Nuvessa gel

A nitroimidazole used to treat amebiasis; vaginitis; trichomonas infections; giardiasis; anaerobic bacteria; and treponemal infections. It has also been proposed as a radiation sensitizer for hypoxic cells. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985, p133), this substance may reasonably be anticipated to be a carcinogen (Merck, 11th ed).

Nuvessa gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a &ldqou;fishy&rdqou; amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.

Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.

Metronidazole is an antibiotic that fights bacteria in the body.

Nuvessa gel (for the skin) is used to treat skin lesions caused by rosacea.

Nuvessa gel may also be used for other purposes not listed in this medication guide.

Usual Adult Dose for Acne Rosacea

Nuvessa gel 1% gel or cream: Apply a thin film to the affected area once a day.

Nuvessa gel 0.75% gel, cream, or lotion: Apply a thin film to the affected area twice a day.

Usual Adult Dose for Bacterial Vaginosis

Insert one applicatorful of Nuvessa gel 0.75% vaginal gel intravaginally once (at bedtime) or twice a day for 5 consecutive days.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Gel, cream, lotion: Data not available

Vaginal gel: The manufacturer recommends caution when administering this drug to patients with severe hepatic disease.

Dose Adjustments

The duration of topical therapy is 4 to 10 weeks depending on the nature and severity of the condition.

Precautions

Patients should be advised to use Nuvessa gel less frequently or discontinue use if a reaction suggesting local irritation occurs.

Convulsive seizures and peripheral neuropathy have been reported in patients receiving oral or IV metronidazole. If abnormal neurologic signs appear, Nuvessa gel vaginal gel should be discontinued at once. The use of Nuvessa gel 1% gel should be reevaluated at once if abnormal neurologic signs appear. Nuvessa gel should be used with caution in patients with central nervous system diseases.

Nuvessa gel should be used with caution in patients with evidence of, or history of blood dyscrasia.

Although disulfiram-like reactions have not been reported in patients receiving vaginal metronidazole, the manufacturer recommends that alcohol be avoided. Nuvessa gel vaginal gel should not be used in patients who have taken disulfiram within the last 2 weeks.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Nuvessa gel may cause eye irritation if applied too close to the eyes. Contact with the eyes should be avoided.

Topical areas to be treated should be washed with a mild cleanser prior to application.

The manufacturer recommends avoidance of vaginal intercourse during treatment with Nuvessa gel vaginal gel.

See also:
What is the most important information I should know about Nuvessa gel?

Do not use Nuvessa gel if you have ever had an allergic reaction to it.

Before using Nuvessa gel, tell your doctor if you are allergic to any drugs, or if you have a blood cell disorder such as anemia or decreased white blood cells.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

Nuvessa gel is for use only on the skin. Avoid getting this medication in your eyes. If this does happen, rinse thoroughly with cool water. Do not use topical metronidazole in the vagina.

Call your doctor if you have severe stinging or burning when you apply Nuvessa gel.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before any infection is completely treated. Do not use Nuvessa gel to treat any other skin infection your doctor has not prescribed it for.

Use Nuvessa gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Nuvessa gel. Talk to your pharmacist if you have questions about this information.
• If you are using Nuvessa gel once daily, use it at bedtime.
• Remove the cap from the tube and break the metal seal on the tube with the pointed tip of the cap. Screw the end of the applicator onto the tube. Slowly squeeze gel out of the tube and into the applicator. The plunger will stop when the applicator is full. Unscrew applicator and replace the cap on the tube.
• You may insert Nuvessa gel lying on your back with your knees bent or in any comfortable position. Hold the filled applicator by the barrel, and gently insert into the vagina as far as it will comfortably go. Slowly press the plunger until it stops, and then remove the applicator.
• If you will be using Nuvessa gel twice daily, you will need to clean the applicator after your first dose of the day and use it again for your second dose. To clean the applicator, pull the plunger out of the barrel. Wash both the plunger and barrel in warm, soapy water and rinse well. To put the applicator back together, gently push the plunger back into the barrel.
• Wash your hands immediately after using Nuvessa gel.
• When you throw the applicator away, be sure that it is out of the reach of children and pets.
• Using Nuvessa gel at the same time each day will help you remember to use it.
• To clear up your infection completely, use Nuvessa gel for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Nuvessa gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nuvessa gel.

Nuvessa gel is used to treat rosacea (enlarged facial blood vessels that cause papules, pustules, and swelling). It is also used to treat bacterial infections of the vagina.

See also:
What other drugs will affect Nuvessa gel?

The intravaginal administration of a single 5 gram dose of Nuvessa gel results in relatively lower mean systemic exposure to metronidazole that is approximately 2% to 5% of that achieved following a 500 mg oral dose of metronidazole. The following drug interactions were reported for oral metronidazole.

Disulfiram

Use of oral metronidazole has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. Nuvessa gel (metronidazole vaginal gel) should not be used by patients who have taken disulfiram within the last two weeks.

Alcoholic Beverages

Use of oral metronidazole has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least three days after Nuvessa gel therapy.

Coumarin and Other

Oral Anticoagulants

Use of oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Nuvessa gel (metronidazole vaginal gel) is prescribed for patients on this type of anticoagulant therapy. In patients on oral anticoagulants, consider monitoring prothrombin time, international normalized ratio (INR), and other coagulation parameters while on Nuvessa gel.

Lithium

Short-term use of oral metronidazole has been associated with elevation of serum lithium concentrations and, in a few cases signs of lithium toxicity, in patients stabilized on relatively high doses of lithium. Use Nuvessa gel (metronidazole vaginal gel) with caution in patients treated with lithium and consider monitoring lithium serum concentrations while on Nuvessa gel.

Cimetidine

Use of oral metronidazole with cimetidine may prolong the half-life and decrease plasma clearance of metronidazole. No dose adjustment of Nuvessa gel (metronidazole vaginal gel) is necessary.

See also:
What are the possible side effects of Nuvessa gel?

In a controlled clinical trial, safety data from 141 patients who used Nuvessa gel® (metronidazole lotion)

Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, Nuvessa gel® (metronidazole lotion)

Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, Nuvessa gel® (metronidazole lotion)

Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, Nuvessa gel® (metronidazole lotion)

Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), Nuvessa gel® (metronidazole lotion)

Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, Nuvessa gel® (metronidazole lotion)

Topical Lotion 4 (6%), lotion vehicle 0; dry skin, Nuvessa gel® (metronidazole lotion)

Topical Lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, Nuvessa gel® (metronidazole lotion)

Topical Lotion 1 (1%), lotion vehicle 7 (10%). The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.