Nordette Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Levonorgestrel 150 mcg, ethinylestradiol 30 mcg

Indications/Uses

Prevention of pregnancy.

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Dosage/Direction for Use

Beginning on day 1 of cycle, 1 tab at about same time daily for 21 consecutive days, followed by 7-day tab-free interval.

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Overdosage

View Nordette overdosage for action to be taken in the event of an overdose.

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 or acquired thrombophilias; headache w/ focal neurological symptoms; diabetes w/ vascular involvement; uncontrolled HTN; known or suspected breast carcinoma or other estrogen-dependent neoplasia; undiagnosed vag bleeding. Concomitant use w/ certain HCV antivirals eg, ombitasvir, paritaprevir, ritonavir. dasabuvir. Hepatic adenomas or carcinomas, active liver disease. Known or suspected pregnancy.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Nordette detailed prescribing information

Special Precautions

Not for protection against HIV infection or other STDs. Venous & 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 premenarche & postmenopausal women.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir, w/or w/o ribavirin. Decreased ethinylestradiol serum conc w/ drugs reducing GI transit time & absorption, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some PIs, modafinil, St. John's wort, ritonavir. Increased ethinylestradiol serum conc w/ atorvastatin, ascorbic acid, paracetamol, indinavir, fluconazole, troleandomycin. Increased risk of intrahepatic cholestasis w/ troleandomycin. Increased plasma & tissue conc w/ cyclosporine, theophylline, corticosteroids. Decreased plasma & tissue conc w/ lamotrigine. Increased risk of galactorrhea w/ flunarizine. Reports of pregnancy w/ certain antibiotics eg, ampicillin, other penicillin & tetracyclines. Interference w/ LFTs, thyroid, adrenal & renal function, other lab & diagnostic tests. False +ve results in neutrophil alkaline phosphatase activity evaluation.

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Storage

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Description

View Nordette description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Oral Contraceptives

ATC Classification

G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

Regulatory Classification

Presentation/Packing

Form

Nordette sugar-coated tab

Packing/Price

21's

Nordette

ethinylestradiol + levonorgestrel

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma