Tarlic

Uses

Higher concentrations of Benzalkonium chloride is used as an antiseptic and disinfectant. This is also widely used as a preservative in eye-drops.

Coal Tar Cream is used for psoriasis. Soritar Cream has a keratoplastic and antipruritic effect in psoriasis.

6% Salicylic Acid: This topical preparations treat the following common scaly conditions:

• Chronic atopic dermatitis
• Lichen simplex
• Psoriasis
• Seborrhoeic dermatitis
• Ichthiosis

12% Salicylic Acid: This topical preparations treat the following common scaly conditions:

• Warts (small excessive growths of skin caused by a type of virus. Warts often occur on the fingers or on the back of the hands).
• Verruca (occurs only on the sole of the feet and can be painful. It often looks like a small white ring of skin with a black dot in the centre).
• Corns and Calluses (are hard, thick pads of skin caused by pressure and friction. They usually occur on the feet due to poorly fitting shoes and can occur on the hands).

Tarlic is also used to associated treatment for these conditions: Diaper Dermatitis, Dry Eye Syndrome (DES), Eye and eyelid infections, Gingivitis, Hemorrhoids, Infantile Eczema, Mouth irritation, Pruritus Ani, Tonsillitis, Throat inflammation, Antisepsis, Disinfection therapy, Eye disinfection, Eye lubrication, Hand Hygiene, Skin disinfection, Wound treatmentDandruff, Psoriasis, Seborrheic Dermatitis, Seborrhoeic Dermatitis of the ScalpAcne, Actinic Keratosis (AK), Alopecia Areata (AA), Atopic Dermatitis (AD), Blackheads, Chronic Eczema, Chronic cutaneous lupus erythematosus, Corns, Dandruff, Dermatitis, Contact, Dermatitis, Eczematous, Dermatitis, Eczematous of the scalp, Discoid Lupus Erythematosus (DLE), Foot Callus, Fungal skin infection, Furuncle, Hand Eczema, Hyperkeratosis, Hyperkeratosis follicularis et parafollicularis, Infections, Fungal, Infections, Fungal of the Skin Folds, Infections, Fungal of the face, Infections, Fungal of the feet, Infections, Fungal of the hand, Keratosis Palmaris et Plantaris, Lichen, Lichen Plano-Pilaris, Lichen Planus (LP), Lichen simplex chronicus, Molluscum Contagiosum, Musculoskeletal Pain, Neurodermatitis, Palmo-Plantar Pustulosis, Plantar Warts, Pruritus, Psoriasis, Psoriasis Vulgaris (Plaque Psoriasis), Psoriasis of the scalp, Rash, Ringworm of the Skin, Ringworm of the scalp, Seborrheic Dermatitis, Seborrhoeic Dermatitis of the Scalp, Skin Infections, Bacterial, Verrucous Psoriasis, Warts, Calluses, Corticosteroid-responsive dermatoses, Keratinization disorders, Scaling, Scaling of skin, Scalp seborrhea, Superficial Fungal skin infection, Keratolysis

How Tarlic works

Although not entirely elucidated, the bactericidal action of benzalkonium chloride is believed to be due to the disruption of intermolecular interactions. Such disruption can cause the dissociation of cellular membrane lipid bilayers of bacteria, resulting in compromised cellular permeability control and the leakage of important cellular contents. Additionally, other important molecular complexes like enzymes which control the maintenance of a great range of respiratory and metabolic cellular activities, are also susceptible to such deactivation. Consequently, a variety of critical intermolecular interactions and tertiary structures in very highly specific biochemical systems that allow bacterial agents to function normally can be readily disrupted or deactivated by cationic surfactants like benzalkonium chloride. .

Coal tar ointment is a keratolytic. It works by slowing bacterial growth and loosening and softening scales and crust.

Salicylic acid directly irreversibly inhibits COX-1 and COX-2 to decrease conversion of arachidonic acid to precursors of prostaglandins and thromboxanes. Salicylate's use in rheumatic diseases is due to it's analgesic and anti-inflammatory activity. Salicylic acid is a key ingredient in many skin-care products for the treatment of acne, psoriasis, calluses, corns, keratosis pilaris, and warts. Salicylic acid allows cells of the epidermis to more readily slough off. Because of its effect on skin cells, salicylic acid is used in several shampoos used to treat dandruff. Salicylic acid is also used as an active ingredient in gels which remove verrucas (plantar warts). Salicylic acid competitively inhibits oxidation of uridine-5-diphosphoglucose (UDPG) with nicotinamide adenosine dinucleotide (NAD) and noncompetitively with UDPG. It also competitively inhibits the transferring of the glucuronyl group of uridine-5-phosphoglucuronic acid (UDPGA) to a phenolic acceptor. Inhibition of mucopoly saccharide synthesis is likely responsible for the slowing of wound healing with salicylates.

