DRUGS & SUPPLEMENTS

Bentelan Depo

Name: Bentelan Depo drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

Rating: 5 - 1 review(s)

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Bentelan Depo uses

Bentelan Depo consists of Betamethasone, Betamethasone Disodium Phosphate.

Betamethasone:

Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Use in specific populations
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Bentelan Depo (Betamethasone) reviews

Bentelan Depo (Betamethasone) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Bentelan Depo (Betamethasone) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)

2 DOSAGE AND ADMINISTRATION

Shake well before use.

Apply Bentelan Depo (Betamethasone) Spray to the affected skin areas twice daily and rub in gently.

Use Bentelan Depo (Betamethasone) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue Bentelan Depo (Betamethasone) Spray when control is achieved.

Do not use if atrophy is present at the treatment site.

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Bentelan Depo (Betamethasone) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Apply to the affected skin areas twice daily. Rub in gently. (2)
Use Bentelan Depo (Betamethasone) Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Bentelan Depo (Betamethasone) Spray contains 0.643 mg Bentelan Depo (Betamethasone) dipropionate USP (equivalent to 0.5 mg Bentelan Depo (Betamethasone)) in a slightly thickened, white to off-white oil-in-water emulsion.

Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Bentelan Depo Spray 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)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

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

Bentelan Depo (Betamethasone) Spray 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.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Bentelan Depo (Betamethasone) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Bentelan Depo (Betamethasone) Spray twice daily for 29 days .

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.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Bentelan Depo (Betamethasone) Spray is not recommended in pediatric patients .

5.2 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

6 ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 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.

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Bentelan Depo (Betamethasone) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Bentelan Depo (Betamethasone) Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Bentelan Depo (Betamethasone) Spray for up to 28 days are presented in Table 1.

	Bentelan Depo (Betamethasone) Spray b.i.d. (N=352)	Vehicle Spray b.i.d. (N=180)
Application site pruritus	6.0%	9.4%
Application site burning and/or stinging	4.5%	10.0%
Application site pain	2.3%	3.9%
Application site atrophy	1.1%	1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Bentelan Depo (Betamethasone) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

6.2 Postmarketing Experience

Because adverse reactions are 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.

Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Bentelan Depo Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Bentelan Depo (Betamethasone) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bentelan Depo (Betamethasone) Spray is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Bentelan Depo Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1)]

Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

8.5 Geriatric Use

Clinical studies of Bentelan Depo (Betamethasone) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Bentelan Depo (Betamethasone) Spray contains 0.0643% Bentelan Depo (Betamethasone) dipropionate (equivalent to 0.05% Bentelan Depo (Betamethasone)), a synthetic, fluorinated corticosteroid.

The chemical name for Bentelan Depo (Betamethasone) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C₂₈H₃₇FO₇ and the molecular weight is 504.6. The structural formula is shown below.

Each gram of Bentelan Depo (Betamethasone) Spray contains 0.643 mg of Bentelan Depo (Betamethasone) dipropionate USP (equivalent to 0.5 mg Bentelan Depo (Betamethasone)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Bentelan Depo (Betamethasone) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

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 of Bentelan Depo Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Bentelan Depo (Betamethasone) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Bentelan Depo (Betamethasone) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Bentelan Depo (Betamethasone) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Bentelan Depo (Betamethasone) Spray for 15 days. No subjects (0 out of 24) treated with Bentelan Depo (Betamethasone) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of Bentelan Depo (Betamethasone) dipropionate, betamethasone-17-propionate, and Bentelan Depo (Betamethasone) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Bentelan Depo (Betamethasone) dipropionate, while the metabolites, betamethasone-17-propionate and Bentelan Depo (Betamethasone), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Analyte (pg/mL)	Bentelan Depo (Betamethasone) Spray b.i.d. (15 days)	Bentelan Depo (Betamethasone) Spray b.i.d. (29 days)
Betamethasone-17-propionate	120 ± 127	63.9 ± 52.6
Bentelan Depo (Betamethasone)	119 ± 176	57.6 ± 55.9

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Bentelan Depo (Betamethasone) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Bentelan Depo (Betamethasone) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Bentelan Depo (Betamethasone) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Bentelan Depo (Betamethasone) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29.

