Daphne

Daphne

lynestrenol

Manufacturer:

DKT

Distributor:

DKT
Full Prescribing Info
Contents
Lynestrenol.
Description
Each white tablet contains: Lynestrenol 500 mcg.
Lynestrenol (DAPHNE) is a progestin-only pill that contains very low doses of a progestin similar to the natural hormone, progesterone, in a woman's body. It consists of 28 white, round, flat, beveled edge, uncoated pill with "L" engraved on one side and plain on the other side and is intended for contraception.
Lynestrenol (DAPHNE) is a hormonal contraceptive of choice for breastfeeding women because it does not affect lactation or infant growth.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Lynestrenol works primarily by thickening cervical mucus (this blocks sperm from meeting an egg) and disrupting the menstrual cycle, including preventing the release of eggs from the ovaries (ovulation).
Pharmacokinetics: Lynestrenol is a progestogen structurally related to norethistrone. Progestogens are derived from progesterone or 19-nortestosterone and with actions similar to those of progesterone. Lynestrenol is highly protein bound and undergo hepatic metabolism to various conjugates, which are excreted in urine.
Indications/Uses
Lynestrenol (DAPHNE) is indicated for contraception, notably in cases of intolerance to estrogen-progestogen combined pills or when estrogens are contraindicated. It is also recommended for lactating mothers and smoking women who require contraception.
Dosage/Direction for Use
Take one pill daily, beginning on the first day of menstrual bleeding. Patient may also start any day as long as patient is not pregnant but use a back-up method such as condom for the next seven days as a precaution to avoid pregnancy. Breastfeeding women can start six weeks after giving birth. Start with the pill marked with the corresponding day of the week. Follow the arrows indicated on the pack.
The interval between two pills should be 24 hours. Incorporate it to patient's daily routine-after evening 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 pill.
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 severe diarrhea can interfere with the absorption of the pill. If vomiting occurs within two hours of taking pill, another pill should be taken as soon as possible. If the replacement pill is not taken within 3 hours of the normal time of taking the pill, or in cases of persistent vomiting or severe diarrhea, a back-up method such as condom should be used during illness and for 2 days after recovery.
If patient missed a pill, it should be taken three 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.
Regularity in taking the pill is very important because contraceptive efficacy is reduced if a pill is delayed by more than three hours.
If the pill is less than three hours overdue, take it as soon as remembered. Resume taking the next scheduled pill. Patient will not need a back-up contraceptive method.
If the pill is more than three hours overdue, take it as soon as remembered and either abstain from sex or use condoms for the next two days. Resume taking the next scheduled pill. (See figure.)

Click on icon to see table/diagram/image

If patient continually forgets to take the pills, ask the healthcare provider for ways to become compliant, or for another method of contraception such as an injectable which will suit the patient better.
Overdosage
No serious ill effects have been reported after ingestion of large doses of oral contraceptives, although it may cause nausea and withdrawal bleeding. Treatment is unnecessary because the overdose is unlikely to be life-threatening. Ask the healthcare provider for further instructions.
Contraindications
Make sure the patient is not pregnant before taking Lynestrenol (DAPHNE). Patient should inform the healthcare provider if she has the following conditions before she start taking Lynestrenol (DAPHNE): porphyria, possible pregnancy, severe arterial disease, undiagnosed vaginal bleeding, hormone-dependent neoplasms, severe liver disease such as hepatic adenoma, after recent evacuation of a hydatidiform mole.
Special Precautions
Regular consultation with a healthcare provider is recommended while taking Lynestrenol (DAPHNE). Inform the healthcare provider if patient is suffering from the following conditions: asthma, diabetes mellitus, epilepsy, heart disease, hypertension, thromboembolic disorders, history of depression, past ectopic pregnancy, functional ovarian cysts, malabsorption syndromes, migraine, renal impairment, liver dysfunction including cholestatic jaundice or a history of jaundice in pregnancy, other conditions which may be aggravated by fluid retention.
Adverse Reactions
The oral contraceptive pill is one of 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 gastrointestinal disturbances, changes in appetite or weight, fluid retention, edema, chloasma (melasma), allergic skin rashes, urticaria, mental depression, breast changes including discomfort or occasionally gynecomastia, changes in libido, hair loss, hirsutism, fatigue, drowsiness, insomnia, fever, headache, premenstrual syndrome-like symptoms and altered menstrual cycles or irregular menstrual bleeding. Anaphylaxis or anaphylactoid reactions may occur rarely. Alteration in the serum lipid profile may occur, and rarely alterations in liver-function tests and jaundice.
Drug Interactions
Taking Lynestrenol (DAPHNE) with drugs that induce hepatic enzyme activity (e.g., carbamazepine, griseofulvin, modafinil, nelfinavir, nevirapine, oxcarbazepine, phenytoin, phenobarbital, primidone, ritonavir, St. John's Wort, topiramate, rifabutin and rifampicin) may reduce the contraceptive efficacy. Women taking a short course of an enzyme-inducing drug should have contraceptive precaution while taking oral contraceptive pill and for four weeks after completing the medication. If patient is required to take a long-term course of an enzyme-inducing drug, using another contraceptive measure is encouraged.
Taking Lynestrenol (DAPHNE) with aprepitant and bosentan can result to a possible contraceptive failure.
Taking Lynestrenol (DAPHNE) with amprenavir, sitaxentan, atorvastatin and tacrolimus may increase the incidence of side effects.
Taking Lynestrenol (DAPHNE) with rufinamide can decrease the contraceptive efficacy.
Lynestrenol (DAPHNE) may enhance or reduce anticoagulant effect of coumarins, can increase clearance of some analgesics (e.g. paracetamol and morphine), can antagonize hypoglycemic effect of antidiabetics, and can antagonize anticoagulant effect of phenindione.
Lynestrenol (DAPHNE) can increase the plasma concentration of ciclosporin, selegiline, and possibly tizanidine and increasing the risk of toxicity.
Lynestrenol (DAPHNE) can reduce the plasma concentration of lamotrigine.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Oral Contraceptives
ATC Classification
G03DC03 - lynestrenol ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Tab 500 mcg (white, round, flat, beveled edge, uncoated pill with "L" engraved on one side and plain on the other side) x 28's.
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