Nordette

Nordette

levonorgestrel + ethinylestradiol

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Concise Prescribing Info
Contents
Levonorgestrel 150 mcg, ethinylestradiol 30 mcg
Indications/Uses
Dosage/Direction for Use
1 tab daily starting on 1st day of menstruation for 21 days, followed by 7 tab-free days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Current or history of DVT, thromboembolism & pancreatitis associated w/ severe hypertriglyceridemia. Cerebrovascular or CAD; thrombogenic valvulopathies & rhythm disorders; hereditary/acquired thrombophilias; headache w/ focal neurological symptoms eg, aura; diabetes w/ vascular involvement; uncontrolled HTN; known or suspected breast carcinoma or other estrogen-dependent neoplasia; undiagnosed vag bleeding. Concomitant use w/ certain antivirals eg, ombitasvir, paritaprevir, ritonavir & dasabuvir. Hepatic adenomas or carcinomas, active liver disease. Known or suspected pregnancy.
Special Precautions
Venous or arterial thrombosis & thromboembolism; ocular lesions; increased BP; cervical & breast cancer; hepatitis C; migraine/headache; angioedema. Impaired glucose tolerance or DM; pancreatitis; genital bleeding; depression; diarrhea &/or vomiting. Smoking. Perform breast, liver, extremities & pelvic organ exam, pap smear prior to therapy. Hepatic neoplasia/liver disease. Not to be used during pregnancy. Not recommended during lactation. Not for postmenopausal & premenarche women.
Adverse Reactions
Headache including migraines; breakthrough bleeding/spotting. Vaginitis including candidiasis; mood changes including depression, changes in libido; nervousness, dizziness; nausea, vomiting, abdominal pain; acne; breast pain, tenderness, enlargement & secretion, dysmenorrhea, change in menstrual flow, cervical ectropion & secretion, amenorrhea; fluid retention/edema; increased/decreased wt.
Drug Interactions
Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir, w/or w/o ribavirin. Decreased serum conc w/ drugs known to reduce GI transit time & absorption, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some PIs, modafinil, St. John's wort, ritonavir, certain antibiotics eg, ampicillin & other penicillins, tetracyclines. Increased serum conc w/ atorvastatin, ascorbic acid, paracetamol, indinavir, fluconazole, troleandomycin. Increased risk of intrahepatic cholestasis by troleandomycin. Increased plasma & tissue conc w/ cyclosporine, theophylline, corticosteroids. Decreased plasma & tissue conc w/ lamotrigine. Increased risk of galactorrhea w/ flunarizine. Increased risk of intrahepatic cholestasis w/ troleandomycin.
MIMS Class
ATC Classification
G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Nordette sugar-coated tab
Packing/Price
21's
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