Special Formula 17900-Forte

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Special Formula 17900-Forte uses

Special Formula 17900-Forte consists of Dihydrostreptomycin Sulfate, Hydrocortisone Acetate, Hydrocortisone Sodium Succinate, Novobiocin Sodium, Penicillin G Procaine, Polymyxin B Sulfate.

Hydrocortisone Acetate:


1 INDICATIONS AND USAGE

Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Do not use Special Formula 17900-Forte (Hydrocortisone Acetate) with occlusive dressings unless directed by the physician. Do not apply Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) contains 1 mg of Special Formula 17900-Forte (Hydrocortisone Acetate) probutate in a cream base.

Cream, 0.1%.

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4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

- Special Formula 17900-Forte 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

Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) probutate during the period of organogenesis. Special Formula 17900-Forte (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 Special Formula 17900-Forte (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, Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) probutate during the perinatal and postnatal period (12 times the human average topical dose of Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) and any potential adverse effects on the breastfed infant from Special Formula 17900-Forte (Hydrocortisone Acetate) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use Special Formula 17900-Forte (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

Special Formula 17900-Forte (Hydrocortisone Acetate)(hydrocortisone probutate) Cream, 0.1% contains Special Formula 17900-Forte (Hydrocortisone Acetate) probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of Special Formula 17900-Forte (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 Special Formula 17900-Forte 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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) for up to 24 hours has not been shown to increase penetration; however, occlusion of Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) probutate.

Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) probutate (5 times the human average topical dose of Special Formula 17900-Forte (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

Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (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

Special Formula 17900-Forte (Hydrocortisone Acetate)® (pan-del)

(hydrocortisone probutate)

cream


Important: Special Formula 17900-Forte (Hydrocortisone Acetate) is for use on skin only (topical). Avoid using Special Formula 17900-Forte (Hydrocortisone Acetate) near or around your eyes.


What is Special Formula 17900-Forte (Hydrocortisone Acetate)?

Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) is safe and effective in children.


Before using Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) will harm your unborn baby.

- are breastfeeding or plan to breastfeed. It is not known if Special Formula 17900-Forte (Hydrocortisone Acetate) can pass into your breast milk and harm your baby.

  • o If you breastfeed during treatment with Special Formula 17900-Forte (Hydrocortisone Acetate), clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of Special Formula 17900-Forte (Hydrocortisone Acetate) with your baby’s skin.
  • o You should use Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate)?

- Use Special Formula 17900-Forte (Hydrocortisone Acetate) exactly as your healthcare provider tells you to use it.

- Apply a thin film to the affected skin area. Gently rub Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) in the diaper area or use with plastic pants.

- Do not use Special Formula 17900-Forte (Hydrocortisone Acetate) on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.

- Wash your hands after applying Special Formula 17900-Forte (Hydrocortisone Acetate), unless your hands are being treated.


What are possible side effects with Special Formula 17900-Forte (Hydrocortisone Acetate)?

Special Formula 17900-Forte (Hydrocortisone Acetate) may cause serious side effects, including:

- Special Formula 17900-Forte (Hydrocortisone Acetate) can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Special Formula 17900-Forte (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 Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) include burning and stinging and moderate tingling or prickling feeling.

These are not all the possible side effects with Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate)?

- Store Special Formula 17900-Forte (Hydrocortisone Acetate) between 68°F to 77°F (20°C to 25°C).

Keep Special Formula 17900-Forte (Hydrocortisone Acetate) and all medicines out of the reach of children.


General information about the safe and effective use of Special Formula 17900-Forte (Hydrocortisone Acetate).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Special Formula 17900-Forte (Hydrocortisone Acetate) for a condition for which it was not prescribed. Do not give Special Formula 17900-Forte (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 Special Formula 17900-Forte (Hydrocortisone Acetate) that is written for health professionals.


What are the ingredients in Special Formula 17900-Forte (Hydrocortisone Acetate)?

Active ingredient: Special Formula 17900-Forte (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

Special Formula 17900-Forte (Hydrocortisone Acetate)®

(hydrocortisone probutate) Cream, 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

80 g

carton

Hydrocortisone Sodium Succinate:


1 INDICATIONS AND USAGE

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)® (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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Do not use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) with occlusive dressings unless directed by the physician. Do not apply Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) contains 1 mg of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate in a cream base.

Cream, 0.1%.

4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

- Special Formula 17900-Forte 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

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) and institute appropriate therapy.

