Ortho Tri-Cyclen Indications and Dosage
- acne vulgaris
- amenorrhea †
- contraception
- dysfunctional uterine bleeding †
- endometriosis †
- hirsutism †
- polycystic ovary syndrome †
† non-FDA-approved indication
Ortho TriCyclen Indications and Dosage
For routine contraception:
Oral dosage (monophasic product, Ortho-Cyclen®, Previfem™ or Sprintec™):
Adult and adolescent females: 1 tablet (containing 0.25 mg of norgestimate and 35 mcg of ethinyl estradiol) PO once daily for 21 days, followed by a period of 7 days without drug. Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Administration of most combination oral contraceptives (OCs) begins on the first Sunday after or on which bleeding has started. However, some clinicians suggest that administration begin on day 1 of the menstrual cycle to decrease the risk of early ovulation. If administration begins on day 1, spotting and breakthrough bleeding may be more common during the initial dosage cycle.
Oral dosage (triphasic product, Ortho TriCyclen®, Tri-Previfem™, Trinessa™, Tri-Sprintec™):
Adult and adolescent females: The dosage regimen is 1 tablet PO once daily in the order indicated in the pack for 21 days, followed by a period of 7 days without drug. Phase 1 has 7 tablets containing 0.18 mg of norgestimate and 35 mcg of ethinyl estradiol. Phase 2 has 7 tablets containing 0.215 mg of norgestimate and 35 mcg of ethinyl estradiol. Phase 3 has 7 tablets containing 0.25 mg of norgestimate and 35 mcg of ethinyl estradiol. Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Administration of most combination oral contraceptives (OCs) begins on the first Sunday after or on which bleeding has started. However, some clinicians suggest that administration begin on day 1 of the menstrual cycle to decrease the risk of early ovulation. If administration begins on day 1, spotting and breakthrough bleeding may be more common during the initial dosage cycle.
Oral dosage (triphasic product, Ortho TriCyclen Lo®):
Adult and adolescent females: The dosage regimen is 1 tablet PO once daily in the order indicated in the pack for 21 days, followed by a period of 7 days without drug. Phase 1 has 7 tablets containing 0.18 mg of norgestimate and 25 mcg of ethinyl estradiol. Phase 2 has 7 tablets containing 0.215 mg of norgestimate and 25 mcg of ethinyl estradiol. Phase 3 has 7 tablets containing 0.25 mg of norgestimate and 25 mcg of ethinyl estradiol. Repeat dosage cycles begin on the eighth day after taking the last hormonally active tablet. Administration of most combination oral contraceptives (OCs) begins on the first Sunday after or on which bleeding has started. However, some clinicians suggest that administration begin on day 1 of the menstrual cycle to decrease the risk of early ovulation. If administration begins on day 1, spotting and breakthrough bleeding may be more common during the initial dosage cycle.
For the treatment of severe acne vulgaris related to sebum overproduction in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications:
Oral dosage:
Adult and adolescent females: Follow dose as for contraception. Improvement in acne may not be noticeable for 2 - 4 months. Prolonged treatment may be needed to control condition. Ortho TriCyclen® is approved for this purpose by the FDA.
For the treatment or adjuvant treatment of amenorrhea † , dysfunctional uterine bleeding † , hirsutism † , hypermenorrhea † , or polycystic ovary syndrome † related to hypoestrogenic or hyperandrogenic conditions in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and have been evaluated for causes of the condition:
Oral dosage:
Adult and adolescent females: Follow dose as for routine contraception. Treatment for 6 - 12 months may be required; OCs have limited utility when the underlying cause of the condition is not related to a hypoestrogenic or hyperandrogenic state.
For the treatment of endometriosis † to induce endometrial involution to a ‘resting’ phase and reduce the size and growth of endometrial tissue in females with no contraindications to oral contraceptives, have achieved menarche and who desire contraception:
Oral dosage:
Adult and adolescent females: Follow dose as for routine contraception; alternatively, the active tablets can be given continuously. Treatment for 6 - 9 months may be needed to induce endometrial atrophy and reduce symptoms.
Maximum Dosage Limits:
- Adults: Dependent on product used and indication for therapy.
- Elderly: Not indicated.
- Adolescents: Dependent on product used and indication for therapy.
- Children: Not indicated in prepubescent females.
Patients with hepatic impairment:
Hormonal contraceptives are contraindicated for use in the presence of active liver disease or markedly impaired liver function.
Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
† non-FDA-approved indication
[ Last revised: 4/6/2004 2:26:00 PM ]
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