Dosage

Tarlic dosage

• Tincture of benzalkonium chloride 1:750 is used for the preoperative disinfection of unbroken skin or treatment of superficial injuries.
• For preoperative disinfection of mucous membranes and denuded skin, benzalkonium chloride solution in concentrations of 1:10000 to 1:2000 is used.
• For irrigation of the eye, a solution of 1:10000 to 1:5000 is used.
• For urinary bladder and urethral irrigation, a solution 1:5000 to 1:20000 is used.
• For vaginal douche and irrigation, benzalkonium chloride solution 1:5000 to 1:20000.

Adults and children over 12 years of age: Ensure that the lesions are clean. Apply a thin layer of Coal Tar Cream two or three times a day on to the affected areas massage in gently and leave to dry.

For young children under 12 years of age and the elderly: The emulsion may be diluted by mixing it with a few drops of cooled freshly boiled in the palm of the hand.

Topical/Cutaneous (Adult)-

Hyperkeratotic and scaling skin conditions: As 1.8-3% preparation: Apply to affected area of the skin and/or scalp 1-4 times daily.

Acne: As 0.5-2% preparation: Apply thinly to affected area 1-3 times daily, reduce to once daily or every other day if dryness or peeling occur.

Warts and calluses:

• As 12-40% plaster: Fit over the wart/callus for 48 hr, repeat process 48 hrly as needed until wart/callus is removed (up to 12 wk for warts or up to 14 days for calluses).
• As 5-17% preparation in collodion-like vehicle: Apply a small amount to sufficiently cover wart/callus and allow to dry. Repeat 1-2 times daily until wart/callus is removed (up to 12 wk for warts or up to 14 days for calluses).
• As 15% preparation in karaya gum-glycol plaster vehicle: Smoothen warts with emery board and place a drop of warm water prior to application. Apply the plaster in the evening and leave in place for at least 8 hr to be removed in the morning. Repeat process 24 hrly, if necessary up to 12 wk.

Side Effects

Repeated application may cause hypersensitivity reactions. May cause nausea and vomiting if ingested.

Skin and subcutaneous tissue disorders: Skin irritation, photosensitivity of the skin, Coal Tar Cream may cause acne-like eruptions of the skin. There is an increased risk of skin cancer in psoriatic patients treated with a combination of Coal Tar Cream and UVB radiation has been reported. However epidemiological studies of patients treated with Coal Tar Cream on its own are inconclusive. The risk of toxicity should be taken into account when considering the prescribing this product for the patient.

An allergic reaction (shortness of breath, closing of the throat, swelling of the lips, face or tongue or hives) or severe skin irritation.

Toxicity

An oral dose of 100-400 mg/kg or a parenteral dose of 5-15 mg/kg is believed to be fatal in humans .

A potential concern for larger concentrations of benzalkonium chloride to possibly cause corneal damage when implemented as an excipient ingredient in aqueous eye products is an issue that should be discussed between potential patents and their health care providers . Since decreased regular blinking and tear generation in patients experiencing dry eyes due to any number of eye conditions can result in reduced dilution of applied eye drops containing the benzalkonium chloride preservative , alternative options including benzalkonium chloride-free products should be considered.

Additionally, benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. In addition, benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses . There may also be the possibility of benzalkonium chloride containing eye drops to cause some stinging and pain .

There is the possibility of ototoxicity occurring when benzalkonium chloride containing ear drops are applied to the ear .

Benzalkonium chloride used as a preservative in nebulised solutions of anti-asthma drugs has been reported to cause dose-related bronchoconstriction especially in asthmatic patients and has been associated with the precipitation of respiratory arrest .

Despite the fairly widespread cutaneous use of benzalkonium chloride, only limited human evidence of sensitization in relatively small populations of individuals have been reported . Nevertheless, the main adverse effect for topical formulations of benzalkonium chloride is usually the warning 'may cause local irritation' .

LD50: Not available.

Oral rat LD50: 891 mg/kg. Inhalation rat LC50: > 900 mg/m3/1hr. Irritation: skin rabbit: 500 mg/24H mild. Eye rabbit: 100 mg severe. Investigated a mutagen and reproductive effector.

Precaution

For external use only. Avoid contact with eyes and other mucous membranes.

Interaction

Disinfectants containing quaternary ammonium salts should not be used for skin preparation before injections of viscoelastic solutions. Hyaluronic acid will precipitate in the presence of these salts.

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.

Volume of Distribution

When applied as a topical antibacterial, antiseptic, disinfectant, or sanitizer it is believed that molecules of benzalkonium chloride are poorly absorbed (perhaps due to their large, positively charged nature ), especially considering expectations for such topical applications to keep their biocidal agents available for action at the topical level and to not be absorbed significantly beyond it.

