INTRODUCTION ABOUT DEAR 21 TABLET

DEAR 21 TABLET is a combination of Levonorgestrel and Ethinylestradiol which belongs to the group of medicines called Hormonal Contraceptive Agents. It is used as a contraceptive pill to manage pregnancy.

Before taking DEAR 21 TABLET inform your doctor if you have any lung, liver, kidney or heart problems. You must also inform your doctor if you have asthma, diabetes, high blood pressure, high blood cholesterol levels, migraine, obesity, epilepsy or depression as a precaution.

DEAR 21 TABLET is strictly not recommended for use in patients with breast cancer, cervical cancer or liver cancer. It is also not suitable for use in patients with depression, blood clots, stroke or any problems in blood circulation.

DEAR 21 TABLET is not intended for use in pregnant women, in children who have not attained puberty and elderly women who have reached menopause. It is also not recommended for use in breastfeeding women and in women (aged above 35 years) who have the habit of smoking.

The most common side effects of taking DEAR 21 TABLET are vaginal infections or inflammation, vaginal discharge, unusual spotting or bleeding, breast tenderness, milk discharge from breasts, mood changes, low sex drive, and changes in body weight. Consult your doctor if any of these side effects worsens.

USES OF DEAR 21 TABLET

Used as a contraceptive to manage pregnancy

HOW DEAR 21 TABLET WORKS

DEAR 21 TABLET is a contraceptive pill. It reduces the chances of pregnancy by suppressing ovulation (release of a mature egg from an ovary). It can also reduce the thickness of the inner lining of the uterus which makes it not suitable for the foetus to implant and grow.

Additionally, it can alter the thickness of the cervical mucus which makes it difficult for the sperm to enter the uterus and fertilize the egg. As a result, they create an unfavourable environment for a successful pregnancy.

DIRECTIONS FOR USE

Take DEAR 21 TABLET strictly as advised by your physician. Swallow DEAR 21 TABLET with a glass of water. Do not crush or chew the medicine. DEAR 21 TABLET can be taken with or without meals.

Do not miss any dose of DEAR 21 TABLET in between the therapy, as it may reduce its effectiveness. In case you have missed a dose of DEAR 21 TABLET, take it as soon as you remember. Avoid taking a double dose of this medicine to compensate for the missed dose.

Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and health condition.

SIDE EFFECTS OF DEAR 21 TABLET

COMMON

vaginal infection, itching or inflammation
discharge from vagina
changes in body weight
changes in mood (mood swings)
depression
changes in sex drive
headache, tiredness
feeling nervous
nausea, vomiting, stomach pain
unusual spotting or bleeding
breast pain or tenderness
milk discharge from breasts
heavy periods or lack of periods
swelling of body parts (edema)

UNCOMMON

changes in blood cholesterol levels
changes in appetite
increase in blood pressure
flatulence (bloating)
skin rashes, dark patches on the skin
hirsutism (abnormal hair growth in the body)
hair loss

RARE

decrease in serum folate levels
unable to wear contact lenses
cholestatic jaundice

Stop taking DEAR 21 TABLET and contact your doctor immediately if you experience any of the following side effects:

signs of allergic reactions (such as swelling of the face, lips, mouth, tongue, or throat causing difficulty in breathing or swallowing)
signs of breast cancer (presence of lumps in the breast, skin dimpling in the breast and changes in the nipple)
signs of cervical cancer (smelly or bloody discharge from the vagina, unusual vaginal bleeding, pelvic pain, and painful sex)
signs of severe liver problems (such as severe pain in your upper abdomen, yellow skin, or eyes, itching in the whole body)
signs of a blood clot in the legs (such as swelling of the affected leg or foot accompanied by pain or tenderness)
signs of a blood clot in the lungs (such as sudden unexplained breathing difficulty, rapid heart rate, sharp chest pain, severe lightheadedness, or dizziness)
signs of a blood clot in the eyes (such as sudden loss of vision or painless blurring of vision)
signs of heart attack (chest pain, pressure, heaviness in the chest, abnormal heartbeat, extreme weakness, anxiety, or shortness of breath, sweating, nausea, vomiting or dizziness)
signs of stroke (sudden weakness or numbness of the face, arm, or legs, especially on one side of the body, confusion, trouble in speaking or understanding, walking, dizziness, loss of balance, fainting with or without seizure)
swelling and slight blue discolouration of an extremity, severe stomach pain
feeling depressed with thoughts of killing or harming yourself

