Sernivo .5 mg/g

betamethasone dipropionate · SPRAY · Primus Pharmaceuticals, Inc.

No Recall History

Plain English

Sernivo is a spray containing betamethasone dipropionate at .5 mg/g, taken topical. Manufactured by Primus Pharmaceuticals, Inc..

Key Facts

Brand Name: Sernivo
Generic Name: betamethasone dipropionate
NDC Code (Product): 68040-714
Manufacturer: Primus Pharmaceuticals, Inc.
Strength: .5 mg/g
Dosage Form: SPRAY
Route: TOPICAL
Marketing Status
Application #: NDA208079
Marketing Start: 06/28/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,373 reports

off label use582 reports

macular degeneration525 reports

nausea474 reports

psoriasis447 reports

pain416 reports

pruritus410 reports

condition aggravated386 reports

pain in extremity360 reports

fatigue354 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Shake well before use. Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently. Use SERNIVO Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended. Discontinue SERNIVO 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. SERNIVO 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 SERNIVO 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 )

Contraindications

4 CONTRAINDICATIONS None. None ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The most common adverse reactions (≥1%) 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 SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray. Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1 . Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d. (N=352) Vehicle Spray b.i.d. (N=180) Application site pru…

Frequently Asked Questions

What is Sernivo used for?

Sernivo contains betamethasone dipropionate. It is a spray taken topical. Consult your doctor for specific uses.

Is Sernivo a controlled substance?

Sernivo is not classified as a controlled substance by the DEA.

What is the generic name for Sernivo?

The generic name for Sernivo is betamethasone dipropionate. There are 12 other brand versions of betamethasone dipropionate.

What is the NDC code for Sernivo .5 mg/g?

The NDC (National Drug Code) for Sernivo .5 mg/g is 68040-714, listed by Primus Pharmaceuticals, Inc..

Product NDC

68040-714

Package NDC

68040-714-08

Other Betamethasone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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