Herz

Herz

ethinylestradiol + drospirenone

Manufacturer:

Biolab

Distributor:

Biopharm

Marketer:

Biopharm
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 0.02 mg
Indications/Uses
Moderate acne; dysmenorrhea. Symptomatic treatment of pre-menstrual dysphoric disorder in women who decide to use OC. Prevention of pregnancy.
Dosage/Direction for Use
1 tab once daily starting on 1st day of menstrual cycle for 24 consecutive days followed by placebo for 4 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Thrombosis; pulmonary embolism; heart attack or stroke; angina pectoris; transient ischaemic attack; visual symptoms, speech disability, body weakness or numbness; DM w/ damaged blood vessels; liver disease; cancer eg, of breast or genital organs; benign or malignant liver tumor; unexplained vag bleeding. High risk of venous or arterial blood clots. Concomitant use or combination w/ ombistavir, paritaprevir or dasabuvir. Severe kidney insufficiency or acute kidney failure. Pregnant or women who might be pregnant.
Special Precautions
Discontinue use if signs of DVT, pulmonary embolism & arterial thromboembolism occur. Discontinue smoking in women >35 yr. Not to be used prior to menarche; after menopause. Increased risk of venous or arterial blood clots or stroke w/ age, prolonged immobilization, high BP, migraine, heart valve or rhythm disorder; overwt; w/ or w/ history of blood clot & high blood levels of cholesterol & triglycerides. Increased risk of developing cervical cancer in women during long-term use. Patient w/ high BP; superficial phlebitis; varicose veins; epilepsy; increased K blood level; liver or gall bladder disease; Crohn's disease or ulcerative colitis; SLE; hemolytic uremic syndrome; sickle cell disease; hearing loss, porphyria, herpes gestationis, Sydenham's chorea; hereditary angioedema; severe abdominal pain; persistent HPV infection. Continuous irregular vag bleeding. History of breast cancer; chloasma. Avoid direct sun or UV light exposure. Regularly check breasts if any lump is felt. Concomitant use w/ diuretics that may increase K in blood. Hepatic & renal dysfunction. Pregnancy. Not recommended during lactation.
Adverse Reactions
Emotional lability (mood swings), depression/depressive mood; migraine; nausea; breast pain, unscheduled uterine bleeding, vag bleeding. Decreased & loss of libido.
Drug Interactions
Primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate; rifampicin; PIs, NNRTIs; griseofulvin, azole antifungals eg, itraconazole, voriconazole, fluconazole, ketoconazole; macrolide antibiotics eg, clarithromycin, erythromycin; Ca channel blockers eg, verapamil, diltiazem; etoricoxib; St. John's wort; grapefruit juice. Influenced effects of cyclosporine, lamotrigine, melatonin, midazolam, theophylline, tizanidine. Drugs known to increase K levels.
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
Herz film-coated tab
Packing/Price
28's
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