Corti Jaikal

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Corti Jaikal uses

Corti Jaikal consists of Hydrocortisone Acetate, Salicylic Acid, Sodium Thiosulfate.

Hydrocortisone Acetate:


1 INDICATIONS AND USAGE

Corti Jaikal (Hydrocortisone Acetate)® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

PANDEL® (hydrocortisone probutate) Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

2 DOSAGE AND ADMINISTRATION

Apply a thin film of Corti Jaikal (Hydrocortisone Acetate) to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.

Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).

Discontinue Corti Jaikal (Hydrocortisone Acetate) when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Do not use Corti Jaikal (Hydrocortisone Acetate) with occlusive dressings unless directed by the physician. Do not apply Corti Jaikal (Hydrocortisone Acetate) in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

- For topical use.

- Apply a thin film to the affected skin areas once daily or twice a day.

- Discontinue therapy when control is achieved.

- If no improvement is seen within 2 weeks, reassess diagnosis.

- Do not use with occlusive dressings unless directed by a physician.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1%. Each gram of Corti Jaikal (Hydrocortisone Acetate) contains 1 mg of Corti Jaikal (Hydrocortisone Acetate) probutate in a cream base.

Cream, 0.1%.

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4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

- Corti Jaikal can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)

- Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)

- Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)

- High potency corticosteroids, large treatment surface area, prolong use, use of occlusion dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)

- Modify use if HPA axis suppression develops. (5.1)

- Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Corti Jaikal (Hydrocortisone Acetate) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with Corti Jaikal (Hydrocortisone Acetate) twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown [see Clinical Pharmacology ( 12.2 )].

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )].

5.2 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. If irritation develops, discontinue Corti Jaikal (Hydrocortisone Acetate) and institute appropriate therapy.

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6 ADVERSE REACTIONS

- Most frequent adverse reactions include burning, stinging, rash, papulovesicular rash, redness, itching, moderate paresthesia, and contact dermatitis.

To report SUSPECTED ADVERSE REACTIONS, contact PharmaDerm®, A division of Fougera Pharmaceuticals Inc. at 1-800-645-9833 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 most frequent adverse reactions reported for Corti Jaikal (Hydrocortisone Acetate) during clinical trials were application site reactions, including burning in 4, stinging in 2, and moderate paresthesia in 1 out of 226 subjects.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Corti Jaikal (Hydrocortisone Acetate) because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are as follows:

Skin and Subcutaneous Tissue Disorders: rash, papulovesicular rash

Application Site Reactions: dryness, erythema, pruritus, allergic contact dermatitis.

The following local adverse reactions are reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There is no clinical information on Corti Jaikal use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, Corti Jaikal (Hydrocortisone Acetate) probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Effects on embryo-fetal development were evaluated in rats and rabbits following subcutaneous administration of Corti Jaikal (Hydrocortisone Acetate) probutate during the period of organogenesis. Corti Jaikal (Hydrocortisone Acetate) probutate was teratogenic in rats when given during the period of organogenesis at subcutaneous doses equal to or greater than 1 mg/kg/day (12 times the human average topical dose of Corti Jaikal (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Abnormalities included delayed ossification of the caudal vertebrae and other skeletal variations, cleft palate, umbilical hernia, edema, and exencephalia.

In rabbits, Corti Jaikal (Hydrocortisone Acetate) probutate given by the subcutaneous route was teratogenic at doses equal to or greater than 0.1 mg/kg/day (2 times the human average topical dose of Corti Jaikal (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Fetal weight and survival were affected. Delayed ossification and increased incidences of malformations (skeletal abnormalities and cleft palate) were also noted.

No adverse effects were seen in rats following subcutaneous administration of up to 1 mg/kg/day of Corti Jaikal (Hydrocortisone Acetate) probutate during the perinatal and postnatal period (12 times the human average topical dose of Corti Jaikal (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual).