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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There is no clinical information on Special Formula 17900-Forte use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate during the period of organogenesis. Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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, Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate during the perinatal and postnatal period (12 times the human average topical dose of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate in breast milk, or on its effects on the breastfed infant or on milk production. It is not known whether topical administration of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) and any potential adverse effects on the breastfed infant from Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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.

11 DESCRIPTION

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)(hydrocortisone probutate) Cream, 0.1% contains Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) for up to 24 hours has not been shown to increase penetration; however, occlusion of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate.

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) probutate (5 times the human average topical dose of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate), 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)® (pan-del)

(hydrocortisone probutate)

cream


Important: Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) is for use on skin only (topical). Avoid using Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) near or around your eyes.


What is Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)?

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) is safe and effective in children.


Before using Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) will harm your unborn baby.

- are breastfeeding or plan to breastfeed. It is not known if Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) can pass into your breast milk and harm your baby.

  • o If you breastfeed during treatment with Special Formula 17900-Forte (Hydrocortisone Sodium Succinate), clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) with your baby’s skin.
  • o You should use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)?

- Use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) exactly as your healthcare provider tells you to use it.

- Apply a thin film to the affected skin area. Gently rub Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) in the diaper area or use with plastic pants.

- Do not use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.

- Wash your hands after applying Special Formula 17900-Forte (Hydrocortisone Sodium Succinate), unless your hands are being treated.


What are possible side effects with Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)?

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) may cause serious side effects, including:

- Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate).

- 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) include burning and stinging and moderate tingling or prickling feeling.

These are not all the possible side effects with Special Formula 17900-Forte (Hydrocortisone Sodium Succinate). 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)?

- Store Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) between 68°F to 77°F (20°C to 25°C).

Keep Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) and all medicines out of the reach of children.


General information about the safe and effective use of Special Formula 17900-Forte (Hydrocortisone Sodium Succinate).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) for a condition for which it was not prescribed. Do not give Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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 Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) that is written for health professionals.


What are the ingredients in Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)?

Active ingredient: Special Formula 17900-Forte (Hydrocortisone Sodium Succinate) 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

Special Formula 17900-Forte (Hydrocortisone Sodium Succinate)®

(hydrocortisone probutate) Cream, 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

80 g

carton

Novobiocin Sodium:



For the Treatment of Subclinical Mastitis in Dry Cows

For Udder Instillation in Dry Cows Only

FOR USE IN ANIMALS ONLY-NOT FOR HUMAN USE

Restricted Drug-Use Only as Directed (California)

DESCRIPTION

Each 10 mL PLASTET® Disposable Syringe contains:
Special Formula 17900-Forte (Novobiocin Sodium) sodium equiv. to Special Formula 17900-Forte (Novobiocin Sodium) 400 mg
Penicillin G procaine 200,000 IU
Chlorobutanol anhydrous

(chloral derivative-used as a preservative)

in a special bland vehicle

50 mg

Manufactured by a non-sterilizing process.

INDICATIONS FOR USE

Special Formula 17900-Forte (Novobiocin Sodium) Suspension is indicated for the treatment, in dry cows only, of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.

WARNINGS

  • Do not use less than 30 days prior to calving.
  • Milk from treated cows must not be used for food during the first 72 hours after calving.
  • Treated animals must not be slaughtered for food for 30 days following udder infusion.

PRECAUTION

Administration of this product in any manner other than shown under DOSAGE may result in drug residues.

DOSAGE

Infuse one tube per quarter at start of dry period (but not less than 30 days prior to calving).

Shake Well Before Using

DIRECTIONS FOR USING THE FLEXI-TUBE® SYSTEM

The FLEXI-TUBE is designed to provide the choice of either insertion of the full cannula, as has traditionally been practiced, or insertion of no more than ⅛ inch of the cannula, as recommended by the National Mastitis Council.

  • Full Insertion: Remove the blue end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product.
  • Partial Insertion: Remove both the blue end cap and the red cannula by pushing sideways as shown. Gently insert the exposed blue tip into the teat canal; carefully infuse the product.
Figure a. Figure b.

