Monograph Details
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Ob/Gyn
> Endometriosis
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LUPRON DEPOT-3 MONTH 11.25mg |
| Manufacturer |
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TAP Pharmaceutical Products, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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GnRH analogue. |
| Generic Name |
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Leuprolide acetate 11.25mg; depot susp for IM inj; preservative-free. |
| Also |
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• LUPRON DEPOT 3.75mg
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| Indications |
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Endometriosis management, including pain relief and reduction of endometriotic lesions. With norethindrone acetate: for initial management and recurrent symptoms. |
| Children |
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<18 years: not applicable (unless endometriosis occurs after puberty; see literature.) |
| Adults |
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≥18 years: 11.25mg IM once every 3 months; treat for up to 6 months (2 injections). May repeat one 6-month cycle; give with norethindrone acetate 5mg daily when retreating. Do not split doses. |
| Contraindications |
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Undiagnosed abnormal vaginal bleeding. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Exclude pregnancy before starting; use nonhormonal methods of contraception during therapy; discontinue if pregnancy occurs. Consider concomitant norethindrone acetate and supplemental calcium with risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, anticonvulsants, corticosteroids). Missing successive doses may cause breakthrough bleeding or ovulation. Retreatment: not recommended. |
| Adverse Reactions |
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Hot flashes, headache, vaginitis, depression, emotional lability, pain, decreased libido, breast changes, amenorrhea, mastodynia, joint disorder, asthenia, GI upset, edema, bone density loss, local reactions, acne, memory disorders, others; rarely: anaphylaxis, asthma, increased serum transaminases or lipids. |
| How Supplied |
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Kit—1 (single-dose syringe w. diluent, supplies) |
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