregnancy. Anacaine HC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under the guidance of a physician, applied to the smallest area for the shortest duration necessary.

Lactation: It is not known whether topically applied hydrocortisone or lidocaine from Anacaine HC is excreted in significant amounts in human breast milk. Caution should be exercised, and a physician should be consulted before use while breastfeeding, particularly if applied to a body area that risks direct infant contact.

The following precautions apply to the use of Anacaine HC:

• External/topical use only: Avoid contact with the eyes, mouth, nose, and other mucous membranes.
• Duration of use: Avoid prolonged, continuous use (generally beyond 7 days) without medical supervision, as this increases the risk of skin atrophy, striae, and systemic absorption.
• Extent of application: Do not apply to large areas of the body or under occlusive dressings unless directed by a physician, as this increases systemic absorption of both hydrocortisone and lidocaine.
• Broken or infected skin: Avoid application to broken, infected, or denuded skin unless directed by a physician (see Contraindications).
• Systemic corticosteroid effects: With extensive or prolonged use, hydrocortisone may be absorbed sufficiently to produce systemic effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression, hyperglycemia, or manifestations of Cushing's syndrome.
• Systemic lidocaine effects: Excessive absorption of lidocaine may cause central nervous system effects (dizziness, drowsiness, confusion) or cardiovascular effects (irregular heart rhythm), particularly in patients with hepatic impairment or those using other sodium-channel-affecting drugs.
• Hepatic impairment: Use with caution in patients with significant liver disease, as reduced metabolism may increase the risk of lidocaine toxicity.
• Children: Children may be more susceptible to systemic absorption and adrenal suppression due to a larger skin-surface-to-body-mass ratio; avoid prolonged use in children unless directed by a physician.
• Discontinue and consult a physician if irritation, sensitization, or signs of infection develop during use.

Topical overdose of Anacaine HC is uncommon with proper use but may occur with excessive application, use over large areas, or accidental ingestion. Signs of significant systemic absorption or overdose may include dizziness, drowsiness, confusion, blurred vision, ringing in the ears, irregular heartbeat, or seizures (from excess lidocaine absorption), or signs of systemic corticosteroid excess with chronic overuse. If accidental ingestion occurs or if signs of systemic toxicity appear, seek immediate medical attention or contact a poison control center/emergency services. Do not attempt to manage a suspected overdose at home without medical guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Do not freeze.

Pregnant women: Use Anacaine HC only if clearly needed, under medical supervision, for the shortest duration and smallest area necessary (see Pregnancy and Lactation).

Breastfeeding women: Consult a physician before use; avoid application to areas that may contact the infant's mouth.

Pediatric patients: Safety and efficacy of Anacaine HC have not been formally established in children. If prescribed, use the lowest effective amount for the shortest duration, as children are more susceptible to systemic absorption.

Elderly patients: No specific dose adjustment is generally required, but elderly patients often have thinner skin and may be more susceptible to local and systemic corticosteroid effects; use the minimum effective duration.

Hepatic impairment: Use with caution due to potentially reduced clearance of absorbed lidocaine, which increases the risk of systemic toxicity.

Renal impairment: No specific dose adjustment is well-established for topical use; use with routine caution.

Anacaine HC is generally intended for short-term, symptomatic use. Unless otherwise directed by a physician, treatment should not exceed 7 consecutive days. If symptoms persist, worsen, or recur after this period, a physician should be consulted to reassess the diagnosis and treatment plan, as prolonged corticosteroid use increases the risk of local and systemic side effects.

Hydrocortisone + Lidocaine falls under the drug classes: Topical Corticosteroid (hydrocortisone) and Local/Topical Anesthetic, Amide-type (lidocaine), combined as a fixed-dose topical anorectal/dermatological preparation.

Hydrocortisone + Lidocaine acts through two mechanisms at the site of application: hydrocortisone binds intracellular glucocorticoid receptors to suppress the local inflammatory cascade (reducing cytokine and prostaglandin production, vasodilation, and edema), while lidocaine blocks voltage-gated sodium channels on sensory nerve fibers, preventing the initiation and propagation of pain and itch signals. The combined effect is reduced inflammation together with rapid, temporary local anesthesia.

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The safety and efficacy of Anacaine HC have not been formally established in pediatric patients. If a physician determines that use in a child is necessary, it should be applied in the smallest effective amount, over the smallest area, and for the shortest possible duration, since children have a greater skin-surface-area-to-body-weight ratio and are more susceptible to systemic absorption of both hydrocortisone and lidocaine, which can increase the risk of HPA-axis suppression or lidocaine toxicity.