Betamethasone valerate/gentamicin/Miconazole Side effects

• Side effects of Betamethasone valerate in details
• Betamethasone valerate contraindications
• Side effects of Gentamicin in details
• Gentamicin contraindications
• Side effects of Miconazole in details
• Miconazole contraindications
• Betamethasone valerate/gentamicin/Miconazole reviews

Consists of betamethasone valerate, gentamicin, Miconazole

What are the possible side effects of Betamethasone valerate?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry skin; mild, temporary stinging when applied.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Betamethasone valerate; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the.

Side effects of Betamethasone valerate in details

The most frequent adverse event was burning/itching/ stinging at the application site; the incidence and severity of this event were as follows:

Other adverse events which were considered to be possibly, probably, or definitely related to Betamethasone valerate, 0.12% occurred in one patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

What is the most important information I should know about Betamethasone valerate?

• Betamethasone valerate is for external use only. Avoid contact with the eyes. If you get Betamethasone valerate in your eyes, immediately flush with cool tap water.
• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.
• Do not use Betamethasone valerate for other skin conditions at a later time.
• Betamethasone valerate has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Check with your doctor before you have any vaccinations while you are using Betamethasone valerate.
• Betamethasone valerate is flammable. Do not store or use near a fire or other open flame, or while you are smoking.
• Dispose of empty containers as directed on the container or by your health care provider. Do not puncture or burn container even if it appears to be empty.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Betamethasone valerate.
• Betamethasone valerate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Betamethasone valerate while you are pregnant. It is not known if Betamethasone valerate is found in breast milk. If you are or will be breast-feeding while you use Betamethasone valerate, check with your doctor. Discuss any possible risks to your baby.

Betamethasone valerate contraindications

Hypersensitivity to betamethasone valerate or to any of the ingredients of Betamethasone valerate Cream/Betamethasone valerate RD Cream/Betamethasone valerate Scalp Application.

Betamethasone valerate is contraindicated in dermatoses in infants <1 year, including dermatitis.

Betamethasone valerate Cream/Betamethasone valerate RD Cream: Rosacea; acne vulgaris; perioral dermatitis; perianal and genital pruritus; pruritus without inflammation; primary cutaneous viral infections (eg, herpes simplex, chickenpox).

The use of Betamethasone valerate Cream/Betamethasone valerate RD Cream is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria.

Betamethasone valerate Scalp Application: Infections of the scalp.

What are the possible side effects of Gentamicin?

If you experience any of the following serious side effects, stop taking gentamicin and seek emergency medical attention:

• an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);

• little or no urine;

• decreased hearing or ringing in the ears;

• dizziness, clumsiness, or unsteadiness;

• numbness, skin tingling, muscle twitching, or seizures; or

• severe watery diarrhea and abdominal cramps.

Other, less serious side effects may be more likely to occur. Continue to take gentamicin and talk to your doctor if you experience

• increased thirst;

• loss of appetite;

• nausea or vomiting;

• a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Gentamicin in details

Applies to gentamicin: injection injectable, injection solution

In addition to its needed effects, some unwanted effects may be caused by gentamicin (the active ingredient contained in Gentamicin). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking gentamicin, check with your doctor or nurse immediately:

Incidence not known:

• Abdominal or stomach cramps or pain
• agitation
• back pain
• black, tarry stools
• blood in the urine
• blurred or double vision
• burning, numbness, tingling, or painful sensations
• change in frequency of urination or amount of urine
• chest pain
• chills
• coma
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• difficult or troubled breathing
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• eye pain
• fast heartbeat
• fever with or without chills
• hallucinations
• headache
• hearing loss
• hives
• hoarseness
• increased thirst
• irregular heartbeats
• irregular, fast or slow, or shallow breathing
• irritability
• itching
• joint pain
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain or weakness
• muscle spasms (tetany) or twitching
• nausea or vomiting
• nervousness
• numbness and tingling around the mouth, fingertips, or feet
• pale or blue lips, fingernails, or skin
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• right upper abdominal or stomach pain and fullness
• seizures
• sensation of spinning
• skin rash
• slow or fast heartbeat
• slow or irregular breathing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• sweating
• swelling of the feet or lower legs
• swollen glands
• tightness in the chest
• trembling
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight chest discomfort
• weight loss
• wheezing

Minor Side Effects

Some of the side effects that can occur with gentamicin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

• Blurred or loss of vision
• decreased appetite
• depression
• disturbed color perception
• hair loss or thinning of the hair
• halos around lights
• hives or welts
• increased salivation
• night blindness
• overbright appearance of lights
• pain at the injection site
• purple spots on the skin
• redness of the skin
• swelling or inflammation of the mouth
• tunnel vision
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

What is the most important information I should know about Gentamicin?

