Rigevidon

Rigevidon

ethinylestradiol + levonorgestrel

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Levonorgestrel 150 mcg, ethinyloestradiol 30 mcg
Dosage/Direction for Use
1 tab daily for 21 consecutive days followed by 7 tab-free days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or risk of VTE & arterial thromboembolism (ATE); known hereditary or acquired predisposition for VTE & ATE; major surgery w/ prolonged immobilisation; cerebrovascular disease, current stroke, history of stroke or prodromal condition eg, transient ischaemic attack; history of migraine w/ focal neurological symptoms; multiple risk factor(s) for VTE & ATE eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinemia; presence or history of benign or malignant liver tumours; known or suspected sex steroid-influenced malignancies of genital organs or breasts; undiagnosed vag bleeding. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir- & dasubuvir-containing medicinal products. Severe hepatic disease.
Special Precautions
Not for protection against HIV infections & other STD. Increased risk of VTE or ATE; +ve family history of VTE or ATE, obesity (BMI >30 kg/m2), increasing age (>35 yr), smoking, cancer, SLE, haemolytic uraemic syndrome, Crohn's disease or ulcerative colitis, sickle cell disease; HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia; cervical & breast cancer; benign or malignant liver tumours. Hypertriglyceridaemia, pancreatitis; glucose intolerance/diabetes; endogenous depression, epilepsy; hyperprolactinaemia; vomiting, diarrhoea; irregular bleeding. Prolonged immobilisation, major surgery or trauma, any leg or pelvis surgery. May induce or exacerbate symptoms of angioedema. Recurrence of cholestatic jaundice and/or cholestasis-related pruritus. Chloasma; avoid exposure to sun or UV radiation. Perform medical & physical exam including BP measurement prior to therapy. Concomitant use of ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Acute or chronic hepatic abnormalities. Not indicated during pregnancy. Not to be used during lactation.
Adverse Reactions
Vaginitis, vag candidiasis; nervousness, mood swings, depression, changes in libido; dizziness, headache; nausea, vomiting, abdominal pain; acne; breast pain, tenderness, enlargement & discharge, dysmenorrhoea, irregular bleeding, cervical ectropion & vag secretion changes, amenorrhoea; fluid retention/oedema, increased/decreased wt.
Drug Interactions
Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. Increased clearance w/ drugs inducing microsomal enzymes. Diminished efficacy by barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, ritonavir, nevirapine, efavirenz, felbamate, griseofulvin, oxcarbazepine, topiramate, St. John's wort. Increased or decreased plasma conc w/ HIV PIs & NNRTIs. Increased plasma conc of ciclosporin. Decreased plasma conc of lamotrigine. Increased risk of intrahepatic cholestasis w/ troleandomycin. Reduced efficacy w/ modafinil, perampanel. Reduced conc w/ vemurafenib. Moderate reduction in ethinylestradiol conc w/ rufinamide. Increased conc w/ etoricoxib. Interference w/ lab tests results.
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.
Presentation/Packing
Form
Rigevidon FC tab
Packing/Price
1 × 21's (RM5.5/box);3 × 21's
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