8.2 Lactation

Risk Summary

There is no information on the presence of Corti Jaikal (Hydrocortisone Acetate) probutate in breast milk, or on its effects on the breastfed infant or on milk production. It is not known whether topical administration of Corti Jaikal (Hydrocortisone Acetate) could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Corti Jaikal (Hydrocortisone Acetate) and any potential adverse effects on the breastfed infant from Corti Jaikal (Hydrocortisone Acetate) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use Corti Jaikal (Hydrocortisone Acetate) on the smallest area of skin and for the shortest duration possible while breastfeeding.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

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11 DESCRIPTION

Corti Jaikal (Hydrocortisone Acetate)(hydrocortisone probutate) Cream, 0.1% contains Corti Jaikal (Hydrocortisone Acetate) probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Corti Jaikal (Hydrocortisone Acetate) probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11β,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is:

Molecular Formula: C28H40O7

Molecular Weight: 488.62

Each gram of Corti Jaikal (Hydrocortisone Acetate) (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of Corti Jaikal (Hydrocortisone Acetate) probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown

12.2 Pharmacodynamics

Vasoconstrictor Assay

Studies performed with Corti Jaikal indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

In an open label HPA axis suppression trial, 19 adult subjects (ages 23 to 82 years) with atopic dermatitis or plaque psoriasis covering greater than 20% Body Surface Area (BSA) were treated with Corti Jaikal (Hydrocortisone Acetate) twice daily for 21 days and were assessed for HPA axis suppression. At baseline, the mean disease BSA involvement was 36%. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation. Of these subjects, 15 were considered evaluable with respect to their adrenal axis function post-treatment. One of the evaluable subjects (6.7%) showed laboratory evidence of suppression on Day 22. This subject had psoriasis covering 48% of BSA at baseline and was reported to have received 98% of the twice-daily applications of Corti Jaikal (Hydrocortisone Acetate) over the 21 day treatment period. It is not known if this subject had recovery of adrenal function because follow-up testing was not performed.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with Corti Jaikal (Hydrocortisone Acetate) for up to 24 hours has not been shown to increase penetration; however, occlusion of Corti Jaikal (Hydrocortisone Acetate) for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Corti Jaikal (Hydrocortisone Acetate) probutate.

Corti Jaikal (Hydrocortisone Acetate) probutate revealed no evidence of mutagenic or clastogenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay).

Effects on fertility and early embryonic development were evaluated in rats following subcutaneous administration of up to 0.4 mg/kg/day Corti Jaikal (Hydrocortisone Acetate) probutate (5 times the human average topical dose of Corti Jaikal (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual) prior to and during mating and through early pregnancy. No treatment related effects on fertility or mating parameters were noted in this study.

16 HOW SUPPLIED/STORAGE AND HANDLING

Corti Jaikal (Hydrocortisone Acetate), a white to off-white opaque cream is supplied as follows:

45 g tubes NDC 10337-153-46

80 g tubes NDC 10337-153-80

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).

Inform patients and/or caregivers of the following:

  • Discontinue therapy when control is achieved unless directed otherwise by the physician.
  • If no improvement is seen within two weeks, contact the physician.
  • Avoid contact with the eyes.
  • Do not use with occlusive dressing unless directed by the physician.
  • Report any signs or symptoms of local or systemic adverse reactions to the physician.
  • Do not treat diaper dermatitis. Do not apply Corti Jaikal (Hydrocortisone Acetate) in the diaper area as diapers or plastic pants may constitute occlusive dressings.
  • Do not use on the face, underarms, or groin areas unless directed by the physician.
  • Advise a woman to use Corti Jaikal (Hydrocortisone Acetate) on the smallest area of skin and for the shortest duration possible while breastfeeding.

Manufactured by:

PharmaDerm®

A division of Fougera

PHARMACEUTICALS INC.

Melville, New York 11747 www.pharmaderm.com


PATIENT INFORMATION

Corti Jaikal (Hydrocortisone Acetate)® (pan-del)

(hydrocortisone probutate)

cream


Important: Corti Jaikal (Hydrocortisone Acetate) is for use on skin only (topical). Avoid using Corti Jaikal (Hydrocortisone Acetate) near or around your eyes.


What is Corti Jaikal (Hydrocortisone Acetate)?

Corti Jaikal (Hydrocortisone Acetate) is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in people 18 years of age or older.

It is not known if Corti Jaikal (Hydrocortisone Acetate) is safe and effective in children.


Before using Corti Jaikal (Hydrocortisone Acetate) tell your healthcare provider about all of your medical conditions, including if you:

- have adrenal gland problems

- have liver problems

- have diabetes

- have thinning skin (atrophy) at the site to be treated.

- are pregnant or plan to become pregnant. It is not known if Corti Jaikal (Hydrocortisone Acetate) will harm your unborn baby.

- are breastfeeding or plan to breastfeed. It is not known if Corti Jaikal (Hydrocortisone Acetate) can pass into your breast milk and harm your baby.