^a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.
	Study 1		Study 2
	Bentelan Depo (Betamethasone) Spray *b.i.d.* (N=182)	Vehicle Spray *b.i.d.* (N=95)	Bentelan Depo (Betamethasone) Spray *b.i.d.* (N=174)	Vehicle Spray *b.i.d.* (N=87)
Treatment Success at Day 15	21.5%	7.4%	19.0%	2.3%
Treatment Success at Day 29	42.7%	11.7%	34.5%	13.6%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

Bentelan Depo Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes:

60 mL (NDC 67857-808-17)
120 mL (NDC 67857-808-04)

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2 Handling/Instructions for the Pharmacist

Remove the spray pump from the wrapper.
Remove and discard the cap from the bottle.
Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly.
Dispense the bottle with the spray pump inserted.
Include the date dispensed in the space provided on the carton.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes.
Avoid use of Bentelan Depo (Betamethasone) Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Bentelan Depo (Betamethasone) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465

140728

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 02/2016

PATIENT INFORMATION
Bentelan Depo (Betamethasone) (ser-ne-vo)
(betamethasone dipropionate)

Spray, 0.05%

Important: Bentelan Depo (Betamethasone) Spray is for use on the skin only. Do not get Bentelan Depo (Betamethasone) Spray near or in your eyes, mouth, or vagina.

What is Bentelan Depo (Betamethasone) Spray?

Bentelan Depo (Betamethasone) Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Bentelan Depo (Betamethasone) Spray is safe and effective in children under 18 years of age. Bentelan Depo (Betamethasone) Spray is not recommended for use in patients under 18 years of age.

Before you use Bentelan Depo (Betamethasone) Spray, tell your doctor about all of your medical conditions, including if you:

are allergic to any of the ingredients in Bentelan Depo (Betamethasone) Spray. See the end of this leaflet for a list of the ingredients in Bentelan Depo (Betamethasone) Spray.
have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if Bentelan Depo (Betamethasone) Spray will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Bentelan Depo (Betamethasone) Spray passes into breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.

How should I use Bentelan Depo (Betamethasone) Spray?

See the “Instructions for Use” for detailed information about the right way to apply Bentelan Depo (Betamethasone) Spray.

Use Bentelan Depo (Betamethasone) Spray exactly as your doctor tells you to use it.
Your doctor should tell you how much Bentelan Depo (Betamethasone) Spray to use and where to apply it.
Apply Bentelan Depo (Betamethasone) Spray 2 times a day.
Use Bentelan Depo (Betamethasone) Spray for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 4 weeks of using Bentelan Depo (Betamethasone) Spray. Do not use Bentelan Depo (Betamethasone) Spray for longer than 4 weeks.
Wash your hands after applying Bentelan Depo (Betamethasone) Spray.
Do not use Bentelan Depo (Betamethasone) Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

What are the possible side effects of Bentelan Depo (Betamethasone) Spray?

Bentelan Depo (Betamethasone) Spray can pass through your skin. Too much Bentelan Depo (Betamethasone) Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.

The most common side effects of Bentelan Depo (Betamethasone) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of Bentelan Depo (Betamethasone) Spray.

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 Bentelan Depo (Betamethasone) Spray?

Store Bentelan Depo (Betamethasone) Spray at room temperature between 68°F to 77°F (20°C to 25°C)
Throw away (discard) any unused Bentelan Depo (Betamethasone) Spray after 4 weeks.

Keep Bentelan Depo (Betamethasone) Spray and all medicines out of the reach of children.

General information about the safe and effective use of Bentelan Depo (Betamethasone) Spray.

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

What are the ingredients in Bentelan Depo (Betamethasone) Spray?

Active ingredient: Bentelan Depo (Betamethasone) dipropionate

Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

007465

140728

Instructions for Use

Bentelan Depo (Betamethasone) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

Important: Bentelan Depo (Betamethasone) Spray is for use on the skin only. Do not get Bentelan Depo (Betamethasone) Spray near or in your eyes, mouth, or vagina.

Read this “Instructions for Use” before you start using Bentelan Depo (Betamethasone) Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Parts of the Bentelan Depo (Betamethasone) Spray bottle.

Figure A

How to apply Bentelan Depo (Betamethasone) Spray:

Step 1: Shake the Bentelan Depo (Betamethasone) Spray bottle well. Remove the cap from the pump top.

Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply Bentelan Depo (Betamethasone) Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Bentelan Depo (Betamethasone) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Bentelan Depo (Betamethasone) Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Bentelan Depo (Betamethasone) Spray to other affected areas as instructed by your doctor.

Step 4: After applying Bentelan Depo (Betamethasone) Spray, place the cap back onto the pump top. (See Figure D )

Figure D

How should I store Bentelan Depo (Betamethasone) Spray?

Store Bentelan Depo (Betamethasone) Spray at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused Bentelan Depo (Betamethasone) Spray after 28 days.

Keep Bentelan Depo (Betamethasone) Spray and all medicines out of the reach of children.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Bentelan Depo (Betamethasone) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528

140693

Betamethasone Disodium Phosphate:

Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Use in specific populations
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Bentelan Depo (Betamethasone Disodium Phosphate) reviews

Bentelan Depo (Betamethasone Disodium Phosphate) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Bentelan Depo (Betamethasone Disodium Phosphate) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)

2 DOSAGE AND ADMINISTRATION

Shake well before use.

Apply Bentelan Depo (Betamethasone Disodium Phosphate) Spray to the affected skin areas twice daily and rub in gently.

Use Bentelan Depo (Betamethasone Disodium Phosphate) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.

Discontinue Bentelan Depo (Betamethasone Disodium Phosphate) Spray when control is achieved.

Do not use if atrophy is present at the treatment site.

Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.

Bentelan Depo (Betamethasone Disodium Phosphate) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Apply to the affected skin areas twice daily. Rub in gently. (2)
Use Bentelan Depo (Betamethasone Disodium Phosphate) Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

3 DOSAGE FORMS AND STRENGTHS

Spray, 0.05% for topical use. Each gram of Bentelan Depo (Betamethasone Disodium Phosphate) Spray contains 0.643 mg Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate USP (equivalent to 0.5 mg Bentelan Depo (Betamethasone Disodium Phosphate)) in a slightly thickened, white to off-white oil-in-water emulsion.

Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Bentelan Depo Spray 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)
Modify use if HPA axis suppression develops. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

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

Bentelan Depo (Betamethasone Disodium Phosphate) Spray 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.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Bentelan Depo (Betamethasone Disodium Phosphate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Bentelan Depo (Betamethasone Disodium Phosphate) Spray twice daily for 29 days .

Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Bentelan Depo (Betamethasone Disodium Phosphate) Spray is not recommended in pediatric patients .

5.2 Allergic Contact Dermatitis

6 ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trials Experience

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Bentelan Depo (Betamethasone Disodium Phosphate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Bentelan Depo (Betamethasone Disodium Phosphate) Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Bentelan Depo (Betamethasone Disodium Phosphate) Spray for up to 28 days are presented in Table 1.

	Bentelan Depo (Betamethasone Disodium Phosphate) Spray b.i.d. (N=352)	Vehicle Spray b.i.d. (N=180)
Application site pruritus	6.0%	9.4%
Application site burning and/or stinging	4.5%	10.0%
Application site pain	2.3%	3.9%
Application site atrophy	1.1%	1.7%

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Bentelan Depo (Betamethasone Disodium Phosphate) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Bentelan Depo Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.3 Nursing Mothers

8.4 Pediatric Use

Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

8.5 Geriatric Use

Clinical studies of Bentelan Depo (Betamethasone Disodium Phosphate) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Bentelan Depo (Betamethasone Disodium Phosphate) Spray contains 0.0643% Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate (equivalent to 0.05% Bentelan Depo (Betamethasone Disodium Phosphate)), a synthetic, fluorinated corticosteroid.

The chemical name for Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C₂₈H₃₇FO₇ and the molecular weight is 504.6. The structural formula is shown below.