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Nausea and Vomiting

Take DEAR 21 TABLET with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

WARNING & PRECAUTIONS

PREGNANCY

DEAR 21 TABLET is not recommended for use in pregnant women and in women who think that they might be pregnant. It is also not recommended for use in women who have or ever had jaundice due to pregnancy. It should be used with caution in pregnant women with a previous history of herpes gestationis (an autoimmune skin disease). Therefore, consult your doctor before taking it.

BREASTFEEDING

DEAR 21 TABLET is not recommended for use in breast-feeding women. Therefore, consult your doctor before taking it.

DRIVING AND USING MACHINES

DEAR 21 TABLET has negligible effects on driving or handling heavy tools or machines. However, do not drive or handle any heavy machines if your ability is affected by DEAR 21 TABLET.

ALCOHOL

Avoid consumption of alcohol while taking DEAR 21 TABLET.

KIDNEY

DEAR 21 TABLET is not recommended for use in patients with kidney diseases (such as kidney failure). It should be used with caution in patients with other kidney problems. Therefore, consult your doctor before taking it.

LIVER

DEAR 21 TABLET is not recommended for use in patients who have or every had liver diseases (such as liver tumours). It should be used with caution in patients with other liver or gall bladder problems (such as jaundice, gall stones). Therefore, consult your doctor before taking it.

ALLERGY

Do not take DEAR 21 TABLET if you are allergic to Levonorgestrel or Ethinylestradiol.

LUNGS

DEAR 21 TABLET is not recommended for use in patients who have blood clots in the lungs (pulmonary embolism). It should be used with caution in patients with asthma. Therefore, consult your doctor before taking it.

HEART DISEASE

DEAR 21 TABLET is not recommended for use in patients who have or ever had heart diseases (such as coronary artery disease, heart attack, angina, valvular heart disease, or arrhythmias). It should be used with caution in patients with other heart problems. Therefore, consult your doctor before taking it.

OTHERS

DEAR 21 TABLET is not recommended for use if you:

have or had blood clots in legs (deep vein thrombosis) or eyes (retinal thrombosis)
have any type of blood clotting disorders (such as APC resistance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, antiphospholipid antibodies in blood which cause immediate blood clots)
have any pre-planned surgery
have severe diabetes with damage to blood vessels
have uncontrolled high blood pressure
have high blood cholesterol and triglyceride levels
have or ever had migraine headaches
have or ever had or at risk of developing breast cancer or cancers in genital organs
have hyperhomocysteinaemia (an increase in the levels of an amino acid called homocysteine in blood)
have unexplained bleeding from the vagina
have pancreatitis (severe inflammation of the pancreas)
have hepatitis C infection (a type of viral infection affecting the liver)
have adrenal insufficiency (when the body does not produce enough aldosterone hormone)
are aged above 35 years and have a habit of smoking
have stroke or problems in blood circulation
have reached menopause

Before taking DEAR 21 TABLET inform your doctor if you:

have family history of breast cancer
have hypertension
have depression
have diarrhoea/vomiting
have otosclerosis (abnormal bone growth in the ears)
have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
have systemic lupus erythematosus (disease affecting your immune system)
have haemolytic uraemic syndrome (blood clotting disorder causing kidney failure)
have sickle cell anaemia (an inherited red blood cell disease)
have just given birth
had an abortion in the second trimester
have been bed-ridden or immobile for a prolonged period
have an inflammation in the veins under the skin (superficial thrombophlebitis)
have varicose veins (enlarged or twisted veins)
have epilepsy
are obese
have porphyria (a rare inherited blood disorder)
have abnormal body movements (chorea)
have multiple sclerosis (an autoimmune disease, causing nerve damage)
have tetany (involuntary muscle contractions)
have a history of chloasma gravidarum (dark patches on the skin) in previous pregnancies
are due to have a lab test

Use in paediatrics:

DEAR 21 TABLET is not recommended for use in children and in adolescent girls aged below 18 years. It is also not intended for use in female children who have not attained puberty. Therefore, consult your doctor before taking it.

