Novelon3mg0.03mg

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 dose intake, take another tablet. You body may take 7 days to get adjust with medicine, hence use condom during first week to avoid pregnancy. In case you missed your dose and you are late by 12 hours in taking the missed dose, in that case must use a condom while intercourse for a period of 2 days. Nausea, headache, breast pain, and weight gain are some commonly seen side effects of this medicine. If these bother you, or appear serious, let your doctor know. There may be ways of reducing or preventing them. You might experience spotting or bleeding between menstrual periods or missed periods. Consult with your doctor if this occurs frequently or persists longer. Inform your doctor if you notice swelling and pain in your limbs, shortness of breath, chest pain or changes in vision, as it may be a sign of blood clot. Before taking this medicine, let your doctor know if you smoke and are over 35, or if you have ever had a heart attack or have cancer of uterus/cervix, or vagina. Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. Do not take the medicine if you are pregnant already or breastfeeding. You might be asked for regular check-up of blood pressure, cholesterol and blood sugar level while on treatment.

Uses of Novelon

• Contraception

Side effects of Novelon

• 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.

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 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 4 days.

Adult 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: Safety and efficacy not established >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 and for 2 wk after elective surgery associated with high risk of thromboembolism or periods of immobilisation. Lactation. 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)

Side 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 combined use is not recommended. May reduce the efficacy of protease inhibitors and lamotrigine.