CHARLIZE 28 Tabs - SET of 2 PACKS - Ethinylestradiol / Levonorgestrel / Ferrous Fumarate 30mcg / 150mcg / 75mg
RXDRUG-DRP-2063-laz2
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) is indicated for contraception and treatment of menstrual disorders such as dysmenorrhea, premenstrual syndrome, and menorrhagia.
Dosage/Direction for Use
Talk to a healthcare provider before taking Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE).
Take one pill daily, beginning on the first day of menstrual bleeding. Patient can also start any day as long as patient is not pregnant and use a back-up method such as condom for the next seven days as a precaution to avoid pregnancy. Start with the pill marked number "1". Follow the arrows indicated on the pack.
The interval between two pills should be 24 hours. Incorporate it to daily routine - after eating meals or before going to sleep to easily remember to take it. A pack is good for 28 days.
Start a new pack the next day after taking the last pinkish-brown pill regardless whether the menstrual bleeding has stopped or not. Patient's menstrual bleeding will return to normal two days after finishing the beige pills and while taking the pinkish-brown pills.
Patient may continue taking the pill as long as wanted to avoid pregnancy. Do not skip taking the pill even if there is a brief pause from sexual activity.
Patient should only stop taking the pill after finishing a pack; otherwise bleeding may start.
Vomiting and persistent diarrhea can interfere with the absorption of the pill. If vomiting occurs within two hours after taking a pill, another pill should be taken as soon as possible. If persistent vomiting and diarrhea last more than 24 hours, follow the instructions on Missed Pills.
If patient missed one beige pill, it must be taken 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.
Missed Pills: The key to effective contraception is following the recommended dosage consistently.
If patient missed taking one beige pill, take it as soon as remembered. 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. Patient will not need a back-up contraceptive method if she only missed one pill.
Missing two or more beige pills consecutively increases the probability of getting pregnant. Take the most recently missed beige pill as soon as remembered and discard all remaining previously missed pills. Resume taking the next scheduled pill and either abstain from sex or use condoms for the next seven days. Count the beige pills left in the pack.
If one to six beige pills are left in the pack, finish the remaining beige pills and discard all pinkish-brown pills. Start a new pack immediately and use condoms for the next seven days. Bleeding may not come at the regular time.
If there are seven or more beige pills left in the pack, continue taking the contents of the pack including the pinkish-brown pills. Start with a new pack.
If patient continually forget to take the pills, ask the healthcare provider for ways to become compliant, or for another method of contraception which will suit better. (See figure.)
Take one pill daily, beginning on the first day of menstrual bleeding. Patient can also start any day as long as patient is not pregnant and use a back-up method such as condom for the next seven days as a precaution to avoid pregnancy. Start with the pill marked number "1". Follow the arrows indicated on the pack.
The interval between two pills should be 24 hours. Incorporate it to daily routine - after eating meals or before going to sleep to easily remember to take it. A pack is good for 28 days.
Start a new pack the next day after taking the last pinkish-brown pill regardless whether the menstrual bleeding has stopped or not. Patient's menstrual bleeding will return to normal two days after finishing the beige pills and while taking the pinkish-brown pills.
Patient may continue taking the pill as long as wanted to avoid pregnancy. Do not skip taking the pill even if there is a brief pause from sexual activity.
Patient should only stop taking the pill after finishing a pack; otherwise bleeding may start.
Vomiting and persistent diarrhea can interfere with the absorption of the pill. If vomiting occurs within two hours after taking a pill, another pill should be taken as soon as possible. If persistent vomiting and diarrhea last more than 24 hours, follow the instructions on Missed Pills.
If patient missed one beige pill, it must be taken 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.
Missed Pills: The key to effective contraception is following the recommended dosage consistently.
If patient missed taking one beige pill, take it as soon as remembered. 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. Patient will not need a back-up contraceptive method if she only missed one pill.
Missing two or more beige pills consecutively increases the probability of getting pregnant. Take the most recently missed beige pill as soon as remembered and discard all remaining previously missed pills. Resume taking the next scheduled pill and either abstain from sex or use condoms for the next seven days. Count the beige pills left in the pack.
If one to six beige pills are left in the pack, finish the remaining beige pills and discard all pinkish-brown pills. Start a new pack immediately and use condoms for the next seven days. Bleeding may not come at the regular time.
If there are seven or more beige pills left in the pack, continue taking the contents of the pack including the pinkish-brown pills. Start with a new pack.
If patient continually forget to take the pills, ask the healthcare provider for ways to become compliant, or for another method of contraception which will suit better. (See figure.)
What to do if patient missed taking the pinkish-brown pill: The patient does not have to worry if she missed the pinkish-brown pill as long as she finished the pack which completes the 28-day cycle. The pinkish-brown pill contains Ferrous Fumarate, an Iron supplement, that helps improve the hemoglobin content of the blood during menstruation.
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. Ask the healthcare provider for further instructions.
Administration
Should be taken on an empty stomach: May be taken w/ meals to reduce GI discomfort.
Contraindications
Make sure the patient is not pregnant before taking Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE). Patient should inform the healthcare provider if she has the following conditions before starting Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE): liver disorders, clotting disorders, breast and cervical cancer, sickle-cell anemia, hormone-active tumors, hyperlipidemia, severe cardiovascular diseases, previous or existing thromboembolic diseases, idiopathic jaundice.
Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) is not recommended for pregnant women.
Breastfeeding mothers should not use Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE). This may reduce the volume of the breast milk. Breastfeeding mothers can use progestin-only pills.
Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) is not recommended for pregnant women.
Breastfeeding mothers should not use Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE). This may reduce the volume of the breast milk. Breastfeeding mothers can use progestin-only pills.
Special Precautions
Regular consultation with a healthcare provider is recommended while taking Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE). If patient suffers from diarrhea and/or vomiting, its efficacy may be reduced. Inform the healthcare provider if patient is suffering from the following conditions: diabetes mellitus, high blood pressure, varicose veins, multiple sclerosis, epilepsy, migraine, ophthalmological problems, tetany.
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 headache, gastric upsets, nausea, vomiting, abdominal cramps, changes in appetite, breast tenderness, change in body weight and libido, depressive moods, or interference with liver functions.
Drug Interactions
Taking drugs for infection (such as ampicillin, chloramphenicol, neomycin, penicillin V, nitrofurantoin, sulfonamides, tetracycline and isoniazid) and pain (analgesic, anti-migraine and tranquilizer) with contraceptive pill may decrease the contraceptive's efficacy. If patient is advised to take the previously mentioned drugs, consult a healthcare provider for proper intake and dosage schedule of the contraceptive pill.
Taking contraceptive pills and anti-infective drugs (such as clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or grapefruit juice may inhibit cytochrome P-450 isoenzyme 3A4. Adverse effects may be seen upon taking these drugs.
Taking oral contraceptive pills and drugs that induce hepatic enzyme such as anti-epileptic drugs (carbamazepine, oxcarbazepine, felbamate, topiramate, phenytoin), anti-fungal (griseofulvin), anti-diabetic (troglitazone), musculoskeletal (phenylbutazone), anti-tuberculosis (rifampicin) drugs can considerably reduce the contraceptive's efficacy.
Taking contraceptives and troleandomycin may increase the risk of cholestatic jaundice.
Taking contraceptive pills and anti-infective drugs (such as clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or grapefruit juice may inhibit cytochrome P-450 isoenzyme 3A4. Adverse effects may be seen upon taking these drugs.
Taking oral contraceptive pills and drugs that induce hepatic enzyme such as anti-epileptic drugs (carbamazepine, oxcarbazepine, felbamate, topiramate, phenytoin), anti-fungal (griseofulvin), anti-diabetic (troglitazone), musculoskeletal (phenylbutazone), anti-tuberculosis (rifampicin) drugs can considerably reduce the contraceptive's efficacy.
Taking contraceptives and troleandomycin may increase the risk of cholestatic jaundice.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate (CHARLIZE) works primarily by preventing the release of eggs from the ovaries. Also, Ethinyl Estradiol acts synergistically with Levonorgestrel to provide regular and consistent suppression of ovulation.
Pharmacokinetics: Ethinyl Estradiol 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%. Ethinyl Estradiol 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.
Levonorgestrel is rapidly and almost completely absorbed after being taken orally and undergoes little first-pass hepatic metabolism. It is highly bound to plasma proteins; 42% to 68% to sex hormone-binding globulin and 30% to 56% to albumin. The proportion bound to sex hormone-binding globulin is higher when it is given with an estrogen. Levonorgestrel is metabolized in the liver to sulfate and glucuronide conjugates, which are excreted in the urine and to a lesser extent in the feces.
Pharmacokinetics: Ethinyl Estradiol 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%. Ethinyl Estradiol 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.
Levonorgestrel is rapidly and almost completely absorbed after being taken orally and undergoes little first-pass hepatic metabolism. It is highly bound to plasma proteins; 42% to 68% to sex hormone-binding globulin and 30% to 56% to albumin. The proportion bound to sex hormone-binding globulin is higher when it is given with an estrogen. Levonorgestrel is metabolized in the liver to sulfate and glucuronide conjugates, which are excreted in the urine and to a lesser extent in the feces.
MedsGo Class
Oestrogens, Progesterones & Related Synthetic Drugs / Oral Contraceptives
Features
Brand
Charlize
Full Details
Dosage Strength
30 mcg / 150 mcg / 75 mg
Drug Ingredients
- Ethinylestradiol
- Ferrous Fumarate
- Levonorgestrel
Drug Packaging
Film-Coated Tablet 28's
Generic Name
Ethinylestradiol / Levonorgestrel / Ferrous Fumarate
Dosage Form
Film-Coated Tablet
Registration Number
DRP-2063
Drug Classification
Prescription Drug (RX)
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