Conrena-R

Uses

Ethinylestradiol, Norgestrel & Ferrous Fumarate is indicatd for prevention of pregnancy.

Conrena-R is also used to associated treatment for these conditions: Menopausal Osteoporosis, Mild to Moderate Acne, Premenstrual Dysphoric Disorder ( PMDD), Moderate Acne vulgaris, Moderate, severe, Vasomotor Symptoms caused by Menopause, Contraception, Folate supplementation therapyFolic acid antagonist overdose, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Oral ContraceptivesAbnormal Uterine Bleeding, Endometriosis, Hypermenorrhea, Menstrual Distress (Dysmenorrhea), Polycystic Ovarian Syndrome, Emergency Contraception, Oral Contraceptives

How Conrena-R works

Ethinylestradiol is a synthetic estrogenic compound. Use of estrogens have a number of effects on the body including reduced bone density. Combined oral contraceptives suppress ovulation by suppressing gonadotrophic hormone, thickening cervical mucus to prevent the travel of sperm, and preventing changes in the endometrium required for implantation of a fertilized egg. Ethinylestradiol decreases luteinizing hormone, decreasing vascularity in the endometrium. It also increases sex hormone binding globulin.

Iron is necessary for the production of hemoglobin. Iron-deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia.

Norgestrel (and more specifically the active stereoisomer levonorgestrel) binds to the progesterone and estrogen receptors within the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins like levonorgestrel will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge. Loss of the LH surge inhibits ovulation and thereby prevents pregnancy.

Dosage

Conrena-R dosage

How to take Levonorgestrel, Ethinylestradiol & Ferrous Fumarate:

To achieve maximum contraceptive effectiveness, Levonorgestrel, Ethinylestradiol & Ferrous Fumarate must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the pills at about the same time every day, preferably after the evening meal or at bedtime. One pill is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after the current pack is completed.

• If you have decided to take Levonorgestrel, Ethinylestradiol & Ferrous Fumarate for contraception, wait for your next menstruation begins.
• From the first day of your menstruation, start taking the first white pill from the left corner of the top row(with arrow mark) of your Levonorgestrel, Ethinylestradiol & Ferrous Fumarate pill pack.
• Continue taking one white pill each day along the arrow mark.
• After taking 21 white pills for 21 days, continue taking one brown iron pill every day from the last row in the foil for next 7 days.

It is most likely that your menstruation will start while taking the brown pills. Do not discontinue taking the brown pills. In addition to giving you iron supplementation regular taking of the brown tablets for 7 days will help you keep your pill taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant.After completing the seven iron pills, start taking white pills from another Levonorgestrel, Ethinylestradiol & Ferrous Fumarate pack and continue taking the pill as long as you don't want to be pregnant.

What to do after missing the pill?

How to delay a period: To delay a period you should continue with another new pack of Levonorgestrel, Ethinylestradiol & Ferrous Fumarate just after finishing the white active pill of the present pack(that is no need to take brownish inert tablet of present pack). The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 7 day red inactive pill interval.

Advice in case of Vomiting: If vomiting occurs within 4 hours after white active pill taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Pills is applicable. The woman must take the extra active pill(s) needed from a back up pack after vomiting.

Side Effects

At the initial stage some women may experience side-effects like dizziness, headache, nausea, diarrhea, abdominal pain, weight gain, fluid retension, depression, mood changes, breast pain, breast tenderness, rash, vaginal discharge, erythema etc. If taken regularly, such types of side-effects normally lessen with time. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor.

Toxicity

Female patients experiencing and overdose may present with withdrawal bleeding, nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Overdose should be treated with symptomatic and supportive care including monitoring for potassium concentrations, sodium concentrations, and signs of metabolic acidosis.