Each gram of Bentelan Depo (Betamethasone Disodium Phosphate) Spray contains 0.643 mg of Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate USP (equivalent to 0.5 mg Bentelan Depo (Betamethasone Disodium Phosphate)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Bentelan Depo (Betamethasone Disodium Phosphate) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

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 of Bentelan Depo Spray in psoriasis is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Bentelan Depo (Betamethasone Disodium Phosphate) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Bentelan Depo (Betamethasone Disodium Phosphate) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Bentelan Depo (Betamethasone Disodium Phosphate) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Bentelan Depo (Betamethasone Disodium Phosphate) Spray for 15 days. No subjects (0 out of 24) treated with Bentelan Depo (Betamethasone Disodium Phosphate) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate, betamethasone-17-propionate, and Bentelan Depo (Betamethasone Disodium Phosphate) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate, while the metabolites, betamethasone-17-propionate and Bentelan Depo (Betamethasone Disodium Phosphate), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Analyte (pg/mL)	Bentelan Depo (Betamethasone Disodium Phosphate) Spray b.i.d. (15 days)	Bentelan Depo (Betamethasone Disodium Phosphate) Spray b.i.d. (29 days)
Betamethasone-17-propionate	120 ± 127	63.9 ± 52.6
Bentelan Depo (Betamethasone Disodium Phosphate)	119 ± 176	57.6 ± 55.9

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Bentelan Depo (Betamethasone Disodium Phosphate) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Bentelan Depo (Betamethasone Disodium Phosphate) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

^a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.
	Study 1		Study 2
	Bentelan Depo (Betamethasone Disodium Phosphate) Spray *b.i.d.* (N=182)	Vehicle Spray *b.i.d.* (N=95)	Bentelan Depo (Betamethasone Disodium Phosphate) Spray *b.i.d.* (N=174)	Vehicle Spray *b.i.d.* (N=87)
Treatment Success at Day 15	21.5%	7.4%	19.0%	2.3%
Treatment Success at Day 29	42.7%	11.7%	34.5%	13.6%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage

60 mL (NDC 67857-808-17)
120 mL (NDC 67857-808-04)

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .

Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2 Handling/Instructions for the Pharmacist

Remove the spray pump from the wrapper.
Remove and discard the cap from the bottle.
Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly.
Dispense the bottle with the spray pump inserted.
Include the date dispensed in the space provided on the carton.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Do not use for longer than 4 consecutive weeks.
Avoid contact with the eyes.
Avoid use of Bentelan Depo (Betamethasone Disodium Phosphate) Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Bentelan Depo (Betamethasone Disodium Phosphate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465

140728

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: 02/2016

PATIENT INFORMATION
Bentelan Depo (Betamethasone Disodium Phosphate) (ser-ne-vo)
(betamethasone dipropionate)

Spray, 0.05%

Important: Bentelan Depo (Betamethasone Disodium Phosphate) Spray is for use on the skin only. Do not get Bentelan Depo (Betamethasone Disodium Phosphate) Spray near or in your eyes, mouth, or vagina.

What is Bentelan Depo (Betamethasone Disodium Phosphate) Spray?

Bentelan Depo (Betamethasone Disodium Phosphate) Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Bentelan Depo (Betamethasone Disodium Phosphate) Spray is safe and effective in children under 18 years of age. Bentelan Depo (Betamethasone Disodium Phosphate) Spray is not recommended for use in patients under 18 years of age.

Before you use Bentelan Depo (Betamethasone Disodium Phosphate) Spray, tell your doctor about all of your medical conditions, including if you:

are allergic to any of the ingredients in Bentelan Depo (Betamethasone Disodium Phosphate) Spray. See the end of this leaflet for a list of the ingredients in Bentelan Depo (Betamethasone Disodium Phosphate) Spray.
have thinning of the skin (atrophy) at the treatment site
are pregnant or plan to become pregnant. It is not known if Bentelan Depo (Betamethasone Disodium Phosphate) Spray will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Bentelan Depo (Betamethasone Disodium Phosphate) Spray passes into breast milk.

How should I use Bentelan Depo (Betamethasone Disodium Phosphate) Spray?

See the “Instructions for Use” for detailed information about the right way to apply Bentelan Depo (Betamethasone Disodium Phosphate) Spray.