ADMINISTRATION

At the time of drying off, but not less than 30 days prior to calving, milk the udder dry. Wash the teats and udder thoroughly with warm water containing a suitable dairy antiseptic. Dry the teats and udder thoroughly. Infuse each quarter using the following procedure. Using the alcohol pads provided, scrub each teat end clean using a separate pad for each teat. Warm Special Formula 17900-Forte (Novobiocin Sodium) Suspension to body temperature and shake thoroughly. Choose the desired insertion length (full or partial) and insert tip into teat canal. Instill entire contents into the quarter. Massage the udder after treatment to distribute the Special Formula 17900-Forte (Novobiocin Sodium) Suspension throughout the quarters. Using a suitable teat dip, dip all teats following treatment.

Discard Empty Container; DO NOT REUSE

KEEP OUT OF REACH OF CHILDREN

STORAGE CONDITIONS

Store at controlled room temperature 20° to 25° C (68° to 77° F).

HOW SUPPLIED

Special Formula 17900-Forte (Novobiocin Sodium) Suspension is available in unbroken packages of 12–10 mL PLASTET Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and unbroken packages of 144–10 mL PLASTET Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.

NADA #55-098, Approved by FDA

Made in the United Kingdom for

Zoetis Inc.

Kalamazoo, MI 49007 USA

By Norbrook Laboratories Limited

Newry, BT35 6JP, Northern Ireland

Revised: February 2013

002544I08

10 mL (.33 FI Oz) Suspension

Special Formula 17900-Forte (Novobiocin Sodium)®

Suspension

penicillin G procaine and Special Formula 17900-Forte (Novobiocin Sodium) sodium

DRY COW FORMULA

Penicillin G Procaine:


DESCRIPTION

Each syringe contains:

100,000 units of Special Formula 17900-Forte (Penicillin G Procaine), sesame oil 8.7g, calcium carbonate 0.089g, corn starch 0.089g, hydrogenated castor oil 0.044g.

INDICATIONS

This product is intended for the treatment of bovine mastitis in lactating cows. This product is effective against udder infection caused by the following susceptible microorganisms:

Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.

For the best results, it should be used promptly at the first signs of mastitis.

Signs of mastitis include:

  • Inflammation of the udder or teat. Inflammation may be recognized by redness, swelling, elevated temperature, or pain in the affected part.
  • Abnormal milk. Presence of flakes or clots in the milk, or milk of a watery character is usually indicative of a mastitis infection.
  • High white-cell counts. The routine use of the California Mastitis Test is encouraged. A high incidence of scores in excess of CMT 2 or a high CMT score on bulk milk samples may indicate a potential mastitis problem. In these situations a veterinarian should be consulted for definitive diagnosis and recommendations.

DIRECTIONS FOR USE

Dosage: The dose is 10mL of this product per infected quarter administered by intramammary infusion. Treatment may be repeated at intervals of 12 hours. Do not administer more than three consecutive doses.

Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy disinfectant. Dry thoroughly. The hands of the operator should be washed and dried before the administration of each treatment. Using the alcohol pads that are provided with each syringe wipe off teat, using a separate pad for each teat. Appropriate sanitation and management procedures to prevent and/or control bovine mastitis should be instituted.

When using this product remove plastic cover from tip of syringe and, while holding teat firmly, insert tip into streak canal; then push plunger and inject entire contents. After injection, grasp the end of the teat firmly, then gently massage the medication up the teat canal into the milk cistern.

Treated quarters should not be milked for at least six hours after treatment but should be milked at regular intervals thereafter. Treatment may be repeated at 12 hour intervals, up to a total of three doses, as indicated by the clinical response.

NOTE: Mastitis cannot be considered cured until bacteriologic examination of milk samples taken approximately three weeks after treatment demonstrates the absence of causative microorganisms.

WARNING

Discard all milk for 60 hours (5 milkings) after the latest treatment.

Animals intended for human consumption must not be slaughtered within 3 days of the last treatment with Masti-Clear®.

Use of this product in a manner other than as directed in the labeling might result in violative residues.

PRECAUTIONS

Keep out of reach of children. Discard empty container; do not reuse. It is a violation of Federal law to use Masti-Clear® in food-producing animals other than as directed in the labeling. If abnormal milk, redness, or swelling persists or increases, discontinue use and consult your veterinarian.

USER SAFETY WARNINGS

Penicillins can cause allergic reactions in sensitized individuals. Topical exposure to penicillin may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing.

Persons with known hypersensitivity to penicillin should avoid exposure to this product.

In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.

The material safety data sheet contains more detailed occupational safety information.

To report side effects in users, to obtain more information or to obtain a Material Safety Data Sheet, call 1-800-234-4263.