  • o If you breastfeed during treatment with Corti Jaikal (Hydrocortisone Acetate), clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of Corti Jaikal (Hydrocortisone Acetate) with your baby’s skin.
  • o You should use Corti Jaikal (Hydrocortisone Acetate) on the smallest area of skin and for the shortest time possible while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


How should I use Corti Jaikal (Hydrocortisone Acetate)?

- Use Corti Jaikal (Hydrocortisone Acetate) exactly as your healthcare provider tells you to use it.

- Apply a thin film to the affected skin area. Gently rub Corti Jaikal (Hydrocortisone Acetate) into your skin until it disappears.

- Tell your healthcare provider if your symptoms do not improve after 2 weeks of treatment.

- Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to.

- Do not apply Corti Jaikal (Hydrocortisone Acetate) in the diaper area or use with plastic pants.

- Do not use Corti Jaikal (Hydrocortisone Acetate) on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.

- Wash your hands after applying Corti Jaikal (Hydrocortisone Acetate), unless your hands are being treated.


What are possible side effects with Corti Jaikal (Hydrocortisone Acetate)?

Corti Jaikal (Hydrocortisone Acetate) may cause serious side effects, including:

- Corti Jaikal (Hydrocortisone Acetate) can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Corti Jaikal (Hydrocortisone Acetate) for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Corti Jaikal (Hydrocortisone Acetate).

- Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skinreactions such as pain, tenderness, swelling, or healing problems.

The most common side effects of Corti Jaikal (Hydrocortisone Acetate) include burning and stinging and moderate tingling or prickling feeling.

These are not all the possible side effects with Corti Jaikal (Hydrocortisone Acetate). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


How should I store Corti Jaikal (Hydrocortisone Acetate)?

- Store Corti Jaikal (Hydrocortisone Acetate) between 68°F to 77°F (20°C to 25°C).

Keep Corti Jaikal (Hydrocortisone Acetate) and all medicines out of the reach of children.


General information about the safe and effective use of Corti Jaikal (Hydrocortisone Acetate).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Corti Jaikal (Hydrocortisone Acetate) for a condition for which it was not prescribed. Do not give Corti Jaikal (Hydrocortisone Acetate) to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Corti Jaikal (Hydrocortisone Acetate) that is written for health professionals.


What are the ingredients in Corti Jaikal (Hydrocortisone Acetate)?

Active ingredient: Corti Jaikal (Hydrocortisone Acetate) probutate

Inactive ingredients: propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Manufactured by:PharmaDerm® A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747

For more information, go to www.pharmaderm.com or call 1-800-645-9833.

  • This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 01/2017

PharmaDerm®

NDC 10337-153-80

Corti Jaikal (Hydrocortisone Acetate)®

(hydrocortisone probutate) Cream, 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

80 g

carton

Salicylic Acid:


Pharmacological action

Corti Jaikal is pharmaceytical active ingredient for topical use. Inhibits the secretion of the sebaceous and sweat glands. At low concentrations it has keratoplastic and in high doses keratolytic effect. Corti Jaikal (Salicylic Acid) has a weak antimicrobial activity.

Why is Corti Jaikal (Salicylic Acid) prescribed?

Monotherapy with Corti Jaikal (Salicylic Acid) and as part of combination therapies for inflammatory, infectious and other skin lesions, including burns, psoriasis, eczema, dyskeratosis, ichthyosis, acne vulgaris, warts, hyperkeratosis, corn, callus, oily seborrhea, scaly skin disease, hair loss, sweating feet.

Dosage and administration

Corti Jaikal is applied to the skin surface 2-3 times / day.

Corti Jaikal (Salicylic Acid) side effects, adverse reactions

Rarely: local reactions such as itching, burning, skin rashes, allergic reactions.

Corti Jaikal contraindications

Hypersensitivity to Corti Jaikal (Salicylic Acid), renal failure, infancy.

Special instructions

The composition of the solution for topical use include ethanol.

Corti Jaikal drug interactions

Corti Jaikal (Salicylic Acid) is pharmaceutically not compatible with resorcinol (forms melted mixture) and zinc oxide (forms insoluble forms of zinc salicylate).

Sodium Thiosulfate:


1 INDICATIONS AND USAGE

Corti Jaikal is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be life-threatening. (1)

  • Use with caution if the diagnosis of cyanide poisoning is uncertain. (1)

1.1 Indication

Corti Jaikal (Sodium Thiosulfate) Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Corti Jaikal (Sodium Thiosulfate) Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

1.2 Identifying Patients with Cyanide Poisoning

Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.

