Rosadan

No information provided.

Rosadan is part of the drug classes:

• Antiinfectives and antiseptics for local oral treatment

• Other chemotherapeutics

Serious side effects have been reported with oral, topical, and injectable forms of metronidazole including the following:

• Rash
• Itching
• Stuffy nose
• Fever
• Joint pain

Metronidazole can cause dizziness. Do not drive or operate heavy machinery until you know how metronidazole affects you.

Do not drink alcohol during therapy or after therapy with metronidazole.  If you drink alcohol, you can experience stomach cramps, severe nausea and vomiting, headaches, and flushing.

Do not take metronidazole if you:

• are allergic to metronidazole or to any of its ingredients
• have trichomaniasis and are in the first trimester of pregnancy
• have taken disulfuram (Antabuse) within the last 2 weeks

Take or use metronidazole exactly as prescribed. Do not drink alcohol while taking or using any form of metronidazole. Alcohol can cause upset stomach, vomiting, stomach cramps, headaches, sweating, and flushing when used at the same time as metronidazole.

Oral forms:

Metronidazole comes in tablet and capsule forms and is taken two or three times a day. Take metronidazole with food to minimize stomach upset.  Do not chew, divide, or break extended release metronidazole tablets. Swallow metronidazole tablets whole.

Topical forms:

Metronidazole comes in gel, cream, and lotion forms and is applied to the skin one or two times a day. The affected skin should be washed with mild soap 15-20 minutes before applying metronidazole. The gel, cream, or lotion should be applied in a thin layer and gently rubbed into the skin. Moisturizers and cosmetics may be applied once the gel, cream, or lotion has dried.

Topical metronidazole may increase sensitivity to sunlight. Avoid unnecessary or prolonged exposure to sunlight. Wear protective clothing, sunscreen, and sunglasses.

Injectable forms:

Metronidazole is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of metronidazole at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

Oral forms:

The recommended dose of metronidazole for the treatment of trichomoniasis is 375 mg two times a day.

The recommended dose of metronidazole for the treatment of amebiasis in adults is 750 mg three times a day.

Topical forms:

The recommended dose of metronidazole for the treatment of rosacea is two applications daily, usually in the morning and evening.

Injectable forms:

The recommended dose range of metronidazole for the treatment of amebiasis in children is 35 to 50 mg/kg every day, divided into three doses.

The recommended dose of metronidazole for the treatment of anaerobic bacterial infections is 7.5 mg/kg every 6 hours. A maximum of 4 grams should not be exceeded within a 24-hour period.

• Store metronidazole at room temperature, away from excess heat and moisture.
• Keep this and all medicines out of the reach of children.
• Protect topical forms of metronidazole from exposure to light.

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided.

Metronidazole is an antibiotic that fights bacteria in the body.

Metronidazole topical (for the skin) is used to treat skin lesions caused by rosacea.

Metronidazole topical may also be used for purposes not listed in this medication guide.

Applies to metronidazole topical: topical cream, topical emulsion, topical gel/jelly, topical lotion

Other dosage forms:

• vaginal cream, vaginal gel/jelly, vaginal suppository

Along with its needed effects, metronidazole topical (the active ingredient contained in Rosadan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of metronidazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry skin
• redness or other signs of skin irritation not present before use of this medicine
• stinging or burning of the skin
• watering of eyes

• Metallic taste in the mouth
• nausea
• tingling or numbness of arms, legs, hands, or feet

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

General

Topical: The most frequently reported side effects were nasopharyngitis, upper respiratory tract infection, and headache.

Vaginal: The most frequently reported side effects were fungal infection, vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, metrorrhagia, breast pain, infection, rash, pharyngitis, abdominal pain, pruritus, and dysmenorrhea.[Ref]

Local

Very common (10% or more): Mild dryness (17.1%), mild scaling (16.2%)
Common (1% to 10%): Moderate dryness, moderate scaling, mild pruritus, moderate pruritus, severe pruritus, mild stinging/burning, moderate stinging/burning, severe stinging/burning, local allergic reaction
Uncommon (0.1% to 1%): Severe dryness, severe scaling
Frequency not reported: Application site reaction, condition aggravated, transient redness[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, breast pain, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge
Uncommon (0.1% to 1%): Vaginal mycosis, urine discolored, vulva edema, menstrual discomfort/irregularities, vaginal spotting/bleeding
Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, leucorrhoea, menorrhagia, salpingitis, urinary frequency, vaginitis, vulvovaginal disorder[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth, abdominal bloating/noise
Frequency not reported: Dyspepsia, flatulence, gingivitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Tingling/numb extremities, taste metallic, dysgeusia, paresthesia, hypothesia
Frequency not reported: Peripheral neuropathy, ataxia
Postmarketing reports: Taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, nasal congestion
Frequency not reported: Asthma, rhinitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort, burning/stinging, erythema, worsening of rosacea, skin irritation
Frequency not reported: Acne, sweating, urticaria, skin exfoliation, facial edema, zoster lesion, nose pustule, vesicular bullous eruption
Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis[Ref]

Other

Very common (10% or more): Fungal infection (12%), flu syndrome (up to 11%)
Common (1% to 10%): Infection, influenza, abscess, pain
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Mucous membrane disorder[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, difficult sleep, irritability
Frequency not reported: Insomnia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, cramp[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma
Frequency not reported: Skin cancer[Ref]

Ocular

Frequency not reported: Eye irritation, watery eye
Postmarketing reports: Eyelid edema[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Appetite decreased
Frequency not reported: Anorexia, hypomagnesemia[Ref]

Renal

Frequency not reported: Pyelonephritis[Ref]

Some side effects of Rosadan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.