When benzalkonium chloride is implemented as an excipient preservative ingredient in various eye, nose, and ear aqueous products, such products will always have other active pharmacological agents whose volume of distribution will be of greater importance. In these cases the excipients will only ever be present at the minimal levels necessary to maintain the integrity of the product substance.

Moreover, Benzalkonium chloride is currently listed as a Category III ingredient by the United States Food and Drug Administration . Ingredients are listed in the FDA Category III when the data available about them are insufficient to classify as safe and effective, requiring further testing to determine more formal details about elements like human pharmacokinetic studies, and studies on the ingredients' absorption, distribution, metabolism, and excretion.

Intended for local use only, no systemic absorption.

The volume of distribution is about 170 mL/kg of body weight.

Elimination Route

Percutaneous absorption is considered to be insignificant .

In one study, benzalkonium chloride absorption was evaluated in women using tampons containing the agent. Venous blood samples were drawn 15 minutes before the tampon application and then again at 15 min, 1 h, 3 h, and 24 h after application. Benzalkonium chloride was not detected in any of the blood samples at any time tested.

Similarly, in another study, benzalkonium chloride absorption was tested in women using tampons containing the agent. Venous blood and breast milk samples were taken 15 minutes before application and 3 h and 24 h after tampon administration. Benzalkonium chloride was not found in any of the subjects' samples. .

Moreover, in a study where benzalkonium chloride solution was placed on the corneal surface of rabbit subjects, at various intervals after administration, the rabbits' eyes would be washed with 1 mL saline and the following tissues and fluids were removed: bulbar and palpebral conjunctiva, aqueous humour, corneal epithelium, endothelium and stroma, iris-ciliary body, lens, vitreous, retina, and choroid. Plasma samples were obtained with direct cardiac punctures. After administration of one drop, benzalkonium chloride was found in the corneal epithelium, endothelium, and stroma, and in the bulbar and palpebral conjunctivae. Benzalkonium chloride loss from ocular tissues was such that about one-third to two thirds of its concentration (depending on the tissue) at 30 min remained after 24 hr; measurable values existed for as long as 120 hr. The administration of multiple drops led to continued accumulation of benzalkonium chloride. .

Intended for local use only, no systemic absorption.

Half Life

Intended for local use only, no systemic absorption.

Clearance

Intended for local use only, no systemic absorption.

Elimination Route

Administered benzalkonium chloride is likely eliminated largely in faeces, similar to other quaternary ammonium compounds .

Intended for local use only, no systemic absorption.

About 10% is excreted unchanged in the urine.

Pregnancy & Breastfeeding use

There is no direct evidence of the safety in pregnant and lactating mother. Coal tar preparations have been in use for many years without apparent ill-consequence. No harmful effects on the health of the child is anticipated with the proper use of coal tar. However it is recommended that the use of coal tar in pregnancy and lactation is restricted to intermittent use in low concentrations on a small percentage of body’s surface, use during the first trimester be avoided.

Pregnancy Category C. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.

Contraindication

Incompatible with soaps and other anionic surfactants, citrates, iodides, nitrates, permanganates, salicylates, silver salts, tartrates, and zinc oxide and sulfate.

Coal Tar should not be used when a patient has known sensitivity to Coal Tar or any of the other ingredients. If you have folliculitis and acne vulgaris. Coal Tar Cream should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or allergy to sunlight. Coal Tar Cream should not be applied to inflamed or broken skin. Warnings and precautions: For topical administration only. Coal Tar Cream may cause skin irritation, should this occur the treatment should be reviewed and if necessary discontinued. Coal Tar enhances photosensitivity of the skin after applying Coal Tar Cream exposure to direct sunlight should be avoided. Use with care near the eyes and mucous membranes. If any emulsion should accidentally enter the eye, flush with normal saline solution or water. Do not apply to genital and rectal areas. Apply with caution to the face do not get in the eyes. Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic reactions that might be cause a delayed reaction.

It should not be used in any patient known to be sensitive to Salicylic Acid or any other listed ingredients.

Special Warning

Salicylic Acid is used in children over 2 years.

Acute Overdose

There is no evidence that an overdose of topical Coal Tar Cream would be harmful other than a hypersensitivity to coal tar. Ingestion of Coal Tar Cream may require gastric lavage depending on the quantity taken and should be treated symptomatically.

An overdose of Salicylic Acid topical is unlikely to occur. If you do suspect an overdose or if the medication has been ingested, call a poison control center or emergency room for advice.

Storage Condition

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Store in a cool and dry place, protected from light.

Store at a temperature below 25° C.

Innovators Monograph

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