The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Corti Jaikal Injection and Sodium Nitrite Injection should be administered without delay.

Symptoms Signs
  • Headache
  • Confusion
  • Dyspnea
  • Chest Tightness
  • Nausea
  • Altered Mental Status

    (e.g., confusion, disorientation)

  • Seizures or Coma
  • Mydriasis
  • Tachypnea/Hyperpnea (early)
  • Bradypnea/Apnea (late)
  • Hypertension (early)/ Hypotension (late)
  • Cardiovascular Collapse
  • Vomiting
  • Plasma Lactate Concentration ≥ 8 mmol/L

In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.

The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.

Smoke Inhalation

Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Corti Jaikal (Sodium Thiosulfate) Injection smoke-inhalation victims should be assessed for the following:

  • Exposure to fire or smoke in an enclosed area
  • Presence of soot around the mouth, nose, or oropharynx
  • Altered mental status

Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.

1.3 Use with Other Cyanide Antidotes

Caution should be exercised when administering cyanide antidotes, other than sodium nitrite, simultaneously with Corti Jaikal (Sodium Thiosulfate) Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than sodium nitrite, with Corti Jaikal (Sodium Thiosulfate) Injection, these drugs should not be administered concurrently in the same IV line. [see Dosage and Administration (2.2) ]

2 DOSAGE AND ADMINISTRATION

Age Intravenous Dose of Sodium Nitrite and Corti Jaikal
Adults
  • Sodium Nitrite -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute
  • Corti Jaikal (Sodium Thiosulfate) - 50 mL of Corti Jaikal (Sodium Thiosulfate) immediately following administration of sodium nitrite.
Children
  • Sodium Nitrite - 0.2 mL/kg (6 mg/kg or 6-8 mL/m2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL
  • Corti Jaikal (Sodium Thiosulfate) - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite.

Redosing: If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and Corti Jaikal (Sodium Thiosulfate).

Monitoring: Blood pressure must be monitored during treatment. (2.2)

2.1 Administration Recommendation

Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Administration of sodium nitrite and Corti Jaikal (Sodium Thiosulfate) should be considered adjunctive to appropriate supportive therapies. Airway, ventilatory and circulatory support, and oxygen administration should not be delayed to administer sodium nitrite and Corti Jaikal (Sodium Thiosulfate).

Sodium nitrite injection and Corti Jaikal (Sodium Thiosulfate) injection are administered by slow intravenous injection. They should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Sodium nitrite should be administered first, followed immediately by Corti Jaikal (Sodium Thiosulfate). Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted.

Age Intravenous Dose of Sodium Nitrite and Corti Jaikal (Sodium Thiosulfate)
Adults
  • Sodium Nitrite -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute
  • Corti Jaikal (Sodium Thiosulfate) - 50 mL of Corti Jaikal (Sodium Thiosulfate) immediately following administration of sodium nitrite.
Children
  • Sodium Nitrite -0.2 mL/kg (6 mg/kg or 6-8 mL/m2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL
  • Corti Jaikal (Sodium Thiosulfate) - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite.

NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and Corti Jaikal (Sodium Thiosulfate).

In adult and pediatric patients with known anemia, it is recommended that the dosage of sodium nitrite should be reduced proportionately to the hemoglobin concentration.

All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.2 Recommended Monitoring

Patients should be monitored for at least 24-48 hours after Corti Jaikal Injection administration for adequacy of oxygenation and perfusion and for recurrent signs and symptoms of cyanide toxicity. When possible, hemoglobin/hematocrit should be obtained when treatment is initiated. Measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on measured PO2 are unreliable in the presence of methemoglobinemia.

2.3 Incompatibility Information

Chemical incompatibility has been reported between Corti Jaikal (Sodium Thiosulfate) Injection and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between Corti Jaikal (Sodium Thiosulfate) and sodium nitrite, when administered sequentially through the same IV line as described in Dosage and Administration.

3 DOSAGE FORMS AND STRENGTHS

Corti Jaikal (Sodium Thiosulfate) Injection consists of:

  • One vial of Corti Jaikal (Sodium Thiosulfate) injection USP 12.5 grams/50 mL (250 mg/mL)

Administration of the contents of one vial constitutes a single dose.

