Prasterone Dehydroepiandrosterone FDA approved

Prasterone Dehydroepiandrosterone FDA approved Brand Name– INTRAROSA

What is Prasterone Dehydroepiandrosterone FDA approved

Prasterone is a synthetic steroid that is chemically identical to the naturally-occurring pro-hormone 5-dehydroepiandrosterone (5-DHEA), a pro-hormone secreted by the adrenal cortex, gonads and brain tissue.

The intravaginal prasterone insert is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

The product provides a non-estrogen, vaginal therapy option to address isolated genitourinary symptoms in these women.

Prasterone was shown to significantly (p less than 0.05) reduce the severity of pain experienced during sexual intercourse when compared to placebo in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women 40 to 80 years of age.

The prasterone vaginal insert was FDA-approved as a prescription-only drug product in November 2016.

Indications

  • atrophic vaginitis
  • dyspareunia

For the treatment of moderate to severe dyspareunia, a symptom of atrophic vaginitis due to menopause

Side Effects

  • vaginal discharge

Vaginal discharge is the most frequently reported adverse reaction with prasterone, with an incidence of greater than or equal to 2%. In four 4 placebo-controlled, 12-week clinical trials, there were 38 cases in 665 women (5.71%) treated with prasterone compared to 17 cases in 464 (3.66%) in the placebo treatment group. In a 52-week non-comparative clinical trial, vaginal discharge and abnormal pap smear were the most frequently reported adverse reactions in women receiving prasterone with an incidence of greater than or equal to 2%. There were 74 cases of vaginal discharge (14.2%) and 11 cases of abnormal pap smear (2.1%) in 521 participating postmenopausal women. Cases of abnormal pap smear include 1 case of low-grade squamous intraepithelial lesion (LSIL) and 10 cases of atypical cells of undetermined significance (ASCUS).

Monitoring Parameters

  • pelvic exam

Contraindications

  • breast cancer
  • breast-feeding
  • children
  • dysfunctional uterine bleeding
  • endometrial cancer
  • infants
  • ovarian cancer
  • pregnancy
  • vaginal bleeding

Interactions

  • Abarelix
  • Acarbose
  • Acetaminophen; Aspirin, ASA; Caffeine
  • Alogliptin
  • Alogliptin; Metformin
  • Alogliptin; Pioglitazone
  • Alpha-glucosidase Inhibitors
  • Alprazolam
  • Amitriptyline; Chlordiazepoxide
  • Anastrozole
  • Anticoagulants
  • Antithrombin III
  • Apixaban
  • Argatroban
  • Aromatase Inhibitors
  • Aspirin, ASA
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Caffeine; Orphenadrine
  • Aspirin, ASA; Carisoprodol
  • Aspirin, ASA; Carisoprodol; Codeine
  • Aspirin, ASA; Citric Acid; Sodium Bicarbonate
  • Aspirin, ASA; Dipyridamole
  • Aspirin, ASA; Omeprazole
  • Aspirin, ASA; Oxycodone
  • Aspirin, ASA; Pravastatin
  • Azelastine; Fluticasone
  • Beclomethasone
  • Benzodiazepines
  • Betamethasone
  • Betrixaban
  • Bivalirudin
  • Budesonide
  • Budesonide; Formoterol
  • Budesonide; Glycopyrrolate; Formoterol
  • Canagliflozin
  • Canagliflozin; Metformin
  • Cetrorelix
  • Chlordiazepoxide
  • Chlordiazepoxide; Clidinium
  • Ciclesonide
  • Clomiphene
  • Clonazepam
  • Clorazepate
  • Conjugated Estrogens
  • Conjugated Estrogens; Bazedoxifene
  • Conjugated Estrogens; Medroxyprogesterone
  • Corticosteroids
  • Cortisone
  • Cyclosporine
  • Dabigatran
  • Dalteparin
  • Danaparoid
  • Dapagliflozin
  • Dapagliflozin; Metformin
  • Dapagliflozin; Saxagliptin
  • Darbepoetin Alfa
  • Deflazacort
  • Degarelix
  • Desirudin
  • Dexamethasone
  • Diazepam
  • Dienogest; Estradiol valerate
  • Diethylstilbestrol, DES
  • Dipeptidyl Peptidase-4 Inhibitors
  • Drospirenone; Estradiol
  • Drospirenone; Ethinyl Estradiol
  • Drospirenone; Ethinyl Estradiol; Levomefolate
  • Edoxaban
  • Elagolix; Estradiol; Norethindrone acetate
  • Empagliflozin
  • Empagliflozin; Linagliptin
  • Empagliflozin; Linagliptin; Metformin
  • Empagliflozin; Metformin
  • Enoxaparin
  • Epoetin Alfa
  • Ertugliflozin
  • Ertugliflozin; Metformin
  • Ertugliflozin; Sitagliptin
  • Estazolam
  • Esterified Estrogens
  • Esterified Estrogens; Methyltestosterone
  • Estradiol
  • Estradiol Cypionate; Medroxyprogesterone
  • Estradiol; Levonorgestrel
  • Estradiol; Norethindrone
  • Estradiol; Norgestimate
  • Estradiol; Progesterone
  • Estrogens
  • Estropipate
  • Ethinyl Estradiol
  • Ethinyl Estradiol; Desogestrel
  • Ethinyl Estradiol; Ethynodiol Diacetate
  • Ethinyl Estradiol; Etonogestrel
  • Ethinyl Estradiol; Levonorgestrel
  • Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
  • Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
  • Ethinyl Estradiol; Norelgestromin
  • Ethinyl Estradiol; Norethindrone
  • Ethinyl Estradiol; Norethindrone Acetate
  • Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
  • Ethinyl Estradiol; Norethindrone; Ferrous fumarate
  • Ethinyl Estradiol; Norgestimate
  • Ethinyl Estradiol; Norgestrel
  • Exemestane
  • Fludrocortisone
  • Flunisolide
  • Flurazepam
  • Fluticasone
  • Fluticasone; Salmeterol
  • Fluticasone; Umeclidinium; Vilanterol
  • Fluticasone; Vilanterol
  • Fondaparinux
  • Formoterol; Mometasone
  • Ganirelix
  • Glipizide; Metformin
  • Glyburide; Metformin
  • Goserelin
  • Heparin
  • Histrelin
  • Hydrocortisone
  • Incretin Mimetics
  • Insulins
  • Lepirudin
  • Letrozole
  • Leuprolide
  • Leuprolide; Norethindrone
  • Linagliptin
  • Linagliptin; Metformin
  • Lorazepam
  • Meglitinides
  • Mestranol; Norethindrone
  • Metformin
  • Metformin; Pioglitazone
  • Metformin; Repaglinide
  • Metformin; Rosiglitazone
  • Metformin; Saxagliptin
  • Metformin; Sitagliptin
  • Methoxy polyethylene glycol-epoetin beta
  • Methylprednisolone
  • Midazolam
  • Miglitol
  • Mometasone
  • Nafarelin
  • Oxazepam
  • Pentosan
  • Platelet Inhibitors
  • Pramlintide
  • Prednisolone
  • Prednisone
  • Progestins
  • Quazepam
  • Ribociclib; Letrozole
  • Rivaroxaban
  • Saw Palmetto, Serenoa repens
  • Saxagliptin
  • Segesterone Acetate; Ethinyl Estradiol
  • SGLT2 Inhibitors
  • Simvastatin; Sitagliptin
  • Sitagliptin
  • Sulfonylureas
  • Temazepam
  • Thiazolidinediones
  • Tinzaparin
  • Triamcinolone
  • Triazolam
  • Triptorelin
  • Warfarin
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