Althea

Althea

cyproterone + ethinylestradiol

Manufacturer:

DKT

Distributor:

DKT
Full Prescribing Info
Contents
Cyproterone acetate, ethinylestradiol.
Description
Each of the 21 pink-orange tablets contains Cyproterone Acetate 2 mg and Ethinylestradiol 35 mcg.
Cyproterone acetate + Ethinylestradiol (ALTHEA) is a combined low-dose oral contraceptive pill with anti-androgenic properties. It decreases sebum secretion during acne breakouts and hair growth.
Action
Pharmacology: Pharmacokinetics: Cyproterone acetate is slowly absorbed from the gastrointestinal tract with peak plasma concentration being achieved in three or four hours. It is about 96% bound to plasma proteins. The terminal elimination half-life is about 38 hours. Cyproterone is metabolized in the liver; about 35% of a dose is excreted in urine as free and conjugated metabolites, the remainder being excreted in the bile. The principal metabolite 15β-hydroxycyproterone, has anti-androgenic activity.
Ethinylestradiol is absorbed well and rapidly by the gastrointestinal tract. The presence of an ethinyl group at the 17-position greatly reduces hepatic first-pass metabolism compared with estradiol, enabling the compound to be much more active if taken orally. There is some initial conjugation at the gut wall, and the systemic bioavailability is only 40%. Ethinylestradiol is highly protein bound, unlike naturally occurring estrogens, which are mainly bound to sex hormone-binding globulin; it is principally bound to albumin. It is metabolized in the liver, and excreted in urine and feces. Metabolites undergo enterohepatic recycling.
Indications/Uses
Cyproterone Acetate + Ethinylestradiol (ALTHEA) is indicated for contraception in women, and control of acne and hirsutism (unwanted hair growth).
Dosage/Direction for Use
Talk to the healthcare provider before taking Cyproterone Acetate + Ethinylestradiol (ALTHEA).
For contraception, control of acne and hirsutism, regulation of the menstrual cycle, reduction of premenstrual tension, and relief from pain and excessive bleeding during menstruation: Take one pill daily, beginning on the first day of menstrual bleeding. The patient can also start any day as long as the patient is not pregnant and is using a back-up method such as a condom for the next seven days as a precaution to avoid pregnancy. Start with the pill marked with the corresponding day of the week. Follow the arrows indicated on the pack.
The interval between two pills should be 24 hours. Incorporate it to the daily routine - after eating meals or before going to sleep, so the patient can easily remember to take it. A pack is good for 21 days.
After taking the last pill, do not take any pill on the next seven days. The seven pill-free days complete the 28-day menstrual cycle.
Start the new pack after seven pill-free days. Normal menstrual cycle period will most likely resume during pill-free days.
The patient may continue taking the pill as long as the patient wants to avoid pregnancy. Do not skip taking the pill even if there is a brief pause from sexual activity.
The patient should only stop taking the pill after finishing a pack; otherwise, bleeding may start.
Vomiting and persistent severe diarrhea can interfere with the absorption of the pill. If vomiting occurs within two hours of taking a pill, another pill should be taken as soon as possible. If persistent vomiting and diarrhea last more than 24 hours, follow the instruction on Missed Pills.
If the patient missed one pill, the patient must take it within 12 hours after the 24-hour lapse to sustain its efficacy. Take the remaining pills as scheduled to avoid premature withdrawal bleeding. Follow the instructions on Missed Pills.
For control of acne and/or hirsutism: Continue taking the pill for additional three to four months after the complete resolution of symptoms.
If acne or hirsutism recurs, take the pill until the complete resolution of the symptoms.
Missed Pills: The key to effective contraception is following the recommended dosage consistently.
If the patient missed one pill, the patient must take it within 12 hours after the 24-hour lapse. Take the pill due for the day at the regular time even if it means taking two pills in one day. Keep taking one pill each day at the usual time. The patient will not need a back-up contraceptive method if the patient missed only one pill.
Missing two or more pills consecutively increases the probability of getting pregnant. Take the most recently missed pill as soon as remembered and discard all previously missed pills. Resume taking the next scheduled pill and either abstain from sex or use condoms for the next seven days. Count the pills left in the pack.
If one to six pills are left in the pack, continue taking the remaining pills. Start with a new pack immediately and either abstain from sex or use condoms for the next seven days. Bleeding may not come at the regular time.
If there are seven or more pills left in the pack, continue taking the contents of the pack. Do not take any pills for the next seven days (seven pill-free days). Start a new pack after the seven pill-free days.
If the patient continually forgets to take the pill, ask the healthcare provider for ways to become compliant, or for another method of contraception which will suit the patient better (see figure).