  • Injection, 12.5 grams/50 mL (250 mg/mL). (3)

4 CONTRAINDICATIONS

None

  • None. (4)

5 WARNINGS AND PRECAUTIONS

  • Sulfites: Corti Jaikal may contain trace impurities of sodium sulfite (5.1)

5.1 Sulfites

Corti Jaikal (Sodium Thiosulfate) drug product may contain trace impurities of sodium sulfite. The presence of a trace amount of sulfites in this product should not deter administration of the drug for treatment of emergency situations, even if the patient is sulfite-sensitive.

6 ADVERSE REACTIONS

There have been no controlled clinical trials conducted to systematically assess the adverse events profile of Corti Jaikal (Sodium Thiosulfate).

The medical literature has reported the following adverse events in association with Corti Jaikal (Sodium Thiosulfate) administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.

Cardiovascular system: hypotension

Central nervous system: headache, disorientation

Gastrointestinal system: nausea, vomiting

Hematological: prolonged bleeding time

Body as a Whole: salty taste in mouth, warm sensation over body

In humans, rapid administration of concentrated solutions or solutions not freshly prepared, and administration of large doses of Corti Jaikal (Sodium Thiosulfate) have been associated with a higher incidence of nausea and vomiting. However, administration of 0.1 g Corti Jaikal (Sodium Thiosulfate) per pound up to a maximum of 15 g in a 10-15% solution over 10-15 minutes was associated with nausea and vomiting in 7 of 26 patients without concomitant cyanide intoxication.

In a series of 11 human subjects, a single intravenous infusion of 50 mL of 50% Corti Jaikal (Sodium Thiosulfate) was associated with increases in clotting time 1-3 days after administration. However, no significant changes were observed in other hematological parameters.

Most common adverse reactions are:

  • Hypotension, headache, disorientation (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 DRUG INTERACTIONS

Formal drug interaction studies have not been conducted with Corti Jaikal (Sodium Thiosulfate) Injection.

8 USE IN SPECIFIC POPULATIONS

  • Renal impairment: Corti Jaikal is substantially excreted by the kidney. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. (8.6).

8.1 Pregnancy

Teratogenic Effects. Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Corti Jaikal (Sodium Thiosulfate) Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

There are no reported epidemiological studies of congenital anomalies in infants born to women treated with Corti Jaikal (Sodium Thiosulfate) during pregnancy. In animal studies, there are no teratogenic effects in offspring of hamsters treated during pregnancy with Corti Jaikal (Sodium Thiosulfate) in doses similar to those given intravenously to treat cyanide poisoning in humans. Other studies suggest that treatment with Corti Jaikal (Sodium Thiosulfate) ameliorates the teratogenic effects of maternal cyanide poisoning in hamsters. In other studies, Corti Jaikal (Sodium Thiosulfate) was not embryotoxic or teratogenic in mice, rats, hamsters, or rabbits at maternal doses of up to 550, 400, 400 and 580 mg/kg/day, respectively.

8.3 Nursing Mothers

It is not known whether Corti Jaikal is excreted in human milk. Because Corti Jaikal (Sodium Thiosulfate) Injection may be administered in life-threatening situations, breast-feeding is not a contraindication to its use. Because many drugs are excreted in human milk, caution should be exercised following Corti Jaikal (Sodium Thiosulfate) Injection administration to a nursing woman. There are no data to determine when breastfeeding may be safely restarted following administration of Corti Jaikal (Sodium Thiosulfate).

8.4 Pediatric Use

There are case reports in the medical literature of sodium nitrite in conjunction with Corti Jaikal (Sodium Thiosulfate) being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of Corti Jaikal (Sodium Thiosulfate) in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.

8.5 Geriatric Use

Corti Jaikal is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Renal Disease

Corti Jaikal (Sodium Thiosulfate) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

10 OVERDOSAGE

There is limited information about the effects of large doses of Corti Jaikal (Sodium Thiosulfate) in humans. Oral administration of 3 g Corti Jaikal (Sodium Thiosulfate) per day for 1-2 weeks in humans resulted in reductions in room air arterial oxygen saturation to as low as 75%, which was due to a rightward shift in the oxygen hemoglobin dissociation curve. The subjects returned to baseline oxygen saturations 1 week after discontinuation of Corti Jaikal (Sodium Thiosulfate). A single intravenous administration of 20 mL of 10% Corti Jaikal (Sodium Thiosulfate) reportedly did not change oxygen saturations.

