Sinecatechins topical

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

You should not use sinecatechins if you are allergic to it.

To make sure sinecatechins is safe for you, tell your doctor if you have:

• a weak immune system (caused by disease or by using certain medicine); or

• an allergy to green tea.

FDA pregnancy category C. It is not known whether sinecatechins will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether sinecatechins passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice.

Sinecatechins is usually applied 3 times per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may perform a Pap smear or other medical tests to make sure sinecatechins is the right treatment for your condition.

Do not take this medicine by mouth. Sinecatechins topical is for use only on the skin. Do not use on open wounds.

Wash your hands before and after applying the ointment.

Apply only a small amount of ointment to each wart. Dab on the ointment, leaving a thin layer over each wart. Do not rub in completely.

Do not cover the warts with bandages, sanitary napkins, or other protective covering. Wear loose-fitting clothing over treated skin areas.

Do not wash off the ointment before applying your next dose. Reapply the ointment after you swim, bathe, or shower.

You should wash off the ointment before inserting a tampon into the vagina to avoid accidentally getting the medicine inside your vagina. Reapply the ointment after tampon insertion.

Men using the ointment on an uncircumcised penis should wash underneath the foreskin each day.

Keep using this medicine until your warts have completely cleared.

Do not use this medicine for longer than 16 weeks. Call your doctor if your warts do not clear up, or if they go away and then come back after treatment.

Sinecatechins topical ointment can stain light-colored clothing or bed sheets. Avoid getting the ointment on these surfaces. Wear dark-colored clothing to prevent unwanted staining.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

You may also store the ointment in the refrigerator. Do not freeze.

An overdose of sinecatechins topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash off the ointment with mild soap and water and call your doctor at once if you have:

• severe redness or swelling of treated skin;

• severe burning, itching, or pain; or

• painful sores or blisters where the ointment was applied.

Common side effects may include:

• mild redness or burning of treated skin; or

• mild pain, itching, or discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

Be sure to keep all medical appointments. HPV can increase the risk of cancer of the cervix. It is very important that women exposed to HPV have regular PAP tests to check for cancer.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store this product in the refrigerator or at room temperature at or below 77 degrees F (25 degrees C) away from moisture. Different brands of this medication may have differentstorage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Close the container tightly after each use. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Administration advice:
-For external use only; not for ophthalmic, oral, intravaginal, or intra-anal use.
-Wash hands before and after applications.
-Treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.
-Uncircumcised males treating warts under foreskin should retract foreskin and clean the area daily.

Storage requirements:
-Prior to dispensing, store in refrigerator at 2C to 8C (36F to 46F); after dispensing, store refrigerated or up to 25C (77F); do not freeze.

General:
-Clinical studies did not include a sufficient number of patients older than 65 years and it is therefore unknown if they respond differently.
-Safety and effectiveness in immunosuppressed patients have not been established.

Patient advice:
-This drug may weaken condoms and vaginal diaphragms; this combination should be avoided.
-Female patients using tampons should insert the tampon prior to ointment application; accidental application into the vagina while changing the tampon must be avoided.
-This drug may stain clothing and bedding.
-Avoid exposure of the genital and perianal area to sun/ultraviolet light.
-All sexual contact should be avoided while ointment is on skin, or ointment should be washed off prior to activities.

This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity or fetal harm. In the presence of maternal toxicity, subcutaneous doses of 12 and 36 mg/kg/day from gestational days 6 to 19 resulted in reduced fetal body weights and delays in skeletal ossification. A pre- and post-natal development study in rats using vaginal administration of 0.10 and 0.15 mL/rat/day resulted in increased mortality of the dams, associated with indications of parturition complications; an increased incidence of still births was also observed (0.15 mL/rat/day dose only). There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.