STORE AT CONTROLLED ROOM TEMPERATURE: 20˚-25˚C (68˚-77˚F)

RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED

THIS PRODUCT WAS MANUFACTURED BY A NON-STERILIZING PROCESS.

Manufactured By:

G.C. Hanford Mfg. Co.

Syracuse, NY 13201

NADA 65-081 APPROVED BY FDA

INS012LC 10 08/2011

NDC10515-014-10

MASTI-CLEAR®

Special Formula 17900-Forte (Penicillin G Procaine) in Sesame Oil

100,000 units/10mL Syringe

For Intramammary Infusion in Lactating Cows Only

Antibacterial

Single Dose Disposable Syringe

CONTENTS:

12-10 mL SYRINGES

12 Alcohol Pads

NDC10515-014-10

MASTI-CLEAR®

Special Formula 17900-Forte (Penicillin G Procaine) in Sesame Oil

100,000 units/10mL Syringe

For Intramammary Infusion in Lactating Cows Only

Antibacterial

Polymyxin B Sulfate:



To reduce the development of drug-resistant bacteria and maintain the effectiveness of Polymyxin and other antibacterial drugs, Special Formula 17900-Forte (Polymyxin B Sulfate) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNINGS

CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY, INTRAVENOUSLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN.

RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO Special Formula 17900-Forte (Polymyxin B Sulfate) SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG.

NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY.

THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH Special Formula 17900-Forte (Polymyxin B Sulfate) SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED.

THE NEUROTOXICITY OF Special Formula 17900-Forte (Polymyxin B Sulfate) SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS.

USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.

DESCRIPTION

Special Formula 17900-Forte (Polymyxin B Sulfate) Sulfate is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea). It has a potency of not less than 6000 Special Formula 17900-Forte (Polymyxin B Sulfate) units per mg, calculated on the anhydrous basis. The structural formulae are:

Special Formula 17900-Forte (Polymyxin B Sulfate) 1 (R=CH 3)            Polymyxin B 2 (R=H)

Each vial contains 500,000 Special Formula 17900-Forte (Polymyxin B Sulfate) units for parenteral or ophthalmic administration.

Special Formula 17900-Forte (Polymyxin B Sulfate) for Injection is in powder form suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.

In the medical literature, dosages have frequently been given in terms of equivalent weights of pure Special Formula 17900-Forte (Polymyxin B Sulfate) base. Each milligram of pure Special Formula 17900-Forte (Polymyxin B Sulfate) base is equivalent to 10,000 units of Special Formula 17900-Forte (Polymyxin B Sulfate) and each microgram of pure Special Formula 17900-Forte (Polymyxin B Sulfate) base is equivalent to 10 units of Special Formula 17900-Forte (Polymyxin B Sulfate).

Aqueous solutions of Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration. In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate should not be stored in alkaline solutions since they are less stable.

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CLINICAL PHARMACOLOGY

Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate has a bactericidal action against almost all gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of bacterial cell wall membranes. All gram-positive bacteria, fungi, and the gram-negative cocci, N gonorrhoeae and N meningitidis, are resistant.

Special Formula 17900-Forte (Polymyxin B Sulfate) has bactericidal action against almost all Gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of the bacterial cell membrane leading to death of the cell. All Gram-positive bacteria, fungi, and Gram-negative cocci, are resistant to Special Formula 17900-Forte (Polymyxin B Sulfate). Appropriate methods should be used when performing in vitro susceptibility testing of Special Formula 17900-Forte (Polymyxin B Sulfate) (1,2,3). The following in vitro susceptibility test criteria should only be used for interpreting the results of Special Formula 17900-Forte (Polymyxin B Sulfate) susceptibility testing against P. aeruginosa when the indicated quality control parameters are met during testing.

