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Low-Ogestrel

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Low-Ogestrel

Low-Ogestrel®
(norgestrel and ethinyl estradiol) Tablets USP, 0.3 mg/0.03 mg

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

ORAL CONTRACEPTIVE AGENTS

Low-Ogestrel

DRUG DESCRIPTION

Low-Ogestrel® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets.

Each white tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

Each inactive peach tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

Norgestrel is a totally s ynthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α;-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:

Low-Ogestrel® (Norgestrel and Ethinyl Estradiol) Structural Formula Illustration

Therapeutic class: Oral contraceptive.

What are the possible side effects of ethinyl estradiol and norgestrel (Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general...

Read All Potential Side Effects and See Pictures of Low-Ogestrel »

Last reviewed on RxList: 12/23/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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