11 DESCRIPTION

Corti Jaikal (Sodium Thiosulfate) has the chemical name thiosulfuric acid, disodium salt, pentahydrate. The chemical formula is Na2S2O3- 5H2O and the molecular weight is 248.17. The structural formula is:

Structure of Corti Jaikal (Sodium Thiosulfate) Pentahydrate

Corti Jaikal (Sodium Thiosulfate) Injection is a cyanide antidote which contains one 50 mL glass vial containing a 25% solution of Corti Jaikal (Sodium Thiosulfate) injection.

Corti Jaikal (Sodium Thiosulfate) injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 12.5 grams of Corti Jaikal (Sodium Thiosulfate) in 50 mL solution (250 mg/mL). Each mL also contains 2.8 mg boric acid and 4.4 mg of potassium chloride. The pH of the solution is adjusted with boric acid and/or sodium hydroxide. Corti Jaikal (Sodium Thiosulfate) injection is a clear solution with a pH between 7.5 and 9.5.

Chemical Structure Figure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.

The synergy resulting from treatment of cyanide poisoning with the combination of sodium nitrite and Corti Jaikal is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.

Sodium Nitrite

Sodium nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a3, forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows:

NaNO2 + Hemoglobin → Methemoglobin

HCN + Methemoglobin → Cyanomethemoglobin

Vasodilation has also been cited to account for at least part of the therapeutic effect of sodium nitrite. It has been suggested that sodium nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, sodium nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue.

Corti Jaikal (Sodium Thiosulfate)

The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN-), which is relatively nontoxic and readily excreted in the urine. Corti Jaikal (Sodium Thiosulfate) is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction:

12. 2 Pharmacodynamics

In dogs, pretreatment with Corti Jaikal (Sodium Thiosulfate) to achieve a steady state level of 2 µmol/mL increased the rate of conversion of cyanide to thiocyanate over 30-fold.

12.3 Pharmacokinetics

Corti Jaikal (Sodium Thiosulfate)

Thiosulfate taken orally is not systemically absorbed. Most of the thiosulfate is oxidized to sulfate or is incorporated into endogenous sulphur compounds; a small proportion is excreted through the kidneys. Approximately 20-50% of exogenously administered thiosulfate is eliminated unchanged via the kidneys. After an intravenous injection of 1 g Corti Jaikal (Sodium Thiosulfate) in patients, the reported serum thiosulfate half-life was approximately 20 minutes. However, after an intravenous injection of a substantially higher dose of Corti Jaikal (Sodium Thiosulfate) (150 mg/kg, that is, 9 g for 60 kg body weight) in normal healthy men, the reported elimination half-life was 182 minutes.

Cyanide

The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with sodium nitrite and Corti Jaikal (Sodium Thiosulfate) administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours.

Thiocyanate

After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the potential carcinogenicity of Corti Jaikal.

Mutagenesis:

The mutagenic potential of Corti Jaikal (Sodium Thiosulfate) has been examined in the in vitro Bacterial Reverse Mutation Assay (Ames Assay). Corti Jaikal (Sodium Thiosulfate) was not mutagenic in the absence of metabolic activation in S. typhimurium strains TA98, TA100, TA1535, TA537, or TA1538. Corti Jaikal (Sodium Thiosulfate) was not mutagenic in the presence of metabolic activation in strains TA 98, TA1535, TA1537, TA1538 or E. coli strain WP2.

Fertility:

Clinical studies to evaluate the potential effects of Corti Jaikal (Sodium Thiosulfate) intake on fertility of either males or females have not been reported.

There are no preclinical studies examining the effects of Corti Jaikal (Sodium Thiosulfate) on fertility.

