Erin

Erin

ethinylestradiol + drospirenone

Manufacturer:

Sun Pharma Industries

Distributor:

DKT

Marketer:

DKT
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 30 mcg
Indications/Uses
OC. Also beneficial for women who experience hormone-related fluid retention & resulting symptoms & for women w/ acne & seborrhea.
Dosage/Direction for Use
1 tab daily for 21 consecutive days. Start each subsequent pack after 7-day tab-free interval.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, deep venous thrombosis, pulmonary embolism, MI) or CVA; presence or history of prodromi of thrombosis (eg, transient ischaemic attack, angina pectoris); high risk of venous or arterial thrombosis; history of migraine w/ focal neurological symptoms; DM w/ vascular involvement; presence or history of liver tumors (benign or malignant); known or suspected sex-steroid influenced malignancies (eg, of genital organs or breasts); undiagnosed vag bleeding. Severe hepatic disease as long as liver function values have not returned to normal; severe renal insufficiency or acute renal failure. Known or suspected pregnancy.
Special Precautions
Increased risk of arterial & venous thrombotic & thromboembolic diseases eg, MI, DVT, pulmonary embolism & CVA. Highest risk of VTE during 1st yr of use. Consider potential for an increased synergistic risk of thrombosis in women who possess combination of risk factors or exhibit greater severity of an individual risk factor. Increased risk of thromboembolism in puerperium. Immediately discontinue if an increase in frequency or severity of migraine occurs. Risk of cervical or breast cancer. Rare reports of benign or malignant liver tumors. May increase risk of pancreatitis in women w/ hypertriglyceridemia or family history thereof. W/draw combined OC (COC) if a sustained clinically significant HTN develops during use. Reports of occurrence or deterioration of the following conditions w/ COC use (inconclusive): Jaundice &/or pruritus related to cholestasis; gallstone formation; porphyria; SLE; hemolytic uremic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss. May induce or exacerbate symptoms of angioedema in women w/ hereditary angioedema. Discontinuation may be necessary in acute or chronic disturbances of liver function until markers of liver function return to normal. Discontinue use in case of recurrence of cholestatic jaundice which occurred 1st during pregnancy or previous use of sex steroids. Carefully observe diabetic women during COC use. Associated w/ Crohn's disease & ulcerative colitis. Chloasma may occasionally occur, especially in women w/ history of chloasma gravidarum. Take complete medical history & physical exam prior to initiation or reinstitution of COC & should be repeated periodically. Advise women that OCs do not protect against HIV infections (AIDS) & other STDs. Efficacy may be reduced in the event of missed tab, GI disturbances during tab taking or concomitant medication. Irregular bleeding (spotting or breakthrough bleeding) may occur, especially during 1st mth. Not to be used in patients w/ galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption. Theoretical risk for hyperkalemia in patients w/ renal impairment whose pretreatment serum K is in the upper reference range, & who are additionally using K-sparing drugs. Not recommended for use until the nursing mother has completely weaned her child. Not indicated after menopause. Only indicated after menarche.
Adverse Reactions
Emotional lability, depression/depressive mood, decrease & loss of libido; migraine; nausea; breast pain, unscheduled uterine bleeding, genital tract bleeding.
Drug Interactions
Increased clearance which may lead to breakthrough bleeding &/or contraceptive failure w/ drugs that induce microsomal enzymes eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's Wort. Increased/decreased plasma conc of estrogen or progestin w/ HIV/HCV PIs & NNRTIs. May increase plasma & tissue conc of ciclosporin or decrease plasma & tissue conc of lamotrigine. Theoretical potential for an increase in serum K w/ other drugs that may increase serum K levels eg, AIIA, K-sparing diuretics & aldosterone antagonists. May influence results of certain lab tests including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins eg, corticosteroids binding globulin & lipid/lipoprotein fractions, carbohydrate metabolism parameters & parameters of coagulation & fibrinolysis. Increased plasma renin activity & aldosterone induced by mild antimineralocorticoid activity of drospirenone.
MIMS Class
Oral Contraceptives / Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Erin FC tab
Packing/Price
21's (P730/box)