Lo/Ovral-28

Uses

Oral contraceptives are used for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Each package contains-

• 21 active tablets containing 0.3 mg norgestrel & 0.03 mg ethinylestradiol per tablet
• 7 brown inert tablets containing 75 mg ferrous fumarate each.

Lo/Ovral-28 is also used to associated treatment for these conditions: Folic 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 Lo/Ovral-28 works

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

Lo/Ovral-28 dosage

To achieve maximum contraceptive effectiveness, Norgestrel & Ethinyl Estradiol and ferrous fumarate must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. The dosage of Norgestrel & Ethinyl Estradiol and ferrous fumarate is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that tablets be taken at the same time each day.

Side Effects

Edema, Weakness, Amenorrhea, Breakthrough bleeding, Change in menstrual flow, Spotting, Anorexia, DVT, Thrombophlebitis, Depression, Dizziness, Headache, Nervousness, Somnolence, B reast tenderness, Galactorrhea, Abdominal pain, Nausea, Vomiting, Change in weight, Cholestatic jaundice

Toxicity

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

Sex-steroid dependent cancer; past ectopic pregnancy; malabsorption syndromes; functional ovarian cysts; active liver disease, recurrent cholestatic jaundice, history of jaundice in pregnancy; history of CV or renal impairment; DM; asthma; epilepsy; migraine; depression; lactation; conditions exacerbated by fluid retention; hypercalcaemia; CV and gall bladder diseases; lipid effects; familial defects of lipoprotein metabolism; patients at risk of venous thromboembolism, breast cancer, preexisting uterine leiomyomata and benign hepatic adenoma; family history of arterial disease in 1 st degree relative systolic 140 mmHg and diastolic 90 mmHg; >35 yr; BMI 30-39 kg/m2; migraine without focal aura, controlled with 5HT1; Gl upset (vomiting and diarrhoea), missed pills and interaction with other drugs may require additional contraceptive precautions. Should be taken at same time each day.

Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning

Interaction

Reduced contraceptive effectiveness with antibiotics, anticonvulsants and drugs that may increase contraceptive steroids clearance (e.g. bosentan, rifampicin, rifabutin, barbiturates, primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate, griseofulvin, aprepitant). Severe pruritus and jaundice with troleandomycin, avoid concurrent use. Decreased effectiveness of ursodeoxycholic acid by increasing the elimination of cholesterol in bile. Effects of danazol or gestrinone and hormonal contraceptives might be altered or reduced by concurrent use, avoid concomittant use.

Decreased contraceptive effectiveness with anti-HIV protease inhibitors. Increased tacrolimus levels with ethinyl estradiol. May increase theophylline, selegiline and tizanidine levels with oral contraceptives.

Elimination Route

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.

Pregnancy & Breastfeeding use

Extensive epidemiological studies have revealed no increased risk of birth defects in infants born to women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.

It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral-contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral-contraceptive use should be discontinued if pregnancy is confirmed.

Contraindication

Pregnancy, undiagnosed vaginal bleeding, severe arterial disease (or family history of atherogenic lipid profile); liver adenoma; porphyria; after evacuation of hydatidiform mole; history of breast cancer; hepatic impairment; thrombophloebitis or thromboembolic disorders; breast carcinoma except in selected patients being treated for metastatic disease; oestrogen-dependent tumour; smoking >40 cigarettes daily; >50 yr; diabetes complications present; BMI >39 kg/m2; migraine with typical focal aura, lasting >72 hr despite treatment or migraine treated with ergot derivatives; BP >160 mmHg systolic and 100 mmHg diastolic; transient ischaemic attacks without headaches; SLE; gallstones; history of haemolytic uraemic syndrome, pruritis during pregnancy; cholestatic jaundice; chorea or deterioration of otosclerosis pemphigoid; breast feeding during 1 st 6 mth after delivery.

Acute Overdose

Symptoms: Nausea, vomiting, abdominal pain, diarrhoea, haematemesis and rectal bleeding. Hypotension, coma and hepatocellular necrosis may occur later.

Treatment: Empty stomach contents by gastric lavage within 1 hr of ingestion. In severe toxicity, IV desferrioxamine may be given. Whole bowel irrigation may also be considered in severe poisoning.

Storage Condition

Should be stored in cool and dry place

Innovators Monograph

You find simplified version here Lo/Ovral-28