Minidoz

Minidoz

ethinylestradiol + gestodene

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Concise Prescribing Info
Contents
24 yellow active tab each containing Gestodene 60 mcg, ethinylestradiol 15 mcg, 4 white inactive tab each containing Lactose monohydrate 70.897 mg
Indications/Uses
Prevent pregnancy. Reduce inflammatory & non-inflammatory lesions in women w/ acne who require contraception.
Dosage/Direction for Use
1 yellow tab daily for 24 days starting on the 1st day of bleeding, followed by 1 white tab daily for 4 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patient w/ history, or family history of blood clot in the legs, lungs, eyes, heart attack or stroke; sickle-cell anemia, disorders of lipid metabolism, breast or endometrial carcinoma, abnormal vag bleeding of unknown cause, Dubin-Johnson or Rotor syndrome, severe diabetes w/ blood vessel changes, liver tumours; any other long-/short-term liver disease. Not to be taken in pregnant patients w/ pruritus of pregnancy, herpes gestations, otosclerosis, jaundice. Pregnancy & lactation.
Special Precautions
Discontinue use if the patient experiences migraine for the 1st time, (or if existing migraine occurs more often than before), unusually bad headaches or have headaches more often than before, sudden changes to eyesight, hearing, speech, sense of smell, taste or touch, dizziness or fainting, unusual leg pain or arm/leg swelling, sharp chest pain or sudden shortness of breath, crushing pains or feeling of heaviness in chest, coughing for no apparent reason or if 1 side of body suddenly becomes very weak or numb. Not to be used in presence of thrombosis & hepatic disease; women w/ history of thrombophlebitis, obesity, diabetes & HTN; presence or history of liver tumors, known or suspected sex hormones related cancer eg, breast or genital organs cancer. Severe depressive states, varicose vein, DM, HTN, epilepsy, otosclerosis, multiple sclerosis, porphyria, tetany, Sydenham's chorea, breast problems, & disturbed liver function, obesity, contact lens intolerance, SLE, asthma, uterine fibroids, gallstones, migraine, chloasma, phlebitis, CV & kidney diseases. History or family history of breast cancer; any illness caused by blood clots, heart attack, or stroke at young age.
Adverse Reactions
Thrombosis or liver disease. Bleeding & spotting; headache, feeling sick, being sick & stomach upset, sore breasts, depressive moods, changes in body wt & libido, chloasma, contact lens intolerance.
Drug Interactions
Concomitant use w/ enzyme-inducing drug eg, antiepileptics (eg, phenytoin, barbiturates, phenobarb, primidone, carbamazepine, oxcarbazepine, felbamate, topiramate), griseofulvin, antibacterials (eg, rifampicin, rifabutin, penicillins), antidepressants (St. John's wort), antivirals (eg, nelfinavir, ritonavir), & modafinil.
MIMS Class
Oral Contraceptives / Acne Treatment Preparations
ATC Classification
G03AA10 - gestodene and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Minidoz FC tab
Packing/Price
1 × 28's
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