12-24 Hours
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Novelon
Renata Limited
Generic: Drospirenone + Ethinylestradiol
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Novelon. Please consult your doctor.
UNSAFE
Novelon is highly unsafe to use during pregnancy. Seek your doctor's advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.
CONSULT YOUR DOCTOR
Novelon is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
Nonhormonal and progestin-only contraceptives are preferred in breastfeeding women, especially during the first 4 weeks postpartum
SAFE
Novelon does not usually affect your ability to drive.
UNSAFE
Novelon is probably unsafe to use in patients with kidney disease and should be avoided. Please consult your doctor.
UNSAFE
Novelon is probably unsafe to use in patients with liver disease and should be avoided. Please consult your doctor.
Medicine Overview of Novelon 0.03 mg+3 mg tablet
Introduction
Novelon is a combination of two medicines used for contraception (to prevent pregnancy) and in the treatment of irregular periods. It helps to prevent release and fertilization of the egg. Novelon can be taken with or without food, but take it at the same time to get the most benefit. It should be taken as your doctor's advice. You should have to start taking the pill on the day one of your menstrual cycle and continue taking it for whole month and start with new pack once the pack get finished. If you experience vomiting with in 4 hours of...
... Show moreUses of Novelon
- Contraception
Side effects of Novelon
Common
- Nausea
- Stomach pain
- Headache
- Weight gain
- Breast pain
- Irregular uterine bleeding
How to use Novelon
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Novelon may be taken with or without food, but it is better to take it at a fixed time.
How Novelon works
Novelon is a combined oral contraceptive pill. It works by preventing the release of egg (ovulation) and affecting sperm movement in the womb to prevent its union with the egg. It also changes the lining of the womb and renders it unsuitable for pregnancy.
Quick Tips
- Your doctor has prescribed Novelon to help you prevent pregnancy.
- It also results in lighter, less painful and more regular menstrual bleeding.
- It may help reduce the risk of ovarian cancer.
- Take your pill at the same time every day to help you remember to take it.
- You may experience menstrual irregularities such as spotting or bleeding between menstrual periods or missed periods. Consult your doctor if this persists.
- Do not use Novelon if you are obese, over 35, smoke, on prolonged bed rest, or have a history of blood clots.
- Stop taking this medicine and inform your doctor immediately if you notice unexplained swelling and pain in your limbs, shortness of breath, chest pain, severe headache, or changes in vision. These could be symptoms of a blood clot in a vein.
- Stop taking Novelon and inform your doctor immediately if you notice your skin and whites of the eye turning yellow (jaundice), severe stomach pain, severe depression or if you think you could be pregnant.
Brief Description
Indication
Acne, Oral contraception, Premenstrual dysphoric disorder.
Administration
May be taken with or without food. Take dose at the same time each day. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. 1 tab/day for 21 days followed by 7 pill-free days before starting on a new pack or after taking 21 light yellow tablets for 21 days, then continue taking one white placebo tablet every day from the last row in the pack for next 7 days. 1 tab/day for 24 days followed by 4 pill-free days before starting on a new pack...
... Show moreAdult Dose
Contraception
1 active tablet (3 mg drospirenone/0.03 mg EE) PO qDay for 21 days, THEN 1 inert tablet PO qDay for 7 days
1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days
Premenstrual Dysphoric Disorder
Symptoms of premenstrual dysphoric disorder (PMDD), but only if oral contraceptive is chosen as method of birth control
1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days
Hepatic impairment: Avoid use.
Child Dose
Contraception
14 years: Same dosing as adult
Renal Dose
Renal impairment:
CrCl (ml/min)
<50 Avoid use.
Contraindication
Pregnancy. Undiagnosed abnormal genital bleeding. Renal insufficiency, hepatic dysfunction or tumor. Adrenal insufficiency, cholestatic jaundice of pregnancy, jaundice with prior oral contraceptive use. Major surgery with prolonged immobilisation. Heavy smoking (>15 cigarettes/day) in patients >35 y.
History of or current thrombophlebitis or venous thromboembolic disorders. Active or recent (within 1 yr) arterial thromboembolic disease; cerebral vascular disease, coronary artery disease, severe hypertension, valvular heart disease with thrombogenic complications. Diabetes with vascular involvement; headache with focal neurological symptoms. Known or suspected breast carcinoma, endometrial cancer, oestrogen-dependent neoplasms.
Mode of Action
Ethinylestradiol is a synthetic oestrogen while drospirenone is a progestogen with antimineralocorticoid and antiandrogenic activity. Combined oral contraceptives act by suppressing the gonadotropins. Oral contraceptives also produce changes in the cervical mucus, making it less favorable for sperm penetration even if ovulation occurs.
Precaution
May increase risk of breast cancer, thromboembolism and glucose intolerance. May lead to hyperkalaemia in patients with adrenal insufficiency. May affect serum triglycerides and lipoprotein levels. May cause retinal vascular thrombosis; discontinue treatment if papilloedema or retinal vascular lesions occur. Caution when used in patients with depression, history of migraines or risk factors for coronary arterial diseases. Patients with diseases which may be worsened by fluid retention. May have dose-related risk of gall bladder disease. Increased risk of CV side effects when used in smokers, especially if they are >35 yr of age. Recommended to stop treatment 4 wk before...
... Show moreSide Effect
>10%
Premenstrual syndrome (13.2%),Migraine/headache (10.7%)
1-10%
Breast pain/discomfort/tenderness (8.3%),Menstrual irregularities (4.7%),Nausea/vomiting (4.5%),Abdominal pain/discomfort/tenderness (2.3%),Mood changes, including affect lability, depression, alteration of mood, mood swings, and irritability (2.3%)
Frequency Not Defined
Irregular uterine bleeding,Venous/arterial thromboembolic events, including DVT, PE, stroke, MI, intracardiac thrombosis, sagittal sinus thrombosis, intracranial venous sinus thrombosis, retinal vein thrombosis,Hypertension,Hypersensitivity,Hyperkalemia,Chloasma,Gallbladder disease,Toxic skin eruption,Uterine leiomyoma
Pregnancy Category Note
Pregnancy category: X
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 (AAP Committee states compatible with nursing)
Interaction
Increased risk of hyperkalaemia when used with ACE inhibitors, angiotensin II receptor antagonists, aldosterone antagonists, potassium salts or NSAIDs. Aminoglutethimide may increase hepatic metabolism of progestins. Increased risk of systemic acidosis when used with ammonium chloride. Serum concentrations may be reduced by aprepitant, topiramate, rifampin or protease inhibitors. Efficacy may be reduced by concurrent use of acitretin, carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, topiramate, barbiturates, griseofulvin, modafinil. Oestrogens may decrease the clearance of benzodiazepines that undergo oxidative metabolism. Concurrent use may increase the serum levels of systemic corticosteroids, ciclosporin, tizanidine, voriconazole and selegiline. May affect the efficacy of coumarin derivativesl; thus...
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