Use Bentelan Depo (Betamethasone Disodium Phosphate) Spray exactly as your doctor tells you to use it.
Your doctor should tell you how much Bentelan Depo (Betamethasone Disodium Phosphate) Spray to use and where to apply it.
Apply Bentelan Depo (Betamethasone Disodium Phosphate) Spray 2 times a day.
Use Bentelan Depo (Betamethasone Disodium Phosphate) Spray for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 4 weeks of using Bentelan Depo (Betamethasone Disodium Phosphate) Spray. Do not use Bentelan Depo (Betamethasone Disodium Phosphate) Spray for longer than 4 weeks.
Wash your hands after applying Bentelan Depo (Betamethasone Disodium Phosphate) Spray.
Do not use Bentelan Depo (Betamethasone Disodium Phosphate) Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

What are the possible side effects of Bentelan Depo (Betamethasone Disodium Phosphate) Spray?

Bentelan Depo (Betamethasone Disodium Phosphate) Spray can pass through your skin. Too much Bentelan Depo (Betamethasone Disodium Phosphate) Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.

The most common side effects of Bentelan Depo (Betamethasone Disodium Phosphate) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of Bentelan Depo (Betamethasone Disodium Phosphate) Spray.

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 Bentelan Depo (Betamethasone Disodium Phosphate) Spray?

Store Bentelan Depo (Betamethasone Disodium Phosphate) Spray at room temperature between 68°F to 77°F (20°C to 25°C)
Throw away (discard) any unused Bentelan Depo (Betamethasone Disodium Phosphate) Spray after 4 weeks.

Keep Bentelan Depo (Betamethasone Disodium Phosphate) Spray and all medicines out of the reach of children.

General information about the safe and effective use of Bentelan Depo (Betamethasone Disodium Phosphate) Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Bentelan Depo (Betamethasone Disodium Phosphate) Spray for a condition for which it was not prescribed. Do not give Bentelan Depo (Betamethasone Disodium Phosphate) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Bentelan Depo (Betamethasone Disodium Phosphate) Spray that is written for health professionals.

What are the ingredients in Bentelan Depo (Betamethasone Disodium Phosphate) Spray?

Active ingredient: Bentelan Depo (Betamethasone Disodium Phosphate) dipropionate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

007465

140728

Instructions for Use

Bentelan Depo (Betamethasone Disodium Phosphate) (ser-ne-vo)

(betamethasone dipropionate)

Spray, 0.05%

Read this “Instructions for Use” before you start using Bentelan Depo (Betamethasone Disodium Phosphate) Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Parts of the Bentelan Depo (Betamethasone Disodium Phosphate) Spray bottle.

Figure A

How to apply Bentelan Depo (Betamethasone Disodium Phosphate) Spray:

Step 1: Shake the Bentelan Depo (Betamethasone Disodium Phosphate) Spray bottle well. Remove the cap from the pump top.

Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply Bentelan Depo (Betamethasone Disodium Phosphate) Spray to the affected area as instructed by your doctor. (See Figure B )

Figure B

Step 3: Spray only enough Bentelan Depo (Betamethasone Disodium Phosphate) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Bentelan Depo (Betamethasone Disodium Phosphate) Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Bentelan Depo (Betamethasone Disodium Phosphate) Spray to other affected areas as instructed by your doctor.

Step 4: After applying Bentelan Depo (Betamethasone Disodium Phosphate) Spray, place the cap back onto the pump top. (See Figure D )

Figure D

How should I store Bentelan Depo (Betamethasone Disodium Phosphate) Spray?

Store Bentelan Depo (Betamethasone Disodium Phosphate) Spray at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away (discard) any unused Bentelan Depo (Betamethasone Disodium Phosphate) Spray after 28 days.

Keep Bentelan Depo (Betamethasone Disodium Phosphate) Spray and all medicines out of the reach of children.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215

Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Bentelan Depo (Betamethasone Disodium Phosphate) is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528

140693

Bentelan Depo pharmaceutical active ingredients containing related brand and generic drugs:

Bentelan Depo available forms, composition, doses:

Injectable; Injection; Betamethasone; Betamethasone Disodium Phosphate

Bentelan Depo destination | category:

Human:
Adrenals
Anti-inflammatory agents

Bentelan Depo Anatomical Therapeutic Chemical codes:

D07AC01 - Betamethasone
H02AB01 - Betamethasone

Bentelan Depo pharmaceutical companies:

References

Dailymed."BETAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"betamethasone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"betamethasone". http://www.drugbank.ca/drugs/DB0044... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Bentelan Depo?

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

Review

sdrugs.com conducted a study on Bentelan Depo, 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 Bentelan Depo 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.