Use in geriatrics:

DEAR 21 TABLET is not indicated for use in elderly women. Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug - Drug interactions:

Before taking DEAR 21 TABLET, inform your doctor if you are taking any of the following medicines such as:

medicines used to manage epilepsy (Ex. primidone, phenytoin, topiramate, phenobarbital, carbamazepine, oxcarbazepine, felbamate, lamotrigine)
medicines used to manage tuberculosis (Ex. rifampicin, rifabutin)
dexamethasone (a medicine used to manage asthma or autoimmune diseases)
atorvastatin (a medicine used to manage high blood cholesterol levels)
modafinil (a medicine used to reduce sleep in narcolepsy)
troleandomycin (a medicine used to manage bacterial infections)
ascorbic acid (a vitamin C supplement)
medicines used to manage HIV infection (Ex. ritonavir, nevirapine, efavirenz)
medicines used to manage fungal infections (Ex. fluconazole, griseofulvin)
St. John’s wort (an herbal remedy used to manage mental illness)
medicines used to manage graft rejection during organ transplants (Ex. cyclosporin)
theophylline (used to manage breathing problems)
flunarizine (a medicine used to manage vertigo)
medicines used to manage hepatitis C infections (Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir)
medicines used to relive pain (Ex. ibuprofen, aceclofenac, phenylbutazone, paracetamol)
heparin (a medicine used to manage blood clots)

Overdosage:

If you or anyone else accidentally took more DEAR 21 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include nausea, vomiting, breast tenderness, dizziness, stomach pain, fatigue and withdrawal bleeding.

SYNOPSIS

Drug	:	Levonorgestrel, Ethinylestradiol
Pharmacological Category	:	Synthetic Progestins, Estrogens
Therapeutic Indication	:	Contraception
Dosage Forms	:	Tablet

MORE INFORMATION

Keep DEAR 21 TABLET out of reach of children
Store DEAR 21 TABLET at room temperature

FAQs ABOUT DEAR 21 TABLET

Is it safe to take DEAR 21 TABLET immediately after delivery?

No. Do not take DEAR 21 TABLET immediately after delivery. Consult your doctor before taking it because DEAR 21 TABLET may increase the risk of blood clots in such patients. It is advisable to take DEAR 21 TABLET only after 4 weeks post-delivery. However, consult your doctor before taking it.

Can DEAR 21 TABLET be used in children?

Can DEAR 21 TABLET be used in post-menopausal women?

DEAR 21 TABLET is a contraceptive pill used to manage pregnancy. It is not intended for use in postmenopausal women.

Do DEAR 21 TABLET cause cancer?

Studies have shown that DEAR 21 TABLET may cause breast cancer in some individuals. This is predominant, particularly in patients who had or have a family of breast cancer. Therefore, inform your doctor if you or anyone of your family member has breast cancer before taking DEAR 21 TABLET as a precaution. Also, during therapy with DEAR 21 TABLET, your doctor would periodically monitor your breasts and overall health to avoid the risk of breast cancer. The risk of breast tumours gradually decreases after stopping DEAR 21 TABLET therapy.

Can the use of DEAR 21 TABLET cause unexpected bleeding?

Yes. Irregular vaginal bleeding or spotting may occur while you are taking DEAR 21 TABLET. Such bleeding may be temporary and usually does not indicate any serious problems. However, consult your doctor if you experience prolonged painful bleeding.

How and when should I take DEAR 21 TABLET?

Take DEAR 21 TABLET strictly as advised by your physician. Swallow DEAR 21 TABLET with a glass of water. DEAR 21 TABLET can be taken with or without meals. Do not miss any dose of DEAR 21 TABLET in between the therapy, as it may reduce its effectiveness.