In vitro susceptibility test interpretive criteria for

Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate against Pseudomonas aeruginosa

Minimal Inhibitory Concentration

(MIC) (mcg/mL)

Disk Diffusion Interpretive

Criteria (mm) (300 unit disk)

Pathogen Susceptible Intermediate Resistant Susceptible Intermediate Resistant
Pseudomonas aeruginosa ≤2 4 ≥8 ≥12 - ≤11
In vitro susceptibility test quality control ranges for Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate against

Pseudomonas aeruginosa

Quality Control Organism

(ATCC* Number)

Minimum Inhibatory Concentration (MIC) Range (mcg/mL)

Disk Diffusion

Quality Control Range (300 unit disk) (mm)

Pseudomonas aeruginosa

(27853)

1 - 4 14 - 18

Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate is not absorbed from the normal alimentary tract. Since the drug loses 50 percent of its activity in the presence of serum, active blood levels are low. Repeated injections may give a cumulative effect. Levels tend to be higher in infants and children. The drug is excreted slowly by the kidneys. Tissue diffusion is poor and the drug does not pass the blood brain barrier into the cerebrospinal fluid. In therapeutic dosage, Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate causes some nephrotoxicity with tubule damage to a slight degree.

INDICATIONS AND USAGE

Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.

Special Formula 17900-Forte (Polymyxin B Sulfate) sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.

It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:

H influenzae, specifically meningeal infections.

Escherichia coli, specifically urinary tract infections.

Aerobacter aerogenes, specifically bacteremia.

Klebsiella pneumoniae, specifically bacteremia.

NOTE: IN MENINGEAL INFECTIONS, Special Formula 17900-Forte (Polymyxin B Sulfate) SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Special Formula 17900-Forte (Polymyxin B Sulfate) for Injection USP and other antibacterial drugs, Special Formula 17900-Forte (Polymyxin B Sulfate) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS

This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.

WARNINGS

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Special Formula 17900-Forte (Polymyxin B Sulfate) for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General.

Prescribing Special Formula 17900-Forte for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increase the risk of the development of drug-resistant bacteria.

See WARNING box.

Baseline renal function should be done prior to therapy, with frequent monitoring of renal function and blood levels of the drug during parenteral therapy.

Avoid concurrent use of a curariform muscle relaxant and other neurotoxic drugs (ether, tubocurarine, succinylcholine, gallamine, decamethonium and sodium citrate) which may precipitate respiratory depression. If signs of respiratory paralysis appear, respiration should be assisted as required, and the drug discontinued.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, appropriate therapy should be instituted.

Information for Patients

Information for Patients.

Patients should be counseled that antibacterial drugs including Special Formula 17900-Forte (Polymyxin B Sulfate) for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Special Formula 17900-Forte (Polymyxin B Sulfate) for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Special Formula 17900-Forte (Polymyxin B Sulfate) for injection or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

ADVERSE REACTIONS

See “WARNING” box.

Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage.

Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.

Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.

To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

DOSAGE AND ADMINISTRATION

PARENTERAL:

Intravenous. Dissolve 500,000 Special Formula 17900-Forte (Polymyxin B Sulfate) units in 300 to 500 mL solutions for parenteral dextrose injection 5 percent for continuous drip.

Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 Special Formula 17900-Forte (Polymyxin B Sulfate) units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1 percent.

Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.

Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 Special Formula 17900-Forte (Polymyxin B Sulfate) units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit.

Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.

TOPICAL:

Ophthalmic. Dissolve 500,000 Special Formula 17900-Forte (Polymyxin B Sulfate) units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.

For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.

Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.

Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.

HOW SUPPLIED

Special Formula 17900-Forte (Polymyxin B Sulfate) FOR INJECTION USP, 500,000 Special Formula 17900-Forte (Polymyxin B Sulfate) units per vial is available in single vial cartons NDC# 39822-0166-5.

Storage recommendations:

Before reconstitution: Store at 20° to 25°C (68° to 77°F).

Protect from light. Retain in carton until time of use.

After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.

Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex.

Manufactured for:

X-Gen Pharmaceuticals, Inc.

Big Flats, NY 14845

POLY-PI-06

Revised December 2012

REFERENCES

  • Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Test for Bacteria That Grow Aerobically; Approved Standard-8th edition. CLSI document M07-A8. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 2009.
  • CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-10th edition. CLSI document M02-A10, 2009.
  • Clinical Laboratory and Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21st Informational Supplement. CLSI document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.

Special Formula 17900-Forte 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.


Special Formula 17900-Forte 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.


Special Formula 17900-Forte 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.


Special Formula 17900-Forte 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.


Special Formula 17900-Forte 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."SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."VETRIPEN G (PENICILLIN G PROCAINE) INJECTION, SUSPENSION [VETONE]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Special Formula 17900-Forte?

Depending on the reaction of the Special Formula 17900-Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Special Formula 17900-Forte 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 Special Formula 17900-Forte 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 Special Formula 17900-Forte, 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 Special Formula 17900-Forte 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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