Indication

Combined hormonal oral contraceptives are used to prevent pregnancy and, when clinically appropriate, to help regulate menstrual cycles, provide mood support, and manage symptoms associated with excess androgens. They do not protect against HIV or other sexually transmitted infections.

Boxed Warning

Cigarette Smoking and Serious Cardiovascular Events. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35, and with the number of cigarettes smoked. Women over 35 who smoke should not use COCs.

Contraindications

• CHigh risk of arterial or venous thrombotic disease.
• Current or history of breast cancer or other estrogen-sensitive cancer.
• Liver tumors or liver disease.
• Undiagnosed abnormal uterine bleeding.
• Headaches with focal neurological symptoms or migraine with aura; uncontrolled hypertension; known or suspected pregnancy.

Warnings & Precautions

• Thromboembolic and other vascular problems.
• Liver disease.
• High blood pressure.
• Gallbladder disease.
• Carbohydrate and lipid metabolic effects.

Drug Interactions

Some medications can reduce contraceptive effectiveness or alter hormone levels, including certain anticonvulsants, rifampin, some HIV medications, and St. John's wort. Tell your provider all medications and supplements you take, and ask whether a backup method is needed.

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Use in Specific Populations

• Pregnancy: discontinue if pregnancy occurs; not for use in pregnancy.
• Breastfeeding: may reduce milk production, particularly early postpartum; discuss alternatives.
• Use with caution in older reproductive-age patients with cardiovascular risk factors.

Common Side Effects

Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet, weight changes, and irregular vaginal bleeding (spotting) between periods.

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Storage & Missed Dose

Take one tablet at the same time each day. A missed or late dose increases pregnancy risk follow the missed-dose instructions in your package insert and use a backup method as directed. Store at room temperature.

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Read the Medication Guide and Patient Information provided with your prescription before you start taking this medication and each time you get a refill.
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You are encouraged to report negative side effects of prescription products to the FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Important Safety Information — Metformin

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Indication

Metformin is used along with diet and exercise to improve blood sugar control in adults and certain children with type 2 diabetes. Your Allara-affiliated provider may also recommend metformin to support insulin resistance and metabolic health, including cycle regulation in conditions such as PCOS.

Boxed Warning

Lactic Acidosis. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.

Contraindications

• Severe renal impairment (eGFR below 30 mL/min/1.73 m²).
• Known hypersensitivity to metformin.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Warnings & Precautions

• Vitamin B12 deficiency.
• Hypoglycemia when used with insulin or insulin secretagogues.

Drug & Alcohol Interactions

• Use caution with carbonic anhydrase inhibitors, certain diuretics, and drugs that reduce kidney function or are cleared by the kidneys, as they can increase the risk of lactic acidosis.
• Temporarily stop metformin before procedures using iodinated contrast or major surgery, as directed by your provider.
• Excessive alcohol intake increases the risk of lactic acidosis and low blood sugar; limit alcohol while taking metformin.

Use in Specific Populations

• Pregnancy/breastfeeding: tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
• Renal/hepatic impairment: not recommended in significant kidney or liver disease. Use with caution in older adults, in whom kidney function declines.

Common Side Effects

Diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.

Storage & Missed Dose

Store at room temperature, away from moisture and heat. Take with food to reduce stomach upset. If you miss a dose, take it with food when you remember unless it is close to your next dose — do not double up. Do not stop or change your dose without talking to your provider.

Read your Medication Guide

Read the Patient Information provided with your prescription before you start taking this medication and each time you get a refill.

You are encouraged to report negative side effects of prescription products to the FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Important Safety Information — Spironolactone

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Indication

Spironolactone is a potassium-sparing diuretic and androgen-receptor blocker. Your Allara-affiliated provider may prescribe it to help manage the metabolic and physical symptoms of conditions such as PCOS, including symptoms of excess androgens, and — off-label — to manage hormonally driven (androgenic) acne and androgenetic hair thinning by blocking the effects of androgens.

Boxed Warning

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. Unnecessary use of this drug should be avoided.

Contraindications

• Hyperkalemia (high blood potassium).
• Addison's disease.
• Concomitant use of eplerenone.

Warnings & Precautions
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• Hyperkalemia, which can be serious; risk is higher with kidney impairment, diabetes, or use of other medications that raise potassium.
• Hypotension and worsening of renal function.
• Electrolyte and metabolic abnormalities.

Drug Interactions

The risk of high potassium increases when spironolactone is taken with ACE inhibitors, ARBs, other potassium-sparing diuretics, potassium supplements, NSAIDs, or salt substitutes that contain potassium. Tell your provider about all medications and supplements you take. Periodic monitoring of potassium and kidney function is recommended.

Use in Specific Populations

• Pregnancy: generally avoided due to anti-androgen effects on a developing fetus. Use effective contraception and tell your provider if you may become pregnant.
• Breastfeeding: discuss with your provider before use.
• Use with caution in renal impairment and in older adults.

Common Side Effects

Menstrual irregularities, breast tenderness, frequent urination, dizziness, and gastrointestinal disturbances.

Storage & Missed Dose

Store at room temperature. If you miss a dose, take it when you remember unless it is close to your next dose — do not double up. Avoid potassium-rich salt substitutes unless your provider approves. Do not stop or change your dose without talking to your provider.

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Read your Medication Guide

Read the Patient Information provided with your prescription before you start taking this medication and each time you get a refill.
You are encouraged to report negative side effects of prescription products to the FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.