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Lunelle (Medroxyprogesterone Acetate / Estradiol Cypionate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG-DRUG INTERACTIONS

No formal drug-drug interaction studies were conduct-ed with LUNELLE™ Monthly Contraceptive Injection. Aminoglutethimide administered concomitantly with LUNELLE™ Monthly Contraceptive Injection may significantly depress the serum concentrations of MPA. Users of LUNELLE™ Monthly Contraceptive Injection should be warned of the possibility of decreased efficacy with the use of this or any related drugs. (See PRECAUTIONS, DRUG INTERACTIONS.)

OVERDOSAGE

Overdosage of a Progestin/estrogen drug combination may cause nausea and vomiting, and vaginal bleeding or other menstrual irregularities in females.

OVERDOSAGE

Serious ill effects have not been reported following ingestion of large doses of oral hormonal contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health care provider or pharmacist.

OTHER INFORMATION

Your health care provider will take a medical and family history before prescribing hormonal contraceptives. You should receive yearly physical examinations by your health care provider. Be sure to inform your health care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care provider, because this is a time to determine if there are early signs of side effects of hormonal contraceptive use. If you want more information about hormonal contraceptives, ask your health care provider or pharmacist for a more technical leaflet called the Prescribing Information that you may wish to read.

Each 0.5 mL dose of LUNELLE™ Monthly Contraceptive Injection contains:

Active Ingredients: medroxyprogesterone acetate (25 mg), estradiol cypionate (5 mg)

Inactive Ingredients: methylparaben (0.9 mg), polyethylene glycol (14.28 mg), polysorbate 80 (0.95 mg), propylparaben (0.1 mg), sodium chloride (4.28 mg), sterile water for injection

Manufactured for: Pharmacia & Upjohn Company

A subsidiary of Pharmacia Corporation

Kalamazoo, MI 49001, USA

by: Pharmacia NV/SA

Puurs, Belgium

(prefilled syringes)

Pharmacia & Upjohn Company

Kalamazoo, MI 49001, USA

(vials)

Revised July 2001 817 821 001

692804

3484-04

CONTRAINDICATIONS

The information contained in this package insert is based not only on information specific to LUNELLE™ Monthly Contraceptive Injection, but also on studies carried out in women who used injectable progestin-only contraceptives (medroxyprogesterone acetate) or oral contraceptives with higher doses of both estrogens and progestogens than those in common use today. The effect of long-term use of hormonal contraceptives with formulations having lower doses of both estrogens and progestogens remains to be determined.

LUNELLE™ Monthly Contraceptive Injection should not be used in women with any of the following conditions or circumstances.

  • Known or suspected pregnancy.
  • Thrombophlebitis or thromboembolic disorders.
  • A past history of deep-vein thrombophlebitis or thromboembolic disorders.
  • Cerebral vascular or coronary artery disease.
  • Undiagnosed abnormal genital bleeding.
  • Liver dysfunction or disease, such as history of hepatic adenoma or carcinoma; history of cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use including severe pruritus of pregnancy.
  • Carcinoma of the endometrium, breast, or other known or suspected estrogen-dependent neoplasia.
  • Known hypersensitivity to any of the ingredients contained in LUNELLE™ Monthly Contraceptive Injection.
  • Heavy smoking (>/=15 cigarettes per day) and over age 35.
  • Severe hypertension.
  • Diabetes with vascular involvement.
  • Headaches with focal neurological symptoms.
  • Valvular heart disease with complications.

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