SmartPill

Uses:

• Contraception

How does SmartPill work?

Drospirenone (Progestin): This component functions by preventing pregnancy through two mechanisms. It inhibits the release of an egg from the ovary (ovulation) and also works to impede the fertilization of the egg by sperm.

Ethinyl Estradiol (Synthetic Estrogen): This synthetic estrogen plays a crucial role in women's reproductive health. It helps in maintaining a normal menstrual cycle in women of childbearing age. Additionally, for women undergoing menopause, Ethinyl Estradiol compensates for the deficiency of estrogen hormone.

Together, these two components contribute to the contraceptive effects of the medication.

Side Effects of SmartPill

• Breast cancer
• Breast lumps
• Cancer of the uterus
• Stroke
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting

Quick Suggestions:

• Quit smoking and avoid alcohol consumption to minimize complications.
• Engage in regular exercise to help manage weight fluctuations associated with the medication.
• Monitor blood pressure regularly. Contact your doctor if there are significant fluctuations.
• Include omega-3 fatty acid-containing foods in your diet.
• Use heart-healthy cooking oils like olive oil, soybean oil, canola oil, and coconut oil.
• Take Ethinyl Estradiol + Drospirenone at the same time every day.
• Benefits include preventing pregnancy, reducing menstrual bleeding, and potentially lowering the risk of ovarian cancer.
• Be aware of potential menstrual irregularities such as spotting or bleeding between periods.
• Consult your doctor if these issues persist.
• Avoid using the medication if you are obese, over 35, smoke, have a history of blood clots, or are on prolonged bed rest.

Contraception

Preventing Ovulation: Contraception aims to inhibit the release of an egg (ovulation) from the woman's ovary. Without the availability of an egg, fertilization cannot occur.

Separating Sperm and Egg: By using various mechanisms, contraception methods work to keep sperm and egg apart. This can involve altering the cervical mucus to make it less conducive for sperm penetration or using barriers that physically prevent sperm from reaching the egg.

Preventing Implantation: Contraception also interferes with the fertilized egg's ability to attach to the lining of the uterus. This prevents the development of a pregnancy.

Pharmacology

Ethinylestradiol, a synthetic estrogen, and drospirenone, a progestogen with anti-mineralocorticoid and antiandrogenic properties, are combined in SmartPill. The combination of these hormones serves as a form of oral contraceptive.

The primary mechanism of action involves the suppression of gonadotropins, which are hormones involved in the regulation of the reproductive system. By doing so, oral contraceptives like SmartPill inhibit the process of ovulation. Additionally, these contraceptives induce changes in cervical mucus, making it less conducive to sperm penetration, even if ovulation were to occur.

Dosage & Administration of SmartPill

Dosage for Contraception:

• Take one active tablet (3 mg drospirenone/0.03 mg EE) orally once a day for 21 days.
• Followed by 7 pill-free days.
• Start a new pack or take one white placebo tablet every day from the last row in the pack for the next 7 days.

OR

• Take one active tablet (3 mg drospirenone/0.02 mg EE) orally once a day for 24 days.
• Followed by 4 pill-free days.
• Start a new pack or take one white placebo tablet every day from the last row in the pack for the next 4 days.

Dosage for PMDD (Only if oral contraceptive is chosen as the method of birth control):

• Take one active tablet (3 mg drospirenone/0.02 mg EE) orally once a day for 24 days.
• Followed by 4 pill-free days.

Dosage for Hepatic Impairment:

• Avoid use in individuals with hepatic impairment.

Renal Dose:

• Avoid use in individuals with renal impairment (CrCl <50 ml/min).

Safety and efficacy are not established for individuals below 14 years. For those above 14 years, the same dosing as adults is recommended.

Administration Tips:

• Take one pill every day at the same time, preferably after the evening meal or at bedtime.
• The pill can be taken with water.
• If a dose is missed, take it as soon as remembered or take the next pill at the regular time.
• If more than one pill is missed, contact the doctor immediately.
• Do not stop taking SmartPill without consulting the doctor.

