Piles Management System Kit

Product Information - Thankgod Pain & Itch Relief Cream™

Product Name	Thankgod Pain & Itch Relief Cream™
Description	Thankgod Pain & Itch Relief Cream™ for hemorrhoids is intended to provide immediate relief from various distressing symptoms of piles such as anal discomfort, pain, bleeding and itching around the anus (pruritus ani).
Composition	Each gram contains: Zinc Oxide IP ….. 50 mg Lignocaine BP ….. 30 mg Chlorhexidine gluconate solution IP (equivalent to chlorhexidine gluconate) ….. 10 mg Hydrocortisone acetate IP ….. 2.5 mg Cream base ….. q.s.
Clinical Pharmacology	Topical corticosteroids (hydrocortisone acetate) are anti-inflammatory and anti-pruritic agents. When corticosteroids are applied to inflamed skin, there is inhibition of migration of macrophages and leukocytes by reversing vascular dilation and permeability. The result is decrease in edema, erythema and pruritus. There is some evidence to suggest their vasoconstrictive action also. Lignocaine is a topical anesthetic agent which provides relief from itching and pain. Local anesthetics act by altering the cell membrane permeability to ions, resulting in inhibition of conduction of nerve impulses from sensory nerves. It is poorly absorbed through intact epidermis. When skin permeability is increased (due to abrasion/ulcer), the absorption and subsequently the efficacy improves, however, side effects also increase. Zinc oxide is an astringent used topically as a soothing and a protective agent. Besides, it is also known to have mild antiseptic effect. Chlorhexidine gluconate is an antiseptic and disinfectant which provides persistent anti-microbial effect against a wide range of bacterias (gram positive & gram negative), some viruses and fungi.
Pharmacokinetics	Topical corticosteroids can be absorbed from intact skin, the extent of which depends upon many factors including the integrity of epidermal barrier, the vehicle and use of occlusive dressings. Inflammation and occlusive dressings can substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin topical corticosteroids are handled through similar pharmacokinetic pathways as of systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degree and metabolized primarily in the liver and then excreted by the kidneys. Lignocaine is poorly absorbed from intact skin; however absorption is rapid from abraded skin and mucous membrane. After absorption, it is bound to plasma α1 acid glycoprotein and metabolized in liver by dealkylation and hydrolysis.
Indications & Usage	Thankgod Pain & Itch Relief Cream™ is indicated for relief from pain, anal discomfort, bleeding, and inflammation in Piles or hemorrhoids.
Contraindications	Use of Thankgod Pain & Itch Relief Cream™ is contraindicated in persons with a history of hypersensitivity to any of the components.
Precautions	General : Systemic absorption of topical corticosteroids has been shown to cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, hyperglycemia, glucosuria and features of Cushing’s syndrome. Prolonged use, occlusive dressings and application over large area increases the systemic absorption. In such situation, periodic evaluation for evidence of HPA axis suppression by ACTH stimulation test and urinary free cortisol measurement is advisable. If HPA axis suppression is present, the drug should be withdrawn or frequency of application should be reduced. Recovery of HPA axis function is generally prompt and complete upon the discontinuation of the drug. Thankgod pain and itch relief cream should be discontinued if irritation develops or in presence of infection and appropriate therapy should be instituted. Thankgod pain and itch relief cream is meant for EXTERNAL USE ONLY. Avoid contact with eyes, ears and mouth. If this occurs accidentally rinse promptly and thoroughly with water. Pregnancy : Teratogenic effects: Dermal application of corticosteroids has been shown to be teratogenic in laboratory animals. There is no adequate and well controlled study in pregnant women on teratogenic effect of topical corticosteroids. Safety of lignocaine and chlorhexidine has not been established during pregnancy. Therefore, Thankgod pain and itch relief cream should be used during pregnancy only if clearly needed and when the potential benefits outweigh the potential hazards to the fetus. Nursing mothers: Systemically absorbed corticosteroids and lignocaine may be excreted in breast milk. Therefore, caution should be exercised while using this product in a nursing woman. Pediatric use : Pediatric patients are more susceptible to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome. Therefore, use of Thankgod pain and itch relief cream is not recommended in pediatric age group.
Adverse reactions	Use of Thankgod Pain & Itch Relief Cream™ is usually safe. Adverse reactions in general are dose related and may result from high plasma levels due to excessive doses or increased absorption. These include burning, stinging, itching, irritation, dryness, tenderness, sloughing, staining, hypopigmentation, hypertrichosis, skin atrophy, striae, cutaneous lesions, urticaria, edema, contact dermatitis, hyperglycemia, glucosuria, bronchospasm, cyanosis (methemoglobinemia) and shock.
Overdoses and Treatment	Symptoms of overdosage (high plasma levels) are systemic and may include suppression of HPA axis, hyperglycemia, glucosuria, light headedness, dizziness, tremors, twitchings, confusion, convulsion, hypotension, bradycardia, cardiac arrhythmias, cardiac and respiratory arrest. Treatment consists of maintenance of airway, use of I.V. fluids, vasopressure agents, diazepam and ventilatory support.
Dosage and Administration	Thankgod Pain & Itch Relief Cream™ should be applied to the affected area three to four times daily depending upon the severity of the condition. FOR EXTERNAL USE ONLY. Keep out of reach of children.
Storage	Store in a cool dry place away from direct sunlight.
Supply	Thankgod pain and itch relief cream is supplied in a 30 gram tube.
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