Betamethasone valerate/gentamicin/Miconazole Side effects

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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

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The most frequent adverse event was burning/itching/ stinging at the application site; the incidence and severity of this event were as follows:

Incidence and severity of burning/itching/stinging

Product

Total incidence

Maximum severity

Mild

Moderate

Severe

Betamethasone valerate, 0.12%

n=63

34 (54%)

28 (44%)

5 (8%)

1 (2%)

Betamethasone

Valerate Lotion

n=63

33 (52%)

26 (41%)

6 (10%)

1 (2%)

Placebo Foam

n=32

24 (75%)

13 (41%)

7 (22%)

4 (12%)

Placebo Lotion

n=30

20 (67%)

12 (40%)

5 (17%)

3 (10%)

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 contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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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:

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

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

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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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:

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:

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

Gentamicin contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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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:

Less serious Miconazole side effects may include:

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

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

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

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.

Table 1 Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial

Adverse Reaction

(MedDRA v 9.1 System Organ Class and Preferred Term)

Miconazole

N = 290 (%)

Clotrimazole

troches

N = 287 (%)

Patients with any adverse reaction during the study

158 (54.5)

146 (50.9)

Gastrointestinal disorders

25.9

23.7

Diarrhea

9.0

8.0

Nausea

6.6

7.7

Vomiting

3.8

3.1

Dry mouth

2.8

1.7

Abdominal pain upper

1.7

2.8

Infections and infestations

15.9

17.1

Upper respiratory infection

2.1

2.4

Gastroenteritis

1.4

2.8

Nervous system disorders

13.1

8.4

Headache

7.6

6.6

Ageusia

2.4

0.3

Blood and lymphatic disorders

6.9

8.4

Anemia

2.8

1.7

Lymphopenia

1.7

2.1

Neutropenia

0.7

2.1

General disorders and administration site conditions

6.6

8.0

Fatigue

2.8

2.1

Pain

1.0

2.8

Respiratory/thoracic

5.2

7.7

Cough

2.8

1.7

Pharyngeal pain

0.7

2.4

Investigations

5.5

6.3

Increased GGT

1.0

2.8

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.

Table 2: Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of Patients with Head and Neck Cancer who had Received Radiation Therapy (Controlled Clinical Trial)
Adverse Reaction

(MedDRA v 9.1 System Organ Class and Preferred Term)

Miconazole

N = 147 (%)

Miconazole gel

N = 147 (%)

Patients with at least one adverse reaction 30 (20.4) 32 (21.8)
Gastrointestinal disorders 8.8 13.6
Abdominal pain, upper 2.7 2.0

Oral discomfort

1.4 2.7
Nausea 0.7 2.7
Vomiting 0.7 2.0
Glossodynia 0 2.0
Nervous system disorders 5.4 1.4
Dysgeusia 4.1 0
Skin and subcutaneous 3.4 0.7
Pruritus 2.0 0.7

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.

Table 3 Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received Miconazole in Clinical Trials
Adverse reaction

(MedDRA v 9.1 System Organ Class and Preferred Term)

Miconazole

N = 480 (%)

Patients with at least one AE 209 (43.5)
Gastrointestinal disorders 20.6
Diarrhea 6.0
Nausea 4.6
Abdominal pain upper 2.5
Vomiting 2.5
Infections and infestations 11.9
Nervous system disorders 10.6
Headache 5.0
Dysgeusia 2.9

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 contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

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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The results of a survey conducted on ndrugs.com for Betamethasone valerate/gentamicin/Miconazole are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Betamethasone valerate/gentamicin/Miconazole. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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