Interaction

• Thyroid hormone replacement therapy: Used for thyroid disorders.
• Ascorbic acid: Vitamin C supplement.
• Paracetamol: Used for fever and pain.
• Itraconazole: Antifungal medication.
• Medicines used to treat HIV infections: Antiretroviral drugs for managing HIV.
• Potassium-sparing diuretics (e.g., spironolactone) and Potassium supplementation: Used for conditions like hypertension and heart failure.
• Captopril, ramipril, telmisartan: Medications for treating high blood pressure.
• Heparin: Anticoagulant used to prevent blood clots.
• Aldosterone antagonists: Medications that block the effects of aldosterone, often used in heart failure.

Contraindications

Pregnancy: SmartPill is contraindicated in pregnancy.

Undiagnosed abnormal genital bleeding: If the cause of abnormal genital bleeding has not been diagnosed, SmartPill should not be used.

Renal insufficiency, hepatic dysfunction, or tumor: Conditions affecting the kidneys, liver dysfunction, or the presence of tumors are contraindications.

• Adrenal insufficiency, cholestatic jaundice of pregnancy, jaundice with prior oral contraceptive use: Conditions related to adrenal function and jaundice are contraindications.
• Major surgery with prolonged immobilization: Following major surgery with prolonged immobilization, the use of SmartPill is not recommended.
• Heavy smoking (>15 cigarettes/day) in patients >35 y: Smoking, especially in individuals over 35 years old, poses additional risks.
• History of or current thrombophlebitis or venous thromboembolic disorders: A history or current presence of blood clotting disorders is a contraindication.
• Active or recent arterial thromboembolic disease; cerebral vascular disease, coronary artery disease, severe hypertension, valvular heart disease with thrombogenic complications: Conditions affecting the arteries and heart are contraindications.
• Diabetes with vascular involvement: Diabetes with vascular complications is a contraindication.
• Headache with focal neurological symptoms: Individuals experiencing headaches with focal neurological symptoms should avoid using SmartPill.
• Known or suspected breast carcinoma, endometrial cancer, estrogen-dependent neoplasms: History or suspicion of certain cancers is a contraindication.

Pregnancy & Lactation

SmartPill falls under Pregnancy Category X, which typically implies that the risks of using the medication during pregnancy outweigh potential benefits. Therefore, it is contraindicated in pregnancy.

Regarding lactation, small amounts of steroids are excreted in breast milk, and estrogens may impact the quality and quantity of milk. It is suggested that other forms of birth control may be more prudent until full weaning. However, the American Academy of Pediatrics (AAP) Committee states that the use of this medication is compatible with nursing.

Precautions & Warnings

• Allergic Reactions: If you are allergic to ethinyl estradiol, drospirenone, or any other ingredients in the medication, it's important to inform your healthcare provider.
• Thromboembolic Disorders and Vascular Problems: Individuals with a history of thromboembolic disorders (blood clots) or other vascular issues should discuss their medical history with their doctor.
• Age and Obesity: Women above the age of 35, particularly those who smoke and are obese, may have an increased risk of certain complications, and the decision to use birth control pills should be made carefully.
• Cardiovascular Risks: The medication may pose risks for individuals with a history of strokes, heart attacks, high blood pressure, and those at risk for these conditions.
• Upcoming Surgery: If you have an upcoming surgery, especially procedures that may involve prolonged immobilization, you should inform your healthcare provider.
• Hyperkalemia: Conditions associated with high levels of potassium in the blood (hyperkalemia) may warrant caution.
• Cancer: A history of breast or reproductive organ cancer may influence the choice of contraceptive method, and consultation with a healthcare provider is important.
• Liver, Gall Bladder, Kidney, or Adrenal Disease: Certain medical conditions affecting these organs may require careful consideration.
• Headaches and Depression: Individuals with a history of severe headaches or depression should discuss their symptoms with their healthcare provider.
• Carbohydrate and Lipid Metabolism Defects: Conditions affecting carbohydrate and lipid metabolism should be considered.
• Unscheduled Bleeding and Spotting: If you experience unscheduled bleeding or spotting while taking the medication, it should be discussed with your healthcare provider.

Storage Conditions

Store in a cool and dry place, protected from light. Do not use this medicine after the expiry date. Keep this medicine out of reach of children