Lyta 28(Levonorgestrel, Ethinylestradiol & Ferrous Fumarate)

Therapeutic Group: Contraceptive

Presentation

Lyta 28 : Each Lyta 28 package contains 28 pills. Among these 21 pills are white in color and each contains Levonorgestrel BP 0.150 mg & Ethinylestradiol BP 0.030 mg. Each of 7 brown pill contains 75 mg of Ferrous Fumarate BP.

Description

Lyta 28 contains two active ingredients, Ethinylestradiol and Levonorgestrel. Ethinylestradiol is a synthetic version of oestrogen and levonorgestrel is a synthetic form of progesterone. The hormonal components of Lyta 28 inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of Lyta 28 as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Indications

Lyta 28 is indicated:

– Primarily for prevention of pregnancy and

– Also to regularize menstrual cycle & helps to reduce discomforts experienced during menstruation.

Dosage & Administration

How to take Lyta 28: To achieve maximum contraceptive effectiveness, Lyta 28 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 Lyta 28 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 Lyta 28 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 Lyta 28 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 Lyta 28 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

Different types of pill suit different types of woman. At the initial stage some women may experience side-effects like dizziness, headache, nausea or inter-menstrual bleeding. If taken regularly, such types of side-effects normally go away after 2-3 months. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor. After starting one brand of oral contraceptive pills, if you feel any inconvenience such as migraine, changes in eyesight or speeh, unusual pain or swelling in your legs, sharp chest pains or shortness of breath, yellow skin or a rise in blood pressure take advice from your doctor or contact the nearest family planning centre.

Precautions

Some medications may interfere with the efficacy of the pill. 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.

Use in Pregnancy & Lactation

Pregnancy Category – B3 .
During Pregnancy:
Pregnancy must be excluded before starting Lyta 28. If pregnancy occurs during use of Lyta 28, 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.

Drug 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 Lyta 28 & 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 Lyta 28.

Over Dose

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

Store in 15 °C to 30 °C, dry place and keep away from light. Keep out of reach of children.

Commercial Pack

Lyta 28 : Each blister contains 21 white pills (each containing Levonorgestrel BP 0.150 mg and Ethinylestradiol BP 0.030 mg) and 7 brown pills (each contains 75 mg of Ferrous Fumarate BP).