INTRODUCTION

PREMARIN VAGINAL contains Conjugated estrogens which belongs to the group of medicines called Hormone Replacement Therapy. It is used to manage vaginal itching, inflammation, dryness, and vaginal thinning caused due to estrogen deficiency (atrophic vaginitis). It can also be used to manage itching and inflammation of vulva and other parts of the genital area such as labia minora, clitoris and vaginal orifice (kraurosis vulvae). It also helps in manageing moderate to severe dyspareunia (genital pain during sexual intercourse) that occurs due to menopause.

Conjugated estrogen is a synthetic derivative of a female sex hormones called estrogen. It supplements our body with sufficient levels of estrogens during estrogen deficiency states. As a result, it prevents the vaginal walls and the genital area from becoming dry, thin, inflamed, or itchy and reduces genital pain.

During management with PREMARIN VAGINAL, your doctor will instruct you to have periodic blood tests and regular physical examination (breast examination) to avoid the risk of unwanted side effects.

Do not use PREMARIN VAGINAL if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding, heart problems or blood clots. Before using PREMARIN VAGINAL inform your doctor if you have any liver or kidney problems, diabetes, migraine headache, asthma, or epilepsy.

PREMARIN VAGINAL should not be used in pregnant or breastfeeding women and in children aged below 18 years. The most common side effects of applying PREMARIN VAGINAL are stomach pain, back pain, breast pain or tenderness, headache, vaginal infection, or vaginal discharge. Consult your doctor if any of these side effect worsens.

Also, inform your doctor if you experience any changes in your breast such as breast pain, tenderness, discharge from the nipple, or lump growth in the breasts, heavy menstrual bleeding, pain, swelling, redness of the legs, sudden chest pain or difficulty in breathing after using PREMARIN VAGINAL.

USES OF PREMARIN VAGINAL

It is used to manage:

• Atrophic vaginitis (vaginal itching, inflammation, dryness, and vaginal thinning)
• Kraurosis vulvae (itching and inflammation of the vulva and other parts of genital area)
• Moderate to severe dyspareunia (genital pain during sexual intercourse)

HOW PREMARIN VAGINAL WORKS

PREMARIN VAGINAL supplements our body with sufficient levels of a female sex hormone called estrogen. This helps in manageing problems associated with estrogen deficiency states. As a result, it prevents the vaginal walls and the genital area from becoming dry, thin, inflamed, or itchy and reduces genital pain.

DIRECTIONS FOR USE

Apply PREMARIN VAGINAL as directed by your physician. It should be used only in and around the vagina or the genital area. PREMARIN VAGINAL comes in a tube along with an applicator. Remove the cap from the tube and connect the nozzle end of the applicator with the tube.

Gently squeeze the sufficient medicine from the tube into the applicator. The marking present in the applicator may help you to measure the correct dosage as instructed by your doctor.

Remove the applicator from the tube and lie down on your back or in any comfortable position that allows deep penetration into the genital area. Gently insert the applicator into the vagina.  Press the plunger present in the applicator downwards to release the medicine in the vagina.

Remove the applicator from the vagina after application. To cleanse the applicator, pull the plunger outside and wash it with mild soap and warm water.

If you want to apply PREMARIN VAGINAL to the external parts of vagina, take the required quantity of PREMARIN VAGINAL and apply it at the required sites of the genital area (such as vulva, labia minora, clitoris and vaginal orifice).

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.

SIDE EFFECTS OF PREMARIN VAGINAL

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before applying PREMARIN VAGINAL, inform your doctor, if you are taking any of the following:

• medicines used to manage epilepsy (Ex. phenobarbital, phenytoin, carbamazepine)
• medicines used to manage tuberculosis (Ex. rifampicin, rifabutin)
• medicine used to manage HIV infection (Ex. nevirapine, efavirenz, ritonavir and nelfinavir)
• medicines used to manage bacterial infections (Ex. erythromycin, clarithromycin)
• medicines used to manage fungal infections (Ex. ketoconazole, itraconazole)
• St. john’s wort (an herbal medication used to manage depression)

B. Drug-Food Interaction:

Avoid drinking grapefruit juice while using PREMARIN VAGINAL since it may alter effect of this medicine.