13.2 Animal Pharmacology

Due to the extreme toxicity of cyanide, experimental evaluation of treatment efficacy has predominantly been completed in animal models. The efficacy of Corti Jaikal (Sodium Thiosulfate) treatment alone to counteract the toxicity of cyanide was initially reported in 1895 by Lang. The efficacy of amyl nitrite treatment in cyanide poisoning of the dog model was first reported in 1888 by Pedigo. Further studies in the dog model, which demonstrated the utility of sodium nitrite as a therapeutic intervention, were reported in 1929 by Mladoveanu and Gheorghiu. However, Hugs and Chen et al. independently reported upon the superior efficacy of the combination of sodium nitrite and Corti Jaikal (Sodium Thiosulfate) in 1932-1933. Treatment consisted of intravenously administered 22.5 mg/kg (half the lethal dose) sodium nitrite or 1 g/kg Corti Jaikal (Sodium Thiosulfate) alone or in sequence immediately after subcutaneous injection of sodium cyanide into dogs over a range of doses. Subsequent doses of 10 mg/kg sodium nitrite and/or 0.5 g/kg Corti Jaikal (Sodium Thiosulfate) were administered when clinical signs or symptoms of poisoning persisted or reappeared. Either therapy administered alone increased the dose of sodium cyanide required to cause death, and when administered together, sodium nitrite and Corti Jaikal (Sodium Thiosulfate) resulted in a synergistic effect in raising the lethal dose of sodium cyanide. The combined therapy appeared to have reduced efficacy when therapy was delayed until signs of poisoning (e.g. convulsions) appeared; however, other investigators have reported survival in dogs that were administered antidotal treatment after respiratory arrest had occurred.

Animal studies conducted in other species (e.g., rat, guinea pig, sheep, pigeon and cat) have also supported a synergistic effect of intravenous sodium nitrite and Corti Jaikal (Sodium Thiosulfate) in the treatment of cyanide poisoning.

While intravenous injection of sodium nitrite and Corti Jaikal (Sodium Thiosulfate) was effective in reversing the effects of lethal doses of cyanide in dogs, intramuscular injection of sodium nitrite, with or without Corti Jaikal (Sodium Thiosulfate), was found not to be effective in the same setting.

14 CLINICAL STUDIES

The human data supporting the use of sodium nitrite for cyanide poisoning consists primarily of published case reports. There are no randomized controlled clinical trials. Nearly all the human data describing the use of Corti Jaikal (Sodium Thiosulfate) report its use in conjunction with sodium nitrite. Dosing recommendations for humans have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.

There have been no human studies to prospectively and systematically evaluate the safety of Corti Jaikal (Sodium Thiosulfate) or sodium nitrite in humans. Available human safety information is based largely on anecdotal case reports and case series of limited scope.

16 HOW SUPPLIED/STORAGE AND HANDLING

Each Corti Jaikal (Sodium Thiosulfate) carton (NDC 60267-705-50) consists of the following:

  • One 50 mL glass vial of Corti Jaikal (Sodium Thiosulfate) injection 250 mg/mL (containing 12.5 grams of Corti Jaikal (Sodium Thiosulfate));

Storage

Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F).

Protect from direct light. Do not freeze.

(Note: Sodium Nitrite must be obtained separately.)

17 PATIENT COUNSELING INFORMATION

Corti Jaikal Injection is indicated for cyanide poisoning and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information.

17.1 Hypotension

When feasible, patients should be informed of the possibility of hypotension.

17.2 Monitoring

Where feasible, patients should be informed of the need for close monitoring of blood pressure and oxygenation.

Manufactured by Cangene BioPharma, Inc., Baltimore, Maryland 21230 for

Hope Pharmaceuticals, Scottsdale, Arizona 85260

PRINCIPAL DISPLAY PANEL - 50 mL Vial Carton

NDC 60267-705-50

Rx Only

Corti Jaikal (Sodium Thiosulfate)

Injection, USP

12.5 grams/50 mL

(250 mg/mL)

FOR INTRAVENOUS USE

SINGLE USE ONLY

Any unused portion of a vial

should be discarded.

Use with

Sodium Nitrite

for Treatment of

Cyanide Poisoning

Manufactured by

CANGENE bioPharma, Inc.

Baltimore, MD for

HOPE

PHARMACEUTICALS ®

Scottsdale, AZ 85260 U.S.A.

Principal Display Panel - 50 mL Vial Carton

Corti Jaikal pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Corti Jaikal available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Corti Jaikal destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Corti Jaikal Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Corti Jaikal pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."IMMEDIATE COMFORT BIOELEMENTS (HYDROCORTISONE ACETATE) LOTION [BIOELEMENTS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."SODIUM THIOSULFATE INJECTION, SOLUTION [HOPE PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."NEUTROGENA RAPID CLEAR 7 DAY ACNE INTERVENTION (SALICYLIC ACID) KIT [NEUTROGENA CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Corti Jaikal?

Depending on the reaction of the Corti Jaikal after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Corti Jaikal 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 Corti Jaikal 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 Corti Jaikal, 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 Corti Jaikal 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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