Acute iron overdosage can be divided into four stages. In the first stage, which occurs up to six hours after ingestion, the principal symptoms are vomiting and diarrhea. Other symptoms include hypotension, tachycardia and CNS depression ranging from lethargy to coma. The second phase may occur at 6-24 hours after ingestion and is characterized by a temporary remission. In the third phase, gastrointestinal symptoms recur accompanied by shock, metabolic acidosis, coma, hepatic necrosis and jaundice, hypoglycemia, renal failure and pulmonary edema. The fourth phase may occur several weeks after ingestion and is characterized by gastrointestinal obstruction and liver damage. In a young child, 75 milligrams per kilogram is considered extremely dangerous. A dose of 30 milligrams per kilogram can lead to symptoms of toxicity. Estimates of a lethal dosage range from 180 milligrams per kilogram and upwards. A peak serum iron concentration of five micrograms or more per ml is associated with moderate to severe poisoning in many.

Precaution

Some medications may interfere with the efficacy of the tablet. Contact your doctor if you are taking any drugs, such as antibiotics, rifampicin or medicines for seizures. You may have to use another method of contraception during this time.

Interaction

Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively.Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of Ethinylestradiol, Norgestrel & Ferrous Fumarate & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non-hormonal back-up method of contraception to be used in addition to the regular intake of Ethinylestradiol, Norgestrel & Ferrous Fumarate.

Volume of Distribution

A 30µg oral dose has an apparent volume of distribution of 625.3±228.7L and a 1.2mg topical dose has an apparent volume of distribution of 11745.3±15934.8L.

Elimination Route

A 30µg oral dose of ethinylestradiol reaches a C_max of 74.1±35.6pg/mL, with a T_max of 1.5±0.5h, and an AUC of 487.4±166.6pg*h/mL. A 1.2mg dose delivered via a patch reaches a C_max of 28.8±10.3pg/mL, with a T_max of 86±31h, and an AUC of3895±1423pg*h/mL.

The efficiency of absorption depends on the salt form, the amount administered, the dosing regimen and the size of iron stores. Subjects with normal iron stores absorb 10% to 35% of an iron dose. Those who are iron deficient may absorb up to 95% of an iron dose.

Half Life

A 30µg oral dose has a half life of 8.4±4.8h and a 1.2mg topical dose has a half life of 27.7±34.2h.

Clearance

Ethinylestradiol has an intravenous clearance of 16.47L/h, and an estimated renal clearance of approximately 2.1L/h. A 30µg oral dose has a clearance of 58.0±19.8L/h and a 1.2mg topical dose has a clearance of 303.5±100.5L/h.

Elimination Route

Ethinylestradiol is 59.2% eliminated in the urine and bile, while 2-3% is eliminated in the feces. Over 90% of ethinylestradiol is eliminated as the unchanged parent drug.

Pregnancy & Breastfeeding use

During Pregnancy: Pregnancy must be excluded before starting Norgestrel, Ethinylestradiol & Ferrous Fumarate. If pregnancy occurs during use of Norgestrel, Ethinylestradiol & Ferrous Fumarate, the preparation must be withdrawn immediately. Oral contraceptives have not been shown to have any deleterious effects on the foetus or to increase the incidence of miscarriage in women who discontinue their use prior to conception. However, in women who discontinue oral contraceptives with the intent of becoming pregnant, a non-hormonal method of contraception is recommended for three months before attempting to conceive.

During Lactation: Estrogen-containing oral contraceptives given in the postpartum period may interfere with lactation. There may be a decrease in the quantity and a change in the composition of the breast milk. Furthermore, small amounts of contraceptive steroids and/or metabolites have been identified in the milk of mothers receiving them. A few adverse effects have been reported, including jaundice and breast enlargement. The use of oestrogen-containing oral contraceptives should be deferred until the infant has been completely weaned.

Contraindication

Ethinylestradiol, Norgestrel & Ferrous Fumarate should not be used:

• If you are pregnant or think to become pregnant
• If you had stroke or thrombosis in blood vessels of heart, legs, lungs or other parts of body
• If you are a heavy smoker
• If you suffer from liver disease or jaundice
• If you are suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
• If you have or had a benign or malignant liver tumor
• Hypersensitivity to any of the components of Ethinylestradiol, Norgestrel & Ferrous Fumarate.

Acute Overdose

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Storage Condition

Store in a cool, dry place. Keep away from light & out of reach of children.

Innovators Monograph

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