Overdosage:

If you or anyone else accidentally used PREMARIN VAGINAL excessively, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding.

SYNOPSIS

MORE INFORMATION

• Keep PREMARIN VAGINAL out of reach of children
• Store PREMARIN VAGINAL at room temperature

FAQs ABOUT PREMARIN VAGINAL

What PREMARIN VAGINAL is used for?

PREMARIN VAGINAL is used to manage vaginal itching, inflammation, dryness, and vaginal thinning caused due to estrogen deficiency (atrophic vaginitis). It can also be used to manage itching and inflammation of vulva and other parts of the genital area such as labia minora, clitoris and vaginal orifice (kraurosis vulvae). It also helps in manageing moderate to severe dyspareunia (genital pain during sexual intercourse) that occurs due to menopause.

Who should not use PREMARIN VAGINAL?

PREMARIN VAGINAL is not recommended for use in patients allergic to Conjugated estrogens. It is also not suitable for use in patients having unusual vaginal bleeding, breast or uterine cancer, blood clot in legs (deep venous thrombosis) or lungs (pulmonary embolism), bleeding disorder or heart problems. PREMARIN VAGINAL should not be used in pregnant or breastfeeding without consulting your doctor.

How to use PREMARIN VAGINAL?

Apply PREMARIN VAGINAL as directed by your physician. It should be used only in and around the vagina or the genital area. PREMARIN VAGINAL comes in a tube along with an applicator. Use the applicator for applying the medicine. Gently squeeze the sufficient medicine from the tube into the applicator. Lie down on your back or in any comfortable position. Gently insert the applicator into the vagina and press the plunger downwards to release the medicine in the vagina. Remove the applicator from the vagina after application. If you want to apply PREMARIN VAGINAL to the external parts of vagina, take the required quantity of PREMARIN VAGINAL and apply it at the required sites of the genital area.

What are the side effects of PREMARIN VAGINAL?

The most common side effects of applying PREMARIN VAGINAL are stomach pain, back pain, breast pain or tenderness, headache, vaginal infection, or vaginal discharge. Consult your doctor if any of these side effect worsens. Also, inform your doctor if you experience any changes in your breast such as breast pain, tenderness, discharge from the nipple, or lump growth in the breasts, heavy menstrual bleeding, pain, swelling, redness of the legs, sudden chest pain or difficulty in breathing after using PREMARIN VAGINAL.

Can PREMARIN VAGINAL cause cancer?

Yes. Research has that shown that prolonged use of PREMARIN VAGINAL may lead to breast cancer or uterine cancer. To avoid this, your doctor will constantly monitor your health condition through periodic blood tests and ultrasounds (breast examination). However, inform your doctor immediately if you experience any unusual symptoms such as severe breast pain or tenderness, purplish discoloration of breasts, discharge from nipples, pelvic pain or abnormal vaginal bleeding.

REFERENCES

1. KD. Tripathi. Estrogens, Progestins and Contraceptives. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 310.

2. Maitri Shah, Zalak Karena, Sangita V. Patel, Niyati Parmar, Pawan K. Singh, and Atul Sharma. Management of Vaginal Atrophy with Vaginal Estrogen Cream in Menopausal Indian Women. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. January 2017. [Accessed on 7th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5187400/

3. Pfizer Wyeth Pharmaceuticals Inc. U.S. Food & Drug Administration. [Revised in December 2015] [Accessed on 2nd June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020216s083lbl.pdf

4. Pfizer Wyeth Pharmaceuticals LLC. PREMARIN (conjugated estrogens) Vaginal Cream. [Revised in September 2018] [Accessed on 2nd June 2022] https://labeling.pfizer.com/showlabeling.aspx?id=132