Volina

Volina

ethinylestradiol + drospirenone

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to drospirenone, ethinylestradiol, peanut or soya. 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; severe or multiple risk factor(s) for arterial thrombosis 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 & renal insufficiency; acute renal failure.
Special Precautions
Hypersensitivity to peanut or soya. Discontinue use if VTE or ATE is suspected or confirmed. Not for protection against HIV infections & other STDs. Circulatory disorders; VTE or ATE; symptoms of VTE/ATE eg, DVT, pulmonary embolism; CVA; MI. Risk factors for VTE eg, obesity (BMI >30 kg/m2), prolonged immobilisation, major surgery, any legs or pelvis surgery, neurosurgery or major trauma, +ve family history, cancer, SLE, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease, increasing age. Risk factors for ATE eg, smoking, HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia. Tumours; hypertriglyceridemia; jaundice &/or pruritus related to cholestasis; gallstones; porphyria; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; hereditary angioedema; endogenous depression, epilepsy; GI disturbances. Irregular or w/drawal bleeding. History of chloasma gravidarum; avoid exposure to sun or UV radiation. Monitor serum K during therapy. Regularly measure BP & perform physical exam prior to therapy. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Ensure adequate alternative contraception w/ concomitant anticoagulant therapy eg, coumarins. Acute or chronic liver function disturbances; cholestatic jaundice &/or cholestasis-related pruritus; ALT elevations. Not to be used during pregnancy. Not recommended during lactation.
Adverse Reactions
Depressive mood; headache; migraine; nausea; menstrual disorders, intermenstrual bleeding, breast pain & tenderness, vag discharge, vulvovag candidiasis.
Drug Interactions
Increased risk of ALT elevations w/ ombitasvir-/paritaprevir-/ritonavir- & dasubuvir-containing medicinal products, w/ or w/o ribavirin. Increased clearance w/ drugs inducing microsomal enzymes, barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, HIV medication (ritonavir, nevirapine, efavirenz), felbamate, griseofulvin, oxacarbazepine, topiramate, St. John's wort-containing products. Increased/decreased plasma conc w/ HIV PIs, NNRTIs, HCV inhibitors. Increased plasma & tissue conc of ciclosporin. Decreased plasma & tissue conc of lamotrigine.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Volina FC tab
Packing/Price
21's
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