Drospi 4 mg (Tablet)

Indications

• Oral contraceptive for females

Pharmacology

• Suppresses ovulation
• Spironolactone analogue with anti-mineralocorticoid activity
• Absorption: Dose-proportional following single doses ranging from 1-10 mg
• Distribution: 95-97% bound to serum albumin
• Metabolism: Extensively metabolized after oral administration
• Excretion: Characterized by a terminal disposition phase half-life of approximately 30 hours

Dosage & Administration

• Swallowed once a day
• 28 consecutive days
• Take at same time daily
• Starting: Day 1 Start
• Switching: From another contraceptive method
• Refer to Patient Information for additional instructions

Interaction

• Substances decreasing systemic concentrations of hormonal contraceptives
• Substances increasing systemic concentrations of hormonal contraceptives
• Potential to increase serum potassium concentration

Contraindications

• Renal impairment
• Adrenal insufficiency
• Progestin sensitive cancers
• Liver tumors or hepatic impairment
• Undiagnosed abnormal uterine bleeding

Side Effects

• Hyperkalemia
• Bleeding irregularities and amenorrhea
• Clinical trial adverse reactions

Pregnancy & Lactation

• No increased risk of birth defects with inadvertent use during early pregnancy
• Discontinue if pregnancy occurs
• Negligible amounts excreted in breast milk

Precautions & Warnings

• Hyperkalemia potential
• Thromboembolic disorders
• Bone loss
• Liver disease
• Ectopic pregnancy alert
• Risk of hyperglycemia in patients with diabetes
• Bleeding irregularities and amenorrhea
• Depression observation

Overdose Effects

• No reports of serious deleterious effects
• Symptoms may include nausea, vomiting, and vaginal bleeding
• No antidotes; treatment is symptomatic support

Therapeutic Class

• Oral Contraceptive preparations

Storage Conditions

• Store below 30°C
• Dry place
• Keep away from light
• Keep out of the reach of children

Related Brands