Glenmark Pharmaceuticals on Friday said its US-based unit has received approval from the US health regulator to market Metronidazole Vaginal gel, in the American market.
The drug firm has received final approval by the United States Food & Drug Administration (USFDA) for its product which is a generic version of Bausch Health US LLC’s MetroGel-Vaginal, the drug firm said in a statement.
According to IQVIA sales data for the 12-month period ending November 2021, the MetroGel-Vaginal Gel achieved annual sales of approximately around USD 60.4 million.
Glenmark’s current portfolio consists of 173 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the USFDA.
In addition to these internal filings, the drug firm continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, Glenmark noted.
Metronidazole Vaginal gel
What is this medicine?
METRONIDAZOLE (me troe NI da zole) VAGINAL GEL is an antiinfective. It is used to treat bacterial vaginitis.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
COMMON BRAND NAME(S): MetroGel, MetroGel Vaginal, MetroGel-Vaginal, NUVESSA, Vandazole
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
- Cockayne syndrome
- history of blood diseases, like sickle cell disease or leukemia
- history of yeast infection
- if you often drink alcohol
- liver disease
- an unusual or allergic reaction to metronidazole, nitroimidazoles, parabens, or other medicines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
How should I use this medicine?
This medicine is only for use in the vagina. Do not take by mouth or apply to other areas of the body. Follow the directions on the prescription label. Wash hands before and after use. Screw the applicator to the tube and squeeze the tube gently to fill the applicator. Lie on your back, part and bend your knees. Insert the applicator tip high in the vagina and push the plunger to release the gel into the vagina. Gently remove the applicator. Wash the applicator well with warm water and soap. Use at regular intervals. Finish the full course prescribed by your doctor or health care professional even if you think your condition is better. Do not stop using except on the advice of your doctor or health care professional.
Talk to your pediatrician regarding the use of this medicine in children. While this drug maybe prescribed for children as young as 12 years for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
- alcohol or any product that contains alcohol
This medicine may also interact with the following medications:
- birth control pills
- other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your symptoms do not improve or if they get worse.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain alcohol. Metronidazole can cause an unpleasant reaction when taken with alcohol. The reaction includes flushing, headache, nausea, vomiting, sweating, and increased thirst. The reaction can last from 30 minutes to several hours.
If you are being treated for a sexually transmitted disease, avoid sexual contact until you have finished your treatment. Your sexual partner may also need treatment.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
- allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
- fast, irregular heartbeat
- fever, chills, sore throat
- fever with rash, swollen lymph nodes, or swelling of the face
- pain, tingling, numbness in the hands or feet
- redness, blistering, peeling or loosening of the skin, including inside the mouth
- sign and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
- vaginal discharge, itching, or odor in women
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
- changes in taste
- nausea, vomiting
- stomach pain
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.