• Gentamicin only works against bacteria; it does not treat viral infections (eg, the common cold).
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Be sure to use Gentamicin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Gentamicin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
• Tell your doctor or dentist that you take Gentamicin before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including kidney function, may be performed while you use Gentamicin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Gentamicin with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney or hearing problems.
• PREGNANCY and BREAST-FEEDING: Gentamicin has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gentamicin while you are pregnant. Gentamicin is found in breast milk. Do not breast-feed while taking Gentamicin.

Gentamicin contraindications

Known hypersensitivity to Gentamicin or aminoglycosides and/or preserving agents (para group allergy); patients with preexisting vestibular and/or cochlear disease should be given aminoglycosides for life-threatening conditions only.

Administration of other ototoxic and/or nephrotoxic antibiotics together with or immediately after Gentamicin should be avoided.

Caution should be exercised in patients with reduced renal function to avoid drug cumulation. Caution is also indicated in patients with milder degrees of renal insufficiency, neuromuscular disease (eg, myasthenia gravis or Parkinson's disease) and at an advanced age. As Gentamicin contains sulfite, it must not be used in asthmatics hypersensitive to sulfite.

Use in pregnancy & lactation: During pregnancy, Gentamicin should only be given for life-threatening conditions or if other antibiotics are ruled out. As Gentamicin is known to be present in breast milk, breastfeeding should be suspended if Gentamicin is administered during lactation.

What are the possible side effects of Miconazole?

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

Call your doctor at once if you have a serious side effect such as:

• severe burning or pain in your mouth;

• new sores in your mouth or on your tongue;

• tooth problems;

• pain or swelling in your gums; or

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Less serious Miconazole side effects may include:

• decreased sense of taste;

• unusual or unpleasant taste;

• mild pain or discomfort in your mouth or tongue;

• cough, dry mouth;

• nausea, vomiting, diarrhea;

• headache; or

• tired feeling.

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.

Side effects of Miconazole in details

The following serious adverse drug reactions are discussed in detail in other sections of labeling:

• Hypersensitivity reactions

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The overall safety of Miconazole was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects.

HIV Infected Patients

Two trials were conducted in immunocompromised HIV infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 Miconazole, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used Miconazole once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are presented in Table 1.

Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches.

Head and Neck Cancer Patients

In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used Miconazole once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days. Adverse reactions occurring in ≥2% of patients in either arm are listed in Table 2.

Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application site discomfort or pain, were experienced by 14 (9.5%) patients who used Miconazole compared to 16 (10.9%) patients who used miconazole gel.

Overall Miconazole Safety Experience In Patients and Healthy Subjects

Adverse reactions reported in the overall safety database of 480 subjects who received miconazole buccal tablet is listed in Table 3.

Discontinuation of Miconazole due to adverse drug reactions occurred in 0.6% overall.

What is the most important information I should know about Miconazole?

• Miconazole is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Miconazole in your eyes, flush with a generous amount of cool water.
• It is important to use Miconazole for the full course of treatment. Failure to do so may decrease the effectiveness of Miconazole and increase the risk that the fungus will no longer be sensitive to Miconazole and will not be able to be treated by this or certain other antibiotics in the future.
• If your symptoms do not improve within 3 days, if they last more than 7 days, or if they become worse, stop using Miconazole and contact your health care provider at once. You may have a more serious illness.
• Do not use Miconazole for itching caused by other conditions.
• Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Miconazole. Change out of wet bathing suits or damp workout clothes as soon as possible.
• Continue using Miconazole even during your menstrual period. Do not use tampons while you are using Miconazole or until all of your symptoms go away. Use unscented pads or pantiliners.
• Do not have vaginal sexual intercourse while you are using Miconazole.
• Miconazole may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use these products for at least 1 day after treatment with Miconazole.
• Do not use tampons, douches, spermicides, or other vaginal products while using Miconazole.
• Overuse of topical products may worsen your condition.
• Do not use Miconazole in CHILDREN younger than 12 years of age unless advised to do so by your health care provider.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Miconazole, discuss with your doctor the benefits and risks of using Miconazole during pregnancy. It is unknown if Miconazole is excreted in breast milk. If you are or will be breast-feeding while you are using Miconazole, check with your doctor or pharmacist.

Miconazole contraindications

Patients with any kind of liver disease; hypersensitivity to any of the ingredients of Daktarin

Oral Gel.

The effects and/or side effects of many prescription medications, when taken with Daktarin

Oral Gel, can be increased. Hence, patients taking or about to take any other medications, must consult the doctor or pharmacist before starting Daktarin

Oral Gel therapy.

Use in infants: Daktarin

Oral Gel is contraindicated in infants <6 months because of the risk of choking.

References

1. DailyMed. "MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "GENTAMICIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. DailyMed. "BETAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology