Althea Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Cyproterone acetate 2 mg, ethinylestradiol 35 mcg

Indications/Uses

Contraception in women, control of acne & hirsutism.

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Dosage/Direction for Use

1 tab starting on the 1st day of menstrual cycle for 21 days. Start new pack after 7 tab-free days.

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Overdosage

View Althea overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: May be taken w/ meals to reduce GI discomfort.

Contraindications

Impaired liver function or cholestasis, Dubin-Johnson or Rotor syndromes, hepatic adenoma, estrogen-dependent neoplasms eg, breast or endometrial cancer, CV disease including previous or current thromboembolic disorders, arterial disease disorders of lipid metabolism, undiagnosed vag bleeding, history of pruritus or cholestatic jaundice during pregnancy, chorea, herpes gestationis, pemphigoid gestationis, deteriorating otosclerosis, severe or focal migraine. Pregnancy & lactation.

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Special Precautions

History of clinical depression, gallbladder disease, sickle-cell disease, condition influenced by fluid retention. Patients w/ varicose veins, risk factor for CV disease eg, DM, smoking, obesity, HTN, family history of CV disease.

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Adverse Reactions

Nausea, vomiting, chloasma (melasma), skin or hair changes, headache, water retention, slight wt changes, breast tenderness, changes in libido. Menstrual irregularities eg, spotting, breakthrough bleeding & amenorrhea.

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Drug Interactions

May reduce contraceptive efficacy &/or increase breakthrough bleeding w/ hepatic microsomal enzyme inducers (eg, carbamazepine, griseofulvin, oxcarbazepine, phenytoin, phenobarb, primidone, St. John's wort, topiramate & rifampicin). May decrease contraceptive efficacy w/ anti-infective drugs (eg, ampicillin, neomycin, nitrofurantoin, penicillin V, sulfonamides, tetracyclines), analgesics, INH, antimigraine drugs & tranquilizers). May increase risk of cholestatic jaundice w/ troleandomycin. May increase plasma conc w/ CYP3A4 inhibitors eg, clarithromycin, erythromycin, grapefruit juice, itraconazole, ketoconazole, ritonavir. Alcohol may reduce the effectiveness of cyproterone acetate.

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Storage

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Description

View Althea description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Oral Contraceptives / Acne Treatment Preparations

ATC Classification

G03CA53 - estradiol, combinations ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.

Regulatory Classification

Presentation/Packing

Form

Althea tab

Packing/Price

21's

Althea

cyproterone + ethinylestradiol

Manufacturer:

DKT

Distributor:

DKT