Click on icon to see table/diagram/image
Overdosage
No serious ill effects have been reported after ingestion of large doses of oral contraceptives, although it may cause nausea and withdrawal bleeding in females. Treatment is unnecessary because the overdose is unlikely to be life-threatening. Consult the healthcare provider for further instructions.
Contraindications
Make sure that the patient is not pregnant before taking Cyproterone Acetate + Ethinylestradiol (ALTHEA). The patient should inform the healthcare provider if the patient has the following conditions before start taking Cyproterone Acetate + Ethinylestradiol (ALTHEA): Impaired liver functions or cholestasis; the Dubin-Johnson or Rotor syndromes; hepatic adenoma; estrogen-dependent neoplasms such as breast or endometrial cancer; cardiovascular disease including previous or current thromboembolic disorders or high risk of them, and arterial disease or multiple risk factors for it; disorders of lipid metabolism; undiagnosed vaginal bleeding; possible pregnancy; history during pregnancy of pruritus or cholestatic jaundice; chorea, herpes gestationis; pemphigoid gestationis; deteriorating otosclerosis; severe or focal migraine.
Cyproterone Acetate + Ethinylestradiol (ALTHEA) is not recommended for pregnant women.
Breastfeeding mothers should not take Cyproterone Acetate + Ethinylestradiol (ALTHEA). This can reduce the volume of breast milk. Breastfeeding women can use progestin-only pills.
Special Precautions
Regular consultation with a healthcare provider is recommended while taking Cyproterone Acetate + Ethinylestradiol (ALTHEA). Inform the healthcare provider if the patient is suffering from the following conditions: history of clinical depression, gallbladder disease, sickle-cell disease, condition influenced by fluid retention, varicose veins, risk factor for cardiovascular disease (diabetes mellitus, smoking, obesity, hypertension, family history of cardiovascular disease).
Adverse Reactions
The oral contraceptive pill is the most researched product in the history of modern medicine, and its safety has long been established. Some women may experience side effects such as nausea, vomiting, chloasma (melasma), skin or hair changes, headache, water retention, slight weight change, breast tenderness, and changes in libido. Menstrual irregularities such as spotting, breakthrough bleeding or amenorrhea can occur during its use.
Drug Interactions
Taking contraceptive pills with drugs that induce hepatic microsomal enzymes (e.g., carbamazepine, griseofulvin, oxcarbazepine, phenytoin, phenobarbital, primidone, St. John's Wort, topiramate, and rifampicin) may reduce the contraceptive efficacy and/or increase breakthrough bleeding.
Taking contraceptive pills with anti-infective drugs (e.g., ampicillin, neomycin, nitrofurantoin, penicillin V, sulfonamides and tetracyclines) may result in decreased contraceptive efficacy.
Taking contraceptive pills with troleandomycin may increase the risk of cholestatic jaundice and should be used cautiously.
Taking contraceptive pills with Ethinylestradiol and drugs or food that inhibit cytochrome P-450 isoenzyme 3A4 (CYP3A4) such as clarithromycin, erythromycin, grapefruit juice, itraconazole, ketoconazole, ritonavir may result in increased plasma concentrations of Ethinylestradiol and an increase in the incidence of adverse effects.
Taking contraceptive pills with analgesics, isoniazid, antimigraine drugs and tranquilizers may decrease contraceptive efficacy.
Taking contraceptive pills with alcohol may reduce the effectiveness of Cyproterone acetate.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
G03CA53 - estradiol, combinations ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation/Packing
Tab (round, biconvex, pink-orange pills) 21's.
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