Can DEAR 21 TABLET cause abortion?

DEAR 21 TABLET is a contraceptive pill. It works by suppressing ovulation and fertilization. It is not capable for causing abortion.

Can the use of DEAR 21 TABLET cause depression?

Yes. DEAR 21 TABLET may make you feel depressed. This is because DEAR 21 TABLET works by controlling the hormones which can exerts its influence on the mood and mental health. If you feel depressed, or have thoughts of harming or killing yourself, consult your doctor immediately.

What to do if I forgot to take DEAR 21 TABLET?

If you have missed a dose of DEAR 21 TABLET, take proper safety measures such as the usage of condoms to avoid pregnancy. Do not take a double dose of DEAR 21 TABLET to compensate for the missed ones. Spotting or sudden bleeding can occur in case if you miss taking DEAR 21 TABLET.

Will the use of DEAR 21 TABLET change the length of the menstrual cycle?

Yes. There are changes for sudden spotting or vaginal bleeding while taking DEAR 21 TABLET. But there has been no reported evidence for long menstrual cycles.

Will the use of DEAR 21 TABLET produce complete protection from pregnancy?

Yes. DEAR 21 TABLET will provide complete protection from pregnancy when all the doses are taken correctly and regularly. But, if you miss any dose of DEAR 21 TABLET, it will not be effective, and you may have higher chances of becoming pregnant.

Is the use of condemn necessary while using DEAR 21 TABLET?

No. It is not required to use condemn while taking DEAR 21 TABLET. But if you miss any dose of DEAR 21 TABLET, you should use condoms to manage unwanted pregnancy.

Does DEAR 21 TABLET stops periods?

No. DEAR 21 TABLET is a birth control pill used to manage pregnancy. It manages ovulation and creates an unfavourable environment for a fertilized egg to implant and grow in the uterus. It is not proven to stop periods. However, it may delay your periods or can cause irregular or scanty periods.

Can DEAR 21 TABLET cause hair loss?

DEAR 21 TABLET may cause hair loss in some patients. Consult your doctor if you experience severe hair loss.

How long can I take DEAR 21 TABLET?

Take DEAR 21 TABLET for the stipulated duration prescribed by your doctor. You may be advised to take DEAR 21 TABLET every day regularly without fail. One course would usually last up to 24 days (approximately a month). However, your doctor will decide the duration of therapy for you. Never miss or skip a dose of DEAR 21 TABLET as may reduce the contraceptive effects or may cause bleeding in between the menstrual cycle.

REFERENCES

1. KD. Tripathi. Estrogens, Progestins and Contraceptives. Essentials of Pharmacology. Seventh edition. 2013. Page – 318 & 322.

2. Giuseppe Benagiano, Sabina Carrara, and Valentina Filippi. Safety, efficacy and patient satisfaction with continuous daily administration of levonorgestrel/ethinylestradiol oral contraceptives. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. November 2009. [Accessed on 20th December 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778424/

3. Pfizer Canada Inc. PrMIN-OVRAL® 21 and PrMIN-OVRAL® 28. [Revised in June 2018]. [Accessed on 20th December 2022]. https://pdf.hres.ca/dpd_pm/00045904.PDF

4. Leepill ET. Leeford Healthcare Pvt Ltd. [Accessed on 20th December 2022]. https://www.leeford.in/product/1510/leepill-et#:~:text=DESCRIPTION%3A,of%20contraception%20to%20avoid%20pregnancy.

5. Central Drugs Standard Control Organization. 21 pills of FDC of levonorgestrel + ethinylestradiol tablets IP: Each sugar-coated tablet contains: Levonorgestrel IP 150 mcg + ethinylestradiol IP 30 mcg 7 pills of placebo/inert tablets. April 2014. Levonorgestrel 0.25mg+Ethinylestradiol 0.05mg tablets. June 2001. [Accessed on 20th December 2022]. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/dciApprovedfdc.pdf

AUTHOR DETAILS

Written By Srilekha. R - B.Pharm

Last updated on 22 Dec 2022 | 07:14 PM(IST)

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