Balcoltra

Generic name: ethinyl estradiol and levonorgestrel
Brand names: Amethyst, Aviane, Balcoltra, Falmina
Drug class: Contraceptives

Medically reviewed by  A Ras MD.

What is Balcoltra?

Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Balcoltra, especially during the first few months of use. This usually is not a serious problem. If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles call your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

 Description

Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 orange active tablets and 7 blue inactive tablets.

21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol, an estrogenic compound

7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate

The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

Levonorgestrel has the empirical formula of C21H28O2 and the molecular weight of 312.4, and ethinyl estradiol has the empirical formula of C20H24O2 and the molecular weight of 296.4.

The molecular structures are provided below:

 Mechanism of Action

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

How should I store Balcoltra?

• Store Balcoltra at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Balcoltra and all medicines out of the reach of children.
• Store away from light.

What are the ingredients in Balcoltra?

Active ingredients: Orange tablets: levonorgestrel and ethinyl estradiol.

Inactive ingredients: Orange tablets: FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.

Inactive ingredients: Blue tablets: ferrous bisglycinate), citric acid NF, glycine, water, maltodextrin NF, silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.

Label

PRINCIPAL DISPLAY PANEL – CARTON BACK

• 1 Blister Pack,
  28 tablets
• NDC 75854-602-28
  28-day regimen
• Balcoltra™
  Levonorgestrel and ethinyl estradiol tablets, USP,
  and ferrous bisglycinate tablets)
  0.1mg/0.02mg and 36.5mg.
• IMPORTANT: Note to Dispensing Pharmacist: Each compact dispenser
  contains a combination Patient Information and Instructions For Use Insert with Day
  Label Stickers. This should be included with each package dispensed to the patient.
• Each active orange tablet (21) contains levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
  Each inactive blue tablet (7) contains ferrous bisglycinate 36.5 mg.
• Contains color additives including FD&C Yellow No. 5 (tartrazine).
• Usual Dosage: One orange tablet daily for 21 consecutive days followed by
  one blue placebo tablet for 7 consecutive days according to prescribed schedule.
• See enclosed prescribing information.
• Store at 20° to 25°C (68° to 77°F); Excursions permitted to 15° to 30°C
  (59° to 86°F). [See USP controlled room temperature.]
  Protect from light.
• Keep out of the reach of children.
• WARNING: Accidental overdose of iron-containing products is a leading cause of
  fatal poisoning in children under 6. Keep this product out of reach of children.
  In case of accidental overdose, call a doctor or poison control center immediately.
• Avion
  Pharmaceuticals
• Manufactured for:
  Avion Pharmaceuticals, LLC., Alpharetta, GA 30005
  1-888-61-AVION