NORGESTIMATE AND ETHINYL ESTRADIOL (Norgestimate and Ethinyl Estradiol)
NORGESTIMATE AND ETHINYL ESTRADIOL risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Norgestimate and Ethinyl Estradiol.
NORGESTIMATE AND ETHINYL ESTRADIOL (brand names: Norgestimate and Ethinyl Estradiol) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Combined hormonal contraceptive with minimal impact on work capacity or cognitive function.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (1 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Combined hormonal contraceptive with minimal impact on work capacity or cognitive function.
Regulatory and Compliance Guidance
When NORGESTIMATE AND ETHINYL ESTRADIOL appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )]. WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Sprintec is contraindicated in women over 35 years old who smoke. (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4)
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.