Minulet 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

Ethinylestradiol 30 mcg, gestodene 75 mcg

Indications/Uses

Prevention of pregnancy.

Click to view Minulet detailed prescribing information

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.

Click to view Minulet detailed prescribing information

Overdosage

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

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 estrogen-dependent neoplasia; undiagnosed vag bleeding. Concomitant use w/ medicinal products containing ombitasvir, paritaprevir, ritonavir, dasabuvir. Hepatic adenomas or carcinomas, active liver disease. Known or suspected pregnancy.

Click to view Minulet detailed prescribing information

Warnings

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

Special Precautions

Discontinue use if visual changes, onset of proptosis or diplopia, papilledema or retinal vascular lesions; significant BP increase occur; cholestasis recurs & hepatocellular injury is diagnosed. Not for protection against HIV infection or other STDs. Venous & arterial thrombosis & thromboembolism; ocular lesions; cervical & breast cancer; hepatitis C; ALT elevations; migraine/headache; angioedema; impaired glucose tolerance or DM, hyperlipidemias, pancreatitis; genital bleeding; depression; diarrhea &/or vomiting; smoking. Perform breast, liver, extremities & pelvic organ exam, pap smear prior to therapy. Discontinue 4 wk prior & 2 wk after elective surgery w/ increased risk of thrombosis & during prolonged immobilization. May affect ability to drive & use machines. Hepatic neoplasia/liver disease. Not to be used during pregnancy. Not recommended during lactation. Not for premenarche & postmenopausal women.

Click to view Minulet detailed prescribing information

Use In Pregnancy & Lactation

Click to view Minulet detailed prescribing information

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.

Click to view Minulet detailed prescribing information

Drug Interactions

Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir, w/or w/o ribavirin. Decreased serum ethinylestradiol 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 serum ethinylestradiol 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 penicillins, tetracyclines. Interference w/ LFTs, thyroid function, other lab & diagnostic tests. False +ve results in neutrophil alkaline phosphatase activity evaluation.

Click to view Minulet detailed prescribing information

Storage

View Minulet storage conditions for details to ensure optimal shelf-life.

Description

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

Action

View Minulet mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Oral Contraceptives

ATC Classification

G03AA10 - gestodene and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

Regulatory Classification

Presentation/Packing

Form

Minulet tab

Packing/Price

1 × 21's

Minulet

ethinylestradiol + gestodene

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma